tag:theconversation.com,2011:/id/topics/patent-law-1148/articlesPatent law – The Conversation2024-03-08T13:38:33Ztag:theconversation.com,2011:article/2228582024-03-08T13:38:33Z2024-03-08T13:38:33ZAsthma meds have become shockingly unaffordable − but relief may be on the way<figure><img src="https://images.theconversation.com/files/579691/original/file-20240304-18-r33cu5.jpg?ixlib=rb-1.1.0&rect=25%2C51%2C8538%2C5469&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Its price will take your breath away.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/man-using-blue-asthma-inhaler-medication-royalty-free-image/1179346207?">Brian Jackson/Getty Images</a></span></figcaption></figure><p>The <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">price of asthma medication has soared</a> in the U.S. over the past decade and a half. </p>
<p>The jump – in some cases from around <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a little over US$10</a> <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">to almost $100</a> for an inhaler – has meant that patients in need of asthma-related products <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">often struggle</a> to buy them. Others simply <a href="https://asthma.net/living/cannot-afford-inhalers">can’t afford</a> them. </p>
<p>To make matters worse, asthma <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">disproportionately affects</a> lower-income patients. Black, Hispanic and Indigenous communities have the <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">highest asthma rates</a>. They also shoulder <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">the heaviest burden</a> of asthma-related deaths and hospitalizations. Climate change will likely <a href="https://www.hsph.harvard.edu/c-change/subtopics/climate-change-and-asthma/">worsen asthma rates</a> and, consequently, these disparities.</p>
<p>I’m a health law professor at <a href="https://www1.villanova.edu/university/law/faculty-scholarship/faculty-directory/profiles/AnaSantosRutschman.html">Villanova University</a>, <a href="https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=2667484">where I study</a> whether patients can get the medicines they need. And I’ve been watching this affordability crisis closely.</p>
<p>In many ways, it shows what happens when law and policy decisions aren’t aligned with public health needs. The good news, however, is that there finally seems to be some political will to rein in the price of asthma meds.</p>
<h2>Why inhaler prices are skyrocketing</h2>
<p>In 2008, the U.S. Food and Drug Administration <a href="https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/transition-cfc-propelled-albuterol-inhalers-hfa-propelled-albuterol-inhalers-questions-and-answers">banned inhalers</a> that use chlorofluorocarbons, or CFCs – which were once widely used as propellants – because they can damage the ozone layer. The FDA was following a timeline set by an environmental treaty, the <a href="https://www.unep.org/ozonaction/who-we-are/about-montreal-protocol">Montreal Protocol</a>, which the U.S. ratified in the late 1980s. </p>
<p>From 2009 onward, CFC inhalers were phased out and replaced with hydrofluoroalkane, or HFA, ones, which are more environmentally friendly. They’re also a lot pricier. For patients with insurance, the average out-of-pocket cost of an inhaler rose from $13.60 per prescription in 2004 to $25 immediately after the 2008 ban, <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a 2015 study found</a>.</p>
<p>Today, the <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">average retail price</a> of an albuterol inhaler is $98. Unlike CFC inhalers, which have <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">generic versions</a>, HFA inhalers are <a href="https://www.scientificamerican.com/article/unlikely-victims-of-banning-cfcs/">covered by patents</a>. While <a href="http://doi.org/10.1089/jamp.2016.1297">the drug itself</a> hasn’t changed, the switch to a different device allowed companies to increase their prices.</p>
<p>In 2020, the FDA finally approved the <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm">first generic version</a> of an albuterol inhaler. But generic competition still isn’t robust enough to lower prices meaningfully.</p>
<p>Patients with good insurance <a href="https://allergyasthmanetwork.org/advocacy-updates/united-healthcare-albuterol-epinephrine-cost/">may pay very little</a> or even nothing. But uninsured patients face steep market prices, and as of 2023, there were <a href="https://aspe.hhs.gov/sites/default/files/documents/e06a66dfc6f62afc8bb809038dfaebe4/Uninsured-Record-Low-Q12023.pdf">over 25 million</a> uninsured Americans. <a href="https://www.cdc.gov/asthma/asthma_stats/insurance_coverage.htm">Even insured patients may have trouble</a> affording their asthma meds, the CDC has found. </p>
