tag:theconversation.com,2011:/es/topics/patents-5861/articlesPatents – The Conversation2024-02-14T13:24:03Ztag:theconversation.com,2011:article/2159982024-02-14T13:24:03Z2024-02-14T13:24:03ZDon’t let ‘FDA-approved’ or ‘patented’ in ads give you a false sense of security<figure><img src="https://images.theconversation.com/files/557351/original/file-20231102-29-y77wkb.jpg?ixlib=rb-1.1.0&rect=10%2C0%2C7156%2C4764&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Is that really a stamp of approval?</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/approved-concept-rubber-stamp-with-fda-and-pills-on-royalty-free-image/1186545957">iStock/Getty Images Plus</a></span></figcaption></figure><p>If you’ve ever reached for a bottle of moisturizer labeled “patented” or “FDA approved,” you might want to think twice. In a <a href="http://dx.doi.org/10.2139/ssrn.4366900">recent study</a> of hundreds of advertisements, I found that supplements and beauty products often misleadingly use these terms to suggest safety or efficacy.</p>
<p>As a <a href="https://law.indiana.edu/about/people/details/mattioli-michael.html">law professor</a>, I suspect this is confusing for consumers, maybe even dangerous. Having a patent means only that you can stop others from making, using, selling or importing your invention. It doesn’t mean the invention works or that it won’t blow up in your face.</p>
<p>“FDA approved,” meanwhile, means <a href="https://www.fda.gov/drugs/development-approval-process-drugs">a product’s benefits have been found to outweigh its risks</a> for a specific purpose – not that it’s of high quality or low risk in general.</p>
<h2>Led astray by the label</h2>
<p>I wanted to know whether companies exploit these sorts of misunderstandings, so I analyzed hundreds of ads from print, television and social media that mention patents or FDA approval. I found that advertisers throw these terms around in confusing ways. </p>
<p>For example, I found an ad for a probiotic supplement stating, “The proof is in the patent”; an ad for an earwax removal product stating its “patented formula is safe, effective, and clinically proven”; and an ad for a headache remedy that made the words “FDA approved” a bold visual focal point. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1312044681551917058"}"></div></p>
<p>Here’s the concerning part: I looked at all kinds of products and found that these terms appear most often in ads for things you eat or rub onto your skin, such as supplements, insecticides, toothpaste and lotions. </p>
<p>That’s probably no coincidence. Products like this aren’t tightly regulated, yet consumers want to know they’re safe. It seems likely that advertisers are name-dropping the government to make people think just that.</p>
<h2>Risks to consumers − and to innovation</h2>
<p>One danger is clear: Ads with vague references to government authorities could dupe consumers into thinking products are safer or more effective than they actually are. In fact, there’s some evidence <a href="https://doi.org/10.1001/archinternmed.2011.396">this is already happening</a>.</p>
<p>Another risk is that this creates perverse incentives for business. Companies could chose to forgo actual innovation, focusing instead on securing dubious patents or regulatory nods to <a href="https://www.voguebusiness.com/beauty/how-patents-became-the-beauty-industrys-secret-weapon">keep up in the advertising race</a>. </p>
<p>These practices could distort competition, burden government agencies with frivolous patent applications and deter new entrants from competing in markets where they can’t employ similar advertising tactics. </p>
<h2>Questions remain</h2>
<p>Even though my study has shed light on how often these tricky advertising methods are used, it leaves some big questions unanswered. What exactly makes consumers <a href="https://doi.org/10.1080/10810730.2016.1179367">respond so favorably</a> to terms like “patented” or “FDA approved”? And who is most likely to be confused by these tactics? </p>
<p>As a next step, I plan to conduct comprehensive surveys of consumers, along with in-depth interviews, to explore how these labels resonate emotionally. I hope to coordinate with researchers from psychology and media studies. Research along these lines could offer policymakers the robust evidence they need to make changes to the law.</p>
<p>What might those changes look like? For one thing, the law could make it easier for groups of consumers to sue in federal courts over misleading ads. The Federal Trade Commission could also place more of a burden on companies to prove their ads are honest. These changes could make a big difference in ensuring companies persuade shoppers without confusing them. </p>
<p>At a time when ads are everywhere and Americans are losing trust in institutions – and each other – the stakes for truthful product claims are high.</p><img src="https://counter.theconversation.com/content/215998/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael Mattioli does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Most people don’t know what these labels really mean − and advertisers take advantage of that fact.Michael Mattioli, Professor of Law and Louis F. Niezer Faculty Fellow, Indiana UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2167092023-12-14T13:16:36Z2023-12-14T13:16:36ZWhen authoritative sources hold onto bad data: A legal scholar explains the need for government databases to retract information<figure><img src="https://images.theconversation.com/files/564733/original/file-20231211-15-sxj8oy.jpg?ixlib=rb-1.1.0&rect=0%2C5%2C3888%2C2578&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Government information sources like the U.S. patent database often file bad information without labeling it or providing a way to retract it.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/junk-drawer-label-royalty-free-image/485963757">Thinglass/iStock via Getty Images</a></span></figcaption></figure><p>In 2004, Hwang Woo-suk was celebrated for his breakthrough discovery creating <a href="https://doi.org/10.1126/science.1094515">cloned human embryos</a>, and his work was published in the prestigious journal Science. But the discovery <a href="https://www.nytimes.com/2009/10/27/world/asia/27clone.html?unlocked_article_code=1.D00.aGQ6.J19oSJ1JE6oX&smid=url-share">was too good to be true</a>; Dr. Hwang had fabricated the data. Science publicly retracted the article and assembled a team to <a href="https://doi.org/10.1126/science.1137840">investigate what went wrong</a>.</p>
<p>Retractions are frequently in the news. The high-profile discovery of a room-temperature superconductor <a href="https://www.wsj.com/science/superconductor-paper-retracted-journal-nature-ranga-dias-c437ce6e">was retracted</a> on Nov. 7, 2023. A series of retractions <a href="https://www.washingtonpost.com/education/2023/07/19/stanford-university-marc-tessier-lavigne-research-controversy/">toppled the president</a> of Stanford University on July 19, 2023. Major early studies on COVID-19 were found to have <a href="https://doi.org/10.1126/science.abd1697">serious data problems</a> and retracted on June 4, 2020. </p>
<p>Retractions are generally framed as a negative: as science not working properly, as an embarrassment for the institutions involved, or as a flaw in the peer review process. They can be all those things. But they can also be part of a story of science working the right way: finding and correcting errors, and publicly acknowledging when information turns out to be incorrect.</p>
<p>A far more pernicious problem occurs when information is not, and cannot, be retracted. There are many apparently authoritative sources that contain flawed information. Sometimes the flawed information is deliberate, but sometimes it isn’t – after all, to err is human. Often, there is no correction or retraction mechanism, meaning that information known to be wrong remains on the books without any indication of its flaws. </p>
<p>As a <a href="https://scholar.google.com/citations?hl=en&user=SlW0VEkAAAAJ&view_op=list_works&sortby=pubdate">patent and intellectual property legal scholar</a>, I’ve found that this is a particularly harmful problem with government information, which is often considered a <a href="https://dx.doi.org/10.2139/ssrn.4372254">source of trustworthy data but is prone to error</a> and often lacking any means to retract the information.</p>
<h2>Patent fictions and fraud</h2>
<p>Consider patents, documents that contain many technical details that can be <a href="https://doi.org/10.1038/nbt.3864">useful to scientists</a>. There is <a href="https://doi.org/10.1162/rest_a_01353">no way to retract a patent</a>. And patents contain <a href="https://dx.doi.org/10.2139/ssrn.3538746">frequent errors</a>: Although patents are reviewed by an expert examiner before being granted, <a href="https://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=5848&context=flr">examiners do not check</a> whether the scientific data in the patent is correct.</p>
<p>In fact, the U.S. Patent and Trademark Office permits patentees to include <a href="https://doi.org/10.1126/science.aax0748">fictional experiments and data</a> in patents. This practice, called <a href="https://doi.org/10.1126/science.aax0748">prophetic examples</a>, is common; about <a href="https://dx.doi.org/10.2139/ssrn.3202493">25% of life sciences patents contain fictional experiments</a>. The patent office requires that prophetic examples be written in the present or future tense while real experiments can be written in the past tense. But this is confusing to nonspecialists, including scientists, who tend to assume that a phrase like “X and Y are mixed at 300 degrees to achieve a 95% yield rate” indicates a real experiment. </p>
<p>Almost a decade after Science retracted the journal article claiming cloned human cells, <a href="https://www.nytimes.com/2014/02/15/science/disgraced-scientist-granted-us-patent-for-work-found-to-be-fraudulent.html?searchResultPosition=1">Dr. Hwang received a U.S patent</a> on his retracted discovery. Unlike the journal article, this patent has not been retracted. The patent office did not investigate the accuracy of the data – indeed, it granted the patent long after the data’s inaccuracy had been publicly acknowledged – and there is no indication on the face of the patent that it contains information that has been retracted elsewhere. </p>
<p>This is no anomaly. In a similar example, Elizabeth Holmes, the former – now imprisoned – CEO of Theranos, <a href="https://doi.org/10.1162/rest_a_01353">holds patents</a> on her thoroughly discredited claims for a small device that could rapidly run many tests on a small blood sample. Some of those patents were granted long after Theranos’ fraud headlined major newspapers.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A document containing numbers and text" src="https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=773&fit=crop&dpr=1 600w, https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=773&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=773&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=972&fit=crop&dpr=1 754w, https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=972&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/564591/original/file-20231208-29-r2pqhk.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=972&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The U.S. Patent and Trademark Office granted a patent to Theranos on Dec. 18, 2018, three months after the company was dissolved following a series of investigations and lawsuits that detailed its fraud. The patent has not been rescinded and contains no notice of the faulty nature of the information it contains.</span>
<span class="attribution"><a class="source" href="https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/10156579">U.S. Patent and Trademark Office</a></span>
</figcaption>
</figure>
<h2>Long-lived bad information</h2>
<p>This sort of under-the-radar wrong data can be deeply misleading to readers. The system of retractions in scientific journals is not without its critics, but it compares favorably to the alternative of no retractions. Without retractions, readers don’t know when they are looking at incorrect information. </p>
<p>My colleague <a href="https://scholar.google.com/citations?hl=en&user=jYI7hFEAAAAJ&view_op=list_works&sortby=pubdate">Soomi Kim</a> and I conducted a study of patent-paper pairs. We looked at cases where the same information was published in a journal article and in a patent by the same scientists, and the journal paper had subsequently been retracted. We found that while citations to papers dropped steeply after the paper was retracted, there was <a href="https://doi.org/10.1162/rest_a_01353">no reduction in citations to patents</a> with the very same incorrect information. </p>
<p>This probably happened because scientific journals paint a big red “retracted” notice on retracted articles online, informing the reader that the information is wrong. By contrast, patents have no retraction mechanism, so incorrect information continues to spread.</p>
<p>There are many other instances where <a href="https://dx.doi.org/10.2139/ssrn.4372254">authoritative-looking information is known to be wrong</a>. The Environmental Protection Agency publishes emissions data supplied by companies but not reviewed by the agency. Similarly, the Food and Drug Administration disseminates official-looking information about drugs that is generated by drug manufacturers and posted without an evaluation by the FDA.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/3jYqgTKVQGE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Retractions play an important role in science.</span></figcaption>
</figure>
<h2>Consequences of nonretractions</h2>
<p>There are also economic consequences when incorrect information can’t be easily corrected. The Food and Drug Administration publishes <a href="https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book">a list of patents</a> that cover brand-name drugs. The FDA won’t approve a generic drug unless the generic manufacturer has shown that each patent that covers the drug in question is expired, not infringed or invalid.</p>
<p>The problem is that the list of patents is <a href="https://dx.doi.org/10.2139/ssrn.4372254">generated by the brand-name drug manufacturers</a>, who have an incentive to list patents that <a href="https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-challenges-more-100-patents-improperly-listed-fdas-orange-book">don’t actually cover their drugs</a>. Doing so increases the burden on generic drug manufacturers. The list is not checked by the FDA or anyone else, and there are few mechanisms for anyone other than the brand-name manufacturer to tell the FDA to remove a patent from the list. </p>
<p>Even when retractions are possible, they are effective only when readers pay attention to them. Financial data is sometimes retracted and corrected, but the revisions are not timely. “<a href="https://www.wsj.com/finance/investing/economic-data-lead-markets-and-governments-astray-abd79102">Markets don’t tend to react to revisions</a>,” Paul Donovan, chief economist of UBS Global Wealth Management, told the Wall Street Journal, referring to governments revising gross domestic product figures.</p>
<p>Misinformation is a growing problem. There are no easy answers to solve it. But there are steps that would almost certainly help. One relatively straightforward one is for trusted data sources like those from the government to follow the lead of scientific journals and create a mechanism to retract erroneous information.</p><img src="https://counter.theconversation.com/content/216709/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Janet Freilich does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Theranos was dissolved years ago, and its CEO, Elizabeth Holmes, is in prison, but the company’s patents based on bad science live on – a stark example of the persistence of faulty information.Janet Freilich, Associate Professor of Law, Fordham UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2115182023-08-20T20:04:20Z2023-08-20T20:04:20ZPatents were meant to reward inventions. It’s time to talk about how they might not<figure><img src="https://images.theconversation.com/files/543050/original/file-20230816-21-rb3fs6.png?ixlib=rb-1.1.0&rect=143%2C269%2C3850%2C1880&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>For hundreds of years, we’ve been told patents help deliver big new inventions, such as life-saving drugs.</p>
<p>They are meant to be a bargain between the inventor and the public: tell us how your invention works, and we’ll give you a fixed time – a patent protection period – in which you’re the only person who can make use of it. </p>
<p>Such exclusive rights make it easier for inventors to profit from their investments in research and development, and in theory encourage innovation we wouldn’t get otherwise, which benefits us all. </p>
<p>We’ve long had to accept this bargain on faith. But those core assumptions about patents are increasingly being subject to empirical testing, and – as we detail in a <a href="https://podcasters.spotify.com/pod/show/ip-provocations">new podcast</a> starting this week – often coming up short.</p>
<h2>Many claimed inventions likely don’t work</h2>
<p>Consider the most basic assumption – that the public will benefit from patented technologies - both as products and services and as building blocks for more innovation. That’s meant to be achieved by inventors coming up with inventions that work, then telling the patent office how they work. </p>
<p>But research by <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3538746">Janet Freilich</a> from Fordham University in the United States suggests there is a “replicability crisis” in patent claims that <a href="https://theconversation.com/how-big-data-has-created-a-big-crisis-in-science-102835">rivals those in other fields</a>.</p>
<p>Freilich graded the experiments said to back up 500 life sciences patents against the requirements of the journal <a href="https://www.nature.com/documents/nr-reporting-life-sciences-research.pdf">Nature</a> – and found as many as <a href="https://core.ac.uk/download/pdf/289227775.pdf">90%</a> didn’t stack up and probably couldn’t be reproduced.</p>
<p>She says</p>
<blockquote>
<p>patent law relies on the assumption that, when a patent is filed, it has been “reduced to practice” – meaning that the invention works. The reality is that most inventions likely do not work, casting serious doubt on this assumption.</p>
</blockquote>
<p>One of the reasons is the way the patent system works. </p>
<p>Under the ‘first-to-file’ system, when two inventors are developing similar technologies, the inventor who gets to the patent office first gets the patent. Freilich argues this means that any experiments they do conduct will inevitably be quick and preliminary. </p>
<p>Worse still, only 45% of the patents she examined were backed up by any sort of experiment. The remaining 55% were supported only by speculative and hypothetical evidence. This is allowed under patent law at least in some countries, but it does raise questions about what exactly the public gets out of the system.</p>
<h2>Research sometimes accelerates when patents expire</h2>
<p>We’re also told we grant patents to “incentivise” (encourage and reward) the kind of work needed to get expensive products, like new drugs, to market. </p>
<p>But again, this theory doesn’t always match the practice. </p>
<p>Research led by <a href="https://link.springer.com/article/10.1007/s40319-022-01241-3">John Liddicoat</a> of King’s College London finds that in the development of many drugs, the most expensive trials (Phase II and Phase III) actually accelerate once patent protection expires, when universities and hospitals feel free to step in. </p>
<p>This raises a number of serious questions:</p>
<ul>
<li><p>why aren’t patents providing an incentive for patent holders to do these trials? </p></li>
<li><p>should we shorten the length of patents to bring forward trials? </p></li>
<li><p>are commercial organisations best suited for trials?</p></li>
</ul>
<h2>An AI-driven flood of low-quality patents</h2>
<p>Artificial intelligence is set to make it easier to <a href="https://virginialawreview.org/articles/patents-new-salience/">find, and perhaps automatically enforce patents</a>, which could frighten away more genuine innovators.</p>
<p>Generative AI could also lead to more patents: in the words of the government agency <a href="https://www.ipaustralia.gov.au/news-and-community/news/2023/07/07/04/48/generative-ai-and-the-ip-system-what-does-it-all-mean">IP Australia</a>, it is likely to reduce “the barrier to creating novelty”. This could potentially overwhelm patent offices with even lower quality patents.</p>
<p>It is also likely to mean patent examiners can no longer rely on the default assumption that the claimed invention is solely the result of human exertion, raising the possibility of needing to rethink the patent bargain.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/if-machines-can-be-inventors-could-ai-soon-monopolise-technology-165604">If machines can be inventors, could AI soon monopolise technology?</a>
</strong>
</em>
</p>
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<h2>Invention matters more than ever</h2>
<p>More and more, new research and new developments are telling us we can no longer take the claims made for the patent system on faith. </p>
<p>Urgent challenges – including climate change, infectious diseases, political polarisation and artificial intelligence – all require cutting-edge science that can be put to work quickly and at scale to solve real-world problems. </p>
<p>That makes this an ideal time to talk about whether our patent system is best equipped for that task, exploring a range of options for finding and applying the innovations we need - and bringing in voices and perspectives that are too often marginalised in intellectual property debates. </p>
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<iframe src="https://podcasters.spotify.com/pod/show/ip-provocations/embed/episodes/Is-patent-law-writing-cheques-it-cant-cash-e28a24a/a-aa9ar2n" height="102px" width="100%" frameborder="0" scrolling="no"></iframe>
<p><em>These ideas are discussed in the first episode of IP Provocations, a new podcast asking challenging and sometimes controversial questions around IP and data. <a href="https://podcasters.spotify.com/pod/show/ip-provocations">You can listen here</a>, or via your favourite podcast platform.</em></p><img src="https://counter.theconversation.com/content/211518/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rebecca Giblin receives funding from the Australian Research Council and state and territory libraries for the Author's Interest Project (authorsinterest.org; FT170100011), the eLending Project (elendingproject.org; LP160100387) and Untapped: the Australian Literary Heritage Project (untapped.org.au). She is a Fellow of the CREATe research centre at the University of Glasgow, and a member of the Author's Alliance and the Australian Digital Alliance. Support for the podcast series referred to in this article has been provided by IP Australia, but note that IP Australia has no editorial control over the content of the podcast.</span></em></p><p class="fine-print"><em><span>Support for the podcast series referred to in this article has been provided by IP Australia, but note that IP Australia has no editorial control over the content of the podcast.</span></em></p><p class="fine-print"><em><span>Kimberlee Weatherall receives funding from the Australian Research Council, including as a Chief Investigator in the ARC Centre of Excellence on Automated Decision-Making and Society (ADM+S) (CE200100005). She is also involved in a number of research projects with external funding relating to artificial intelligence and automation. Her research is supported via funding and in-kind contributions by the NSW Ombudsman, the Gradient Institute and IAG. Support for the podcast series referred to in this article has been provided by IP Australia, but note that IP Australia has no editorial control over the content of the podcast. </span></em></p>From diseases to climate change, we need new solutions more than ever – yet patents may be slowing us down. For example, there is growing evidence new drug development speeds up once patents expire.Rebecca Giblin, ARC Future Fellow; Professor; Director, Intellectual Property Research Institute of Australia, The University of MelbourneAnders Furze, Research Assistant, Melbourne Law School, The University of MelbourneKimberlee Weatherall, Professor of Law, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2068482023-07-20T12:29:04Z2023-07-20T12:29:04ZBlame capitalism? Why hundreds of decades-old yet vital drugs are nearly impossible to find<figure><img src="https://images.theconversation.com/files/537557/original/file-20230714-29-wo8n77.jpg?ixlib=rb-1.1.0&rect=0%2C17%2C6000%2C3970&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There is presently no end in sight to the drug supply shortage. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-pharmacist-checking-the-shelves-with-a-royalty-free-image/1344251576?phrase=generic+drugs&adppopup=true">FG Trade/E+ via Getty Images</a></span></figcaption></figure><p><a href="https://www.npr.org/sections/health-shots/2019/12/31/792617538/a-decade-marked-by-outrage-over-drug-prices">Past public ire</a> over high drug prices has recently taken a back seat to a more insidious problem – <a href="https://pharmanewsintel.com/features/drug-shortages-a-growing-concern-for-the-healthcare-industry-worldwide">no drugs</a> <a href="https://www.nytimes.com/2023/05/17/health/drug-shortages-cancer.html">at any price</a>.</p>
<p>Patients and their providers increasingly face <a href="https://www.nytimes.com/2023/06/26/health/cancer-drugs-shortage.html">limited or nonexistent supplies of drugs</a>, many of which treat essential conditions such as cancer, heart disease and bacterial infections. The American Society of Health System Pharmacists now <a href="https://www.ashp.org/products-and-services/database-licensing-and-integration/ashp-drug-shortages">lists over 300 active shortages</a>, primarily of decades-old generic drugs no longer protected by patents.</p>
<p>While this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products <a href="https://www.hsgac.senate.gov/wp-content/uploads/2023-03-20-HSGAC-Majority-Draft-Drug-Shortages-Report.pdf">in short supply for over a decade</a>. Current shortages <a href="https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?">include widely known drugs</a> such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is critical for treating asthma and other diseases affecting the lungs and airways.</p>
<p>What’s going on?</p>
<p>I’m a <a href="https://scholar.google.com/citations?user=3jf-nyIAAAAJ&hl=en&oi=ao">health economist</a> who has studied the pharmaceutical industry for the past 15 years. I believe the drug shortage problem illustrates a major shortcoming of capitalism. While costly brand-name drugs often yield high profits to manufacturers, there’s relatively little money to be made in supplying the market with low-cost generics, no matter how vital they may be to patients’ health. </p>
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<figcaption><span class="caption">The shortage includes chemotherapy drugs, antibiotics, medications to treat ADHD and other critical drugs. Some patients are able to get their drugs, while others are not, and in some cases patients are getting ‘rationed care.’</span></figcaption>
</figure>
<h2>A generic problem</h2>
<p>The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate. Perhaps the clearest indication of this is the fact that <a href="https://www.rand.org/pubs/research_reports/RR2956.html">prices of brand drugs in the U.S. are among the highest</a> in the developed world, while generic drug prices are among the lowest. </p>
<p>When a drugmaker develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, and thus the effective patent life is closer to eight to 12 years. Nonetheless, patents allow the drugmakers to cover the cost of research and development and earn a profit without the threat of competition from a rival making an identical product.</p>
<p>But once the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are essentially producing the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost. This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply. </p>
<h2>Outsourced production creates more supply risks</h2>
<p>One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.</p>
<p>As of mid-2019, 72% of the manufacturing facilities making active ingredients for drugs sold in the U.S. <a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">were located overseas</a>, with India and China alone making up nearly half of that. </p>
<p>While overseas manufacturers often <a href="https://openknowledge.worldbank.org/server/api/core/bitstreams/3842481d-7bc7-532b-8cd2-ab30f57c6519/content">enjoy significant cost advantages</a> over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply. <a href="https://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=al">Foreign factories are more difficult</a> for the <a href="https://theconversation.com/the-fdas-lax-oversight-of-research-in-developing-countries-can-do-harm-to-vulnerable-participants-170515">Food and Drug Administration to inspect</a>, tend to have more production problems and are far more likely than domestic factories to be shut down once a problem is discovered. </p>
<p><a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">In testimony to a House subcommittee</a>, Janet Woodcock, the FDA’s principal deputy commissioner, acknowledged that the agency has little information on which Chinese facilities are producing raw ingredients, how much they are producing, or where the ingredients they are producing are being distributed worldwide. </p>
<p>The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.</p>
<p>India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About <a href="https://www.cidrap.umn.edu/sites/default/files/downloads/cidrap-covid19-viewpoint-part6.pdf">one-third of factories</a> in China shut down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medications, <a href="https://www.nytimes.com/2020/03/03/business/coronavirus-india-drugs.html">disrupting the global supply chain</a>. This led to shortages of drugs to treat COVID-19, such as for respiratory failure and sedation, as well as for a wide range of other conditions, <a href="https://www.uspharmacist.com/article/drug-shortages-amid-the-covid19-pandemic">like drugs to treat chemotherapy</a>, heart disease and bacterial infections. </p>
<h2>Low profits hurt quality</h2>
<p>Manufacturing drugs to consistently high quality standards requires constant testing and evaluation. </p>
<p>A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high. That’s often not the case for generic drug manufacturers, and <a href="https://www.statnews.com/2020/06/02/bring-manufacturing-generic-drugs-back-to-u-s/">this can result in shortages</a>. </p>
<p>In 2008, an adulterated version of the blood-thinning drug Heparin <a href="https://www.pharmaceutical-technology.com/features/generic-drug-safety-us-regulators-struggle-global-market">was recalled worldwide</a> after being linked to 350 adverse events and 150 deaths in the U.S. alone.</p>
<p>In 2013, the Department of Justice <a href="https://oig.hhs.gov/fraud/enforcement/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-to-pay-500-million-to-resolve-false-claims-allegations-cgmp-violations-and-false-statements-to-the-fda/#">fined the U.S. subsidiary of Ranbaxy Laboratories</a>, India’s largest generic drug manufacturer, US$500 million after it pleaded guilty to civil and criminal charges related to drug safety and falsifying safety data. In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the U.S., <a href="https://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html">including generic versions of gabapentin</a>, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.</p>
<p>And while there may be multiple companies selling the same generic drug in the U.S., there may be only a single manufacturer supplying the basic ingredients. Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.</p>
<p>A recent analysis found that approximately 40% of generic drugs sold in the U.S. <a href="https://ssrn.com/abstract=3011139">have just one manufacturer</a>, and the share of markets supplied by just one or two manufacturers has increased over time. </p>
<figure class="align-center ">
<img alt="A man in a suit points in front of a lectern that says $30 insulin, with fridges of insulin in the background." src="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">California Gov. Gavin Newsom partnered with Civica Rx to manufacture insulin for the state.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/CaliforniaGovernor/fb9c46b454aa451b87d3120061aa4fd2/photo?Query=insulin%20california&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=27&currentItemNo=6">AP Photo/Damian Dovarganes</a></span>
</figcaption>
</figure>
<h2>Repatriating the drug supply</h2>
<p>It is hard to quantify the impact of drug shortages on population health. However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages <a href="https://www.usp.org/sites/default/files/usp/document/supply-chain/pediatric-oncology-drugs-and-supply-chain.pdf">led to increased medication errors</a>, delayed administration of lifesaving therapies, inferior outcomes and patient deaths. </p>
<p>What can be done?</p>
<p>One option is to simply find ways to produce more generic drugs in the U.S.</p>
<p>California <a href="https://nashp.org/california-enacts-law-to-produce-generic-prescription-drugs/#">passed a law</a> in 2020 to do just that by allowing the state to contract with domestic manufactures to produce its own generic prescription drugs. In March 2023, California <a href="https://californiahealthline.org/news/article/california-generic-insulin-contract-civica-rx-newsom/">selected a Utah company</a> to begin producing low-cost insulin for California patients.</p>
<p>Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.</p><img src="https://counter.theconversation.com/content/206848/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Geoffrey Joyce does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The shortages, which have been going on for years, have typically affected only low-cost generics rather than profitable brand-name drugs.Geoffrey Joyce, Director of Health Policy, USC Schaeffer Center, and Associate Professor, University of Southern CaliforniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1993722023-02-22T12:55:04Z2023-02-22T12:55:04ZIn rural America, right-to-repair laws are the leading edge of a pushback against growing corporate power<figure><img src="https://images.theconversation.com/files/510919/original/file-20230217-18-bzd402.jpg?ixlib=rb-1.1.0&rect=140%2C101%2C5052%2C3355&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Waiting for repairs can cost farmers time and money.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/combine-harvester-moves-through-a-field-of-barley-grains-news-photo/1162778105">VW Pics/Universal Images Group via Getty Images</a></span></figcaption></figure><p>As tractors became more sophisticated over the past two decades, the big manufacturers allowed farmers fewer options for repairs. Rather than hiring independent repair shops, farmers have increasingly had to wait for company-authorized dealers to arrive. Getting repairs could take days, often leading to lost time and high costs.</p>
<p>A new <a href="https://www.fb.org/news-release/afbf-signs-right-to-repair-memorandum-of-understanding-with-john-deere">memorandum of understanding</a> between the country’s largest farm equipment maker, John Deere Corp., and the American Farm Bureau Federation is now raising hopes that U.S. farmers will finally regain the right to repair more of their own equipment. </p>