<p>The same asthma medication for which U.S. patients pay top dollar is available elsewhere at much cheaper prices. Consider the following case for inhalers. The pharmaceutical company Teva sells <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ccd3aaec-4892-40d0-ad60-3e570178fbe1">QVAR RediHaler</a>, a corticosteroid inhaler, <a href="https://doi.org/10.1016/S2213-2600(24)00012-2">for $286</a> in the U.S.</p>
<p>In Germany, Teva sells that same inhaler for $9.</p>
<h2>Seeking meds from Mexico and Canada</h2>
<p>Some U.S. patients have traveled abroad to obtain cheaper asthma medication. After the 2008 ban on CFCs, it became common for patients to <a href="https://doi.org/10.1177/8755122515595052">visit border towns in Mexico</a> to purchase albuterol inhalers. They were sold for <a href="https://doi.org/10.1177/8755122515595052">as little as $3 to $5</a>. </p>
<p>A study of inhalers available to U.S. patients in Nogales, Mexico – about an hour south of Tucson, Arizona – found that Mexican products were <a href="http://doi.org/10.1177/8755122515595052">generally comparable to U.S. inhalers</a>. But researchers found some differences in performance, suggesting that American patients who use them could be getting a slightly different dose than their usual.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Asthma medication is seen on the shelves of a Mexican pharmacy." src="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.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">Asthma meds are considerably more affordable south of the border.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/the-interior-of-farmacia-san-pablo-news-photo/1041982048">Jeffrey Greenberg/Universal Images Group via Getty Images</a></span>
</figcaption>
</figure>
<p>There have also been reports of Americans turning to Canadian pharmacies to purchase asthma inhalers at much cheaper prices. In one case, a U.S. pharmacy would have charged $857 for a three-month supply. A patient obtained it for <a href="https://www.seattletimes.com/life/wellness/canadian-pharmacy-provided-inhaler-at-a-fraction-of-us-cost/">$134 from a pharmacy in Canada</a>.</p>
<h2>One potential fix: Importing cheaper meds</h2>
<p>U.S. law has long <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-drugs">prohibited</a> personal importation of pharmaceutical drugs. However, a recent development could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05">pave the way for states</a> to import cheaper asthma drugs.</p>
<p>In January 2024, the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05/">FDA authorized</a> the importation of certain prescription drugs from Canada for the first time. <a href="https://www.kff.org/policy-watch/what-to-know-about-the-fdas-recent-decision-to-allow-florida-to-import-prescription-drugs-from-canada/">For now</a>, this authorization is limited to Florida, and it covers only drugs for HIV/AIDS, prostate cancer and certain mental health conditions.</p>
<p>Should it prove successful, the program could serve as a blueprint for other states.</p>
<h2>Another possible solution: Price-capping</h2>
<p>Policymakers could also try borrowing a page from the insulin playbook. Insulin prices <a href="https://doi.org/10.1001/jamanetworkopen.2023.18074">climbed for almost two decades</a> before Congress acted, capping the cost of insulin for Medicare patients. The 2022 <a href="https://www.congress.gov/bill/117th-congress/house-bill/5376/text">Inflation Reduction Act</a> established an out-of-pocket ceiling of $35 per month for prescription-covered insulin products. </p>
<p>If this cap had been in effect two years earlier, it would have saved 1.5 million Medicare patients about $500 annually, <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">a recent study estimated</a>. It also would have saved Medicare <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">$761 million</a>.</p>
<p>A similar approach could be taken for asthma meds.</p>
<p>Congress could create an asthma-specific rule similar to the insulin case. Or it could place provisions for asthma-med prices into a larger piece of legislation.</p>
<p>While this approach depends on the political environment, there are signs the government is becoming more willing to act. In January 2024, the U.S. Department of Health and Human Services <a href="https://www.hhs.gov/about/news/2024/01/29/readout-hhs-officials-meeting-private-sector-patient-advocacy-leaders-improve-national-access-important-asthma-medications.html">hosted a meeting</a> to discuss the problem with manufacturers and other stakeholders.</p>
<p>It’s a start. And – together with other measures – it brings some hope that asthma meds might soon become more affordable to those in need.</p><img src="https://counter.theconversation.com/content/222858/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>An inhaler that costs nearly $300 in the US goes for just $9 in Germany. What gives?Ana Santos Rutschman, Professor of Law, Villanova School of LawLicensed 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>