<p>However, supporters of right-to-repair laws suspect a more sinister purpose: <a href="https://www.npr.org/2023/01/10/1147934682/john-deere-right-to-repair-farmers-tractors">to slow the momentum</a> of efforts to secure right-to-repair laws around the country. </p>
<p>Under the agreement, John Deere promises to give farmers and independent repair shops access to manuals, diagnostics and parts. But there’s a catch – the agreement isn’t legally binding, and, as part of the deal, the influential Farm Bureau promised not to support any federal or state right-to-repair legislation.</p>
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<p>The right-to-repair movement has become the leading edge of a pushback against growing corporate power. Intellectual property protections, whether patents on farm equipment, crops, computers or cellphones, have become more intense in recent decades and cover more territory, giving companies more control over what farmers and other consumers can do with the products they buy. </p>
<p>For farmers, few examples of those corporate constraints are more frustrating than repair restrictions and patent rights that prevent them from saving seeds from their own crops for future planting.</p>
<h2>How a few companies became so powerful</h2>
<p>The United States’ market economy requires competition to function properly, which is why U.S. <a href="https://www.hbs.edu/faculty/Pages/item.aspx?num=56116">antitrust policies were strictly enforced</a> in the post-World War II era.</p>
<p>During the 1970s and 1980s, however, political leaders began following the advice of a <a href="https://www.antitrustlawsource.com/2021/06/1990s-to-the-present-the-chicago-school-and-antitrust-enforcement/">group of economists</a> at the University of Chicago and relaxed <a href="https://www.jstor.org/stable/j.ctv1fx4h9c">enforcement of federal antitrust policies</a>. That led to a concentration of economic power in many sectors.</p>
<p>This concentration has become especially pronounced in agriculture, with a few companies <a href="https://farmaction.us/concentrationreport/">consolidating market share</a> in numerous areas, including seeds, pesticides and machinery, as well as commodity processing and meatpacking. One study in 2014 estimated that Monsanto, now owned by Bayer, was responsible for approximately <a href="https://fortune.com/2014/06/26/monsanto-gmo-crops/">80% of the corn and 90% of the soybeans</a> grown in the U.S. In farm machinery, John Deere and Kubota account for about a third of the market.</p>
<figure class="align-center ">
<img alt="A tractor with several computer screens in the cab on the floor of a convention, with several people in the background." src="https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/510917/original/file-20230217-28-unn1iv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">New tractors are increasingly high-tech, with GPS, 360-degree camera and smartphone controls.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/inside-the-cab-of-the-deer-co-john-deere-8r-fully-news-photo/1237542314">Patrick T. Fallon/AFP via Getty Images</a></span>
</figcaption>
</figure>
<p>Market power often translates into political power, which means that those large companies can influence regulatory oversight, legal decisions, and legislation that furthers their economic interests – including securing more expansive and stricter intellectual property policies.</p>
<h2>The right-to-repair movement</h2>
<p>At its most basic level, right-to-repair legislation seeks to protect the end users of a product from anti-competitive activities by large companies. New York <a href="https://www.natlawreview.com/article/new-york-enacts-first-state-right-to-repair-law">passed the first broad right-to-repair law</a>, in 2022, and <a href="https://www.repair.org/stand-up">nearly two dozen states</a> have active legislation – about half of them <a href="https://apnews.com/article/agriculture-colorado-business-d5ea466725328d965a85a62130503d49">targeting farm equipment</a>.</p>
<p>Whether the product is an automobile, smartphone or seed, companies can extract more profits if they can force consumers to purchase the company’s replacement parts or use the company’s exclusive dealership to repair the product.</p>
<p><iframe id="yk0ep" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/yk0ep/7/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>One of the <a href="https://openscholarship.wustl.edu/cgi/viewcontent.cgi?article=4247&context=law_lawreview">first cases</a> that challenged the right to repair equipment was in 1939, when a company that was reselling refurbished spark plugs was sued by the Champion Spark Plug Co. for violating its patent rights. The <a href="https://www.lexisnexis.com/community/casebrief/p/casebrief-champion-spark-plug-co-v-sanders">Supreme Court agreed</a> that Champion’s trademark had been violated, but it allowed resale of the refurbished spark plugs if “used” or “repaired” was stamped on the product.</p>
<p>Although courts have often sided with the end users in right-to-repair cases, large companies have vast legal and lobbying resources to argue for stricter patent protections. Consumer <a href="https://pirg.org/california/media-center/california-right-repair-bill-dies-senate-committee/">advocates contend</a> that these protections prevent people from repairing and modifying the products they rightfully purchased.</p>
<p>The ostensible justification for patents, whether for equipment or seeds, is that they provide an incentive for companies to invest time and money in developing products because they know that they will have exclusive rights to sell their inventions once patented.</p>
<p>However, <a href="https://doi.org/10.7916/d8-xg80-ct59">some scholars claim</a> that recent legal and legislative changes to patents are instead limiting innovation and social benefits. </p>
<h2>The problem with seed patents</h2>
<p>The extension of utility patents to agricultural seeds illustrates how intellectual property policies have expanded and become more restrictive.</p>
<p>Patents have been around since the founding of the U.S., but agricultural crops were initially considered natural processes that couldn’t be patented. That changed in 1980 with the U.S. Supreme Court decision <a href="https://www.oyez.org/cases/1979/79-136">Diamond v. Chakrabarty</a>. The case involved genetically engineered bacteria that could break down crude oil. The court’s ruling allowed inventors to secure patents on living organisms.</p>
<p>Half a decade later, the U.S. Patent Office extended patents <a href="https://doi.org/10.3109/10731198909118281">to agricultural crops generated</a> through transgenic breeding techniques, which inserts a gene from one species into the genome of another. One prominent example is the insertion of a gene into corn and cotton that enables the plant to produce its own pesticide. In 2001, the Supreme Court <a href="https://www.oyez.org/cases/2001/99-1996">included conventionally bred crops</a> in the category eligible for patenting.</p>
<figure class="align-center ">
<img alt="Seeds grow in segmented compartments of petri dishes. The dishes have writing in marker on the top." src="https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=408&fit=crop&dpr=1 600w, https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=408&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=408&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=513&fit=crop&dpr=1 754w, https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=513&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/510918/original/file-20230217-364-qm2ktu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=513&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Genetically modified seeds, and even conventionally bred crops, can be patented.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/petri-dishes-containing-sprouting-embryos-of-an-news-photo/1314013422">Sean Gallup/Getty Images</a></span>
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<p>Historically, farmers would save seeds that their crops generated and replant them the following season. They could also sell those seeds to other farmers. They lost the right to sell their seeds in 1970, when Congress passed the <a href="https://www.ams.usda.gov/services/plant-variety-protection">Plant Variety Protection Act</a>. Utility patents, which grant an inventor exclusive right to produce a new or improved product, are even more restrictive.</p>
<p>Under a utility patent, farmers can no longer save seed for replanting on their own farms. University scientists even face <a href="https://doi.org/10.1002/9780470752555">restrictions on the kind of research</a> they can perform on patented crops.</p>
<p>Because of the clear changes in intellectual property protections on agricultural crops over the years, researchers are able to evaluate whether those changes correlate with crop innovations – the primary justification used for patents. The short answer is that they do not.</p>
<p>One study revealed that companies have used intellectual property to enhance their market power more than to enhance innovations. In fact, some vegetable crops with <a href="https://illinoislawreview.org/print/volume-2012-issue-4/veggie-tales-pernicious-myths-about-patents-innovation-and-crop-diversity-in-the-twentieth-century/">few patent protections had more varietal innovations</a> than crops with more patent protections.</p>
<h2>How much does this cost farmers?</h2>
<p>It can be <a href="https://nap.nationalacademies.org/catalog/23395/genetically-engineered-crops-experiences-and-prospects">difficult to estimate</a> how much patented crops cost farmers. For example, farmers might pay more for the seeds but save money on pesticides or labor, and they might have higher yields. If market prices for the crop are high one year, the farmer might come out ahead, but if prices are low, the farmer might lose money. Crop breeders, meanwhile, <a href="https://doi.org/10.1007/978-3-319-06892-3">envision substantial profits</a>.</p>
<p>Similarly, it is difficult to calculate the costs farmers face from not having a right to repair their machinery. A machine breakdown that takes weeks to repair during harvest time could be catastrophic.</p>
<p>The nonprofit U.S. Public Interest Research Group calculated that <a href="https://pirg.org/resources/repair-saves-families-big/">U.S. consumers could save</a> US$40 billion per year if they could repair electronics and appliances – about $330 per family.</p>
<p>The memorandum of understanding between John Deere and the Farm Bureau may be a step in the right direction, but it is not a substitute for right-to-repair legislation or the enforcement of antitrust policies.</p><img src="https://counter.theconversation.com/content/199372/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Leland Glenna does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Corporations restrict what farmers can do with their own seeds, as well as their farm equipment when it breaks down.Leland Glenna, Professor of Rural Sociology and Science, Technology, and Society, Penn StateLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1961942023-01-13T13:30:49Z2023-01-13T13:30:49ZBringing manufacturing back to the US requires political will, but success hinges on training American workers<figure><img src="https://images.theconversation.com/files/500565/original/file-20221212-1590-z6pe3e.jpg?ixlib=rb-1.1.0&rect=34%2C23%2C3805%2C2993&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Geopolitics is a significant consideration in the manufacture of computer chips. </span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/aQYgUYwnCsM">Michael Dziedzic for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>Supply chain <a href="https://www.sciencedirect.com/science/article/pii/S2212420922002023">disruptions</a> during COVID-19 brought to light how interdependent nations are when it comes to manufacturing. The inability of the U.S. to produce such needed goods as test kits and personal protective equipment during the pandemic revealed our <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/06/08/fact-sheet-biden-harris-administration-announces-supply-chain-disruptions-task-force-to-address-short-term-supply-chain-discontinuities/">vulnerabilities as a nation</a>.
<a href="https://www.rand.org/pubs/research_reports/RRA1378-1.html">China’s rise as a global production superpower</a> has further underscored the weaknesses of American manufacturing. </p>
<p>In addition to fixing supply chain disruptions, bringing manufacturing back to the U.S. will benefit national security. <a href="https://smallwarsjournal.com/jrnl/art/battle-worlds-most-advanced-microchips">Advanced computer chips</a>, for example, are disproportionately made by a single firm, the <a href="https://www.tsmc.com/english">Taiwan Semiconductor Manufacturing Co</a>. These microchips are critical to smartphones, medical devices and self-driving cars, as well as military technology. TSMC, from a <a href="https://www.reuters.com/breakingviews/tsmc-is-chinas-trump-card-against-us-taiwan-2022-08-05/">U.S. national security perspective</a>, is located too close to China. Taiwan’s proximity to China makes it vulnerable because the Chinese government <a href="https://www.voanews.com/a/china-reaffirms-threat-of-military-force-to-annex-taiwan-/6695555.html">threatens to use force</a> to unify Taiwan with the mainland. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Workers wearing blue clean suits in a manufacturing plant." src="https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/500583/original/file-20221213-304-clx9a3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Chip technology makes production more efficient, reducing the need for people and jobs.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/WNX6uk-1LV4">Glsun Mall for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<p><a href="https://people.rit.edu/aabgsh/">My research</a> and that <a href="https://hbr.org/2020/04/bringing-manufacturing-back-to-the-u-s-is-easier-said-than-done">of others</a> examines how the lack of manufacturing competitiveness in the U.S. leaves the U.S. vulnerable to shortages of critical goods during times of geopolitical disruption and global competition. The strategies the U.S. employs in bringing back manufacturing, along with innovative practices, will be key to ensure national security.</p>
<h2>Strengthening national security</h2>
<p>President Joe Biden has signed two bills that propose to rebuild American manufacturing. The <a href="https://www.vanhollen.senate.gov/imo/media/doc/CHIPS%20and%20Science%20Act%20of%202022%20Summary.pdf">CHIPS and Science Act of 2022</a> will provide <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/09/fact-sheet-chips-and-science-act-will-lower-costs-create-jobs-strengthen-supply-chains-and-counter-china/">US$52.7 billion</a> for American semiconductor research, development, manufacturing and workforce development.</p>
<p>The <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/15/by-the-numbers-the-inflation-reduction-act/">Inflation Reduction Act of 2022</a> will invest <a href="https://www.democrats.senate.gov/imo/media/doc/inflation_reduction_act_one_page_summary.pdf">$369 billion</a> to promote a clean energy economy, in part by offering generous incentives for U.S.-made electric cars.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A computer chip with a black square surrounded by metal dots and lines on a green board." src="https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/500795/original/file-20221213-22444-rbisur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Taiwan leads the world in computer chip manufacturing.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/-9jmFkN-_U4">alerkiv for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Training workers for new advanced manufacturing is another key factor in strengthening a sector that has become increasingly reliant on technology. In fact, while the number of jobs in American manufacturing fell by 25% after 2000, manufacturing <a href="https://www.pewresearch.org/fact-tank/2017/07/25/most-americans-unaware-that-as-u-s-manufacturing-jobs-have-disappeared-output-has-grown/">output did not decline</a>. Still, American manufacturing is <a href="https://www.industryweek.com/talent/education-training/article/21243760/manufacturings-back-is-to-the-wall-on-skilled-labor">facing a massive shortage of labor</a>, especially among those workers with <a href="https://theconversation.com/how-to-ensure-the-fourth-industrial-revolution-is-made-in-the-usa-81385">skills</a> needed to power a new generation of manufacturing.</p>
<p>This need to train a new group of skilled workers explains why federal funds in the <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/09/fact-sheet-chips-and-science-act-will-lower-costs-create-jobs-strengthen-supply-chains-and-counter-china/">CHIPS Act</a> are set aside for workforce development. Complementing federal legislation are programs such as <a href="https://www.americascuttingedge.org/">America’s Cutting Edge</a>, a national initiative that provides free online and in-person training designed to meet the growing need in the U.S. machining and machine tool industry for skilled operators, engineers and designers.</p>
<h2>The power of innovation</h2>
<p>It is impractical to bring all manufacturing back to the U.S. Offshoring is often less expensive. But research shows that certain types of in-country manufacturing can not only help secure national security but also spark innovation. </p>
<p>When research and development are conducted close to where the goods are physically made, this proximity <a href="https://doi.org/10.1016/j.techfore.2021.120575">can increase the likelihood</a> of collaboration between these two activities. Collaboration can lead to <a href="https://doi.org/10.1016/j.jom.2016.12.005">greater efficiencies</a>. </p>
<p>Product development can benefit as well. <a href="https://faculty.tuck.dartmouth.edu/images/uploads/faculty/teresa-fort/FKSYZ_colocation_dec20.pdf">New research</a> demonstrates that U.S. firms that located their manufacturing and R&D physically close to each other generated more <a href="https://www.wipo.int/patents/en/">patents</a> than firms that did not.</p>
<p>Even so, the contribution of U.S. manufacturing firms to innovation <a href="https://faculty.tuck.dartmouth.edu/images/uploads/faculty/teresa-fort/FKSYZ_colocation_dec20.pdf">declined greatly</a> between 1977 and 2016. That’s because the benefits of locating manufacturing and R&D close to each other depends on the nature of the manufacturing itself, <a href="https://www.hbs.edu/competitiveness/research/Pages/research-details.aspx?rid=39">researchers have found</a>.</p>
<p>For instance, the design of new drugs often requires manufacturing facilities to be located nearby. In that respect, <a href="https://www.pharmafocusasia.com/manufacturing/pharma-rd-manufacturing-excellence">co-locating manufacturing and research and development</a> makes sense. This can be true for semiconductors as well. World-class chip manufacturers in Taiwan, such as TSMC, are located alongside a <a href="https://on5g.es/en/taiwan-wants-to-design-more-advanced-chips-apart-from-manufacturing-them/">growing chip design industry</a>, which permits designers to prototype and test new ideas quickly. </p>
<p>The U.S. and other countries are betting on the same potential benefits from co-location. For instance, to minimize the dependence on TSMC and, more generally, on foreign sources for chips, the European Union is spending <a href="https://www.bloomberg.com/news/articles/2022-11-23/eu-nations-advance-43-billion-plan-to-become-semiconductor-hub?leadSource=uverify%20wall">43 billion euros</a>, while Japan is encouraging chip manufacturing at home with a <a href="https://www.bloomberg.com/news/newsletters/2022-01-04/japan-has-big-plans-for-chips">$6.8 billion</a> investment. </p>
<h2>People are the bottom line</h2>
<p>In a <a href="https://rbj.net/2011/04/29/are-calls-to-promote-manufacturing-justified/">2011 op-ed</a>, I argued that while federal legislation to promote U.S. manufacturing could succeed in bringing more manufacturing back to the U.S., there was no guarantee that large numbers of jobs would be created – a key point made by those seeking to promote manufacturing.</p>
<p>Governments are generally poor at picking <a href="https://www.cato.org/white-paper/questioning-industrial-policy">winning technologies and industries</a>. <a href="https://www.powermag.com/doe-sank-billions-of-fossil-energy-rd-dollars-in-ccs-projects-most-failed/">Governmental mistakes</a> in picking supposedly winning industries or sectors have, generally, led to a great deal of <a href="https://www.cato.org/blog/american-industrial-policy-action">waste</a> of taxpayer dollars. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Tiny figures stand on the open pages of a stamped passport." src="https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=511&fit=crop&dpr=1 600w, https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=511&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=511&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=643&fit=crop&dpr=1 754w, https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=643&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/500790/original/file-20221213-22657-576dx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=643&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Immigration policies designed to encourage highly skilled workers to come to the U.S. may be key to a stronger American manufacturing base.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/s/photos/passports">mana5280 for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>In fact, market forces and informed company decisions should, I believe, play a <a href="https://store.hbr.org/product/producing-prosperity-why-america-needs-a-manufacturing-renaissance/10345?sku=10345-HBK-ENG">larger role picking winners</a> than federal investment. Where that investment comes from, what it supports and how much money is needed are critical questions. </p>
<p>If firms choose to relocate their companies to benefit from the synergy of R&D, then they must be able to attract the best human resource talent available. This is where U.S. investment can help build a <a href="https://hbr.org/2012/03/does-america-really-need-manufacturing">more skilled workforce</a>.</p>
<p>As pointed out by the economist <a href="https://gpisano.com/book/creative-construction/">Gary Pisano</a>, many policymakers in the U.S. have long believed that manufacturing is an attractive sector for people with less education and training. Therefore, as a nation, we have not devoted <a href="https://hbr.org/2012/03/does-america-really-need-manufacturing">many resources</a> to train people with specialized skills in manufacturing. </p>
<p>This approach stands in stark contrast to the <a href="https://www.npr.org/2018/01/04/575114570/robust-apprenticeship-program-key-to-germanys-manufacturing-might">approach followed in Germany</a>. There, practical work is valued by employers and employees and hence apprenticeship programs are <a href="https://www.theatlantic.com/business/archive/2014/10/why-germany-is-so-much-better-at-training-its-workers/381550/">routinely used</a> to train workers who are well qualified to work in the manufacturing sector. While the U.S. approach is changing with recently announced investment by the White House through the CHIPS and the Inflation Reduction acts, more is needed. </p>
<p>It is my belief that if the U.S. is to remain an economic powerhouse, then corporations should not separate their workforce, sending cost-saving manufacturing offshore while retaining the innovators. Corporations like <a href="https://www.cfr.org/blog/why-manufacturing-really-matters-gary-pisano-and-willy-shih-innovation">Apple</a> have sent nearly all of their production offshore, retaining only the most skilled parts of the supply chain involving activities like R&D. </p>
<p>Instead, the U.S. needs to financially support firms wishing to bring manufacturing back by making it easier for such firms to find qualified manufacturing workers at home – and close to innovators when practical. This effort will bolster the U.S.’s ability to be self-sufficient, innovative and secure in times of geopolitical conflicts.</p><img src="https://counter.theconversation.com/content/196194/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Amitrajeet A. Batabyal does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The incentives to bring manufacturing back to the US will affect productivity, but in ways that might be surprising.Amitrajeet A. Batabyal, Distinguished Professor, Arthur J. Gosnell Professor of Economics, & Interim Head, Department of Sustainability, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1924842022-12-05T20:27:58Z2022-12-05T20:27:58ZWhy we need open-source science innovation — not patents and paywalls<figure><img src="https://images.theconversation.com/files/497727/original/file-20221128-18-7scacf.jpg?ixlib=rb-1.1.0&rect=77%2C54%2C5099%2C2437&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A virology lab researcher works to develop a test that will detect the P.1 variant of the coronavirus, in São Paulo, Brazil, in March 2021. </span> <span class="attribution"><span class="source">(AP Photo/Andre Penner)</span></span></figcaption></figure><p>As we prepare to <a href="https://theconversation.com/canada-needs-to-invest-more-money-into-science-innovation-to-help-prevent-the-next-global-crisis-182575">invest money to prevent the next global pandemic</a> and <a href="https://theconversation.com/as-the-coronavirus-interrupts-global-supply-chains-people-have-an-alternative-make-it-at-home-133218">find solutions to many other problems</a>, science funders have a large opportunity to move <a href="https://www.oecd.org/sti/inno/open-science.htm">towards open science</a> and more research collaboration by offering open-source endowed chairs.</p>
<p>In these research positions, professors agree to ensure all of their writing is distributed via open access — and they release all of their intellectual property in the public domain or under appropriate open-source licences.</p>
<p>The global scholarly publishing <a href="https://openresearch.community/posts/the-open-access-sector-outperforms-the-scholarly-publishing-market">market has grown steadily and is now worth over US$28 billion</a>. Researchers estimate universities are also able to capture <a href="https://doi.org/10.1016/j.respol.2020.104076">billions through patent licensing</a>, although <a href="https://www.researchgate.net/publication/268286085_How_are_US_Technology_Transfer_Offices_Tasked_and_Motivated-_Is_It_All_About_the_Money">most technology transfer offices at universities actually lose money</a>.</p>
<p>But many academics want to see their research fully accessible — free for everyone. My research with colleagues has found the majority of <a href="https://doi.org/10.1007/s43545-022-00524-3">American</a> and <a href="https://doi.org/10.1080/2331186X.2022.2122255">Canadian academics</a> want to see universities establish open-source endowed chairs.</p>
<h2>How academics use intellectual property</h2>
<p>Intellectual property (IP) refers to mind creations like patents and copyrights. Academics use all kind of IP. For example, professors publish their work as articles in peer-reviewed journals, the majority of which are under copyright. </p>
<p>If you have ever tried to read an academic paper, you probably couldn’t. Most academic papers are behind paywalls. </p>
<figure class="align-left ">
<img alt="A red journal seen tipping off a shelf." src="https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=899&fit=crop&dpr=1 600w, https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=899&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=899&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/497752/original/file-20221128-20781-6apq1k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Most academic papers are behind paywalls.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>To gain access through the paywalls costs an enormous amount of money for a library (even <a href="https://www.theguardian.com/science/2012/apr/24/harvard-university-journal-publishers-prices">Harvard’s library</a> balked at having to pay more than US$1 million per year to access articles from a single publisher). </p>
<p>At the beginning of the pandemic, when fast innovation was needed, most major <a href="https://www.continuum.umn.edu/2020/10/covid-publishers-and-open-access/">publishers made their COVID-19 collections “open access,”</a> which means everyone could read them for free. They did this to speed up innovation because it is obvious that paywalls slow science. </p>
<p>Accessible research in science matters because the more scientists that can read the relevant literature, the more scientists can help push innovations forward and the faster we are able to find solutions. </p>
<p>The <a href="https://doi.org/10.1371/journal.pbio.1001686">open access movement is growing quickly</a>. Authors must pay to make their work available in some open-access journals. Now, however, there are <a href="https://doi.org/10.3390/knowledge2020013">many respected peer-reviewed open-access journals that are free to publish in and free to read</a>.</p>
<h2>Patents hamper innovation</h2>
<p>Many universities <a href="https://www.latimes.com/california/story/2021-01-19/uc-publishes-brag-sheet-2021-college-admissions-season">brag about the number of patents</a> their professors write. Patents are supposed to encourage innovation because they give the inventor a 20-year monopoly to profit from an invention and this provides a financial incentive. </p>
<p>The basic idea is a professor would patent an invention that could be mass manufactured and then reap licence revenue for 20 years. </p>
<p>This does happen. However, a tidal wave of <a href="https://doi.org/10.1093/icc/dtm016">academic study</a> after <a href="https://doi.org/10.2202/1555-5879.1438">study</a>, have shown that <a href="https://jost.syr.edu/wp-content/uploads/6_Azzarelli-SSTLR-Vol.-21-Fall-2009-FINAL.pdf">patents actively hamper innovation</a>. </p>
<p>This is because most innovation builds on other ideas and there is no “fair use” for patents. </p>
<p>It is illegal to even experiment on a patented idea without a licence. If you need to wait 20 years to build on a good idea, it obviously takes a lot of time to innovate. Historically innovation moved rather slowly, now the rate of innovation is fast. Consider now how ancient a 20-year-old phone would be in your pocket.</p>
<p>Some academics like science and engineering professors <a href="https://www.forbes.com/2008/09/12/google-general-electric-ent-tech-cx_mf_0912universitypatent_slide.html?sh=647862fb721c">do make money on patents for their universities</a>. But the patent revenue they keep tends to be meager, because the costs to get the patent must first be recovered before the inventors get anything. </p>
<figure class="align-center ">
<img alt="People stand next to fake coffins with signs that say 'drop the patents.'" src="https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/497739/original/file-20221128-19-2lt2oq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Advocacy to drop patents grew in the pandemic, seen in the work of global justice campaigners standing by fake coffins to highlight COVID-19 deaths globally, in October 2021, in London.</span>
<span class="attribution"><span class="source">(AP Photo/Alastair Grant)</span></span>
</figcaption>
</figure>
<h2>Open source is a better way</h2>
<p>Open source is the answer to speeding up innovation. Open source originally was developed in the software industry as inventors would share the source code of computer programs to innovate faster. </p>
<p>Open source works amazingly well because having a lot of people work on a problem together tends to get a much better solution than a few. </p>
<p>Today open source is dominant in <a href="https://www.zdnet.com/article/supercomputers-all-linux-all-the-time/">all supercomputers</a>, <a href="https://www.rackspace.com/en-gb/blog/realising-the-value-of-cloud-computing-with-linux">90 per cent of cloud servers</a>, <a href="https://www.idc.com/promo/smartphone-market-share">82 per cent of smartphones</a> and <a href="https://spectrum.ieee.org/open-source-ai">most artificial intelligence</a>. Ninety per cent <a href="https://fortune.com/2013/05/06/how-linux-conquered-the-fortune-500/">of the Fortune Global 500 use open-source software</a>.</p>
<h2>Study on university professors</h2>
<p>The results of a survey study of university professors in Canada found <a href="https://doi.org/10.1080/2331186X.2022.2122255">81.1 per cent of Canadian faculty would trade all IP for an open-source endowed chair</a> and 34.4 per cent of these faculty would require no additional compensation. Surprisingly, even more <a href="https://doi.org/10.1007/s43545-022-00524-3">American faculty (86.7 per cent) are willing to accept an open-source endowed professorship</a>. </p>
<p>In both these studies, we presented participants with information about open-source endowed professorships to provide context and clarity for the subsequent multiple-choice and open-ended questions. </p>
<p>We looked at professors in every stage of their career (assistant to emeritus), tenured and non-tenured, at all types of universities (colleges to institutions with <a href="https://carnegieclassifications.acenet.edu/classification_descriptions/basic.php">very high research activity</a>), and in all disciplines including professional programs. </p>
<p>We analyzed results for three core disciplines of engineering/technology, natural sciences and social sciences to assess if there are differences in preferred compensation types among scholars of various disciplines. </p>
<p>The will to share was robust across all variables. Professors as a whole would be willing to make all of their IP freely available in exchange for the open-source endowed chair. </p>
<h2>Accelerating innovation</h2>
<p>I currently hold the John M. Thompson Chair in Information Technology and Innovation, and am one of the first endowed chairs to make an open-source commitment. </p>
<p>It is clear, even from <a href="https://www.appropedia.org/Category:FAST">my own work</a> that has been sped along by many others freely contributing to my open-source projects, that science will move faster with open-source methods. </p>
<p>There is a clear willingness of academics to leave behind antiquated IP models for the good of science and society. It is time to provide incentives to accelerate innovation using open science to hasten scientific progress while also making science more just and inclusive.</p>
<p>All research funders — governments, foundations, private companies, donors and universities — should start funding open-source endowed chairs to maximize the impact of their resources.</p><img src="https://counter.theconversation.com/content/192484/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Professor Joshua M. Pearce has received funding from the Natural Sciences and Engineering Research Council of Canada, MITACS, The Canada Foundation for Innovation, the Air Force Research Laboratory (ARFL) through America Makes: The National Additive Manufacturing Innovation Institute, which is managed and operated by the National Center for Defense Manufacturing and Machining (NCDMM), the U.S. Defense Advanced Research Projects Agency (DARPA), the U.S. Department of Energy (DOE) and the Advanced Research Projects Agency-Energy (ARPA-E), and the National Science Foundation (NSF) for open source related projects.
In addition, his past and present research is supported by many non-profits and for-profit companies in the open source arena including ALLFED, Mosaic Manufacturing, Heliolytics, BeeHex, Glia, re:3D, Miller, Aleph Objects, Lulzbot, Virtual Foundry, Ultimaker and Youmagine, Cheap 3D Filaments, MyMiniFactory, Zeni Kinetic, Matter Hackers, and Ultimachine.
He is the editor-in-chief of HardwareX, the first journal dedicated to open source scientific hardware and the author of the Open-Source Lab:How to Build Your Own Hardware and Reduce Research Costs, Create, Share, and Save Money Using Open-Source Projects, and To Catch the Sun, an open source book of inspiring stories of communities coming together to harness their own solar energy, and how you can do it too.</span></em></p>In open-source endowed research positions, professors release all of their intellectual property. Surveys of academics in the U.S. and Canada find most like the idea.Joshua M. Pearce, Department of Electrical and Computer Engineering, Western UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1898682022-12-05T13:27:20Z2022-12-05T13:27:20ZPharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation<figure><img src="https://images.theconversation.com/files/498366/original/file-20221130-8007-d247y0.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicines-and-money-the-cost-of-treatment-and-royalty-free-image/1129305852">Andrii Zastrozhnov/iStock via Getty Images Plus</a></span></figcaption></figure><p>Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs. </p>
<p>I am an <a href="https://www.lucyxiaoluwang.com/">economist</a> who studies <a href="https://scholar.google.com/citations?user=M0QlVjcAAAAJ&hl=en">innovation and digitization</a> in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">patent pool geared toward public health</a> can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/hGbJclE-Tw4?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Patent pools can help increase access to expensive drugs.</span></figcaption>
</figure>
<h2>Drug patents in the global landscape</h2>
<p>Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, <a href="https://www.wipo.int/patents/en/faq_patents.html">typically 20 years</a> from the application filing date. </p>
<p>However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “<a href="https://doi.org/10.1016/j.jhealeco.2012.01.004">evergreens</a>” the company’s patent portfolio without requiring substantial new investments in research and development. </p>
<p>Furthermore, because patents are <a href="https://www.wipo.int/patents/en/faq_patents.html">jurisdiction-specific</a>, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.</p>
<p>To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a>, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/RrN7IxvAJto?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Determining what is patentable can be complicated.</span></figcaption>
</figure>
<p>The 2001 <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Doha Declaration</a> clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.</p>
<p>One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court <a href="https://doi.org/10.1186/1744-8603-10-3">denied Novartis’s patent application</a> for Glivec for <a href="https://www.upcounsel.com/patent-obviousness">obviousness</a>, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been <a href="https://doi.org/10.1136/bmj.f2099">patented in 40 other countries</a>. As a result of India’s landmark ruling, the price of Glivec <a href="https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/">dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88)</a> for one month of treatment.</p>
<h2>Patent challenges and pools</h2>
<p>Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain <a href="https://doi.org/10.1038/s41587-021-01137-6">multiple patented compounds</a>, each of which can be owned by different companies. Overlapping patent rights can create a “<a href="https://doi.org/10.1086/ipe.1.25056143">patent thicket</a>” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.</p>
<p>One solution to these drug access issues is <a href="https://doi.org/10.1257/0002828041464641">patent pools</a>. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of licensing markets with and without a patent pool" src="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=264&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=264&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=264&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=332&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=332&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=332&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Patent pools were first used <a href="https://www.jstor.org/stable/43186442">in 1856 for sewing machines</a> and were once <a href="https://doi.org/10.1257/0002828041464641">ubiquitous across multiple industries</a>. Patent pools gradually disappeared after a <a href="https://supreme.justia.com/cases/federal/us/323/386/">1945 U.S. Supreme Court decision</a> that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later <a href="https://firstmonday.org/ojs/index.php/fm/article/view/1912/1794">revived in the 1990s</a> in response to licensing challenges in the information and communication technology sector.</p>
<h2>The Medicines Patent Pool</h2>
<p>Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The <a href="https://medicinespatentpool.org/">Medicines Patent Pool, or MPP</a>, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.</p>
<p>But how much has the MPP improved drug access?</p>
<p>I sought to <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">answer</a> <a href="https://dx.doi.org/10.2139/ssrn.4016897">this question</a> by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of the Medicines Patent Pool licensing structure" src="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=320&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=320&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=320&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.</p>
<p>I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.</p>
<p>The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.</p>
<p>Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.</p>
<h2>Technology licensing for COVID-19 and beyond</h2>
<p>Since May 2020, the Medicines Patent Pool has become a key partner of the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool">World Health Organization COVID-19 Technology Access Pool</a>, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an <a href="https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme">mRNA vaccine technology transfer hub</a> in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.</p>
<p>Licensing COVID-19-related technologies can be complicated by the <a href="https://pubmed.ncbi.nlm.nih.gov/34194207">large amount of trade secrets</a> involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/ilr101&div=32&id=&page=">manufacturing details</a>. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to <a href="https://medicinespatentpool.org/partners/how-to-get-or-give-a-licence">close the licensing knowledge gap</a>. </p>
<p>Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug <a href="https://medicinespatentpool.org/news-publications-post/mpp-signs-licence-agreement-to-increase-access-to-nilotinib-for-the-treatment-of-chronic-myeloid-leukaemia">nilotinib</a> – the first time a cancer drug has come under a public health-oriented licensing agreement.</p><img src="https://counter.theconversation.com/content/189868/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.</span></em></p>The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting low- and middle-income countries.Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass AmherstLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1886002022-09-25T20:03:19Z2022-09-25T20:03:19ZWe studied 309,544 patent applications – and found inventing is still a man’s world<figure><img src="https://images.theconversation.com/files/485752/original/file-20220921-27-1wjkec.jpeg?ixlib=rb-1.1.0&rect=37%2C68%2C5015%2C3295&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Are women as successful as men in securing a patent for their invention? </p>
<p>We set out to investigate gender bias in patent outcomes at IP Australia – the government agency responsible for administering intellectual property rights.</p>
<p>To do so, we <a href="https://www.unswlawjournal.unsw.edu.au/wp-content/uploads/2022/09/04-Huang-Patrick-Finch.pdf">analysed</a> 309,544 patent applications from across a 15-year period (2001-2015), and categorised close to one million inventors’ names based on whether they sounded male or female.</p>
<p>We found that having a male-sounding first name increases the odds of securing a patent. This gender bias can have serious implications for women’s health, female career progression and equity policies in STEM. But what’s causing it?</p>
<h2>Women are increasingly applying for patents</h2>
<p>Patents provide a 20-year monopoly over a new invention and are a well-known measure of the output from STEM-based industries. </p>
<p>Global studies show the number of patent applications from female inventors (while still lower than the number from men) has grown significantly over the past 20 years. What has been less clear is whether these applications convert to granted patents. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=360&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=360&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=360&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=452&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=452&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484502/original/file-20220914-23-zvcpay.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=452&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The proportion of female inventors associated with patent applications worldwide has grown from 1915 to 2017.</span>
<span class="attribution"><span class="source">Intellectual Property Office UK, Gender Profiles in Worldwide Patenting: An Analysis of Female Inventorship (2019 edition)</span></span>
</figcaption>
</figure>
<p><a href="https://www.nature.com/articles/nbt.4120">Studies</a> of data from the United States Patent and Trademark Office unfortunately reveal inventors with a female-sounding first name are less successful at having their patent granted than those with a male-sounding first name. </p>
<p>This is irrespective of the technical field and the gender of the <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3828216#:%7E:text=We%20find%20evidence%20that%20the,the%20examiner%20of%20the%20application.">patent examiner</a>, and despite evidence that female inventor patents are <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1508287">just as good</a> as male inventor patents. </p>
<p>We wanted to investigate whether a similar gender bias exists for patents filed at IP Australia, where most applications come from non-residents. Inventors who plan to operate internationally will often file in multiple jurisdictions, including filing in Australia. </p>
<p>So unlike studies of the US Patent and Trademark Office, where the majority of patents come from US residents, a study of patents at IP Australia reflects more worldwide applications.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=248&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=248&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=248&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=312&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=312&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484494/original/file-20220914-22-1qjanc.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=312&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A profile of 2020 patent applications to IP Australia.</span>
<span class="attribution"><span class="source">IP Australia</span></span>
</figcaption>
</figure>
<h2>A gender gap persists</h2>
<p>Our analysis of 309,544 patent applications submitted over 15 years found 90% of applications had at least one male inventor. Just 24% had at least one female inventor (typically as part of a mixed-gender team).</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484509/original/file-20220914-13-oa7x6k.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The percentage of applications per year, per team composition (male, female, ambiguous, unidentified).</span>
</figcaption>
</figure>
<p>We then examined whether these applications converted into a successful patent grant. We found inventors with a female-sounding first name had slightly lower odds of having their patent granted.</p>
<p>Also, as the number of males on a team increased, so did the odds of the team being granted a patent – whereas adding a female had a negligible impact. In other words, bigger teams of inventors had more patent success, unless the additional inventors had female-sounding names.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484511/original/file-20220914-12-2u0kw6.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">This graph shows the pattern that emerges when you vary the composition of a single-gender team. You can see more men increases chances of success, whereas more women does not.</span>
<span class="attribution"><span class="source">Author provided</span></span>
</figcaption>
</figure>
<h2>But why is it like this?</h2>
<p>One question for us was whether this gender disparity could be explained by the types of fields patents were being granted in, and whether women simply work in less “patentable” fields such as life sciences.</p>
<p>We found more than 60% of female inventors were clustered in just four of 35 technical fields (the 35 science categories recognised in patents). These were all in the life sciences: chemistry, biotechnology, pharmaceuticals and medical technology. </p>
<p>We also found patents in three of these fields had a lower-than-average success rate. In other words, it’s generally harder to get a patent in these fields, regardless of whether you’re a woman or man.</p>
<p>Nevertheless, even after we statistically controlled for the effect of participating in a less successful field, we still found a gender disparity – male-named inventors did better than female-named inventors. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="An old-timey depiction of a male inventor in black and white." src="https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=409&fit=crop&dpr=1 600w, https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=409&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=409&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=514&fit=crop&dpr=1 754w, https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=514&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/485489/original/file-20220920-12-awunyy.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=514&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Women are responsible for some of the greatest inventions, yet inventorship remains a male-dominated field. We’ll have to fight historical biases against women if this is to change.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<h2>Women in STEM must be supported</h2>
<p>The implications of women falling out of the patent system are significant for a number of reasons. For one, patents with female inventors are more likely to focus <a href="https://theconversation.com/too-few-women-get-to-invent-thats-a-problem-for-womens-health-162576">on female diseases</a>. </p>
<p>Also, getting a patent can be important for career progression and for securing investment capital. And <a href="https://theconversation.com/how-talented-kids-from-low-income-families-become-americas-lost-einsteins-89126">research has</a> shown a lack of female inventors today impacts the rate at which girls aspire to be the inventors of tomorrow. </p>
<p>The next step in our research is to find out why there is a gender gap in successful patent applications. </p>
<p>We don’t believe it’s a simple case of gender bias at the patent office. We suspect the issues are complex, and related to the systemic and institutional biases that hold back women’s progress in STEM more generally. </p>
<p>Country and cultural differences may also be at play, particularly since more than 90% of patent applications received by IP Australia come from non-Australian inventors (and overwhelmingly from the United States). </p>
<p>We want to look deeper into our results to figure out what’s driving the gender disparity, and what we can do to support female inventors. </p>
<p>The first step in fixing a problem is acknowledging it exists. We hope our research starts a conversation that prompts people to reflect on their own biases. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/caring-or-killing-harmful-gender-stereotypes-kick-in-early-and-may-be-keeping-girls-away-from-stem-169742">Caring or killing: harmful gender stereotypes kick in early — and may be keeping girls away from STEM</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/188600/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Although female inventorship has grown over the years, 15 years’ worth of patent outcomes from IP Australia suggests inventing is still a luxury for women.Vicki Huang, Senior Lecturer, Intellectual Property, Deakin UniversityCameron Patrick, Statistical Consultant, The University of MelbourneSue Finch, Statistical Consultant, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1812352022-06-05T12:22:00Z2022-06-05T12:22:00ZWe still need a vaccine patent waiver, but not the one on offer at the World Trade Organization meeting<figure><img src="https://images.theconversation.com/files/466910/original/file-20220603-17-5nwz4k.jpg?ixlib=rb-1.1.0&rect=382%2C238%2C4930%2C3241&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Global Justice campaigners in London stand by fake coffins to highlight global COVID-19 deaths. If pharma companies waived intellectual property rights, it would be easier for low- and middle-income countries to access COVID-19 vaccines.
</span> <span class="attribution"><span class="source">(AP Photo/Alastair Grant)</span></span></figcaption></figure><p>In mid-June, the <a href="https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm">World Trade Organization (WTO) will meet</a> to finish negotiations to waive certain sections of the agreement on Trade Related Intellectual Property Rights (TRIPS). However, it is not the TRIPS waiver originally proposed 18 months ago by member states South Africa and India, which would have allowed countries to produce lower-cost generic vaccines and other COVID-19 medical tools without the risk of legal trade challenges.</p>
<p>The opposition to the waiver from a few WTO member states — home to the pharma companies holding monopoly patent rights over the vaccines — has resulted in “<a href="https://doi.org/10.1016/S0140-6736(22)00328-2">vaccine apartheid</a>” (rich countries buying up all the early supplies) and “<a href="https://www.thenation.com/article/economy/pfizer-pandemic-profiteering/">vaccine profiteering</a>” (companies making multi-billion-dollar profits and fighting every effort to allow generic competition). </p>
<p>Vaccine supply is no longer the main issue. Pharma companies still holding the vaccine patents can now produce enough for everyone — though not necessarily at affordable prices — and have described the <a href="https://healthpolicy-watch.news/with-covid-vaccine-supply-outstripping-vaccination-rates-pharma-giants-question-pursuit-of-ip-waiver/">idea of a TRIPS waiver now as “insane” and “unproductive</a>.” </p>
<p>But for the scores of WTO member states and thousands of global health researchers still supporting the waiver <a href="https://theconversation.com/covid-19-drug-and-vaccine-patents-are-putting-profit-before-people-149270">(myself included)</a>, getting the WTO to approve one at its upcoming June ministerial meeting remains important. Just not the waiver that’s on the negotiating table. </p>
<h2>Worse than no waiver</h2>
<p><a href="https://www.wto.org/english/news_e/news22_e/trip_06may22_e.htm">The current version</a> is the outcome of discussions involving the two original proposing members, the United States and the European Union. It is restricted to vaccines — a U.S. request — ignoring, for now at least, therapeutics, diagnostics and other essential COVID-19-related health products. </p>
<figure class="align-center ">
<img alt="Hands holding a syringe and vial of vaccine" src="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The waiver under negotiation puts a time limit on the waived obligations.</span>
<span class="attribution"><span class="source">(AP Photo/Michel Euler)</span></span>
</figcaption>
</figure>
<p>It requires generic manufacturers to identify all related patents, which is impossible given vaccines’ complex “<a href="https://doi.org/10.1007/s10551-021-04873-6">patent thickets</a>” (overlapping patent rights), and something not required under present TRIPS rules. It puts a time limit on the waived obligations, as though pandemics are calendar-savvy. </p>
<p>While it removes barriers to generic companies exporting to developing countries that lack their own manufacturing capacity, it excludes countries that supplied more than 10 per cent of global vaccine exports in 2021, namely, China. </p>
<p>A shadow of its original intent, the new waiver is <a href="https://twn.my/title2/wto.info/2022/ti220514.htm">endorsed only by the EU, with support from the WTO director-general</a>. </p>
<h2>Why the new waiver proposal should be opposed</h2>
<p>If enacted as currently drafted, the new waiver sets a precedent that will restrict the ability of countries with the capacity to mass produce therapeutics, diagnostics and even personal protective equipment. This would apply to the still-with-us COVID-19 pandemic and for any new zoonotic outbreaks that are <a href="https://theconversation.com/future-infectious-diseases-recent-history-shows-we-can-never-again-be-complacent-about-pathogens-177746">almost certainly on the near horizon</a>. </p>
<p>Without a meaningful waiver, new variant-ready vaccines <a href="https://medicalxpress.com/news/2022-04-pfizer-eyes-covid-vaccine-variants.html">expected later this year</a> are likely to be gobbled up once more by high-paying rich countries, with the poorer ones left with older less-effective versions. </p>
<figure class="align-center ">
<img alt="Vials of vaccine with purple caps shot from above" src="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Pharma companies holding patents can now produce enough vaccine for everyone, though not necessarily at affordable prices.</span>
<span class="attribution"><span class="source">(AP Photo/Achmad Ibrahim)</span></span>
</figcaption>
</figure>
<p>The same scenario applies to therapeutics such as <a href="https://www.bloomberg.com/news/articles/2022-04-22/covid-antiviral-pills-seen-surging-after-slow-initial-uptake">Pfizer’s antiviral drug, Paxlovid</a>. Most of its current supply will go to wealthy countries that can afford the high prices Pfizer charges. Pfizer will allow licences for generic versions to be produced for distribution to 95 developing countries, but not until 2023. </p>
<p>Moderna, the other mRNA vaccine leader, is busy <a href="https://www.aljazeera.com/opinions/2022/3/16/modernas-profits-show-why-big-pharma-cant-meet-our-health-needs">registering patents for its vaccine in South Africa</a> as that country, with WTO support, is close to copying Moderna’s recipe, the know-how for which it plans to share publicly. Moderna’s new patents could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-patent-application-raises-fears-africa-covid-vaccine-hub-2022-02-17/">jeopardize this effort</a>. The company meanwhile has plans to create its own mRNA plant in Kenya to supply the African continent <a href="https://socialeurope.eu/control-the-vampire-companies">on its own profitable terms</a>. </p>
<p>On May 25, Pfizer announced that it would eventually provide all “<a href="https://www.weforum.org/agenda/2022/05/pfizer-launches-an-accord-for-a-healthier-world-a-call-for-action-to-improve-health-equity-globally/?utm_source=sfmc&utm_medium=email&utm_campaign=2778051_Am22-AgendaDaily-26May2022&utm_term=&emailType=Agenda%20Week">current and future patent-protected medicines on a not-for-profit basis” to 45 lower-income countries</a>, beginning with five countries in Africa. </p>
<p>The company’s decision is welcome, but questions remain. Will Pfizer forego lucrative sales of its current and future drugs to rich countries in order to supply (eventually) the 1.2 billion people living in the world’s poorest nations? Or will these countries have to wait until the paying world’s 6.7 billion people have had their supply needs met? </p>
<h2>Current property rights not fit for global health purpose</h2>
<p>The bottom line: for-profit companies should not be setting public health policy during global health emergencies. Individual corporate decisions to supply life-saving health innovations at cost in otherwise unprofitable markets is not a sustainable or ethical solution. </p>
<p>Bluntly stated: companies’ intellectual property rights should not be allowed to trump people’s health rights. </p>
<figure class="align-center ">
<img alt="A crowd outdoors with people holding blue signs reading 'Support patent waivers on COVID-19 vaccines'" src="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=417&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=417&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=417&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=524&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=524&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=524&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Activists support patent waivers on COVID-19 vaccines in front of the European Union office during an EU summit in Kyiv, Ukraine, on Oct. 12, 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Efrem Lukatsky)</span></span>
</figcaption>
</figure>
<p>Investment into new health products means taking risks, and it warrants some reward. However, much of the groundwork in pharmaceutical research is publicly funded. </p>
<p>This was certainly the case with COVID-19 vaccines, and one of the reasons why many organizations argued that these discoveries <a href="https://peoplesvaccine.org/">should be considered “people’s vaccines” and treated as public goods</a>. Governments need to place <a href="https://www.who.int/publications/m/item/governing-health-innovation-for-the-common-good">conditions on the financial support they give to health research</a> to ensure that the results are more equitably shared. </p>
<p>In the case of public health emergencies, such as pandemics, this should include requirements that companies forego their monopoly property rights, accept negotiated royalties for their efforts and share their knowledge. </p>
<p>President Joe Biden’s administration recently took a step in this direction. It <a href="https://www.hhs.gov/about/news/2022/05/12/nih-licenses-covid-19-research-tools-early-stage-technologies-who-program.html">licensed 11 COVID-19 inventions</a> that arose from in-house research at the National Institutes of Health, including early-stage development of the stabilized spike protein that forms the base of mRNA vaccines. </p>
<p>Described as “<a href="https://www.science.org/content/article/pretty-big-deal-u-s-makes-covid-19-technologies-available-use-developing-countries">a pretty big deal</a>” by an advocate of shared intellectual property, the licenses will be administered by the non-profit <a href="https://medicinespatentpool.org/">Medicines Patent Pool</a> that negotiates low royalty costs for generic manufacturers, so inventors will still get some reward. </p>
<p>But this early-stage knowledge-sharing is insufficient to enable full development of medical innovations, which requires drug companies holding patents on the finished, commercialized vaccines and COVID-19-related technologies to waive these rights and to share their technical know-how. </p>
<h2>Canada and the June WTO meeting</h2>
<p>As with the rest of the world, Canada’s attention is moving away from COVID-19 to <a href="https://www.cbc.ca/news/business/canada-inflation-april-1.6457520">inflation fears</a> and <a href="https://theconversation.com/why-did-russia-invade-ukraine-faqs-about-the-conflict-that-has-shocked-the-world-177963">Russia’s war against Ukraine</a>. With surprisingly little media coverage, the government began holding <a href="https://www.ourcommons.ca/Committees/en/FAAE/StudyActivity?studyActivityId=11504514">parliamentary committee hearings on vaccine equity</a> this past spring. Still, it remains uncommitted on the waiver, as it has since the original waiver was proposed. </p>
<figure class="align-center ">
<img alt="A globe and a syringe against a blue background" src="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&rect=748%2C30%2C3341%2C2501&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Companies’ intellectual property rights should not be allowed to trump people’s health rights.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Health and civil society groups, meanwhile, remain committed to urging the government to make the right ethical and health protective decision. They are calling on Canada to <a href="https://policyalternatives.ca/newsroom/updates/canada-should-reject-compromise-proposal-trips-waiver-its-present-form-civil">use the June WTO meeting to bring the deeply flawed new waiver proposal closer to the original one</a>. </p>
<p>There is still a need for a decent TRIPS waiver to ensure that intellectual property rights do not get in the way of rapid and equitable access to medicines or any other essential health innovations. That must be one of the key lessons we take from our COVID-19 experience.</p><img src="https://counter.theconversation.com/content/181235/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ronald Labonte receives funding from the Canadian Institutes of Health Research, and is a member of the Steering Council of the People's Health Movement, which advocates for global health equity.</span></em></p>Waiving patent rights on COVID-19 vaccines and drugs is still crucial to ensure access globally, but the waiver on the table at the June World Trade Organization meeting doesn’t do the job.Ronald Labonte, Professor and Distinguished Research Chair, Globalization and Health Equity, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1814642022-06-01T23:46:43Z2022-06-01T23:46:43ZHere’s a scheme Labor should ditch in its bid to boost productivity. It’s the ‘patent box’<figure><img src="https://images.theconversation.com/files/465835/original/file-20220528-19-wi9jdd.png?ixlib=rb-1.1.0&rect=141%2C178%2C2603%2C1330&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Australia’s new treasurer Jim Chalmers says his biggest priorities include <a href="https://ministers.treasury.gov.au/ministers/jim-chalmers-2022/transcripts/joint-press-conference-parliament-house-canberra">boosting productivity and business investment</a>.</p>
<p>If so, he would be wise not to follow in the footsteps of his predecessor Josh Frydenberg, who tried for more than a year to introduce Australia’s first so-called <a href="https://joshfrydenberg.com.au/latest-news/patent-box-legislation-introduced-into-parliament-to-support-investment-and-jobs/">Patent Box</a> before the legislation lapsed ahead of the election without a vote.</p>