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<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/1840472022-05-30T04:04:35Z2022-05-30T04:04:35ZArtificial ‘inventors’ are pushing patent law to its limits<figure><img src="https://images.theconversation.com/files/465894/original/file-20220530-26-baq322.jpg?ixlib=rb-1.1.0&rect=11%2C3%2C2544%2C1433&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://betterimagesofai.org/images?artist=AlanWarburton&title=VirtualHuman">Alan Warburton / Better Images of AI</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>It was the veritable search for a needle in a haystack. With drug-resistant bacteria on the rise, researchers at MIT were sifting through a database of more than 100 million molecules to identify a few that might have antibacterial properties. </p>
<p>Fortunately, the search proved successful. But it wasn’t a human who found the promising molecules. It was a <a href="https://www.nature.com/articles/d41586-020-00018-3">machine learning program</a>. </p>
<p>One compound has been patented under the name <a href="https://en.wikipedia.org/wiki/Halicin">Halicin</a> in homage to HAL, the artificial intelligence (AI) in Arthur C Clarke’s classic 2001: A Space Odyssey. Halicin works differently from existing antibiotics, disrupting the bacteria’s ability to access energy, and researchers hope bacteria may struggle to develop resistance to it. </p>
<p>Halicin might be the first antibiotic discovered using AI, but AI programs have played an important role in other patented inventions from electrical circuits, through meta-materials and drugs, to consumer products such as toothbrushes. As we argue in <a href="https://www.nature.com/articles/d41586-022-01391-x">a recent article in Nature</a>, society urgently needs to consider the impact of AI on the innovation system, particularly on laws regarding intellectual property and patents.</p>
<h2>AI patents in court</h2>
<p>Can software be an “inventor”? This question has been the focus of some recent high profile court cases about <a href="https://artificialinventor.com/dabus/">an AI system called DABUS</a> (Device for the Autonomous Bootstrapping of Unified Sentience), created by Stephen Thaler, president and chief executive of US-based AI firm Imagination Engines.</p>
<p>Thaler <a href="https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020079499">claims DABUS is the inventor</a> of a new type of food container with a specially patterned surface, as well as a light that flashing with a special pattern of pulses for attracting attention in emergencies. The inventions are perhaps not very noteworthy, but the attempts to patent them certainly are. </p>
<p>Thaler’s international legal team, led by Ryan Abbott from the University of Surrey, has filed applications to patent offices around the world in which DABUS is named as the sole inventor. These cases are likely the first to test whether an AI system can be recognised as an inventor under existing intellectual property laws.</p>
<h2>For now, inventors must be human</h2>
<p>Patent registration offices have rejected the DABUS patent applications in multiple jurisdictions, including the United Kingdom, United States, the European Patent Office, Germany, South Korea, Taiwan, New Zealand and Australia. The one outlier is South Africa, where <a href="https://theconversation.com/in-a-world-first-south-africa-grants-patent-to-an-artificial-intelligence-system-165623">a patent has been granted</a> but without substantive examination of the patent application having yet occurred.</p>
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Read more:
<a href="https://theconversation.com/in-a-world-first-south-africa-grants-patent-to-an-artificial-intelligence-system-165623">In a world first, South Africa grants patent to an artificial intelligence system</a>
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<p>In Australia, a challenge against the rejection was initially accepted but <a href="https://www.corrs.com.au/insights/can-an-ai-system-be-an-inventor-full-court-says-no">overturned on appeal</a>. Thaler has sought “special leave to appeal” the case to the High Court of Australia, though it remains to be seen whether this will be granted. </p>
<p>In Germany, the Federal Patent Court set aside the initial patent refusal, instead accepting a compromise position in which <a href="https://www.ipwatchdog.com/2022/04/20/german-decision-provide-answer-ai-inventorship/id=148555/#">“Stephen L. Thaler, PhD who prompted the artificial intelligence DABUS to create the invention”</a> was listed as the inventor. Meanwhile, DABUS cases continue to be fought in other jurisdictions around the world.</p>
<p>For now at least, it seems courts have largely concluded that, for the purposes of patentability, inventors must be human. Nevertheless, the cases have thrown up a range of important questions we need to answer as AI takes on ever more roles in our lives.</p>
<h2>Can an AI invent?</h2>
<p>Given the ever-increasing power of AI, it’s not a wild leap to suppose that AI will take on a greater role in coming up with inventions. </p>
<p>We don’t claim that computer-aided design (CAD) software “invents”. But such software lacks the increasing autonomy that AI is starting to have.</p>
<h2>Can an AI be named as an inventor?</h2>