<p>First introduced in Ireland in the early 1970s, and adopted later in countries such as France, Spain, China and the United Kingdom, patent boxes are said to get their name from a box on the tax form that companies tick if they have income deriving from <a href="https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/rp/BudgetReview202122/PatentBoxTaxRegime">intellectual property</a>, which is taxed at a discounted rate.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1131&fit=crop&dpr=1 754w, https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1131&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/465827/original/file-20220528-21-84fq66.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1131&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Former treasurer Josh Frydenberg, wanted to tax income from patents at a lower rate.</span>
</figcaption>
</figure>
<p>The theory is that if such income is taxed less, international corporations will do more of their <a href="https://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22chamber%2Fhansardr%2F25466%2F0034%22">research and development</a> in Australia. </p>
<p>When announced in the 2021 budget, the discount was to be limited to income from patents on medical and biological technologies, although (also before the bill became law) the 2022 budget announced plans to <a href="https://www.managingip.com/article/b1y23cdntbzyg8/expansion-of-the-patent-box-scheme-in-australia">extend it</a> to agricultural and low emission technologies.</p>
<p>Income derived directly from patents in these fields was to be taxed at just <a href="https://treasury.gov.au/sites/default/files/2021-07/c2021_177849.pdf">17%</a>, instead of the prevailing company tax rate of 30%.</p>
<h2>Doubts ahead of time</h2>
<p>Doubts were expressed ahead of time. In <a href="https://www.industry.gov.au/sites/default/files/May%202018/document/pdf/patent_box_policies.pdf">2015</a> the industry department’s office of the chief economist said while a patent box tax break would certainly increase
the number of patent applications filed, most of the extra ones were
“likely to be opportunistic” (filed on inventions that would have taken place without patents).</p>
<p>Any extra patent fees collected were unlikely to offset the tax lost.</p>
<p>And the advice had a broader point. Rewarding investors well after risky research had been undertaken was unlikely to do much to encourage such research. </p>
<p>Research and development tax credits, on the other hand, provide tax breaks at time the research is being funded, according to one Australian study, creating <a href="https://www.sciencedirect.com/science/article/pii/S0166497221000742">A$1.90</a> of research for each dollar of tax lost.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/patent-boxes-are-said-to-boost-innovation-the-evidence-says-they-dont-160861">'Patent boxes' are said to boost innovation. The evidence says they don't</a>
</strong>
</em>
</p>
<hr>
<p>Supporters of the concept point to the Australian biotech company CSL Limited, which set up a new plant in <a href="https://www.gtlaw.com.au/insights/treasurer-sparks-hope-australia-will-implement-patent-box-system">Switzerland</a> rather than Australia in 2014 in part because Switzerland had a patent box and <a href="https://cdn.theconversation.com/static_files/files/2116/132.pdf">Australia did not</a>.</p>
<p>Critics observe that income from patents is <a href="https://www.bruegel.org/wp-content/uploads/imported/events/GriffithMillerOConnell_CEPR.pdf">highly mobile</a>, meaning it can be easily separated from real inventive activity moved across borders. </p>
<p>One study found <a href="https://www.nber.org/papers/w24701">40% of multinational profits</a> had been moved from one location to another on the basis of tax rather than where the profits were made.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/artificial-inventors-are-pushing-patent-law-to-its-limits-184047">Artificial 'inventors' are pushing patent law to its limits</a>
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</em>
</p>
<hr>
<p>Another study noted that businesses can get the tax breaks by <a href="https://www.gtlaw.com.au/insights/treasurer-sparks-hope-australia-will-implement-patent-box-system">acquiring</a> patents eligible for patent box treatment without doing the patentable research.</p>
<p>A review of the UK scheme published in November 2021 identified “abuse and boundary-pushing” and made a number of recommendations designed to refocus it on activity <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1037348/RD_Tax_Reliefs.pdf">actually taking place</a> within the UK.</p>
<h2>Tinkering, not transformation</h2>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=970&fit=crop&dpr=1 600w, https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=970&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=970&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1219&fit=crop&dpr=1 754w, https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1219&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/465830/original/file-20220528-11-gik57u.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1219&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption"></span>
<span class="attribution"><a class="source" href="https://archive.budget.gov.au/2021-22/download/glossy_jobs.pdf">Information Sheet, 2021 Budget</a></span>
</figcaption>
</figure>
<p>The scheme Frydenberg put forward had safeguards. </p>
<p>It was to be limited to income derived from patents issued after budget night 2021, which meant (at least at first) it would be limited to income derived from new patents.</p>
<p>Licensees of patents would not be eligible, only firms that held the patent themselves.</p>
<p>And, where patents were filed overseas, they had to be owned in Australia, and the underlying research had to have <a href="https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/rp/BudgetReview202122/PatentBoxTaxRegime">occurred in Australia</a>.</p>
<p>Labor has given no guarantee it will proceed with the scheme announced in the past two budgets and not yet legislated.</p>
<p>There are reasons why it should not. Australia’s really big productivity gains, in the 1990s and early 2000s, had more to do with reforming or replacing lacklustre industries than with patents.</p>
<p>Australia is on the cusp of yet another transformation, into a low-carbon energy producer and exporter. This is where our focus should be, rather than on tinkering with tax support for innovations that might take place regardless.</p><img src="https://counter.theconversation.com/content/181464/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Beth Webster receives funding from the Australian and Victorian departments of industry and trade and the Australian Research Council. </span></em></p>The Coalition planned to tax company income from patents at 17% instead of 30%. While it would have lifted the number of patents, there’s little to suggest it would have lifted productivity.Beth Webster, Director, Centre for Transformative Innovation, Swinburne University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1821472022-05-15T20:15:16Z2022-05-15T20:15:16ZAustralia risks relying on Pfizer and Moderna for its COVID vaccines. 3 ways to break free<figure><img src="https://images.theconversation.com/files/460499/original/file-20220429-26-ut9yfa.jpg?ixlib=rb-1.1.0&rect=14%2C0%2C3180%2C1992&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/coronavirus-vaccine-affordability-people-want-buy-1908778336">Shutterstock</a></span></figcaption></figure><p>The rapid development and deployment of COVID vaccines has been one of the greatest achievements of the pandemic.</p>
<p>However, Australia <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">risks relying on</a> COVID vaccines from two main companies – Pfizer and Moderna – and that’s a problem.</p>
<p>While the need for COVID vaccines is not going away anytime soon, we need to shape the market to drive more competition for better access to improved vaccines.</p>
<p>Here’s what Australia needs to do to break free from an effective duopoly dominating the local market, especially when many of us are likely to <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-your-vaccination/booster-doses">need boosters</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccination-recommendations-evolve-over-time-who-is-due-for-which-dose-now-181779">COVID vaccination recommendations evolve over time. Who is due for which dose now?</a>
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</em>
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<hr>
<h2>How did we get here?</h2>
<p>When COVID finally broke out at scale in Australia late last year, the vaccines (and high levels of adult vaccination) worked extremely well to reduce deaths and severe illness.</p>
<p>Since January 1 this year, there have been <a href="https://ourworldindata.org/coronavirus/country/australia">more than</a> 5.9 million confirmed COVID infections nationwide, but about 5,300 deaths.</p>
<p>Yet current vaccines aren’t 100% effective at protecting against infection; new viral variants (<a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">and sub-variants</a>) continue to emerge; protection via <a href="https://www1.racgp.org.au/newsgp/clinical/booster-protection-wanes-after-four-months-what-do">vaccination</a> and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">prior infection wanes</a> quite quickly, meaning reinfection is becoming more common and booster shots may remain part of the landscape for some time to come.</p>
<p>Meanwhile, <a href="https://www.sciencedirect.com/science/article/pii/S0140673622003282?via%3Dihub">vaccine inequity</a> remains an unresolved problem. This has led to a situation where rich countries, such as Australia, are giving booster shots where some <a href="https://www.sciencedirect.com/science/article/pii/S0140673622008170?via%3Dihub">poorer countries</a> don’t even have enough vaccine for first doses.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-australias-fickleness-on-covid-vaccines-is-perpetuating-global-vaccine-inequity-165001">How Australia's fickleness on COVID vaccines is perpetuating global vaccine inequity</a>
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</p>
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<h2>Pfizer and Moderna, but not much else</h2>
<p>In <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">a recent article</a> in the Medical Journal of Australia, we outline the need to break free from the handful of powerful players still dominating Australia’s COVID vaccine market.</p>
<p>While the number of <a href="https://covid19.trackvaccines.org/agency/who/">approved COVID vaccines</a> <a href="https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations">is growing</a> around the world, Australia largely still relies on only two, namely vaccines from Pfizer and Moderna.</p>
<p>The AstraZeneca and Novavax vaccines are only rarely <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations">used as boosters</a> if <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/approved-vaccines/novavax">no other vaccines</a> are suitable.</p>
<p>More than <a href="https://www.health.gov.au/sites/default/files/documents/2022/05/covid-19-vaccine-rollout-update-11-may-2022.pdf">95% of Australian adults</a> have received two doses of COVID vaccine already. So future requirements are primarily for boosters and child vaccines. Australia, therefore, continues to face an effective duopoly.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Middle-aged lady smiling with bandaid on upper arm" src="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Future supplies of COVID vaccines will be used for booster shots and children.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-mature-female-smiling-after-getting-1927590569">Shutterstock</a></span>
</figcaption>
</figure>
<h2>The power of patents</h2>
<p>This effective duopoly further reinforces the already considerable power these manufacturers hold via the intellectual property rights to their vaccines.</p>
<p>These vaccine patents are protected by the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights (or <a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">TRIPS</a>). This prevents international competitors from replicating patented technologies. </p>
<p>These patent rights allow companies to earn higher profits (or “economic rents”) than if their technologies were freely available to allow open competition.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1523962841178558469"}"></div></p>
<p>The intellectual property dimensions of COVID vaccines have been controversial. </p>
<p>Pfizer and Moderna have continued <a href="https://peoplesvaccine.org/resources/media-releases/pharma-companies-make-1000-dollars-per-second/">to make extraordinary profits</a> from COVID vaccines.</p>
<p>Yet Moderna found itself <a href="https://www.ipwatchdog.com/2022/03/31/nihs-fight-ownership-modernas-covid-19-patent-highlights-hazards-business-collaborations/id=148040/">in dispute</a> with the United States government, conceding <a href="https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html?msclkid=2baf60f6d0f511ec9526396a701fee1f">US government employees</a> had directly developed several technologies key to the Moderna vaccine (not to mention years of publicly-funded basic research). </p>
<p>Moderna has also <a href="https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun">resisted sharing</a> the formulation of its vaccine to allow key middle-income countries to manufacture it.</p>
<p>Meanwhile, Pfizer has negotiated <a href="https://www.citizen.org/article/pfizers-power/?eType=EmailBlastContent&eId=9b708ddb-d34d-4dfa-95e4-d4d672a82a1b">advantageous</a> and <a href="https://www.theguardian.com/uk-news/2021/dec/05/wall-of-secrecy-in-pfizer-contracts-as-company-accused-of-profiteering">secretive</a> vaccine contracts with governments, shifting liability and risk onto governments and controlling nations’ ability to redistribute stock between themselves. </p>
<p>High-income countries have <a href="http://aftinet.org.au/cms/Civil-society-organisations-urge-Australia-to-oppose-ineffective-TRIPS-proposal">consistently resisted</a> or watered down <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W688.pdf&Open=True">calls for a TRIPS waiver</a>, which would have allowed global sharing of manufacturing technologies. </p>
<p><a href="https://journals.plos.org/globalpublichealth/article?id=10.1371%2Fjournal.pgph.0000427">Critics argue</a> the opponents of a TRIPS waiver are largely concerned about avoiding setting any precedents that might allow the profits of Big Pharma to be limited in future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-a-leaked-wto-solution-for-a-covid-patent-waiver-is-unworkable-and-wont-make-enough-difference-for-developing-countries-179642">Why a leaked WTO 'solution' for a COVID patent waiver is unworkable and won't make enough difference for developing countries</a>
</strong>
</em>
</p>
<hr>
<h2>What should Australia do next?</h2>
<p>In Australia, the reality that current COVID vaccines only partially prevent transmission leaves us dependent on this effective duopoly for ongoing boosters. Boosters also remain mandated for people in <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/information-for-aged-care-providers-workers-and-residents-about-covid-19-vaccines/residential-aged-care-workers">many occupations</a>.</p>
<p>Australia can escape this captive vaccine market in three steps.</p>
<p><strong>1. Approve more vaccines</strong></p>
<p>Australia needs to expand the supply of new COVID vaccines by actively assisting a wider range of manufacturers to bring their products to the Therapeutic Goods Administration for approval. This would increase competition for boosters and stimulate the development and supply of more effective “sterilising” vaccines (ones that prevent viral transmission).</p>
<p>Meanwhile, Australia must extract maximum value from all existing vaccine contracts, and insist upon full freedom to transfer supplies to our regional neighbours.</p>
<p><strong>2. Push for patent reform</strong></p>
<p>Australia should use its influence to vigorously drive a TRIPS waiver at the World Trade Organization. It should also explore strategic options with a coalition of partners to consider how the current global intellectual property regime could be rapidly reformed or, if necessary, circumvented. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/3-ways-to-vaccinate-the-world-and-make-sure-everyone-benefits-rich-and-poor-155943">3 ways to vaccinate the world and make sure everyone benefits, rich and poor</a>
</strong>
</em>
</p>
<hr>
<p><strong>3. Set up domestic, not-for-profit capability</strong></p>
<p>Australia should institute an economic “mission” to establish publicly-owned, not-for-profit vaccine and essential pharmaceuticals research, development and manufacturing infrastructure and capability in Australia. This would serve domestic and wider regional needs for COVID and beyond. </p>
<p>Sadly, the Australian government’s recent agreement with Moderna for the company to establish <a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">mRNA manufacturing here</a> is <em>not</em> such an example. It may risk entrenching existing power. The agreement is also <a href="https://www.abc.net.au/radionational/programs/sciencefriction/moderna-mrna-australia-covid-pharmaceutical-profits-business/13849344">still secret</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">New facility to be built in Victoria to produce mRNA vaccines</a>
</strong>
</em>
</p>
<hr>
<p>In an increasingly insecure world of growing disruptions – ecological and health crises, fracturing supply chains and heightened military tensions – Australia can provide a safe and resilient vaccine and pharmaceutical manufacturing capability to protect the health of Australians and our neighbours. </p>
<p>However, old models that privilege shareholders, via excess profits and intellectual property protection, will not deliver this new vision.</p>
<hr>
<p><em><a href="https://www.deakin.edu.au/about-deakin/people/sithara-wanni-arachchige-dona2">Sithara Dona</a>, an associate research fellow at Deakin University, co-authored the research mentioned in this article.</em></p><img src="https://counter.theconversation.com/content/182147/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Hensher has received an honorarium from Novartis SA (Brazil) for a lecture delivered to the Novartis Access 2021 conference. He is a member of the South Australian Health Performance Council and a board member of Glenview Community Services, Tasmania (a not-for-profit aged care provider).</span></em></p>Boosters and vaccinating children mean we’re relying on two pharmaceutical companies to supply Australia’s COVID vaccines. That needs to change.Martin Hensher, Henry Baldwin Professorial Research Fellow in Health System Sustainability, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1748742022-04-06T12:24:13Z2022-04-06T12:24:13ZRepurposing generic drugs can reduce time and cost to develop new treatments – but low profitability remains a barrier<figure><img src="https://images.theconversation.com/files/455834/original/file-20220401-30230-ka75fr.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1998%2C1488&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">From thalidomide to Viagra, drug repurposing salvaged failed treatments by giving them new targets.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-jars-royalty-free-illustration/676746260">smartboy10/DigitalVision Vectors via Getty Images</a></span></figcaption></figure><p>Discovering new ways to use existing drugs can come about intentionally or by chance. </p>
<p>Sometimes physicians or patients notice an unanticipated beneficial effect from a drug. One example is <a href="https://dx.doi.org/10.1038%2Fnrd2030">sildenafil</a>, a drug originally developed to treat severe chest pain from coronary artery disease. While sildenafil failed clinical trials, researchers noticed that one of its side effects was induced erections. This led to its successful rebranding as the erectile dysfunction drug Viagra.</p>
<p>Most of the time when drugs are repurposed for diseases or conditions they were not originally intended for, it’s done deliberately. As scientists raced to develop treatments for COVID-19, drug repurposing came into the spotlight for reasons <a href="https://www.scientificamerican.com/article/common-antidepressant-slashes-risk-of-covid-death/">good</a> and <a href="https://www.nytimes.com/2022/03/30/health/covid-ivermectin-hospitalization.html">bad</a>. </p>
<p>As a <a href="https://scholar.google.com/citations?user=O4qsjycAAAAJ&hl=en">researcher focused on drug discovery and development</a>, I have seen the potential of repurposing and the challenges it faces. While finding new uses for drugs that have already been tested for safety and approved by the FDA can substantially <a href="https://doi.org/10.1038/534314a">reduce the time and cost</a> of development, financial and logistical barriers can make it difficult to get to market.</p>
<h2>The success of thalidomide</h2>
<p>When repurposing is successful, a drug that is ineffective or harmful for one condition can be lifesaving for others. </p>
<p>One such drug is <a href="https://dx.doi.org/10.1177%2F2040620711413165">thalidomide</a>, first approved as a morning sickness treatment. It gained notoriety in the late 1950s when it caused birth defects in an estimated 10,000 infants worldwide, resulting in <a href="https://www.medicalnewstoday.com/articles/how-the-thalidomide-scandal-led-to-safer-drugs">changes in drug regulation and development</a> that included increased developmental toxicity testing. Thalidomide was globally banned by the end of the 1960s.</p>
<p>In the 1990s, however, researchers discovered that thalidomide <a href="https://dx.doi.org/10.1073%2Fpnas.91.9.4082">inhibits angiogenesis</a>, or the growth of new blood vessels that deliver nutrients and oxygen to tumors. Its new use as a treatment for a blood cancer called <a href="https://dx.doi.org/10.1177%2F2040620711413165">multiple myeloma</a> ultimately saw clinical and commercial success. This led to the development of <a href="https://dx.doi.org/10.1177%2F2040620711413165">improved versions</a> of the drug that treat cancer with reduced side effects.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/5olSLe4faiw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Repurposing generic drugs could offer a cheaper and faster way to develop new treatments.</span></figcaption>
</figure>
<p>Scientists have continued to find other therapeutic uses for thalidomide. </p>
<p>When researchers discovered that thalidomide <a href="https://dx.doi.org/10.1016%2Fj.chembiol.2015.05.009">targets a molecule in the body</a> that marks other proteins for destruction, they leveraged this function into an emerging technology called <a href="https://doi.org/10.1038/s41392-019-0101-6">PROTACs</a>. Many drugs work in the body by inhibiting a particular target that produces an unwanted effect, typically in a way that is reversible and temporary. PROTACs, on the other hand, are a type of drug that can destroy the target altogether. This potentially increases the effectiveness of the drug and reduces the chance of drug resistance.</p>
<p>An example is <a href="https://clinicaltrials.gov/ct2/show/NCT03888612">bavdegalutamide</a>, a PROTAC that combines thalidomide with an inhibitor typically used to treat prostate cancer. This inhibitor works by blocking a target that supplies the tumor with hormones that help it grow. An ongoing phase 2 clinical trial on bavdegalutamide hinges on the idea that destroying the target would cut off hormone supply to tumors and stop their growth more effectively than conventional inhibitors.</p>
<p>Researchers are currently churning out PROTACS often by repurposing existing drugs. With ongoing promising results, 2021 saw the launch of a <a href="https://doi.org/10.1038/d41573-021-00052-4">flurry of clinical trials</a> testing PROTACs as a treatment for a number of different cancers.</p>
<h2>Repurposing for COVID-19</h2>
<p>Reearchers have used a myriad of drug repurposing approaches <a href="https://doi.org/10.1016/j.patter.2020.100090">during the COVID-19 pandemic</a>, ranging from educated guesses to large-scale drug screening and data mining from millions of electronic health records. Irrespective of how researchers decide which drugs to repurpose, all candidates must demonstrate strong clinical benefit in people before they can be authorized or approved for a new proposed use by the FDA.</p>
<p>My research team and I tested 1,425 FDA-approved drugs in human cells infected with COVID-19 and found <a href="https://doi.org/10.1073/pnas.2105815118">17 repurposing candidates</a> for further examination. Several of the leads we identified have since entered preliminary clinical trials, including drugs originally intended to treat <a href="https://clinicaltrials.gov/ct2/show/NCT04465695">leprosy</a> and <a href="https://doi.org/10.1101/2021.06.22.21259318">prostate cancer</a>, as well as a <a href="https://doi.org/10.3390/medicina57080842">supplement derived from milk</a>.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of pill capsules falling into pill bottle." src="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=826&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=826&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=826&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1038&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1038&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1038&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drug repurposing could help expand treatment options for various diseases, including COVID-19.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-and-capsule-jar-royalty-free-illustration/676742914">smartboy10/DigitalVision Vectors via Getty Images</a></span>
</figcaption>
</figure>
<p>Researchers initiated <a href="https://dx.doi.org/10.3389%2Ffphar.2021.704205">hundreds of clinical studies</a> early in the pandemic to test drug repurposing candidates for COVID-19. There have been a few notable successes including the generic antidepressant <a href="https://dx.doi.org/10.1016%2FS2214-109X(21)00448-4">fluvoxamine</a>, which reduced the risk of hospitalization by 32% in one clinical study. One <a href="https://doi.org/10.1080/07853890.2022.2034936">meta-analysis</a> on fluvoxamine and two other <a href="https://theconversation.com/could-oral-antiviral-pills-be-a-game-changer-for-covid-19-an-infectious-disease-physician-explains-why-these-options-are-badly-needed-169919">antiviral COVID-19 drugs</a>, molnupiravir and Paxlovid, found that they all offered protective benefits against COVID-19 with comparable safety profiles.</p>
<p>Unlike these new COVID-19 antivirals, however, fluvoxamine has a <a href="https://doi.org/10.1176/appi.books.9781615371624.as13">40-year track record</a> of safely treating depression and obsessive-compulsive disorder. Despite this, fluvoxamine has not been authorized for emergency use by the FDA, and the National Institutes of Health states that there is <a href="https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/fluvoxamine/">insufficient evidence</a> for its use against COVID-19.</p>
<h2>Drug discovery challenges</h2>
<p>Successful drug repurposing highlights the difficulty of predicting off-target effects of new treatments. </p>
<p>Eflornithine, for example, is a drug found to be ineffective against cancer – but it does turn out to inhibit <a href="https://doi.org/10.1111/j.1365-4632.2006.03079.x">facial hair growth</a> in women and cure a parasitic infection called <a href="https://doi.org/10.1016/s0140-6736(87)91131-7">trypanosomiasis</a>, or sleeping sickness. It’s often not immediately obvious why one drug would effectively treat two seemingly different health issues like these.</p>
<p>There are approximately 2,500 FDA-approved drugs, and an average of 46 new drugs are <a href="https://doi.org/10.1038/d41573-021-00002-0">approved each year</a>. However, <a href="https://doi.org/10.1038/nrd.2016.136">over 90%</a> of drugs that enter clinical trials fail. This increases to <a href="http://dx.doi.org/10.1126/scitranslmed.aaw8412">97% for cancer drugs</a>. While many shots on goal are required to produce a viable drug, each failed drug is a candidate for repurposing. Researchers like me have been collecting these “failed” compounds for further testing, trawling through research papers, patents and clinical trial databases to find repurposing candidates. Some labs have used <a href="https://doi.org/10.1016/S2589-7500(20)30192-8">artificial intelligence</a> to automate this process. </p>
<p>But it can be difficult to ascertain what drugs are available to repurpose. While one drug development database proposes that there are <a href="https://www.gostardb.com/about">47,000 previously tested compounds</a> ready for repurposing, there is <a href="https://doi.org/10.1093/bib/bbaa003">no central repository</a> for this information.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of various pills falling into an open hand" src="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=793&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=793&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=793&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=997&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=997&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=997&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Parsing through the thousands of drugs for repurposing candidates can be difficult without knowing all the available options.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/catching-pills-royalty-free-illustration/676747518">smartboy10/DigitalVision Vectors via Getty Images</a></span>
</figcaption>
</figure>
<h2>Commercialization landscape</h2>
<p>Drug repurposing faces an <a href="https://doi.org/10.1126/scitranslmed.3009120">intellectual property barrier</a>. Repurposing is most accessible with <a href="https://doi.org/10.1186/s40545-020-00282-8">generic drugs</a> that don’t have patents restricting their use for other conditions. But there is <a href="https://doi.org/10.1186/s40545-020-00282-8">less opportunity for profit</a> with generics than with new drugs.</p>
<p>Patents allow drug suppliers to have a monopoly over sales for a span of time. Repurposed drugs are typically granted “<a href="https://doi.org/10.1126/scitranslmed.3009120">use patents</a>” that protect the use of an existing drug for a new particular disease. But companies consider this type of protection less valuable than a “composition of matter” patent that restricts drug sales just to patent owners. An <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices">FDA analysis</a> found a drug with two drug suppliers resulted in an average 39% price reduction, and six or more suppliers resulted in a 95% reduction. With less patent protection on a drug, more competitors can enter the market and manufacturers make less money.</p>
<p>Because of this perceived lack of commercial potential, drug repurposing is typically left to academic institutions that don’t have the resources to get either new or retooled drugs through the <a href="https://doi.org/10.1001/jama.2020.1166">costly approval process</a>.</p>
<p>It’s possible that if fluvoxamine were a new drug in development with patent protection within a Big Pharma company, it might have already gained FDA approval to treat COVID-19. But as it stands, fluvoxamine is a widely available generic that any doctor can prescribe “<a href="https://theconversation.com/off-label-use-is-common-in-medicine-a-bioethicist-and-legal-philosopher-explain-why-the-covid-19-vaccines-are-different-171007">off-label</a>” to treat conditions that have not been approved by the FDA, like COVID-19. </p>
<p>[<em>Over 150,000 readers rely on The Conversation’s newsletters to understand the world.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-150ksignup">Sign up today</a>.]</p>
<p>This leads to a <a href="https://globalforum.diaglobal.org/issue/june-2020/repurposing-challenges-conceptualization-of-a-research-agenda/">tragedy of the commons</a> whereby no company will invest in the clinical trials needed to bring a repurposed drug to the marketplace because the resulting benefits would be immediately shared with all competitors.</p>
<p>Bringing a new drug to market is a <a href="https://doi.org/10.1038/d41573-021-00190-9">lengthy</a> and <a href="https://doi.org/10.1001/jama.2020.1166">costly</a> process with a <a href="https://doi.org/10.1038/nrd.2016.136">high failure rate</a>. When the pharmaceutical industry can’t justify developing a new drug because of a low return on investment, drug repurposing can fill the gap. <a href="https://covid19.nih.gov/news-and-stories/repurposing-drugs-to-save-time-and-lives">Federal support</a> could make repurposing more appealing from a business standpoint, giving companies the incentive to enter the marketplace and boost this cost-effective way to address unmet medical needs.</p><img src="https://counter.theconversation.com/content/174874/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jonathan Sexton receives funding from the National Institutes of Health. </span></em></p>Drug repurposing can redeem failed treatments and squeeze out new uses from others. But many pharmaceutical companies are hesitant to retool existing drugs without a high return on investment.Jonathan Sexton, Assistant Professor of Internal Medicine and Medicinal Chemistry, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1792602022-03-18T11:23:05Z2022-03-18T11:23:05ZHow Russia is using intellectual property as a war tactic<figure><img src="https://images.theconversation.com/files/452883/original/file-20220317-25-1hr7nnr.jpg?ixlib=rb-1.1.0&rect=667%2C171%2C3418%2C2548&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/03052022russiarussian-president-vladimir-putin-speaks-during-2132517573">ApostolisBril / Shutterstock</a></span></figcaption></figure><p>As part of its deadly assault on Ukraine, Russia has taken the rare step to use intellectual property rights as a war tactic. In early March, the Russian government <a href="http://publication.pravo.gov.ru/Document/View/0001202203070005?index=0&rangeSize=1">issued a decree</a> saying that Russian companies are no longer obliged to compensate owners of patents, utility models and industrial designs from <a href="http://publication.pravo.gov.ru/Document/View/0001202203070001?index=1&rangeSize=1">“unfriendly” countries</a>. These are the western states who have issued sanctions against Russia, including the UK and US. </p>
<p>This means that Russian businesses can use intellectual property, such as patented inventions or fashion designs, without having to pay or seek the consent of the rights holders. Affected companies cannot enforce their patents and designs against Russian imitators.</p>
<p>This effectively legalises intellectual piracy in a country already known for failing to adequately protect intangible assets. Last year, <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/april/ustr-releases-annual-special-301-report-intellectual-property-protection#:%7E:text=Nine%20countries%20%E2%80%94%20Argentina%2C%20Chile%2C,engagement%20during%20the%20coming%20year">Russia was added</a> to a US government “priority watch list” of countries which do not sufficiently protect US intellectual properties.</p>
<p>Vladimir Putin’s move is clearly a reaction to the west’s <a href="https://www.bbc.co.uk/news/world-europe-60125659">economic sanctions</a> and suspension of Russia’s <a href="https://www.politico.eu/article/remove-russia-trade-privilege-what-need-know/">trade privileges</a>. It is also an answer to many multinational companies’ decisions to <a href="https://theconversation.com/shell-bp-and-exxonmobil-have-done-business-in-russia-for-decades-heres-why-theyre-leaving-now-178269">cease doing business</a> with Russian companies. </p>
<p>Sanctions and boycotts have massively affected the Russian economy to the extent that the country is now <a href="https://theconversation.com/the-cost-of-war-how-russias-economy-will-struggle-to-pay-the-price-of-invading-ukraine-178826">on the verge of bankruptcy</a> with interest <a href="https://www.wsj.com/livecoverage/russia-ukraine-latest-news-2022-02-28/card/russia-s-central-bank-more-than-doubles-interest-rates-in-response-to-sanctions-p7602Gbo1YpFdLBardRo">rates having doubled</a>. The stock market has remained <a href="https://markets.businessinsider.com/news/stocks/russia-stock-market-closed-bonds-default-sovereign-debt-deadline-2022-3">closed</a> for weeks and the rouble has <a href="https://www.economist.com/finance-and-economics/2022/02/28/the-roubles-collapse-compounds-russias-isolation">fallen dramatically</a>.</p>
<h2>Unprecedented attack on intellectual property</h2>
<p>The suspension of intellectual property rights as an economic weapon in the context of a conflict is unprecedented, at least in recent decades. Historical examples date back to the first world war, when the US introduced the <a href="https://uscode.house.gov/view.xhtml?path=/prelim@title50/chapter53&edition=prelim">Trading With the Enemy Act</a>. This act seized copyright and patents owned by enemy countries, including the patent to aspirin, famously a German invention.</p>
<p>Following the war, the Aspirin trademark owned by the German pharmaceutical company Bayer was <a href="http://www.ipdigit.eu/2011/10/bayers-aspirin-a-lasting-success-without-patent-and-trademark-protection/?pdf=1059">given up to</a> the US, France, UK and Russia, as part of Germany’s war reparations agreed in the Treaty of Versailles. </p>
<p>Russian officials have <a href="https://tass.ru/ekonomika/13982403">hinted</a> that other intellectual property rights owned by western countries may be soon restricted, including software and trademarks. This could allow local entrepreneurs to appropriate and exploit – without permission and for free – brands such as <a href="https://nypost.com/2022/03/11/russia-could-reopen-mcdonalds-stores-by-scrapping-trademark-protections-expert/">McDonald’s</a>. One Russian restaurant chain has even recently adopted, and applied to register locally, a <a href="https://www.washingtonpost.com/world/2022/03/18/uncle-vanya-russian-mcdonalds-replacement-logo">logo</a> very similar to the famous golden arches.</p>
<figure class="align-center ">
<img alt="A McDonald's restaurant in Russia, with the golden arches and company name in Cyrillic." src="https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/453010/original/file-20220318-21-kq2gkt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">McDonald’s, perhaps the most famous western trademarks, now at risk of intellectual piracy in Russia.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/krasnoyarsk-russia-march-10-2022-closed-2134722073">Al.geba / Shutterstock</a></span>
</figcaption>
</figure>
<p>The sanctions have also led a Russian judge to dismiss a copyright and trademark infringement lawsuit brought by the British company that produces animated series Peppa Pig. Andrei Slavinsky <a href="https://www.independent.co.uk/news/world/europe/peppa-pig-russia-trademark-ukraine-b2034842.html">said in court</a> that the “unfriendly actions of the United States of America and affiliated foreign countries” influenced his decision. </p>
<p>Ukraine, for its part, has not been inactive in this intellectual property battle. Its ministry of defence <a href="https://www.scmagazine.com/analysis/breach/in-a-first-ukraine-leaks-russian-intellectual-property-as-act-of-war">recently</a> hacked and leaked confidential documents it claimed to have taken from a Russian nuclear power station.</p>
<h2>Does it violate international law?</h2>
<p>Russia’s suspension of patents and other intellectual property rights owned by western companies may violate <a href="https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm">international treaties</a> which protect these assets at global level. All countries of the World Trade Organization (WTO) need to respect these laws and guarantee that foreign businesses can enforce intellectual property rights against imitators.</p>
<p>Countries damaged by the Russian measure may bring Russia to a WTO court and ask for additional sanctions to be imposed. This would again hit Russian businesses, especially those which rely on brands and patented technology, as well as the creative industry sector.</p>
<p>The only way Russia could justify the measure would be to rely on a <a href="http://www.cptech.org/ip/texts/trips/73.html">security exception</a> made available by the WTO itself. This exception allows countries to take any action they consider necessary to protect their essential security interests in times of war. But it has never been invoked by any state in the context of an armed conflict, and therefore never tested before the WTO judges.</p>
<p>If Russia is expelled from the WTO club, as has been <a href="https://www.washingtonpost.com/politics/2022/03/11/russia-wto-penalize-ukraine-conflict/">proposed</a>, that would, paradoxically, insulate it from global intellectual property challenges. No country would be able to bring Russia before a court of an organisation it is no longer a member of.</p>
<p>These are predictions of what could happen if the war continues. It goes without saying that a prompt end to the conflict may instead relax the tension between the west and Russia, and put an end to the current intellectual property battle.</p><img src="https://counter.theconversation.com/content/179260/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The Russian government has essentially legalised intellectual piracy as a response to sanctions.Enrico Bonadio, Reader in Intellectual Property Law, City, University of LondonAlina Trapova, Assistant Professor in Law and Autonomous Systems, University of NottinghamLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1789902022-03-13T19:16:28Z2022-03-13T19:16:28ZTwo years into the pandemic, unequal access to COVID-19 treatments threatens the global recovery<figure><img src="https://images.theconversation.com/files/451508/original/file-20220311-15-1e9j5t5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">AAP/AP/Brian Inganga</span></span></figcaption></figure><p>It’s now two years since the <a href="https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020">World Health Organization began calling</a> the COVID-19 outbreak a pandemic.</p>
<p>Two years ago, it was <a href="https://www.nejm.org/doi/full/10.1056/NEJMp2005630">unclear whether it would even be possible</a> to develop an effective vaccine or treatment for the novel coronavirus. In the interim, we’ve seen <a href="https://www.nature.com/articles/d41586-020-03626-1">enormous scientific advances made in record time</a>, bringing not one but several vaccines, and a range of treatments, to the market.</p>
<p>But access to vaccines is still extremely uneven across the world. And now similar problems are emerging with inequitable access to COVID-19 treatments.</p>
<p>Meanwhile, negotiations at the World Trade Organization (WTO) for a waiver of intellectual property rights for COVID-19 health products and technologies, underway for almost 18 months, are still in a state of paralysis. And there is a risk that any agreement reached at the WTO might only apply to vaccines, leaving treatments unavailable or unaffordable for around half the global population.</p>
<h2>Access to vaccines is still vastly unequal</h2>
<p>Almost 11 billion COVID-19 vaccine doses have been administered worldwide, but more than a third of the world’s population remains unvaccinated and only <a href="https://ourworldindata.org/covid-vaccinations#what-share-of-the-population-has-received-at-least-one-dose-of-the-covid-19-vaccine">13.7% of people in low-income countries</a> have yet received one or more doses. </p>
<p>By the end of 2021, <a href="https://www.ft.com/content/5144cd19-2c67-46d0-a37d-a869006bfbdb">more boosters had been administered</a> in high-income countries than the total doses given in low-income countries. </p>
<p>While the supply flowing through COVAX has been increasing over the last few months, there is still a long way to go to reach the <a href="https://www.who.int/news/item/23-12-2021-achieving-70-covid-19-immunization-coverage-by-mid-2022">WHO target</a> to vaccinate 70% of the population of every country by the end of June 2022.</p>
<p>And with effective treatments now entering the market, we are likely to see similar patterns of inequity unless we address the dynamics that prevent equitable access.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/451509/original/file-20220311-27-qx54r3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Global access to the COVID-19 vaccine has been vastly unequal.</span>
<span class="attribution"><span class="source">AAP/Richard Wainwright</span></span>
</figcaption>
</figure>
<h2>Antiviral treatments have become increasingly important</h2>
<p>Treatments such as the oral antivirals Paxlovid, made by Pfizer, and Lagevrio, made by Merck Sharpe & Dohme with Ridgeback Biotherapeutics, are an increasingly important part of the toolkit for fighting the pandemic. </p>
<p>Pfizer’s Paxlovid is a combination of a new chemical entity called nirmatrelvir, and ritonavir, an older drug used to treat HIV. Paxlovid works by <a href="https://www.pharmaceutical-technology.com/features/paxlovid-pfizer-covid-19-pill/">binding to an enzyme</a> that is needed for viral replication. <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">Pfizer reported</a> that clinical trial participants who received the drug within three days of symptom onset had an 89% lower risk of hospital admission or death. </p>
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Read more:
<a href="https://theconversation.com/merck-v-pfizer-heres-how-the-two-new-covid-antiviral-drugs-work-and-will-be-used-171247">Merck v Pfizer: here's how the two new COVID antiviral drugs work and will be used</a>
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<p>Merck’s molnupiravir (brand name Lagevrio) also prevents viral replication, but in this case by incorporating itself into the viral RNA, <a href="https://www.sciencefocus.com/news/molnupiravir-covid-pill/">disabling its ability to reproduce</a>. Molnupiravir <a href="https://www.nature.com/articles/d41586-021-03667-0">reduces the risk of hospitalisation</a> by around 30%. </p>
<p>While <a href="https://theconversation.com/taking-covid-pills-at-home-sounds-great-but-we-need-to-use-them-wisely-or-risk-drug-resistance-and-new-variants-176235">both drugs have limitations</a>, they have been shown to reduce the risk of severe illness among adults who are at higher risk, and have the advantage over other types of treatment in that they can be taken at home. This is particularly important for countries <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00372-5/fulltext">without strong health systems</a>, and where vaccination coverage is less than ideal.</p>
<h2>Patents on treatments enable high prices and profits</h2>
<p>Pfizer has signalled it has filed, or intends to file, <a href="https://www.citizen.org/article/paxlovid-patent-landscape/">patent applications covering Paxlovid</a> in at least 61 countries as well as a number of regional patent offices. </p>
<p><a href="https://www.keionline.org/36779">Multiple patent applications</a> have also been filed for <a href="https://theconversation.com/molnupiravir-why-are-there-potential-safety-issues-around-this-covid-antiviral-173285">molnupiravir</a> in many high income countries and some middle income countries such as India and Brazil.</p>
<p>It may take years for some of these patent applications to be either rejected or granted, but the uncertainty makes it difficult for generic companies to enter the market. </p>
<p>Merck is selling a course of molunpiriavir to high income countries such as the United States <a href="https://scholar.harvard.edu/files/melissabarber/files/estimated_cost-based_generic_prices_for_molnupiravir_for_the_treatment_of_covid-19_infection.pdf">for US$712 (A$970)</a>, around 40 times the cost of production. Pfizer is <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/price-covid-treatments-pfizer-merck-gsk-align-with-patient-benefits-report-2022-02-03/">charging US$530 ($A722)</a> for a course of Paxlovid. </p>
<p>While both <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">Pfizer </a>and <a href="https://www.merck.com/news/merck-and-ridgeback-announce-u-s-government-to-purchase-1-4-million-additional-courses-of-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-covid-19-in-a/">Merck</a> have offered tiered pricing based on a country’s income level, it remains unclear what prices will be set and whether they will be affordable. Tiered pricing has been <a href="https://globalizationandhealth.biomedcentral.com/articles/10.1186/1744-8603-7-39">criticised for failing to lower prices sufficiently</a> for middle-income countries in the past.</p>
<p>Paxlovid is another huge money-spinner for Pfizer, which expects to generate <a href="https://www.cnbc.com/2022/02/08/covid-pfizer-pfe-earnings-q4-2021.html">US$22 billion (A$30 billion) in revenue</a> from sales of the drug in 2022. And Merck’s 2022 revenue forecast for Lagevrio is <a href="https://www.cnbc.com/2022/02/03/merck-mrk-earnings-q4-2021.html">$5-6 billion</a> (A$6-8 billion).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/451511/original/file-20220311-27-zewq1c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Paxlovid is a COVID-19 treatment expected to be another huge money-earner for its maker, Pfizer.</span>
<span class="attribution"><span class="source">AAP/AP/Pfizer</span></span>
</figcaption>
</figure>
<h2>Generic antivirals for low-income countries, but middle-income countries miss out</h2>
<p>Both Pfizer and Merck have entered into voluntary licensing agreements with the Medicine Patents Pool which will enable generic companies anywhere in the world to make cheaper copies of the drugs for certain low-income countries.</p>
<p>But these license agreements are tightly restricted. Merk’s <a href="https://medicinespatentpool.org/licence-post/molnupiravir-mol">agreement with the Medicines Patent Pool</a> permits supply of the generic copies to only 105 countries. <a href="https://medicinespatentpool.org/licence-post/pf-07321332">Pfizer’s license agreement for Paxlovid</a> restricts its supply even more tightly, to 95 low and middle-income countries covering only 53% of the global population. </p>
<p>These licensing agreements both exclude middle-income countries such as Thailand, China, and Mexico – countries where the prices for the patented products risks putting them out of reach. </p>
<h2>High income countries have pre-purchased large quantities</h2>
<p>Making the situation even worse, rich countries are buying up the limited supplies of the patented products, as they did for vaccines. </p>
<p>Pfizer expects to manufacture <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provide-us-government-additional-10-million">120 million courses of Paxlovid this year</a>. At least 30 million of the treatment courses have <a href="https://www.reuters.com/world/pfizer-provide-10-mln-courses-covid-pill-developing-countries-the-global-fund-2022-03-02/">already been pre-purchased</a> by rich countries, including 20 million contracted to the United States. In contrast, Pfizer has promised to provide only 10 million doses for low-income countries, a very inadequate amount in comparison with the burden of disease.</p>
<p>Merck plans to make 20 million courses of Lagevrio in 2022, 3.1 million of which have been promised to the US government, and Merck has also entered into deals with <a href="https://www.pmlive.com/pharma_news/merck_and_ridgeback_fulfil_us_deal_for_molnupiravir_1387623?SQ_DESIGN_NAME=2">“over 30 markets globally including Canada, Korea, Australia, Japan, Thailand and Ukraine”</a>.</p>
<p>Australia’s Health Minister <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/australia-secures-additional-covid-19-treatments">announced</a> advance purchase agreements for 500,00 doses of Paxlovid and 300,000 courses of molnupiravir in October 2021.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/451515/original/file-20220311-21-1fvc7dw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">In 2021, federal Health Minister Greg Hunt announced purchase agreements for Paxlovid and molnupiravir.</span>
<span class="attribution"><span class="source">AAP/Con Chronis</span></span>
</figcaption>
</figure>
<h2>Stalemate at the WTO</h2>
<p>Unfortunately, the effort invested in creating new products has not been matched by efforts to share them equitably.</p>
<p>A proposal to waive WTO rules that require countries to provide patents and other intellectual property rights for COVID-19 health products and technologies, first made by India and South Africa in October 2020, is now <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True">co-sponsored by 63 of the WTO’s 164 countries</a> and supported by more than 100. </p>
<p>Adoption of this proposal, known as the <a href="https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/FlagPost/2021/September/Intellectual_property_agreements_and_COVID-19">TRIPS waiver</a>, would enable manufacturers to enter the market without fear of litigation over infringing intellectual property rights. It would clear the way for far more widespread production of COVID-19 vaccines, treatments, diagnostic tests and other technologies to fight the pandemic. </p>
<p>But the TRIPS waiver proposal is still languishing due to <a href="https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/msf-urges-rich-nations-to-accept-trips-waiver/articleshow/89757281.cms">opposition by the EU, UK and Switzerland</a> - headquarters to powerful pharmaceutical corporations - and the <a href="https://corporateeurope.org/en/2021/04/big-pharma-lobbys-self-serving-claims-block-global-access-vaccines#">pharmaceutical industry has been lobbying against it</a>. </p>
<p>The EU is pushing a separate proposal, which <a href="https://msfaccess.org/analysis-eu-position-compulsory-licensing-and-trips-waiver-covid-19-pandemic">relies on existing WTO rules that allow for compulsory licensing</a>. However, this is an onerous and protracted process that is unworkable for providing speedy access on a global scale.</p>
<p>And the US is <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">only supporting a waiver for vaccines</a>. This is a limited approach that would leave many middle-income countries unable to either afford patented drugs or to buy the generic versions.</p>
<p>Two years into the pandemic, it’s well past time for a global solution that provides access to all the products and technologies the world needs to manage COVID-19.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-the-intellectual-property-monopoly-has-impeded-an-effective-response-to-covid-19-173298">How the intellectual property monopoly has impeded an effective response to Covid-19</a>
</strong>
</em>
</p>
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<img src="https://counter.theconversation.com/content/178990/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Deborah Gleeson has received funding in the past from the Australian Research Council. She has received funding from various national and international non-government organisations to attend speaking engagements related to trade agreements and health. She has represented the Public Health Association of Australia on matters related to trade agreements and public health</span></em></p><p class="fine-print"><em><span>Brigitte Tenni receives PhD scholarship funded by the Australian government. She is affiliated with the People's Health Movement and the Public Health Association of Australia.</span></em></p>Just as access to vaccines was vastly more difficult for low-income countries, the same is now true for the virus’ treatments: at potentially great cost to the world.Deborah Gleeson, Associate Professor in Public Health, La Trobe UniversityBrigitte Tenni, Senior Technical Advisor - HIV, The Nossal Institute for Global Health, PhD candidate La Trobe University, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1746722022-01-19T13:46:08Z2022-01-19T13:46:08ZCORBEVAX, a new patent-free COVID-19 vaccine, could be a pandemic game changer globally<figure><img src="https://images.theconversation.com/files/440522/original/file-20220112-25-tuq2mh.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2191%2C1363&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">CORBEVAX uses recombinant DNA technology that many countries already have the infrastructure to produce.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/global-vaccination-of-planet-earth-royalty-free-illustration/1315224179">Artis777 via iStock/Getty Images Plus</a></span></figcaption></figure><p>The world now has a new COVID-19 vaccine in its arsenal, and at a fraction of the cost per dose.</p>
<p>Two years into the COVID-19 pandemic, the world has seen <a href="https://www.worldometers.info/coronavirus/">over 314 million infections and over 5.5 million deaths worldwide</a>. Approximately <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">60% of the world population</a> has received at least one dose of a COVID-19 vaccine. But there is still a glaring and alarming gap in global access to these vaccines. As a <a href="https://www.rit.edu/ferranlab/maureen-ferran">virologist</a> who has followed this pandemic closely, I contend that this vaccine inequity should be of grave concern to everyone.</p>
<p>If the world has learned anything from this pandemic, it’s that viruses do not need a passport. And yet approximately 77% of people in high- and upper-middle-income countries have received at least one dose of the vaccine – and <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">only 10% in low-income countries</a>. <a href="https://www.washingtonpost.com/world/2021/11/12/coronavirus-vaccine-boosters-global/">Wealthy countries</a> are giving boosters, and even fourth doses, while first and second doses are not available to many worldwide. </p>
<p>But there is hope that a new vaccine called <a href="https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor-college-medicine-covid-19-vaccine-technology-secures-emergency">CORBEVAX</a> will help close this vaccination gap.</p>
<h2>How does the CORBEVAX vaccine work?</h2>
<p>All <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html">COVID-19 vaccines</a> teach the immune system how to recognize the virus and prepare the body to mount an attack. The <a href="https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor-college-medicine-covid-19-vaccine-technology-secures-emergency">CORBEVAX vaccine</a> is a <a href="https://www.gavi.org/vaccineswork/what-are-protein-subunit-vaccines-and-how-could-they-be-used-against-covid-19">protein subunit vaccine</a>. It uses a harmless piece of the spike protein from the coronavirus that causes COVID-19 to stimulate and prepare the immune system for future encounters with the virus. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/sVKjEiD6IoM?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Recombinant vaccines commonly use yeast to produce the immune-stimulating proteins of a virus in the lab.</span></figcaption>
</figure>
<p>Unlike the three vaccines approved in the U.S. – <a href="https://theconversation.com/how-do-mrna-vaccines-work-and-why-do-you-need-a-second-dose-5-essential-reads-157198">Pfizer and Moderna’s mRNA vaccines</a> and <a href="https://theconversation.com/how-does-the-johnson-and-johnson-vaccine-compare-to-other-coronavirus-vaccines-4-questions-answered-155944">Johnson & Johnson’s viral vector vaccine</a>, which provide the body instructions on how to produce the spike protein – CORBEVAX delivers the spike protein to the body directly. Like those other approved COVID-19 mRNA vaccines, CORBEVAX also requires <a href="https://timesofindia.indiatimes.com/india/india-approves-corbevax-covovax-vaccines-for-emergency-use/articleshow/88555029.cms">two doses</a>.</p>
<h2>How was CORBEVAX developed?</h2>
<p>CORBEVAX was developed by the co-directors of the <a href="https://www.bcm.edu/departments/pediatrics/divisions-and-centers/tropical-medicine/research/vaccine-development">Texas Children’s Hospital Center for Vaccine Development</a> at Baylor College of Medicine, Drs. <a href="https://www.bcm.edu/people-search/maria-bottazzi-18431">Maria Elena Bottazzi</a> and <a href="https://www.texaschildrens.org/find-a-doctor/peter-jay-hotez-md-phd">Peter Hotez</a>. </p>
<p>During the <a href="https://www.cdc.gov/sars/about/fs-sars.html">2003 SARS outbreak</a>, these researchers created a similar type of vaccine by inserting the genetic information for a portion of the SARS virus spike protein into yeast to produce large amounts of the protein. After isolating the virus spike protein from the yeast and adding an <a href="https://www.thehindu.com/business/biological-e-to-use-dynavaxs-adjuvant-in-corbevax/article35179401.ece">adjuvant</a>, which helps trigger an immune response, the vaccine was ready for use.</p>
<p>The first SARS epidemic was short-lived, and there was little need for Bottazzi and Hotez’s vaccine – until the virus that causes COVID-19, SARS-CoV-2, emerged in 2019. So they dusted off their vaccine and updated the spike protein to match that of SARS-CoV-2, creating the <a href="https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor-college-medicine-covid-19-vaccine-technology-secures-emergency">CORBEVAX vaccine</a>. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/UNXJHUnTCxE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">CORBEVAX received emergency use authorization in India on December 28, 2021.</span></figcaption>
</figure>
<p>Two large clinical trials of <a href="https://www.biologicale.com/news.html">over 3,000 people in India</a> found the vaccine to be safe, well-tolerated and <a href="https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor-college-medicine-covid-19-vaccine-technology-secures-emergency">over 90% effective at preventing symptomatic infections</a> from the original strain of COVID-19, and over 80% effective against the delta variant. The vaccine received <a href="https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor-college-medicine-covid-19-vaccine-technology-secures-emergency">emergency use authorization</a> in India, and other developing countries are expected to follow.</p>
<p>Interestingly, the group at Baylor was <a href="https://www.npr.org/sections/goatsandsoda/2022/01/05/1070046189/a-texas-team-comes-up-with-a-covid-vaccine-that-could-be-a-global-game-changer">not able to drum up interest or funding in the U.S.</a> for their vaccine. Instead, newer technologies such as mRNA vaccines raced ahead, even though Bottazzi and Hotez’s vaccine design was more advanced, thanks to their <a href="https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911">previous work during the 2003 SARS and 2012 MERS outbreaks</a>.</p>
<h2>A vaccine built for the world</h2>
<p>Protein subunit vaccines have an advantage over mRNA vaccines in that they can be readily produced using well-established <a href="https://dx.doi.org/10.1016%2Fj.addr.2021.01.001">recombinant DNA technology</a> that is relatively inexpensive and fairly easy to scale up. A similar protein recombinant technology that’s been around for 40 years has been used for the <a href="https://www.who.int/news-room/feature-stories/detail/the-novavax-vaccine-against-covid-19-what-you-need-to-know">Novavax COVID-19 vaccine</a>, which is <a href="https://www.cnbc.com/2022/01/10/novavax-ceo-covid-vaccine-could-be-cleared-in-multiple-countries-soon.html">available for use in 170 countries</a>, and the <a href="https://www.nature.com/articles/d42859-020-00016-5">recombinant hepatitis B vaccine</a>.</p>