<p>Patent systems are currently premised on a (human) inventor who owns or assigns the rewards coming from the patent. </p>
<p>Who might own the rewards from an AI patent? The programmer? The owner of the computer on which it runs? And what about the owner(s) of the data on which the AI might be trained?</p>
<h2>Will AI change invention?</h2>
<p>AI might speed up the rate at which inventions are made, potentially overwhelming the patent system. This might widen inequality between the haves who possess AI systems that can invent, and the have-nots who don’t. </p>
<p>It might also change the character of invention. Under well established patent principles, an “inventive step” occurs when an invention is considered “non-obvious” to a “person skilled in the art”. But an AI system might be more knowledgeable and skilled than any one person on the planet.</p>
<h2>A path forward</h2>
<p>In response to these sort of questions, we argue that the patent system must be re-examined to ensure it remains fit for purpose, and that it continues to reward and encourage innovation appropriately. </p>
<p>We suggest society might benefit from a new type of intellectual property designed specifically to deal with AI inventions (which we call “AI-IP”). </p>
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<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>
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<p>The principles underpinning patent legislation are more than 500 years old and have evolved to deal with fresh technological changes from genetic sequencing to human-made living organisms. However, the fresh tests presented by AI inventiveness might be so significant that they push those patent principles to breaking point. </p>
<p>AI presents a watershed challenge that requires us to think once again carefully about how to reward and encourage innovation.</p><img src="https://counter.theconversation.com/content/184047/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Toby Walsh receives funding from the Australian Research Council in the form a Laureate Fellowship. </span></em></p><p class="fine-print"><em><span>Alexandra 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>Can software be an ‘inventor’? As courts wrestle with AI patent applications, the law must change to keep up.Toby Walsh, Professor of AI at UNSW, Research Group Leader, UNSW SydneyAlexandra George, Associate Professor in Law, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1583842021-04-14T19:20:16Z2021-04-14T19:20:16ZHow to get COVID-19 vaccines to poor countries – and still keep patent benefits for drugmakers<figure><img src="https://images.theconversation.com/files/395076/original/file-20210414-13-heql0s.jpg?ixlib=rb-1.1.0&rect=535%2C23%2C4640%2C3150&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Hospital staff in Lagos, Nigeria, administer the AstraZeneca vaccine.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakNigeriaAfricaVaccines/f37e2b62ec484fc1970d3dbcbb49c3b3/photo">AP Photo/Sunday Alamba</a></span></figcaption></figure><p>The world has a COVID-19 vaccine access problem: Almost half of all doses administered so far have been in Europe and North America, while many poorer countries have vaccinated <a href="https://ourworldindata.org/explorers/coronavirus-data-explorer">less than than 1%</a> of their populations.</p>
<p>With new coronavirus variants raising the health risk, South Africa and India have proposed that the World Trade Organization <a href="https://www.wto.org/english/news_e/news21_e/trip_11mar21_e.htm">temporarily waive intellectual property rights</a> for COVID-19 vaccines to help ramp up production.</p>
<p>The U.S., Britain and the European Union <a href="https://www.reuters.com/article/uk-health-coronavirus-wto-idUKKBN28020X">rejected the idea</a>, arguing that intellectual property rights – which give vaccine creators the power to prevent other companies from reproducing their products – are necessary to ensure innovation and waiving them would not result in increased production. They are now <a href="https://www.rollcall.com/2021/04/05/fellow-democrats-pressure-biden-to-weaken-vaccine-patents/">under pressure</a> to change their minds.</p>
<p>So, are there only two paths here? Patents remain inviolate, or patents are disregarded?</p>
<p><a href="https://udayton.edu/directory/law/shabalala_dalindyebo.php">I have worked on legal issues related to access to medicines</a> since 2004 and have been involved in these debates at the WTO and the World Intellectual Property Organization, working with civil society groups and developing countries. I believe there is a middle way: compulsory licensing.</p>
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<h2>Governments can already get around patents</h2>
<p>When a country approves a patent, it gives the patent holder a monopoly for a limited term, usually 20 years, for new and highly inventive ideas.</p>
<p>The promise of having a monopoly gives the patent holder more incentive to take on the risk of research and development and get a product to market. The company can charge a high price for a limited time to recoup that investment.</p>