<p>This vaccine can be produced at a much larger scale because <a href="https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911">appropriate manufacturing facilities are already available</a>. Also key to global access is that CORBEVAX can be <a href="https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/new-protein-based-covid-vaccine-doesnt-need-cold-storage-study/articleshow/87580913.cms">stored in a regular refrigerator</a>. Therefore, it is possible to produce millions of doses rapidly and distribute them relatively easily. In comparison, <a href="https://www.nytimes.com/interactive/2021/health/pfizer-coronavirus-vaccine.html">producing mRNA vaccines</a> is more expensive and complicated because they are based on newer technologies, rely on highly skilled workers and often require <a href="https://www.technologynetworks.com/biopharma/articles/covid-19-vaccine-storage-and-stability-349023">ultralow temperatures</a> for storage and transport.</p>
<p>Another major difference is that the CORBEVAX vaccine was developed with <a href="https://www.advancedsciencenews.com/corbevax-vaccine-offers-solution-to-global-vaccine-inequity/">global vaccine access in mind</a>. The goal was to make a low-cost, easy-to-produce and -transport vaccine using a well-tested and safe method. Key to this, the researchers were <a href="https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911">not concerned with intellectual property or financial benefit</a>. The vaccine was produced without significant public funding; the <a href="https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911">US$7 million</a> needed for development was provided by philanthropists. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman holding child gets vaccinated by a health care worker in India." src="https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/440919/original/file-20220114-30-1l4ut2k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">India is the first country to grant emergency use authorization to CORBEVAX.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakIndiaVaccination/a7d7130831b6471ca08c028908d84745">Anupam Nath/AP</a></span>
</figcaption>
</figure>
<p>COBREVAX is currently <a href="https://www.advancedsciencenews.com/corbevax-vaccine-offers-solution-to-global-vaccine-inequity/">licensed patent-free</a> to Biological E. Limited (BioE), India’s largest vaccine maker, which plans to manufacture <a href="https://www.scientificamerican.com/article/a-covid-vaccine-for-all/">at least 100 million doses per month starting in February 2022</a>. This patent-free arrangement means that other low- and middle-income countries can produce and distribute this cheap, stable and relatively easy-to-scale vaccine locally.</p>
<p>Combined, this means that CORBEVAX is <a href="https://www.axios.com/india-authorizes-covid-vaccines-corbevax-novavax-795a5b7e-d9b7-4e8f-a1ec-bdaba5c5b13b.html">one of the cheapest vaccines currently available</a>. How well it works against the <a href="https://www.scientificamerican.com/article/a-covid-vaccine-for-all/">omicron variant</a> is under investigation. However, the CORBEVAX story can be <a href="https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911">used as a model</a> to address vaccine inequity when it is necessary to vaccinate the world population – against COVID-19 and other diseases on the horizon.</p>
<h2>The necessity of vaccine equity</h2>
<p>There are many reasons <a href="https://www.cgdev.org/debate/would-exempting-covid-19-vaccines-intellectual-property-rights-improve-global-access">global access to vaccines is inequitable</a>. For example, the governments of wealthy nations purchase vaccines in advance, which limits supply. While developing countries do have vaccine production capacity, low- and middle-income countries in Africa, Asia and Latin America still need to be able to afford the cost of placing orders.</p>
<p>The Indian government has ordered <a href="https://www.healio.com/news/infectious-disease/20220105/qa-unpatented-covid19-vaccine-could-finally-vaccinate-the-world">300 million doses of CORBEVAX, and BioE plans to produce more than 1 billion shots</a> for people in developing countries. For context, the U.S. and other G7 nations have pledged to donate <a href="https://launchandscalefaster.org/covid-19/vaccinedonations">over 1.3 billion doses of COVID vaccines, yet only 591 million doses have been shipped</a>. These numbers mean that if BioE is able to produce 1.3 billion doses of CORBEVAX as planned, this vaccine will <a href="https://www.healio.com/news/infectious-disease/20220105/qa-unpatented-covid19-vaccine-could-finally-vaccinate-the-world">reach more people than those vaccinated by what’s been donated and shipped by the wealthiest nations</a>.</p>
<p>[<em>Over 140,000 readers rely on The Conversation’s newsletters to understand the world.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-140ksignup">Sign up today</a>.]</p>
<p>As the <a href="https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html">omicron variant</a> has shown, new variants can spread across the world quickly and are much more likely to <a href="https://www.healthline.com/health-news/unvaccinated-people-are-increasing-the-chances-for-more-coronavirus-variants-heres-how">develop in unvaccinated people</a> and <a href="https://www.msn.com/en-us/health/medical/expect-more-worrisome-variants-after-omicron-scientists-say/ar-AASOna4?li=BBnb7Kz">continue to emerge</a> as long as global vaccination rates remain low. It is <a href="https://www.theguardian.com/world/2022/jan/12/repeated-covid-boosters-not-viable-strategy-against-new-variants-who-experts-warn">unlikely that boosters</a> will end this pandemic. Rather, developing globally accessible vaccines like CORBEVAX represent an important first step in vaccinating the world and ending this pandemic.</p>
<p><em>Article updated to indicate percentage of people in low- and upper-middle to high income countries who have received at least one vaccine dose. Article also updated to note that clinical trials were performed in India and include more information on effectiveness against different strains.</em></p><img src="https://counter.theconversation.com/content/174672/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Maureen Ferran receives funding from The National Institutes of Health.</span></em></p>CORBEVAX is anticipated to significantly expand vaccine access to people in low- and middle-income countries.Maureen Ferran, Associate Professor of Biology, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1720082021-11-18T20:16:48Z2021-11-18T20:16:48ZWhy Moderna won’t share rights to the COVID-19 vaccine with the government that paid for its development<figure><img src="https://images.theconversation.com/files/432489/original/file-20211117-9381-40y1m2.jpg?ixlib=rb-1.1.0&rect=87%2C40%2C4265%2C2961&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The U.S. government funded a significant portion of the R&D behind the Moderna vaccine. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/march-2021-saxony-leipzig-a-hand-with-disposable-gloves-news-photo/1231919693">Peter Endig/picture alliance via Getty Images</a></span></figcaption></figure><p>A quiet <a href="https://www.thedenverchannel.com/news/national/moderna-us-government-at-odds-over-covid-19-vaccine-patent">monthslong legal fight</a> between the U.S. National Institutes of Health and drugmaker Moderna over COVID-19 vaccine patents recently burst into public view. The outcome of the battle has important implications, not only for efforts to contain the pandemic but more broadly for drugs and vaccines that could be critical for future public health crises. </p>
<p><a href="https://www.slu.edu/law/faculty/ana-santos-rutschman.php">I teach drug regulation</a> and patent law at Saint Louis University’s <a href="https://www.slu.edu/law/health/index.php">Center for Health Law Studies</a>.</p>
<p>Moderna recently <a href="https://www.cbsnews.com/news/moderna-covid-vaccine-patent-dispute-national-institutes-health/">offered to share ownership</a> of its main patent with the government to resolve the dispute. Whether or not this is enough to satisfy the government’s claims, I believe the dispute points to serious problems in the ways U.S. companies bring drugs and vaccines to market. </p>
<h2>US was a major funder of the Moderna vaccine</h2>
<p>Vaccines have <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines">played a crucial role</a> in the response to the pandemic.</p>
<p>In December 2020, Moderna became the second pharmaceutical company after Pfizer to <a href="https://www.raps.org/news-and-articles/news-articles/2020/12/fda-issues-eua-for-moderna-covid-vaccine">obtain authorization</a> from the Food and Drug Administration to market a COVID-19 vaccine in the United States. People have since grown so used to talking about the “<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/french-health-authority-advises-against-moderna-covid-19-vaccine-under-30s-2021-11-09/">Moderna vaccine</a>” that a crucial element in the history of how it was developed risks being overshadowed: Moderna was <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">not the sole developer</a> of the vaccine.</p>
<p>Unlike many of the other pharmaceutical companies involved in the <a href="https://openscholarship.wustl.edu/law_journal_law_policy/vol64/iss1/12/">COVID-19 vaccine race</a>, Moderna is a newcomer to drug and vaccine commercialization. Founded in Massachusetts in 2010, the company had <a href="https://fortune.com/2020/11/19/moderna-vaccine-distribution-lonza-swiss/">never brought a product to market</a> until the FDA authorized its COVID-19 vaccine last year.</p>
<p>Throughout the 2010s, Moderna focused on the development of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mRNA.html">mRNA technology</a>, attracting over <a href="https://www.science.org/content/article/mysterious-2-billion-biotech-revealing-secrets-behind-its-new-drugs-and-vaccines">US$2 billion in funding</a> from pharmaceutical companies and other investors. <a href="https://www.marketwatch.com/story/moderna-ipo-5-things-to-know-about-what-could-be-the-largest-biotech-ipo-in-history-2018-12-05">It went public</a> in 2018.</p>
<p>Even <a href="https://direct.mit.edu/qss/article/1/4/1381/96111/Coronavirus-research-before-2020-is-more-relevant">before the pandemic</a>, research on both coronaviruses and vaccine candidates against emerging pathogens was a priority for agencies operating in the public health space. In 2015, the <a href="https://www.niaid.nih.gov">National Institute of Allergy and Infectious Diseases</a>, an institute within the NIH, <a href="https://www.documentcloud.org/documents/6935295-NIH-Moderna-Confidential-Agreements.html">signed a cooperative R&D agreement</a> with Moderna on basic research, including the development of new vaccines. The agreement resulted in an <a href="https://www.usatoday.com/story/news/factcheck/2020/11/24/fact-check-donations-research-grants-helped-fund-moderna-vaccine/6398486002/">undisclosed amount of funding</a> and assistance with research. </p>
<p>In addition, after the COVID-19 outbreak began Moderna also <a href="https://www.reuters.com/article/us-health-coronavirus-moderna-funding/moderna-gets-further-472-million-u-s-award-for-coronavirus-vaccine-development-idUSKCN24R0IN">received almost $1 billion</a> in <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million">funding</a> from the <a href="https://www.phe.gov/about/barda/Pages/default.aspx">Biomedical Advanced Research and Development Authority</a>, which operates within the Department of Health and Human Services. This funding was specifically targeted to the development of a COVID-19 vaccine candidate. </p>
<p>Researchers have calculated that, collectively, the U.S. government <a href="https://www.usatoday.com/story/news/factcheck/2020/11/24/fact-check-donations-research-grants-helped-fund-moderna-vaccine/6398486002/">has provided $2.5 billion</a> toward the development and commercialization of Moderna’s COVID-19 vaccine. </p>
<h2>US, Moderna scientists working side by side</h2>
<p>In addition to providing financial support, the federal government was instrumental in the development of Moderna’s vaccine for other reasons. Namely, federal scientists worked alongside Moderna scientists on different components of the vaccine.</p>
<p>These contributions included <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">working on dosing mechanisms</a>, and the NIH said federal scientists created the <a href="https://www.documentcloud.org/documents/6956323-NIH-Statement-to-Axios.html">stabilized spike proteins</a> that are a key component of the vaccine made by Moderna.</p>
<p>The importance of the role played by federal scientists in their work with Moderna would soon become apparent. A <a href="https://www.documentcloud.org/documents/6935295-NIH-Moderna-Confidential-Agreements.html#document/p105/a568569">2019 agreement</a> with a third party explicitly acknowledged this, alluding to mRNA vaccine candidates “developed and jointly owned by NIAID and Moderna.” And by late 2020, the U.S. government was calling it the “<a href="https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine">NIH-Moderna COVID-19 vaccine</a>.”</p>
<p>While the U.S. government has spent money on <a href="https://www.nytimes.com/2020/07/22/us/politics/pfizer-coronavirus-vaccine.html">COVID-19 vaccines</a> <a href="https://www.aha.org/news/headline/2021-03-10-federal-government-purchase-additional-100-million-doses-johnson-johnsons">made by other companies</a>, its close involvement in the R&D stages of Moderna’s sets it apart. </p>
<h2>How it became a patent dispute</h2>
<p>As development of the vaccine progressed, Moderna applied for <a href="https://www.modernatx.com/patents">several patents</a>, each one covering different components of the vaccine. U.S. law allows inventors to apply for patents on products or methods that are <a href="https://www.uspto.gov/patents/basics/general-information-patents">new, not obvious and useful</a>. While some early modern vaccines – like the <a href="https://www.history.com/this-day-in-history/salk-announces-polio-vaccine">polio vaccine</a> developed by Jonas Salk’s team – were <a href="https://slate.com/technology/2014/04/the-real-reasons-jonas-salk-didnt-patent-the-polio-vaccine.html">not covered</a> by patents, from the late 20th century onward <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3437006">it became very common</a> for one or multiple patents to cover a newly developed vaccine.</p>
<p>In applying for some patents related to its vaccine, Moderna named National Institute of Allergy and Infectious Diseases scientists as co-inventors alongside Moderna scientists. This was the case, for example, in a <a href="https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021159130">patent application</a> dated May 2020 for a relatively minor component of the vaccine. </p>
<p>However, in July 2021, Moderna made it clear that it would not name government scientists as co-inventors in a <a href="https://patentscope.wipo.int/search/docs2/wipocase/505ZsMDTUgVOqJF7T5XENxyO6tAyZyhu2VjKp25wWCc1G0VAtPuhbCFZOpp-d79HpUrKxDRzhZhLRGVvlDiE3NgLw3QMAP3mkUwKxrJkQHVT7e0ImBPSldyY2tt3-Whp1e5VI8D_InSWK-6CzQMToUJHq4SPXkX1vxlWCT95M8EOIXzWRp_Hq3nTwgotDaOmMXdDoeh8LkRUic82FMd7qN7ymc8Hgg_Rr94szG4fhkaukT6ahB2kq3Lf3fRyk06ellqMDBIo3z4aSa1jfU2VuBXr0Gd4_VguMOcIGyYWGHcTvAjdLob5BFLOj9ZE8HIGI4AtqeOF0idCAgbhj10sNw?filename=Letter_specifying_the_conditions_for_filing_under_37CFR1.97.pdf">patent application</a> covering a much more significant component of the vaccine: the mRNA sequence used to produce the vaccine, known as mRNA-1273.</p>
<p>Moderna’s position was that <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">Moderna scientists alone</a> had selected the sequence. The <a href="https://patentscope.wipo.int/search/docs2/wipocase/505ZsMDTUgVOqJF7T5XENxyO6tAyZyhu2VjKp25wWCc1G0VAtPuhbCFZOpp-d79HpUrKxDRzhZhLRGVvlDiE3NgLw3QMAP3mkUwKxrJkQHVT7e0ImBPSldyY2tt3-Whp1e5VI8D_InSWK-6CzQMToUJHq4SPXkX1vxlWCT95M8EOIXzWRp_Hq3nTwgotDaOmMXdDoeh8LkRUic82FMd7qN7ymc8Hgg_Rr94szG4fhkaukT6ahB2kq3Lf3fRyk06ellqMDBIo3z4aSa1jfU2VuBXr0Gd4_VguMOcIGyYWGHcTvAjdLob5BFLOj9ZE8HIGI4AtqeOF0idCAgbhj10sNw?filename=Letter_specifying_the_conditions_for_filing_under_37CFR1.97.pdf">company informed</a> the Patent and Trademark Office of its position in a 2020 statement.</p>
<p>In November 2021, government officials publicly challenged the company’s decision after months of <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">failed negotiations</a> with the company. Moderna then <a href="https://twitter.com/moderna_tx/status/1458896909008048131?s=20">took to social media</a> to defend its position, tweeting:</p>
<p>“Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine.”</p>
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<p>By contrast, the National Institutes of Health <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">argued that three NIAID scientists</a> – Kizzmekia Corbett, Barney Graham and John Mascola – had meaningfully contributed to the invention, though <a href="https://www.yahoo.com/now/dr-kizzy-breaks-silence-us-010000004.html">they’ve declined</a> to <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">publicly specify how</a>. If true, patent law says they <a href="https://www.uspto.gov/web/offices/pac/mpep/s2109.html">should be named co-inventors</a>. </p>
<p>But this dispute is not merely about scientific principles or technical aspects of the law. While patents are also regarded as proxies for measuring scientific reputation, their most immediate and powerful effect is to give patent holders a <a href="https://www.wipo.int/patents/en/">significant amount of control</a> over the covered technology – in this case, the main component of the vaccine made by Moderna.</p>
<p>From a practical perspective, excluding federal scientists from the application means that Moderna alone gets to decide how to use the vaccine, whether to license it and to whom. If, by contrast, the government co-owns the vaccine, <a href="https://www.law.cornell.edu/uscode/text/35/262">federal patent law allows</a> each of the joint owners to engage in a variety of actions – from making and selling the vaccine to licensing it – without the consent of the other owners.</p>
<p>This is especially relevant in cases of product scarcity or potential pricing issues in connection with the commercialization of the vaccine. For instance, the U.S. <a href="https://www.law.cornell.edu/uscode/text/35/262">would have the ability</a> to allow more manufacturers to produce vaccines using the mRNA-1273 technology. In addition, it could direct vaccine doses wherever it likes, including to <a href="https://ourworldindata.org/covid-vaccinations">lower-income countries that have received few vaccines so far</a>.</p>
<h2>Broader implications</h2>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A graphic shows how its mRNA technology works" src="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=968&fit=crop&dpr=1 600w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=968&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=968&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1216&fit=crop&dpr=1 754w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1216&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1216&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Moderna explains its mRNA technology.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/ModernaAnnouncesFundingAwardfromBARDAfor8MillionwithPotentialofupto125MilliontoAccelerateDevelopmentofZikaMessengerRNAmRNAVaccine/4b1115aa7055e766289234593ca164bb/photo?Query=mrna&mediaType=photo&sortBy=arrivaldatetime:asc&dateRange=Anytime&totalCount=23&currentItemNo=4">Business Wire</a></span>
</figcaption>
</figure>
<p>The ongoing battle between the government and an emerging star in the pharmaceutical industry is yet another episode in a complicated relationship between actors with complementary yet distinct roles in the production of drugs and vaccines.</p>
<p>On the one hand, the federal government <a href="https://www.science.org/content/article/data-check-us-government-share-basic-research-funding-falls-below-50">has long played a critical role</a> in both performing and funding basic research. On the other, it does not have the resources and capacity to bring most types of new drugs and vaccines to market on its own. </p>
<p>The pharmaceutical industry thus plays an important and necessary role in drug innovation, which I believe should be rewarded – although not boundlessly.</p>
<p>If the NIH is correct about co-ownership of the vaccine, then Moderna is unduly using a legal tool to achieve a position of market control – a reward it does not deserve. This position of sole control becomes even more problematic in light of the significant amounts of public money that funded the development of this vaccine. This offset some of Moderna’s financial risk, even as the <a href="https://investors.modernatx.com/static-files/24613a26-607a-4012-b0c2-df415ca09e36#page=6">company projects</a> to make $15 billion to $18 billion in revenue from vaccine sales in 2021 alone, with much more expected in 2022. </p>
<p>[<em>More than 140,000 readers get one of The Conversation’s informative newsletters.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-140K">Join the lists today</a>.]</p>
<p>However, even if the NIH prevails in the patent dispute, it is important to understand the limitations of such a “win.” The U.S. would be in a position to license the vaccine, for example, and could do so by requiring that licensees agree to equitable distribution of vaccine doses. </p>
<p>But co-ownership would not enable the government to fix any of the <a href="https://www.nature.com/articles/d41586-021-02383-z">other problems</a> that currently affect the manufacturing and distribution of COVID-19 vaccines, such as scaling up production or building infrastructure to deliver vaccine doses.</p>
<p>In my view, the dispute is a reminder of the <a href="https://healthcareglobal.com/procurement-and-supply-chain/challenges-vaccine-distribution-affecting-everyone">many</a> <a href="https://www.forbes.com/sites/edwardsegal/2021/01/26/new-vaccine-supply-and-distribution-problems-slow-fight-against-covid---and-provide-more-crisis-management-lessons/">problems</a> embedded in how vaccines are made and delivered in the U.S. And it shows that when taxpayers fund basic research of a drug, they deserve more of the control – and rewards – when that drug succeeds.</p><img src="https://counter.theconversation.com/content/172008/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Moderna claims its scientists alone invented the mRNA sequence used to produce its COVID-19 vaccine. The US government, which helped fund the drug, disagrees.Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1706212021-10-26T18:00:50Z2021-10-26T18:00:50ZOld wine in new bottles – why the NZ-UK free trade agreement fails to confront the challenges of a post-COVID world<figure><img src="https://images.theconversation.com/files/428374/original/file-20211025-23-ib3hi0.jpg?ixlib=rb-1.1.0&rect=26%2C0%2C8677%2C3727&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>When the sales pitch for a free trade agreement is that “British consumers will enjoy more affordable Marlborough sauvignon blanc, mānuka honey and kiwifruit, while Kiwis enjoy the benefit from cheaper gin, chocolate, clothing and buses”, you know this is hardly the deal of the century. </p>
<p>Indeed, the New Zealand-United Kingdom Free Trade Agreement (FTA) announced last Thursday would cause barely a blip on the radar of either country’s GDP – in New Zealand’s case, using the most optimistic projections, less than 0.3% of GDP in 15 years’ time.</p>
<p>Of course, there is more to it than that. Notably, it will impose significant longer-term regulatory constraints on future governments. Yet these barely rate a mention in the <a href="https://www.mfat.govt.nz/en/trade/free-trade-agreements/free-trade-agreements-under-negotiation/new-zealand-united-kingdom-free-trade-agreement/resources/agreement-in-principle/">Agreement in Principle</a> that summarises agreed outcomes and provides neither the full text nor politically inconvenient details.</p>
<p>These kinds of “trade agreements” have become Trojan horses for reaching ever further into countries’ domestic policy and regulatory processes and choices. </p>
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<h2>What Britain really wants</h2>
<p>The most extensive to date is the Trans-Pacific Partnership Agreement (TPPA), which became the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (<a href="https://www.mfat.govt.nz/vn/trade/free-trade-agreements/free-trade-agreements-in-force/comprehensive-and-progressive-agreement-for-trans-pacific-partnership-cptpp/">CPTPP</a>) in 2017, after the US withdrew and some of the most controversial items the US had insisted on were suspended (but not removed).</p>
<p>Britain now wants to join the CPTPP and needs New Zealand’s consent to do so. New Zealand’s price was a range of quotas and removal of tariffs on primary products, phased in over 15 years. In return, it would not seek more in Britain’s accession to CPTPP. </p>
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Read more:
<a href="https://theconversation.com/theres-a-lot-we-dont-know-about-the-uk-trade-agreement-we-are-about-to-sign-162841">There's a lot we don't know about the UK trade agreement we are about to sign</a>
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<p>That also meant the CPTPP was the starting point for the rules in the new FTA. This brought one clear plus. As it tried to do when renegotiating the TPPA, the New Zealand government insisted it would not accept investor-state dispute settlement (<a href="https://www.mfat.govt.nz/en/trade/free-trade-agreements/free-trade-agreements-in-force/comprehensive-and-progressive-agreement-for-trans-pacific-partnership-cptpp/understanding-cptpp/investment-and-isds/">ISDS</a>), whereby foreign investors can sue the government in pro-corporate offshore tribunals and seek huge damages for alleged breaches of broadly worded investor protections. </p>
<p>Readers will remember the Philip Morris <a href="https://www.theguardian.com/australia-news/2015/dec/18/australia-wins-international-legal-battle-with-philip-morris-over-plain-packaging">plain packaging dispute</a> that cost the Australian government many millions of dollars to win. The exclusion of ISDS is a victory for campaigners who highlighted the fiscal and policy risk of arming foreign investors with such tools. </p>
<p>However, those investor protections will remain available to enforcement at a country level under the NZ-UK FTA. </p>
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<h2>Patent monopolies still a problem</h2>
<p>The Agreement in Principle says neither country will need to change its CPTPP-compatible patent laws. That allows British-based pharmaceutical firms like AstraZeneca, Johnson & Johnson and Pfizer to invoke their patent monopolies to reap massive profits from life-saving COVID-19 vaccines and other health resources, often funded by public subsidies. It’s something a post-COVID agreement could and should have changed. </p>
<p>Likewise, more extensive commitments on government procurement and labour mobility appear to contradict the government’s post-COVID commitments to build local resilience through domestic production, and to train and employ New Zealand’s own workforce.</p>
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Read more:
<a href="https://theconversation.com/what-new-zealand-should-win-from-its-trade-agreement-with-post-brexit-britain-163423">What New Zealand should win from its trade agreement with post-Brexit Britain</a>
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<p>Some rules go further than the CPTPP, reinstating US demands that were suspended from the TPPA. The clearest example is extension of the copyright term to the author’s life plus 70 years. </p>
<p>That’s a gain for British media, entertainment and publishing firms and potentially a hit for our libraries, education system and theatres, depending on the exact terms. The agreement has an exception for the creative arts, but that does not apply to the intellectual property chapter. There is no explicit protection for Māori cultural or physical <a href="https://maoridictionary.co.nz/search?keywords=taonga">taonga</a>.</p>
<p>The vaunted clause on the Ngāti Toa haka <a href="https://www.ngatitoa.iwi.nz/ka-mate/the-origins-of-ka-mate">Ka Mate</a> (famously used by the All Blacks before Test matches) merely promises to “co-operate to identify ways” to advance its recognition and protection.</p>
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<h2>Big Tech a winner</h2>
<p>In several other areas the FTA adopts texts that are subject to controversial negotiations at the WTO and build on and extend the TPPA. Most notably, the digital trade chapter protects the rights of Big Tech to mine data and relocate it to wherever best facilitates its exploitation with minimal regulatory constraints, and to entrench its dominance over the digital domain.</p>
<p>Unlike the TPPA/CPTPP, the FTA includes similar rights over financial data in the hands of the UK’s massive financial services industry.</p>
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Read more:
<a href="https://theconversation.com/new-zealand-is-overdue-for-an-open-and-honest-debate-about-21st-century-trade-relations-160922">New Zealand is overdue for an open and honest debate about 21st-century trade relations</a>
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<p>The Agreement in Principle is suspiciously silent about prohibitions on the right of governments to require the disclosure of source codes and algorithms. This power is often essential to identify the nature and causes of digital harms and to prosecute them.</p>
<p>Nor does it address a crucial concern for Māori to protect their sovereignty over data and systems of digital governance to prevent foreign control of their whakapapa, the essence of Māori collective identity and being. Exceptions to these rules are limited, ambiguous and highly contestable.</p>
<h2>Light-handed regulation</h2>
<p>Other chapters might appear more benign, but are potentially as ominous. Two chapters deliberately lock in the failed neoliberal regulatory regime of the past 40 years. </p>
<p>The chapter on Good Regulatory Practice extends the CPTPP chapter on Regulatory Coherence, despite the latter becoming muted and unenforceable after vigorous pushback from developing countries’ negotiators. </p>
<p>It seems the FTA will require governments to maintain the current OECD-style regime that presumes light-handed pro-market regulation, supported by regulatory impact assessments and rights of affected commercial interests to pressure governments not to adopt measures they don’t support.</p>
<p>The complementary Domestic Regulation chapter imposes pro-market “disciplines” on licensing and technical standards (such as zoning, construction standards and water-testing requirements) and their administration across the whole economy.</p>
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Read more:
<a href="https://theconversation.com/the-uk-wants-to-join-a-pacific-trade-deal-why-that-might-not-be-a-risk-worth-taking-162900">The UK wants to join a Pacific trade deal – why that might not be a risk worth taking</a>
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<h2>A new paradigm is needed</h2>
<p>This comes at a time when New Zealand’s domestic regulatory regime urgently needs reform. The past four decades have seen multiple avoidable regulatory failures – often costing lives – in mining, forestry, ports, aged-care homes and warranting of unsafe motor vehicles.</p>
<p>Other failures have caused significant financial losses and distress, including leaky buildings and finance company collapses.</p>
<p>Of course, trade officials point to various exceptions and exclusions they say protect everything about which people might be concerned. But the governments’ refusal to release the FTA text until it is signed is a tacit acknowledgement that it won’t stand up to close scrutiny. </p>