<p>The key phrase is “limited time.” This makes sure that once a patent runs out, others can make the product. Generic drugs are an example. Competition typically lowers prices and ensures greater access for those who want or need the product.</p>
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<img alt="Employees in protective coveralls work on a machine filling vials with vaccine." src="https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/395083/original/file-20210414-23-1yqeiyc.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">
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<span class="caption">AstraZeneca issued a license to the Serum Institute of India to produce its COVID-19 vaccine.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakIndia/d7d89250c6ed43d19370970f200a0d3a/photo">AP Photo/Rafiq Maqbool</a></span>
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<p>For emergencies, the patent system has a series of safety valves that allow governments to intervene before that limited time is up. The most important safety valve for COVID-19 vaccine production is the compulsory license. Based on public needs – including health emergencies – a government can allow others to make the product, usually with a reasonable royalty, or fee, paid to the patent owner.</p>
<p>Today, any country that has issued a patent to a COVID-19 vaccine maker can use that patent simply by issuing a compulsory license to enable production by its own companies.</p>
<p>So, why doesn’t this solve the COVID-19 vaccine access problem?</p>
<h2>Vaccine patents end at the border</h2>
<p>The same issue arose in the context of <a href="https://www.who.int/bulletin/volumes/84/5/news10506/en/">access to HIV medications</a> during the late 1990s.</p>
<p>Just like with HIV drugs then, the capacity to manufacture vaccines today is unevenly distributed. The real issue isn’t whether a country like Botswana can issue a compulsory license allowing its domestic companies to manufacture the vaccines – many countries don’t have that kind of production facility and, in many cases, the drugs aren’t even patented there.</p>
<p>The real issue is whether India or China or the Philippines – countries with thriving pharmaceutical industries and where drugs are much more likely to be patented – can issue a compulsory license that would allow their companies to export to Botswana.</p>
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<img alt="Two people in lab coats hold a box showing the label" src="https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/395091/original/file-20210414-16-1t8mv8l.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">
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<span class="caption">Technicians in Nairobi, Kenya, hold a carton of AstraZeneca COVID-19 vaccine manufactured in India.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakAfricaVaccinesKenya/338446ad563d4555b0efcd24d69016f6/photo">AP Photo/Ben Curtis</a></span>
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<p>Why isn’t this happening under the existing rules?</p>
<p>Article 31 of the WTO’s <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement of Trade-Related Aspects of Intellectual Property</a>, or TRIPS, limits compulsory licenses primarily to domestic production and use. It does not allow a country to issue a compulsory license to a company outside its territory. Countries also cannot issue compulsory licenses to companies within their territories to produce products primarily for export.</p>
<p>There have been several attempts to solve this problem, including a change to the TRIPS Agreement approved in 2005. But <a href="https://www.wto.org/english/tratop_e/trips_e/tripsfacsheet_e.htm">only one country – Rwanda – has used that system</a> to access drugs. After an almost two-year process, Rwanda was able to import 7 million doses from Canada. However, the Canadian generic producer, Apotex, declared that the system was <a href="https://www.biospace.com/article/releases/apotex-corp-receives-final-tender-approval-from-rwanda-for-vital-aids-drug-/">economically unsustainable for a private company</a>. During a 2010 review of the system, <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/IP/C/57.pdf&Open=True">many developing countries noted how difficult</a> it was to use, with several generic producers giving up in the middle of the process.</p>
<p>The process requires an agreement between the two countries issuing compulsory licenses. It also comes with a series of legal requirements, including producing only the amount ordered by the importing country; using entirely different packaging, coloring or shapes to distinguish the drug from regular production; and following special processes in the importing country to prevent the product from being diverted elsewhere. A different compulsory license and production line would be needed for each additional country.</p>
<p>For COVID-19, there is also another problem: The technologies in COVID-19 vaccines are complex and involve multiple patents, trade secrets and know-how. A compulsory licensing system would need to address not just patents but all related intellectual property.</p>
<h2>What to do about it</h2>
<p>An international consortium called <a href="https://theconversation.com/the-best-hope-for-fairly-distributing-covid-19-vaccines-globally-is-at-risk-of-failing-heres-how-to-save-it-158779">COVAX</a> is trying to expand COVID-19 vaccine deliveries to low-income countries through agreements with vaccine producers, but <a href="https://www.who.int/news/item/08-04-2021-covax-reaches-over-100-economies-42-days-after-first-international-delivery">it is struggling</a> to reach its <a href="https://www.who.int/news/item/08-04-2021-covax-reaches-over-100-economies-42-days-after-first-international-delivery">goal of providing 2 billion doses</a> by the end of 2021.</p>
<p>To successfully expand vaccine production, countries need a relatively seamless system that allows a country like India to grant a single, blanket license allowing its companies to produce vaccines developed by U.S. or European companies for export to all countries that lack their own manufacturing capacity.</p>
<p>This is ideally what a properly functioning system of global compulsory licensing would enable, in my view. Compulsory licensing is not a violation of patent or intellectual property. The rights holder still gets compensated, and access is assured when it is most needed.</p>
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<p>The proposed WTO waiver of intellectual property rights seeks to address this need, but it may be broader than necessary. A better solution as I see it would be to smooth the way for using compulsory licensing across all relevant intellectual property needed to expand vaccine manufacturing.</p>
<p>Removing the TRIPS limitations on production for export would allow a country like India, at the request of a qualifying country, to issue blanket compulsory licenses covering all COVID-19 vaccine technologies, set the compensation prices and allow the vaccines to be exported to multiple countries simultaneously. </p>
<p>The company would make the vaccine in its existing facilities and would be allowed to stockpile for future orders. Additional requests from other countries could be fulfilled from the same production line on the same basis, ensuring a sustainable business model. The patent owner – Moderna, for example – may lose control over the market, but it maintains its right to be compensated, as is normal for any compulsory license. </p>
<p>This is part of the bargain Moderna and Pfizer made when they received patent protection. </p>
<p>The result could be a fast increase in vaccine manufacturing that reaches countries that have been left out. Without global vaccinations, it’s <a href="https://doi.org/10.1038/d41586-021-00728-2">hard to see an end</a> to this pandemic. This emergency is exactly what the patent system is designed for, if it’s allowed to operate properly for the patent holder and for the public.</p>
<p>[<em>More than 104,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p><img src="https://counter.theconversation.com/content/158384/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dalindyebo Shabalala is affiliated with the Center for International Environmental Law (CIEL) as a Board Member. He has previously worked at the South Centre, an intergovernmental organization of developing countries on Access to Medicines projects funded by the Rockefeller Foundation, SIDA, and GIZ among others.</span></em></p>India and South Africa are pressing the World Trade Organization to waive patent rights to help ramp up vaccine production. There’s a better solution.Dalindyebo Shabalala, Associate Professor, University of DaytonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1480752021-03-16T19:04:46Z2021-03-16T19:04:46ZPatent system often stifles the innovation it was designed to encourage<figure><img src="https://images.theconversation.com/files/389683/original/file-20210315-23-1ia171j.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C3406%2C2328&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Attorneys for Apple heading to court during the so-called smartphone patent wars.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/ADDITIONAppleSamsungTrial/0c156dac0ddf458dbab913fe270b6d44/photo?Query=patent%20AND%20lawyer&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=23&currentItemNo=9">AP Photo/Jeff Chiu</a></span></figcaption></figure><p>Over his career Thomas Edison garnered <a href="https://www.scientificamerican.com/article/edison-on-patents/">more U.S. patents than anyone</a> in his time. Edison profited from his patents, but he was also exposed to the dark side of the patent system. He had to contend with lawsuits by other patentees who sought – and sometimes won – a piece of his success. While the patent system is designed to spur innovation like Edison’s, it also hampers it.</p>
<p>Easy copying and imitation discourage innovation, because why make the effort if someone else will profit from it? The patent system works by enabling inventors <a href="https://www.uspto.gov/patents/basics#heading-2">to block unauthorized use</a> of patented technology.</p>