<p>The price of allowing this FTA to proceed without open public and media debate is just too high. Another TPPA-style agreement will lock us into the failed neoliberal project of the 20th century at a time when we desperately need to discuss and develop a new paradigm that will confront the realities of a 21st century already beset with multiple, potentially existential crises.</p><img src="https://counter.theconversation.com/content/170621/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jane Kelsey is a Professor of Law at the University of Auckland. She has previously received funding from the Marsden Fund.</span></em></p>New Zealanders won’t see the full text of the UK free trade agreement until it is signed, meaning it will proceed without open public debate – despite locking in constraints on future governments.Jane Kelsey, Professor of Law, University of Auckland, Waipapa Taumata RauLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1656042021-08-05T20:09:22Z2021-08-05T20:09:22ZIf machines can be inventors, could AI soon monopolise technology?<figure><img src="https://images.theconversation.com/files/414478/original/file-20210804-12-yt1peg.jpg?ixlib=rb-1.1.0&rect=0%2C745%2C6000%2C3008&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>What does it mean to be an inventor?</p>
<p>In patent law, designed to protect the intellectual property of inventors, officials are used to thinking of inventors as humans, taking an “inventive step” – a new way of doing something, not obvious to a person skilled in the same art.</p>
<p>But last week, in a judicial world first, Australia’s Federal Court ruled an artificial intelligence (AI) system can be named as an inventor.</p>
<p>That judgement overturned a decision by the nation’s Commissioner of Patents that meant US scientist Stephen Thaler could not patent inventions by his AI system, DABUS (Device for Autonomous Bootstrapping of Unified Sentience).</p>
<p>Thaler says DABUS independently designed a fractal-shaped container for improved grip and heat transfer, and an emergency beacon that flashes more noticeably. So he can’t take credit as the actual inventor. </p>
<p>He has filed patent applications <a href="https://artificialinventor.com/patent-applications/">in 17 countries</a>, as permitted by the international Patent Cooperation Treaty. In the US, UK, Germany, Europe and Australia, the patent offices have not approved them. Patent office decisions are pending in 11 other countries. </p>
<p>Just one patent office has granted the patent: <a href="https://iponline.cipc.co.za/Default.aspx">South Africa’s</a> Companies and Intellectual Property Commission, which published the Thaler patent on July 28, two days before the Australian Federal Court ruling.</p>
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<a href="https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="An extract from Stephen Thaler's patent application for a 'Food container and devices and methods for attracting attention' on behalf of the inventor, DABUS." src="https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=489&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=489&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=489&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=615&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=615&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414515/original/file-20210804-17-1f5t3p4.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=615&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">An extract from Stephen Thaler’s patent application for a ‘Food container and devices and methods for attracting attention’ on behalf of the inventor, DABUS.</span>
<span class="attribution"><a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
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<p>So Australia is not the world’s first nation to allow a machine to be named as inventor. But the South African patent office granted the patent because its <a href="https://www.iam-media.com/patents/sa-ai-patent-grant-attack-vulnerable">practice</a> prevented examination of inventorship and ownership.</p>
<p>Accordingly, the ruling of the Federal Court — to which Thaler appealed the Patent Commissioner’s decision — is a world first in terms of a court ruling in favour of AI as an inventor in its own right. </p>
<h2>A machine can invent, but can’t own its invention</h2>
<p>The specific reasons why most patent offices have rejected Thaler’s application differ according to the wording of legislation and how patents officials have interpreted the rules. </p>
<p>But there are some common themes. In the case of the UK and Australian patent offices, the main stumbling block was not that the examiners couldn’t accept a machine could invent something; it was that they did not see how a machine could own what it invented.</p>
<p>This issue of ownership is essential to the patent process. It requires, in cases where the applicant is different to the inventor, that the applicant show they have properly obtained ownership — or “title” — from the inventor. </p>
<p>The patent offices rejected Thaler’s application on the basis DABUS, as a machine, couldn’t “hold” title or pass it to Thaler, who didn’t want to name himself as the inventor because he didn’t do the inventing.</p>
<p>The English and Australian patent offices also argued the wording of their respective patent laws suggested an inventor needed to be human. The US and European offices also made this argument.</p>
<h2>Why Australia’s Federal Court ruled for AI</h2>
<p>But Australian Federal Court judge Jonathan Beach ruled, at least when it comes to Australia, <a href="https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca0879">this is not the case</a>. </p>
<p>In overturning interpretation made by Australia’s Commissioner of Patents, Justice Beach said the patents legislation did not require the inventor to hold title, or pass it to the applicant. It simply required the applicant to receive title in a way the law recognises — like, for example, a dairy farmer receives “title” in their cows’ milk. </p>
<p>Thaler received title because he owned and controlled DABUS, its code, and he possessed DABUS’ output: the invention. </p>
<p>Justice Beach noted his interpretation served the rationale of the Patents Act, which is to incentivise innovation. Without taking this view, the “odd outcome” would be that DABUS’ invention was not owned, and was unpatentable. There would therefore be a patent black hole for AI-generated inventions. </p>
<h2>Fears of AI monopolising technology</h2>
<p>For now, Justice Beach’s decision means Australia and South Africa are the only two countries in the world accepting AI as inventors. </p>
<p>That won’t necessarily be the case for long, depending on the outcome of Thaler’s UK legal challenge against the decision of the High Court of Justice. The <a href="https://www.judiciary.uk/publications/thaler-v-the-comptroller-general-of-patents-designs-and-trademarks/">Court of Appeal</a> is due to hand down a decision on the appeal in October. Thaler is also making legal challenges against the decisions of the <a href="https://www.uspto.gov/sites/default/files/documents/16524350_22apr2020.pdf">US Patent and Trademark Office</a> and the <a href="https://register.epo.org/application?documentId=E4B63SD62191498&number=EP18275163&lng=en&npl=false">European Patent Office</a>. </p>
<p>If these other courts decide differently to Justice Beach, it could mean Australia and South Africa become beacons for the lodging of AI-invented patents. This would not be the bonus it might seem. It could leave local companies having to pay even more to use patented foreign inventions.</p>
<p>But what if other jurisdictions do follow Australia’s lead? </p>
<p>There are concerns that accepting machines as inventors could, as Melbourne Law School senior fellow Mark Summerfield has warned, create an avalanche of “<a href="https://www.iam-media.com/law-policy/australia-court-decision-dabus">automated patent generators</a>” monopolising technology. </p>
<p>This would further entrench the dominance of tech companies for whom AI is central, such as Google, Apple, Facebook, Amazon and Alibaba. As University College Cork economist Wim Naudé, has written, these platforms have a huge first-mover advantage in AI, “turning them into monopolists and gatekeepers”. </p>
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Read more:
<a href="https://theconversation.com/artificial-intelligence-governments-see-huge-business-potential-but-ignore-the-downsides-164645">Artificial intelligence: governments see huge business potential, but ignore the downsides</a>
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<p>Summerfield has argued restricting the notion of invention to humans is the “primary legal barrier” to prevent this.</p>
<h2>Phantom fears</h2>
<p>But there are three reasons to agree with Justice Beach that such fears are a “phantom”. </p>
<p>First, to get a patent an invention must satisfy a stringent range of requirements. Applicants must prove, among other things, the invention has “worldwide novelty” and involves an inventive step.</p>
<p>Second, patents are expensive. It’s not like speculating on a domain name. The cost of a PCT patent in 10 jurisdictions is <a href="https://www.business.qld.gov.au/running-business/ip/types/patents/applying">about A$150,000</a> plus maintenance fees. This is a big disincentive to abusing the patents system. </p>
<p>Finally, since 2019, patent owners are <a href="https://www.accc.gov.au/publications/guidelines-on-the-repeal-of-subsection-513-of-the-competition-and-consumer-act-2010-cth">subject to anti-monopoly laws</a>, so the competition watchdog, the Australian Competition and Consumer Commission, can take action against those seeking to abuse intellectual property rights to stifle competition. </p>
<p>So this patent decision is not <a href="https://www.technologyreview.com/2015/02/11/169210/our-fear-of-artificial-intelligence/">AI-mageddon</a>.</p>
<p>But as with all things AI, caution is prudent. </p>
<p>As the <a href="https://futureoflife.org/ai-open-letter/">Open Letter on Artificial Intelligence</a> signed by Stephen Hawking, Elon Musk and many others involved in AI research says, more research on AI needed “to reap its benefits while avoiding potential pitfalls”.</p><img src="https://counter.theconversation.com/content/165604/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Amanda-Jane George does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The Federal Court of Australia has made a world-first ruling in favour of granting a patent to an artificial intelligence. But what comes next?Amanda-Jane George, Postgraduate Research Coordinator, Senior Lecturer in Innovation & Intellectual Property Law, School of Business and Law, CQUniversity AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1656232021-08-05T09:18:24Z2021-08-05T09:18:24ZIn a world first, South Africa grants patent to an artificial intelligence system<figure><img src="https://images.theconversation.com/files/414762/original/file-20210805-23-ndaih5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">"Creativity machines" are capable of independent and complex functioning, so they can invent things.</span> <span class="attribution"><span class="source">Blue Planet Studio/Shutterstock</span></span></figcaption></figure><p>At first glance, a <a href="https://iponline.cipc.co.za/Publications/PublishedJournals/E_Journal_July%202021%20Part%202.pdf">recently granted South African patent</a> relating to a “food container based on fractal geometry” seems fairly mundane. The innovation in question involves interlocking food containers that are easy for robots to grasp and stack.</p>
<p>On closer inspection, the patent is anything but mundane. That’s because the inventor is not a human being – it is an artificial intelligence (AI) system called DABUS.</p>
<p>DABUS (which stands for “device for the autonomous bootstrapping of unified sentience”) is an AI system created by <a href="https://imagination-engines.com/founder.html">Stephen Thaler</a>, a pioneer in the field of AI and programming. The system simulates human brainstorming and creates new inventions. DABUS is a particular type of AI, often referred to as “<a href="https://imagination-engines.com/cm.html">creativity machines</a>” because they are capable of independent and complex functioning. This differs from everyday AI like Siri, the “voice” of Apple’s iPhones.</p>
<p>The patent application listing DABUS as the inventor was filed in patent offices around the world, including the US, Europe, Australia, and South Africa. But only South Africa granted the patent (Australia followed suit a few days later after a <a href="https://www.ipwatchdog.com/2021/08/02/dabus-scores-win-ai-inventorship-question-australia-court/id=136304/">court judgment</a> gave the go-ahead). </p>
<p>South Africa’s decision has received widespread backlash from intellectual property experts. Some have labelled it a <a href="https://www.iam-media.com/law-policy/south-africa-ai-patent-award">mistake</a>, or an <a href="https://www.mathys-squire.com/insights-and-events/news/south-africa-issues-worlds-first-patent-naming-ai-as-inventor/">oversight</a> by the patent office. However, as a <a href="https://law.ukzn.ac.za/team/mr-meshandren-naidoo/">patent and AI scholar</a> whose PhD aims to address the <a href="https://osf.io/7uctg/">gaps in patent law – as I examine in this pre-print article –</a> created by AI inventorship, I suggest that the decision is supported by the government’s policy environment in recent years. This has aimed to increase innovation, and views technology as a way to achieve this.</p>
<h2>Creativity machines</h2>
<p>Creativity machines can process and critically analyse data, learning from it. This process is known as <a href="https://www.sas.com/en_za/insights/analytics/machine-learning.html">machine learning</a>. Once the machine learning phase has occurred, the machine is able to “autonomously” create without human intervention. As has been seen in the <a href="https://www.techrepublic.com/article/how-ai-is-being-used-for-covid-19-vaccine-creation-and-distribution/">COVID pandemic</a>, as just one example, AI is able to solve problems <a href="https://www.nature.com/articles/d41586-020-03348-4">humans were unable to</a> – and also <a href="https://www.forbes.com/sites/forbestechcouncil/2019/10/03/are-ai-systems-about-to-outperform-humans/?sh=2f59905722b3">much faster</a> than people can.</p>
<p>Over the years there have been many kinds of creativity machines. Prior to DABUS, Thaler built another AI which created <a href="https://imagination-engines.com/history.html">novel sheet music</a>, and which he credited with inventing the <a href="https://imagination-engines.com/history.html">cross-bristle toothbrush design</a>. He filed a patent for the cross-bristle design, and it was granted – proving AI’s ability to generate truly novel inventions that meet the standards for patents. However, Thaler listed himself, rather than the AI, as the inventor at that time.</p>
<p>When it came to the food container invention by DABUS, Thaler, assisted by Ryan Abbott of the University of Surrey, decided instead to list DABUS as the rightful inventor, as the invention was entirely devised by the AI. This was the start of their push for AI to be recognised as inventors the world over. </p>
<p>The <a href="https://www.uspto.gov/">United States Patent and Trademark Office</a> and the <a href="https://www.epo.org/">European Patent Office</a> rejected these applications in the formal examination phase. They gave three reasons. First, their respective patent laws only provide for human inventors – not AI – as indicated by the use of pronouns such as “him” and “her” in their text. Second, ideas, for the purposes of patents, require the element of “mental conception” – something of which only a human mind is capable. Finally, inventorship comes with rights, which AI is not legally capable of possessing.</p>
<p>Much to the <a href="https://www.iam-media.com/law-policy/south-africa-ai-patent-award">surprise of the global community</a>, South Africa’s patent office, the <a href="http://www.cipc.co.za/za/">Companies and Intellectual Property Commission</a>, granted the patent, recognising DABUS as an inventor. It has not yet explained its reasons for doing so. </p>
<p>This patent was <a href="https://iponline.cipc.co.za/Publications/PublishedJournals/E_Journal_July%202021%20Part%202.pdf">published</a> in July 2021 in the South African Patent Journal, with major news agencies including <a href="https://www.thetimes.co.uk/article/patently-brilliant-ai-listed-as-inventor-for-first-time-mqj3s38mr">The Times reporting on the matter</a>.</p>
<p>The granting of the DABUS patent in South Africa has received widespread backlash from intellectual property experts. The critics argued that it was the incorrect decision in law, as AI lacks the necessary legal standing to qualify as an inventor. <a href="https://www.iam-media.com/law-policy/south-africa-ai-patent-award">Many have argued</a> that the grant was simply an oversight on the part of the commission, which has been known in the <a href="https://researchspace.ukzn.ac.za/bitstream/handle/10413/19131/Naidoo_Meshandren_2020.pdf?sequence=1&isAllowed=y">past to be less than reliable</a>. Many also saw this as an indictment of South Africa’s patent procedures, which currently only consist of a formal examination step. This requires a check box sort of evaluation: ensuring that all the relevant forms have been submitted and are duly completed. </p>
<p>Critics feel that if South Africa instead had a substantive search and examination system in place, the DABUS patent application would have been rejected.</p>
<p>I disagree. </p>
<h2>Enabling policy environment</h2>
<p>While it is possible that the commission erred in granting the patent, South Africa’s policy environment in recent years suggests otherwise. </p>
<p>The first relevant policy was the <a href="https://www.gov.za/sites/default/files/gcis_document/201808/ippolicy2018-phasei.pdf">Intellectual Property Policy of the Republic of South Africa Phase I of 2018</a>. It marked the beginning of patent reform in the country. Since then, from 2019 to 2021, three other notable instruments have been published: the <a href="https://www.dst.gov.za/images/2019/White_paper_web_copyv1.pdf">Department of Science and Technology’s White Paper on Science, Technology, and Innovation</a>; <a href="https://www.gov.za/sites/default/files/gcis_document/202010/43834gen591.pdf">the Presidential Commission on the Fourth Industrial Revolution</a>; and the proposed <a href="https://www.gov.za/sites/default/files/gcis_document/202104/44389gon206.pdf">National Data and Cloud Policy in terms of the Electronic Communications Act 36 of 2005</a>.</p>
<p>The core message of all these documents is that South Africa’s government wants to increase innovation to solve the country’s socio-economic issues. There is clear worry about issues such as poor innovation levels, lack of funding and lack of suitable infrastructure which is necessary to really capitalise on the fourth industrial revolution. </p>
<p>Given the policy environment and the vast potential of AI, the granting of the patent makes sense. Perhaps this will turn out to be a strategic masterclass by the South African office which will lead to a much more innovative nation.</p><img src="https://counter.theconversation.com/content/165623/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Meshandren Naidoo receives funding from the National Research Foundation. He is affiliated with the African Health Research and Ethics Flagship at the University of KwaZulu-Natal. </span></em></p>The decision is supported by the government’s policy environment in recent years. This has aimed to increase innovation, and views technology as a way to achieve this.Meshandren Naidoo, PhD Fellow, University of KwaZulu-NatalLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1652512021-08-01T09:10:59Z2021-08-01T09:10:59ZResearch and development are key to resilient food systems in Africa<figure><img src="https://images.theconversation.com/files/413527/original/file-20210728-13-1t4jblc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Innovation in food systems and agricultural research is critical for African countries.</span> <span class="attribution"><span class="source"> krumanop/Shutterstock</span></span></figcaption></figure><p>What will it take to build sustainable, resilient food systems in African countries? This was among the questions considered at the 2021 <a href="https://www.unfoodsystems.org/">United Nations Food Systems Pre-Summit</a> in late July. The summit, the first of its kind in this century, aims to identify bold, innovative actions, with measurable outcomes. These actions are needed to achieve many of the Sustainable Development Goals in what the UN has dubbed the “<a href="https://www.sustainablegoals.org.uk/the-decade-of-action/#:%7E:text=In%20September%202019%2C%20the%20United,universal%20and%20inclusive%202030%20Agenda.">Decade of Action</a>”. </p>
<p>African ministers of agriculture met before the summit to discuss the continent’s common position. Among the issues they tabled was using agriculture to reduce poverty, particularly for women and youth. We want to contribute to the African common position by flagging the importance of technical innovation and the role of agricultural research and development (R&D) in building the food systems the continent needs.</p>
<p>When agriculture grows, there are benefits across the board. Its extensive linkages with the off-farm stages of the agrifood system and non-farm sectors expand employment and livelihoods in the rest of the economy. High farm production growth in sub-Saharan Africa since 2000 has <a href="https://openknowledge.worldbank.org/bitstream/handle/10986/32350/9781464813931.pdf">contributed to high overall economic growth</a> and improvements in the welfare of most people in the region. But <a href="https://science.sciencemag.org/content/372/6546/1045">approximately 75%</a> of Africa’s agricultural production growth resulted from area expansion and only 25% from yield improvements. This is not sustainable in the long run: <a href="https://www.sciencedirect.com/science/article/pii/S0306919214000761">90% of Africa’s available arable land is located in eight countries</a>. Many of these countries are fragile states. </p>
<p>The future livelihoods of millions of land-constrained African farmers <a href="https://science.sciencemag.org/content/372/6546/1045">will depend on raising the productivity of existing farmland</a>. Technical innovation is key to raising yields and productivity. This sort of innovation comes from continuous investments in agricultural R&D and extension systems. Examples include higher yielding seed varieties, mechanisation, improved soil management and conservation practices. Profitable and efficient fertiliser use is also critical.</p>
<h2>Spending below target</h2>
<p>In 2006 African leaders met in Khartoum, Sudan and pledged to allocate 1% of agricultural GDP to R&D. However, most countries in sub-Saharan Africa have <a href="https://doi.org/10.4060/cb4492en">failed to achieve this target</a>. The average <a href="https://openknowledge.worldbank.org/bitstream/handle/10986/32350/9781464813931.pdf?sequence=6&isAllowed=y">for sub-Saharan African countries is only 0.38%</a>.</p>
<p>We examined the International Food Policy Research Institute’s <a href="http://www.asti.cgiar.org/">Agricultural Science and Technology Indicators</a> database for more nuanced detail. It revealed that, for the latest available year, only six of the 40 sub-Saharan African countries tracked – Botswana, Cabo Verde, Mauritius, Namibia, South Africa and Zimbabwe – spent more than 1% of agricultural GDP on agricultural R&D. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=862&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=862&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=862&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1084&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1084&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413530/original/file-20210728-17-1rt4q1s.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1084&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><span class="source">Data from the Agricultural Science and Technology Indicators, International Food Policy Research Institute</span></span>
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<p>As a continent, Africa has set a target and made a political commitment. It needs to get serious about achieving this target. Governments must identify and address the factors constraining their ability to achieve the 1% target. The consequence of not achieving it includes constrained productivity and limited transformation of Africa’s agricultural sector. Ultimately, it also means slower progress in reducing poverty and food insecurity. </p>
<h2>Innovation at all stages</h2>
<p>While it’s a necessary condition, increased R&D spending alone is certainly not sufficient. It’s also important for African countries to produce agricultural innovations and technologies at all levels of the food system. </p>
<p>An interesting pattern emerges when looking at the number of <a href="https://www3.wipo.int/ipstats/pmhindex.htm?tab=pct&lang=en">published patents by Africans in Africa</a> across two decades: 2000-2009 and 2010-2019. In fields of technologies with greater on-farm application, the <a href="https://www3.wipo.int/ipstats/pmhindex.htm?tab=pct&lang=en">number of patents</a> published increased between the two decades. </p>
<p>For example, in biotechnology and environmental technology, the number of patents published increased from 133 to 200 and from 197 to 212, respectively.</p>
<p>However, in fields with greater technology application in downstream levels of the food system, the number of patents published tended to decline between the two decades. In food chemistry this number fell from 216 to 190. Handling technologies saw a significant decline in the number of patents published, from 650 in 2000-2009 to 264 in 2010-2020. </p>
<p>Ultimately, Africa’s food system needs to produce healthy and nutritious food that meets the standards of the global end consumer. Innovation at every level of the food system is crucial to achieving this objective. </p>
<p>In addition, beyond the hard sciences, we need to think differently about which disciplines contribute to the adoption of agricultural innovations at scale. People don’t typically think of the social sciences and humanities when discussing agricultural R&D. In general, investments in these disciplines tend to be a small share of gross domestic expenditure on R&D. This trend needs to be reversed.</p>
<p>Social scientists can achieve two important goals in the food system. First, they can provide relevant evidence to support decision-making. After all, these disciplines are centred on the study of what motivates decision makers. </p>
<p>Second, social scientists can provide concrete evidence to policymakers on how alternative national agricultural investments will affect welfare. They are able to facilitate dialogue between stakeholders to set priorities, shape research agendas, and build coalitions of support on the way forward. For example, they can help to create platforms or dialogue spaces that ensure global research institutions do not crowd out local institutions and instead work collaboratively with them to share knowledge.</p>
<h2>Sustainable solutions</h2>
<p>Agricultural R&D focused on farm productivity is critical. However, resilience and sustainability of the entire food system will be enhanced by public investments that include technologies relevant to the downstream stages of the food system, too. </p>
<p>And in the conversation on R&D, let’s not forget the role social scientists can play in helping policymakers appreciate the actions needed to achieve their national objectives. The combination of strengthened R&D for the food system and stronger local policy analysis will certainly help Africa realise its “Decade of Action”.</p><img src="https://counter.theconversation.com/content/165251/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Wandile Sihlobo is the Chief Economist of the Agricultural Business Chamber of South Africa (Agbiz), and also a member of the South African President's Economic Advisory Council (PEAC).</span></em></p><p class="fine-print"><em><span>Lulama Ndibongo Traub and Thomas Jayne do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Stronger agricultural R&D systems will enable agriculture to power Africa’s transformation.Lulama Ndibongo Traub, Technical Chair, Regional Network of Agricultural Policy Research Institutes (ReNAPRI), Stellenbosch UniversityThomas Jayne, MSU Foundation Professor, Agricultural, Food and Resource Economics, Michigan State UniversityWandile Sihlobo, Visiting Research Fellow, Wits School of Governance, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1625762021-06-17T18:04:38Z2021-06-17T18:04:38ZToo few women get to invent – that’s a problem for women’s health<figure><img src="https://images.theconversation.com/files/406880/original/file-20210616-15-bv772g.jpg?ixlib=rb-1.1.0&rect=1112%2C0%2C3622%2C2301&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Inequality has cost women the benefits of thousands of "lost" medical inventions.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/researcher-in-hematology-lab-portrait-royalty-free-image/516052151">Ron Levine/Stone via Getty Images</a></span></figcaption></figure><p>MacArthur Genius and MIT professor Linda Griffith has built an <a href="https://scholar.google.com/citations?user=gZ-RhocAAAAJ&hl=en">epic career</a> as a scientist and inventor, including growing a human ear on a mouse. She now spends her days unpacking the <a href="https://www.nytimes.com/2021/04/27/health/endometriosis-griffith-uterus.html">biological mechanisms underlying endometriosis</a>, a condition in which uterus-like tissue grows outside of the uterus. Endometriosis can be brutally painful, is regularly misdiagnosed and misunderstood, and has affected Griffith’s life along with the lives of over 6 million other women in the U.S. </p>
<p>Griffith’s research and inventions have the potential to improve women’s health dramatically. The problem for women is that she stands out for another reason: She’s female. In 2020, <a href="https://www.uspto.gov/ip-policy/economic-research/publications/reports/progress-potential">only 12.8% of U.S. inventors</a> receiving patents were women, and historically male researchers have ignored conditions like endometriosis. </p>
<p>Male researchers have tended to downplay or even outright overlook the medical needs of women. The result is that innovation has focused mainly on what men choose to research. My colleagues <a href="https://scholar.google.com/citations?user=ZboIq6YAAAAJ&hl=en">John-Paul Ferguson</a>, <a href="https://scholar.google.com/citations?user=GXbzIdkAAAAJ&hl=en">Sampsa Samila</a> and <a href="https://scholar.google.com/citations?user=sChrXHUAAAAJ&hl=en">I</a> show in a newly published study that patented biomedical inventions in the U.S. created by women are <a href="https://doi.org/10.1126/science.aba6990">35% more likely to benefit women’s health</a> than biomedical inventions created by men.</p>
<h2>Bias by the numbers</h2>
<p>To determine which inventions are female-focused, male-focused or neutral, we analyzed the title, abstract and start of the summary text from 441,504 medical patents using the National Library of Medicine’s <a href="https://ii.nlm.nih.gov/MTI/">Medical Text Indexer</a>. The indexer uses machine learning to categorize the subject of a text document, including whether it has a female or male focus.</p>
<p>Our data reveal that inventions by research teams that are primarily or completely composed of men are significantly more likely to focus on the medical needs of men. In 34 of the 35 years from 1976 to 2010, male-majority teams produced hundreds more inventions focused on the needs of men than those focused on the needs of women. These male inventors were more likely to generate patents that addressed topics like “erectile” or “prostate” than “menopause” or “cervix.” Male inventors also tended to target diseases and conditions like Parkinson’s and sleep apnea that disproportionately affect men.</p>
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<p>Conversely, inventions patented by research teams that are primarily or completely composed of women were more likely to be focused on the needs of women in all 35 years of our data. These patents are more likely to address conditions like breast cancer and <a href="https://www.mayoclinic.org/diseases-conditions/postpartum-preeclampsia/symptoms-causes/syc-20376646">postpartum preeclampsia</a> and diseases that disproportionately affect women like <a href="https://www.mayoclinic.org/diseases-conditions/fibromyalgia/symptoms-causes/syc-20354780">fibromyalgia</a> and lupus. However, in 1976 only 6.3% of patents were invented by teams with as many women as men. By 2010 that figure had risen to only 16.2%. As a result, while inventions by women were more likely to be female-focused, such patents were uncommon because so few inventors were women.</p>
<p>We found that across inventor teams of all gender mixes, biomedical invention from 1976 to 2010 focused more on the needs of men than women. Our calculations suggest that had male and female inventors been equally represented over this period, there would have been an additional 6,500 more female-focused inventions. In percentage terms, equal representation would have led to 12% more female-focused inventions.</p>
<h2>Looking out for women’s needs</h2>
<p>There are also more subtle benefits when more women invent. Female inventors are more likely to identify how existing treatments for non-sex-specific diseases like heart attacks, diabetes and stroke can be improved and adapted for the needs of women. Indeed, women are more likely to test whether their ideas and inventions <a href="https://doi.org/10.1038/s41562-017-0235-x">affect men and women differently</a>: for example, if a drug has more adverse side effects in women than in men. </p>
<p>In our study, we found that even within narrow disease areas like <a href="https://www.hopkinsmedicine.org/health/conditions-and-diseases/atrial-flutter">atrial flutter</a>, women are still more likely to see opportunities to target their inventions for the specific health needs of women. Our results suggest that increasing representation should address these <a href="https://www.penguin.co.uk/books/111/1113605/invisible-women/9781784706289.html">invisible biases</a>.</p>
<p>The growing number of female inventors is starting to close the gap. In three of the five years from 2006 to 2010, the U.S. granted more female- than male-focused patents. In fact, since 2010, there has been a boom in female-founded startups building new and disruptive women’s health products ranging from <a href="https://www.economist.com/business/2018/03/31/a-long-overdue-disruption-in-menstrual-products">new types of period underwear</a> to <a href="https://www.marieclaire.co.uk/life/work/femtech-innovators-revolutionising-womens-health-700549">smart breast pumps</a>.</p>
<h2>Mind the gaps</h2>
<p>Increasing the proportion of inventors who are women is important for improving women’s health care, but simply increasing the number of female scientists isn’t enough. It’s also the case that female scientists <a href="https://doi.org/10.1126/science.1124832">are 40% less likely</a> to commercialize their research ideas than male scientists. The causes of this gender gap are myriad, from <a href="https://doi.org/10.1093/icc/dtm021">differences in mentoring</a> to <a href="https://doi.org/10.3386/w28882">biases in the early-stage feedback</a> women receive when trying to commercialize female-focused ideas. </p>
<p>No matter the underlying causes, the result is that while nearly 33% of published scientific discoveries were produced by majority-female research teams in 2010, only 16.2% of patents were invented by majority-female inventor teams in the same year. As with invention, we found that scientific discoveries by female scientists as measured by published research papers are 12% more likely to benefit women than discoveries by men. At least in the short term, helping female scientists commercialize their current research should boost the number of female inventors and the number of female-focused inventions. </p>
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<figcaption><span class="caption">Dr. Patricia Bath, inventor of a laser treatment to remove cataracts.</span></figcaption>
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<p>More generally, our findings highlight how demographic inequities in who gets to invent lead to demographic inequities in who benefits from invention. Recent work shows how <a href="https://doi.org/10.1257/aer.20181446">increasing the number of Black physicians benefits Black patients</a>, and more generally the benefits of <a href="https://theconversation.com/minority-patients-benefit-from-having-minority-doctors-but-thats-a-hard-match-to-make-130504">matching minority patients with minority physicians</a>. This suggests the world doesn’t just need more inventors like MIT’s Griffith, but also more inventors like Dr. Patricia Bath, <a href="https://www.nytimes.com/2019/06/04/obituaries/dr-patricia-bath-dead.html">the first Black woman to receive a U.S. medical patent</a>. Bath’s invention, a laser treatment to remove cataracts, was inspired by her observation that Black Americans were twice as likely as white Americans to suffer from blindness. </p>
<p>Be it gender or race, biases in who gets to conduct research and commercialize inventions is more than a matter of who gets to play. It’s also a matter of who benefits from the march of progress.</p>
<p>[<em>The Conversation’s science, health and technology editors pick their favorite stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-favorite">Weekly on Wednesdays</a>.]</p><img src="https://counter.theconversation.com/content/162576/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rem Koning does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Boosting the number of female inventors isn’t just a matter of fairness. Inventions by men are more likely to ignore women’s needs.Rem Koning, Assistant Professor of Business Administration, Harvard UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1608612021-05-17T02:44:00Z2021-05-17T02:44:00Z‘Patent boxes’ are said to boost innovation. The evidence says they don’t<p>On budget night federal Treasurer Josh Frydenberg announced Australia is getting its own “patent box”.</p>
<p>What is a patent box? </p>
<p>Despite its odd name, it is a relatively straightforward concept. It means <a href="https://www.industry.gov.au/data-and-publications/patent-box-policies">lowering the tax rate</a> on all income derived from patents registered in a nation. About half the members of the European Union, Britain and China are among those to adopt patent boxes in some form.</p>
<p>Australia’s patent box scheme will initially be limited to medical and biotechnology patents, but with scope to expand it down the track.</p>
<p>If a company has a drug patent, for example, the profit from selling that drug will be taxed at a rate of 17%, instead of the usual company tax rate (now 25% for companies with an annual turnover less than A$50 million and 30% for those with more).</p>
<p>In <a href="https://joshfrydenberg.com.au/latest-news/budget-2021-2022/">his budget speech</a> Frydenberg cited world-leading Australian innovations such as Wi-Fi, the Cochlear bionic ear and a vaccine for cervical cancer. “We want to see more innovation commercialised in Australia,” he said.</p>
<p>Will the patent box help? The evidence from overseas is not promising.</p>
<h2>Another race to the bottom</h2>
<p>A 2015 <a href="https://ec.europa.eu/taxation_customs/sites/taxation/files/resources/documents/taxation/gen_info/economic_analysis/tax_papers/taxation_paper_57.pdf">European Commission report</a> examined the effect of patent boxes on 2,000 companies in 12 countries from 2000 to 2011. It found the patent boxes benefited companies financially but had limited effect on increasing local research & development. </p>
<p>To take advantage of the lower tax rate, multinational companies filed more patents in these countries with patent boxes than previously. But they didn’t change the location of their research teams.</p>
<p>The European Commission report noted fears about patent boxes sparing another “race to the bottom” in corporate taxation, with nations competing to be more attractive to foreign companies. If one country had more preferential tax rates, it would attract more patent filings. If other nations followed suit, the only real beneficiaries would be the multinational corporations using the schemes to reduce their tax obligations “without a change in real research activity”</p>
<p>Its results, the report concluded, “confirm these fears”.</p>
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Read more:
<a href="https://theconversation.com/how-to-get-the-most-out-of-research-when-universities-and-industry-team-up-156590">How to get the most out of research when universities and industry team up</a>
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<h2>Australian warnings</h2>
<p>This all should be known to the Australian government.</p>
<p>A <a href="https://www.industry.gov.au/sites/default/files/May%202018/document/pdf/patent_box_policies.pdf?acsf_files_redirect">2015 report</a> from Australia’s Office of the Chief Economist came to a similar conclusion to the European Commission study.</p>
<p>Introducing a patent box might lead to more patents being filed in Australia, it said, but they would mostly be ones derived from research and development done overseas. It warned:</p>
<blockquote>
<p>The most important cost associated with the implementation of a patent box regime is a fall in tax revenues collected from innovative companies. Since the fall is likely to exceed revenues collected from (re)allocation of IP income to Australia, the overall return of a patent box regime is likely to be negative.</p>
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<p>IP Australia, the federal agency administering intellectual property rights, detailed the poor record of patent boxes in its submission to the federal parliament’s <a href="https://www.aph.gov.au/ResearchandInnovation">Inquiry into Australia’s Future in Research and Innovation</a> in 2016. It said the literature on such schemes found little if any benefit for actual innovation, at great cost to taxpayers.</p>
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Read more:
<a href="https://theconversation.com/money-for-telescopes-and-vaccines-is-great-but-the-budgets-lack-of-basic-science-funding-risks-leaving-australia-behind-160780">Money for telescopes and vaccines is great, but the budget's lack of basic science funding risks leaving Australia behind</a>
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<h2>Bad plan, bad design</h2>
<p>On top of all this, Frydenberg’s proposed patent box is poorly targeted. </p>
<p>Ideally the subsidy should only apply to new patents - or better yet, new inventions. But the scheme will allow the lower tax rate on all patents, even if they were granted many years ago or are no longer owned by their original inventor. </p>
<p>This means in its first year alone the patent box is set to deliver a $100 million gift to companies sitting on old patents without any actual new innovation.</p>
<p>Even if you want to subsidise innovation, it makes zero sense to subsidise old patents. Other countries have avoided this pitfall by limiting the subsidy to new ones. </p>
<p>In short, a patent box is good in theory but bad in practice; and the design of the Australian government’s patent box is particularly bad. It will likely end up being just another way multinational companies can avoid paying tax.</p><img src="https://counter.theconversation.com/content/160861/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Isaac Gross does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Lowering the tax rates on profits from patents registered in Australia is unlikely to increase local research and development. But it will be a gift for multinationals.Isaac Gross, Lecturer in Economics, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1608022021-05-12T14:56:17Z2021-05-12T14:56:17ZPush for COVID-19 vaccine patent waiver isn’t a panacea: but it could nudge companies to share<figure><img src="https://images.theconversation.com/files/400295/original/file-20210512-19-32xcql.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>A new proposal, this time from the US, on how to open up access to vaccines against COVID-19 by relaxing patent rights, has added to an already complex and fraught debate between the World Trade Organisation’s 164 members. </p>
<p>In early May, the US took the world by surprise when it <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">announced</a> that Washington supported an exemption from the World Trade Organisation intellectual property (IP) rules protecting vaccines. The waiver would allow each state to authorise the production of patented vaccines without the consent of the pharmaceutical companies holding the patent.</p>
<p>South Africa and India originally proposed an <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext">exemption</a> in October 2020. It was opposed by the US (initially), the EU, Switzerland, the UK and Japan. Such a waiver would be optional (countries could opt out) and suspend specific IP rights protected by the WTO <a href="https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm">TRIPS Agreement</a>. </p>
<p>This exemption plan is supported by more than 100 countries. It would allow states to bypass the monopoly of IP holders by authorising the production of cheaper generic drugs and other anti-COVID technologies. The waiver would be temporary, until the majority of the world’s population developed immunity.</p>
<p>The US-supported exemption is slightly different. It covers vaccines only, maintaining IP protection on other products such as diagnostics, treatments, ventilators, respirators, syringes and refrigerators maintaining low temperatures during storage and transport of doses.</p>
<p>But would the WTO waiver be enough? </p>
<p>We believe there are arguments against the waiver. These include the fact that other factors would still stand in the way of easy and quick access to COVID-19 medicines for all countries. But we also argue that the campaign to have a waiver agreed at the WTO could have beneficial outcomes, such as pushing pharmaceutical companies which hold important IP to share it voluntarily.</p>
<h2>The cons</h2>
<p>One <a href="https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-property-rights-covid-19-vaccines#does-novel-virus-present-novel-issues">argument</a> against the waiver is that it is unnecessary. </p>
<p>The TRIPS already allows flexibilities. Countries seeking access to medicines can grant compulsory licences (that is, without the IP holder’s consent) under certain conditions. Some have done so during the pandemic. </p>
<p>In March 2020 Israel <a href="https://www.keionline.org/32503">issued</a> one, speeding up the production and sale of Kaletra as an anti-COVID treatment. The US-based pharmaceutical company AbbVie holds the patent.</p>
<p>And the Indian generic manufacturer Natco recently <a href="https://spicyip.com/2021/05/natco-files-compulsory-licence-application-for-covid-drug-baricitinib.html">applied</a> for a licence to produce Baricitinib. This is a rheumatoid arthritis drug that can also treat coronavirus. The IP is held by the US pharmacuetical company Eli Lilly.</p>
<p>States that lack production capacity can, meeting additional conditions, license production abroad with a view to importing the drugs. On 10 May, Bolivia <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=s:/IP/N/9BOL1.pdf&Open=True">notified</a> a <a href="https://healthpolicy-watch.news/company-pushes-canada-to-grant-compulsory-license-for-johnson-johnson-covid-19-vaccine/">licence</a> to the WTO, for 15 million doses of Johnson & Johnson vaccine produced by the Canadian company Biolyse.</p>
<p>However, compulsory licences must meet a host of requirements. These include the payment of <a href="https://www.mondaq.com/india/patent/616430/fair-remuneration-for-compulsory-licensing">fair compensation</a> to the patent holder. </p>
<p>The waiver proposed by South Africa and India would instead allow countries to circumvent these requirements, insulating generic manufacturers of anti-COVID drugs and technologies from lawsuits.</p>
<p>Another <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3789820">argument</a> undermining the waiver is that it cannot benefit generic producers (and patients), because it would not address the lack of production capacity and poor healthcare systems of many countries. Moreover, it could not alleviate the shortage in raw materials and the steep learning curve of manufacturing processes.</p>
<p>Take the Pfizer <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">mRNA</a> vaccines. This technology was developed recently and with revolutionary know-how: no pharmaceutical company can replicate it quickly. The bottleneck is not just IP protection, but the underlying processes around the protected technology. </p>
<p>If a TRIPS waiver passes, Pfizer could lawfully engage in being obstructive by, for example, refusing to disclose its know-how. It would be difficult, if not impossible, to require pharmaceutical companies to reveal that secret, also <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327">because</a> even if such companies were dragged into courts judges would not know which information should be disclosed.</p>
<p>Patents can be suspended by law, but confidential information kept by pharmaceutical companies is not easily retrievable. This has become clear in Bolivia’s plan to import Canadian-made generics. The Canadian manufacturer admitted that “<a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">if Johnson & Johnson agree to hand over the formula</a>” production could start in less than half the time. </p>
<h2>The pros</h2>
<p>Waiving or relaxing IP rights over anti-COVID technologies cannot fix the global pandemic alone. Nevertheless it could remove some roadblocks. </p>
<p>Arguably, the waiver could push pharma companies holding patents to increase the supply of their drugs. For example, the recent Natco application for a compulsory licence over Baricitinib has prompted Eli Lilly, the patent holder, to grant royalty-free and non-exclusive <a href="https://www.business-standard.com/article/companies/eli-lilly-signs-licensing-pact-with-cipla-sun-lupin-for-covid-19-drug-121051100039_1.html">voluntary licences</a> to Indian generic manufacturers Sun, Cipla and Lupin. Eli Lilly is also negotiating licences with other Indian producers.</p>
<p>So, flexing the muscles via granting compulsory licences sometimes seems to pay off in terms of encouraging patent owners to share their technology. This happened at the beginning of the pandemic. After Israel issued the compulsory licence over the Kaletra drug early last year, the patentee AbbVie voluntarily <a href="https://www.statnews.com/pharmalot/2020/03/20/abbvie-israel-hiv-kaletra-coronavirus-covid19/">dropped</a> its patent rights.</p>
<p>Waiver talks might produce a similar effect: convincing companies to focus on technology transfer and training, perhaps at a profit, and letting go of the plan to maximise patent-based revenues.</p>
<p>It could also be argued that a waiver would be a fair move to make given that over US$12 billion of <a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">public funding</a> has gone into the research and development of vaccines.</p>
<h2>A compromise in sight?</h2>
<p>It is still not clear what kind of a waiver WTO members can agree – if any. Negotiations might produce a softer solution than proposed by South Africa and India: perhaps a very short exemption with limited coverage, for example only vaccines, as proposed by the US.</p>
<p>Such compromise could neutralise the <a href="https://www.ft.com/content/f54bf71b-87be-4290-9c95-4d110eec7a90">refrain</a> of big pharmaceutical companies against any unwelcome relaxation of IP rights. A limited and short suspension of proprietary rights over COVID vaccines would have a lesser impact on innovation incentives.</p>
<p>A game changer in the fight against COVID could be last week’s WHO <a href="https://www.ft.com/content/7220cbdd-4b8c-49f1-9cf7-5146a691adb6">approval</a> of the vaccine produced by the China-owned company Sinopharm and the Beijing Institute of Biological Products. This is the first vaccine developed by a non-Western country to obtain the WHO green light.</p>
<p>This vaccine can be stored in a standard refrigerator, and “easy storage requirements” – the WHO <a href="https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-use-and-issues-interim-policy-recommendations">pointed out</a> – make it particularly suitable for developing and least-developed countries. </p>
<p>In addition, there’s a strong likelihood that China could produce enough vaccines to meet its own needs, and still have surplus that it can export. One <a href="https://www.nytimes.com/2021/05/07/business/economy/china-sinopharm-vaccine-who.html">estimate</a> is that the Sinopharm vaccine could be supplied to more than 80 countries. </p>
<p>This would benefit people in states which have not been able to access sufficient vaccines and that have recently been hit hard by COVID. These include India, Brazil, Indonesia and the Philippines.</p>
<p>Strengthening the global supply of vaccines would provide a major boost to efforts to contain COVID-19. Running in parallel with efforts to ease IP rules could see the balance shifted towards containment.</p><img src="https://counter.theconversation.com/content/160802/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Waiver talks might convince companies to focus on technology transfer and training, and let go of the plan to maximise patent-based revenues.Enrico Bonadio, Reader in Intellectual Property Law, City, University of LondonFilippo Fontanelli, Senior Lecturer in International Economic Law, The University of EdinburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1606382021-05-12T12:26:49Z2021-05-12T12:26:49ZTRIPS waiver: US support is a major step but no guarantee of COVID-19 vaccine equity<figure><img src="https://images.theconversation.com/files/400035/original/file-20210511-13-e00ped.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Protesters gather in Cambridge to demand that AstraZeneca shares blueprints for its COVID-19 vaccine.</span> <span class="attribution"><span class="source"> Luciana Guerra/PA Images via Getty Images</span></span></figcaption></figure><p>In a momentous shift, the US recently agreed to <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">support a waiver</a> of the Trade Related Intellectual Property Rights (TRIPs) agreement at the World Trade Organisation (WTO). The waiver backed by the US would suspend intellectual property rights on vaccines.</p>
<p>Until the announcement, the US, alongside the European Union, Norway, Canada, Australia, the UK, Switzerland, Brazil and Japan, had been steadfast in their position that stringent patent protection is key to vaccine supply and the global effort to tackle COVID-19.</p>
<p>But proponents of the waiver argued that the temporary suspension of intellectual property rights was key to achieving vaccine equity and global health security. India and South Africa, with the support of over 100 countries, have been passionately making this case from inside the WTO since October 2020. Their call is for a braoder waiver – one that would cover patents and trademarks on all products required to fight COVID-19 for the duration of the pandemic. </p>
<p>Beyond the WTO, members of global civil society view the waiver on vaccines as essential to securing a <a href="https://peoplesvaccine.org/">“People’s Vaccine”</a> which is universally available to all, free at the point of delivery. </p>
<p>Washington’s support for a TRIPs waiver may, therefore, seem like a substantive win. This is especially so when considered against the backdrop of the horrors unfolding in countries such as <a href="https://theconversation.com/what-indias-second-wave-means-for-its-vaccine-coverage-and-the-rest-of-the-world-159937">India</a>. </p>
<p>But this move marks the start of the battle, not the end of the war. Much remains to be resolved before the waiver is translated into increased vaccine supply.</p>
<h2>The devil is in the detail</h2>
<p>Five key areas remain fundamental to vaccine equity for COVID-19 and tackling any future pandemic.</p>
<p>First, the problem is less about permission and more about how the waiver may work. WTO rules already allow for the temporary suspension of intellectual property rights in situations of public health emergencies like the COVID-19 pandemic. The <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">2001 Doha Declaration</a> re-affirmed that states can issue compulsory licenses on patented drugs in order to produce generic versions at quicker and more affordable rates. The <a href="https://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm">2005 TRIPs amendment</a> further clarified that countries without manufacturing capacity or insufficient demand can import generic versions of drugs with the cooperation of producing or exporting states.</p>
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<a href="https://theconversation.com/the-global-approach-to-vaccine-equity-is-failing-additional-steps-that-would-help-158711">The global approach to vaccine equity is failing: additional steps that would help</a>
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<p>In other words, countries with surplus capacity could already be producing generic versions of COVID-19 vaccines. These could be for domestic use and for export to countries lacking domestic manufacturing capacity. </p>
<p>The question is how to translate rights under WTO rules into access to medicines on the ground. The 2005 TRIPs amendment has <a href="https://lawecommons.luc.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=1067&context=lucilr">only ever been used once</a> in 2007 when Canada supplied generic antiretroviral drugs to Rwanda. Those involved subsequently criticised the amendment for being overly bureaucratic, <a href="http://www.ip-watch.org/2010/03/01/efficacy-of-trips-public-health-amendment-in-question-at-wto/">costly and complicated</a>. </p>
<p>The TRIPs waiver is only a progressive move if it helps to expedite the generic production and export of affordable vaccines (and related medical products), beyond what is already permissible under the existing rules.</p>
<p>Second, the details of the COVID-19 vaccine waiver are still to be worked out and require consensus among the WTO membership. This could take months, years, or even prove to be impossible. US support is a major step toward agreement. But other countries that see the intellectual property regime as part of the solution, not the problem, may yet hold out against the waiver. Momentum of support and effective trade and health diplomacy is key.</p>
<p>Third, the Biden administration has only indicated that it would be willing to waive patent protection for vaccines. This is insufficient. In line with the original <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True">proposal</a> made by India and South Africa at the WTO, the waiver should apply to all medical products. These include treatments, diagnostic kits, ventilators, crucial manufacturing components, and protective gear. This is important if the waiver is to help combat COVID-19. </p>
<p>Fourth, the poorest countries will still be unable to produce vaccines. Even if WTO members approve it, the waiver will be more form than substance. Pharmaceutical companies may need to be incentivised to share knowledge and build capacity in developing countries to produce quality, generic versions of the vaccines. The TRIPs agreement mentions technology transfer numerous times, particularly to the least developing countries. It reads:</p>
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<p><a href="https://www.wto.org/english/docs_e/legal_e/trips_e.htm#ann1">…recognising</a> the desirability of promoting the transfer of technology and capacity building in the pharmaceutical sector in order to overcome the problem faced by Members with insufficient or no manufacturing capacities.</p>
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<p>However, as with all such “best endeavour” clauses in the WTO, nothing has been done to make this supposed aspiration a reality.</p>
<p>Finally, we need to ensure the waiver is progressive. Tampering with the TRIPs amendment risks rolling back existing flexibilities. The roll back will happen if there is a restriction on the types of products for which a compulsory licence can be issued. It will also happen if limits are placed on the export of generic versions of the vaccines to those countries with no manufacturing capacity. Time limitations will also roll back existing flexibilities. Emergency measures to respond to COVID-19 must not cause harm for long term flexibilities on patents and licensing.</p>
<h2>The next battle: technology and production</h2>
<p>A TRIPs waiver on its own will allow access to patents. But such patents are only a part of the barriers to countries beginning to expand manufacturing. </p>
<p>Making vaccines is complicated – much more so than many other pharmaceutical products – and technology and know-how <a href="https://www.ft.com/content/b0f42409-6fdf-43eb-96c7-d166e090ab99">will be crucial</a> to expand supply. This point is frequently raised by critics of the waiver. They argue that there is insignificant existing production capacity that can be brought online even if freed of patent obligations. </p>
<p>However, there is evidence that unutilised capacity is available. For example, the Canadian pharmaceutical company <a href="https://globalnews.ca/news/7743371/biolyse-covid-19-vaccines-health-canada-johnson-and-johnson/">Biolyse</a> has been seeking a compulsory licence to produce viral vector vaccines like the Johnson and Johnson vaccine for export to developing countries. Such a step would be compliant with both the TRIPs agreement and the Canadian Access to Medicines Regime.</p>
<p>If the necessary technology sharing does not take place, governments are going to need to provide greater incentives to bring it about. They are, in short, going to need to make good on some of the promises for technology transfer and capacity building made in the TRIPs agreement all the way back in 1995.</p><img src="https://counter.theconversation.com/content/160638/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Erin Hannah receives funding from the Social Sciences and Humanities Research Council of Canada. </span></em></p><p class="fine-print"><em><span>James Scott receives funding from The British Academy. </span></em></p><p class="fine-print"><em><span>Silke Trommer receives funding from the Social Sciences and Humanities Research Council of Canada. </span></em></p><p class="fine-print"><em><span>Sophie Harman receives funding from The Leverhulme Trust. </span></em></p>Much remains to be resolved before the waiver is translated into increased vaccine supply.Erin Hannah, Department Chair/Associate Professor of Political Science, King's University College, Western UniversityJames Scott, Senior Lecturer in International Politics, King's College LondonSilke Trommer, Senior Lecturer Politics, University of ManchesterSophie Harman, Professor of International Politics, Queen Mary University of LondonLicensed as Creative Commons – attribution, no derivatives.