<p>Most technologies are developed by many inventors over many years, a process called <a href="https://doi.org/10.1017/CBO9781107709409.010">“cumulative” innovation</a>. Too often, however, early inventors get a patent on a small and perhaps insignificant piece of the technological puzzle, yet their patent covers the entire puzzle. Inventors who solve subsequent parts of the puzzle may need to pay royalties to the patentee, even if their contributions are larger.</p>
<p>As <a href="https://scholar.google.com/citations?user=Xx0JFNwAAAAJ&hl=en">legal experts</a> who focus on <a href="https://scholar.google.com/citations?user=SlW0VEkAAAAJ&hl=en">technology law and policy</a>, we suggest that the problem boils down to two issues: too many patents and too little accurate information about them.</p>
<h2>Too many patents</h2>
<p>The U.S. is awash in patents. <a href="https://www.uspto.gov/web/offices/ac/ido/oeip/taf/us_stat.htm">Over 350,000</a> U.S. patents were granted in 2019, four times the per capita rate in 1980. From the perspective of research managers at big firms, patents are cheap and easy to get. For example, in the early 2000s Bill Gates decided that <a href="https://www.nytimes.com/2005/07/31/business/digital-domain-why-bill-gates-wants-3000-new-patents.html">Microsoft was patent-poor</a>, and within a few years the company increased annual patent applications by 50%. </p>
<p><a href="https://scholarship.law.wm.edu/wmlr/vol51/iss2/11/">Patents are easy to get</a> because the standards of patentability are low and because the burden is on the U.S. Patent and Trademark Office to prove an invention is not patentable. <a href="https://www.uspto.gov/dashboard/patents/">Patent examination is slow</a>. It often takes three years or more. Despite increased staffing, the backlog of patent applications has continued to grow, and examiners spend on average only 20 hours reviewing each application. The patent examiner <a href="https://www.uspto.gov/sites/default/files/documents/InventionCon2020_Understanding_the_Patent_Examination_Process.pdf">is required to</a> read and understand the invention in an application, determine whether the invention meets the claims of the application, search existing technology to see if the invention already exists and write a response to the application.</p>
<p><a href="https://www.gao.gov/products/gao-16-490">Helter-skelter examination causes errors</a> – many patents are too broad, or they cover obvious inventions. To draw attention to problems caused by the <a href="https://openscholarship.wustl.edu/law_journal_law_policy/vol8/iss1/12/">flood of low-quality patents</a>, billionaire entrepreneur Mark Cuban <a href="https://www.wired.com/2012/12/eff-patent-donation/">endowed a chair</a> at the Electronic Frontier Foundation dedicated to elimination of “stupid patents.” </p>
<p>Innovative firms that succeed in assembling many pieces of a technology puzzle into a finished product must consult with a patent lawyer to learn whether their new technology is covered by one or more patents owned by others. Ideally an innovator will get permission to use patented technology, usually for a fee, or redesign its technology to steer clear of relevant patents. </p>
<p>In practice this patent “clearance” process is <a href="https://doi.org/10.1093/jla/las019">difficult, costly and sometimes impossible</a>. For technologies like smartphones, a patent attorney likely would need to review hundreds of patents, including many patents that are not granted until long after the new product is launched. Failure to license relevant patents creates a risk of litigation and the threat the new technology could be forced out of the marketplace.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Screenshot of an iPod showing an image of the earth and the slide-to-unlock bar" src="https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1131&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1131&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389676/original/file-20210315-15-2cp6l0.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">Apple secured a patent on slide-to-unlock despite earlier work that set the stage for the feature.</span>
<span class="attribution"><a class="source" href="https://flickr.com/photos/angelosu/3590292559/">Angelo Su/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>As a result, smartphone patent litigation is far too common. Apple – a smartphone pioneer – has participated in scores of lawsuits around the globe as both a defendant and plaintiff. As a plaintiff, Apple sometimes uses its patents opportunistically to hinder innovation by its rivals.</p>
<p>For example, Apple sued Samsung using a patent that claimed the <a href="https://www.nytimes.com/2012/10/08/technology/patent-wars-among-tech-giants-can-stifle-competition.html">slide-to-unlock</a> feature on a phone as Apple’s invention. Despite strong evidence that inventors before Apple had already accomplished the key steps to implement this feature, Apple convinced the courts that their version of this feature was patentable, and after seven years Samsung agreed to pay license fees to Apple to <a href="https://www.nytimes.com/2018/06/27/technology/apple-samsung-smartphone-patent.html">settle the case</a>. </p>
<p><a href="https://dx.doi.org/10.2139/ssrn.2091210">Economic research</a> suggests that these litigation costs and license fees burden innovative firms to such a degree that on balance the patent system discourages innovation. In other words, innovative firms gain a benefit from their patents on their new technology, but that benefit is more than offset by the many patents owned by others that might be asserted against the new technology. </p>
<h2>Too little information</h2>
<p>When an inventor gets a patent, she is supposed to reveal the secret sauce behind the invention in the patent, a public document. This allows scientists and engineers to learn about the invention and use that information to improve the technology. </p>
<p>Or at least, that’s the theory. In practice, many inventors make shoddy disclosures. Experiments reported in patents are sometimes <a href="https://science.sciencemag.org/content/364/6445/1036">fictional</a> and often rely on <a href="https://dx.doi.org/10.2139/ssrn.3538746">dubious methodology</a>. For instance, patent law permits an inventor to disclose the fictional finding that a drug treats cancer as evidence that she deserves a patent on that drug. </p>
<p>Inventors applying for patents are allowed to include predicted experimental results. The intent is to allow for earlier disclosure and to help smaller companies secure funding. But when evidence in patents is wrong, other innovators can be <a href="https://dx.doi.org/10.2139/ssrn.3202493">misled</a>. Further, if other innovators want to figure out if the patented drug really treats cancer – or any other disease – they need a license from the patentee.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A graphical representation of an early electric incandescent lightbulb" src="https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=915&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=915&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=915&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1150&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1150&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389680/original/file-20210315-15-1qujb86.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1150&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Edison was the victim of a broad light bulb patent that covered one of his subsequent inventions.</span>
<span class="attribution"><a class="source" href="https://archive.org/details/TheEdisonIncandescentElectricLightItsSuperiorityToAllOther">Edison Electric Light Company</a></span>
</figcaption>
</figure>
<p>Sometimes key pieces of evidence are missing entirely from patents. This happens when a patent covers aspects of a technology that the patentee <a href="https://ssrn.com/abstract=2785886">didn’t actually invent</a>. Imagine discovering that paper is a mediocre incandescent conductor in light bulbs and using that discovery to get a patent covering thousands of other conductors, including ones that, unbeknownst to you, work much better. Later innovators might want to figure out whether other substances are better conductors than paper, but they can’t even start experiments without a license. </p>
<p><a href="https://www.nytimes.com/1895/11/12/archives/sustained-the-edison-company-supreme-court-decides-against-the.html">This happened to Edison</a>. He was <a href="https://supreme.justia.com/cases/federal/us/159/465/">sued for patent infringement</a> after discovering a far better conductor than that discovered by the patentee – but because the patent was written broadly, it nevertheless covered Edison’s invention.</p>
<p>There is also too little information about the <a href="https://press.princeton.edu/books/paperback/9780691143217/patent-failure">boundaries of patents</a>. When an inventor gets a patent, she is also supposed to provide clear boundary information – what a patent application covers and what it doesn’t – to the public about her patent rights. The patent system fails to ensure this, however. </p>
<p>The boundary information in patent applications is hidden for <a href="https://www.uspto.gov/web/offices/pac/mpep/s1120.html">18 months</a> until the application is published, and even longer if the boundaries change later during examination. Once the patent is granted, lawyers, judges and the public often have <a href="https://ilr.law.uiowa.edu/print/volume-103-issue-3/patent-clutter/">difficulty reaching agreement</a> on the meaning of boundary language that may be <a href="https://www.harvard-jlpp.com/wp-content/uploads/sites/21/2010/01/39_1_Meurer_F.pdf">intentionally vague or ambiguous</a>.</p>
<h2>How to fix the system</h2>
<p>Inventors who come up with new chemicals, including pharmaceuticals, <a href="https://doi.org/10.1377/hlthaff.2014.1047">tend to benefit from the patent system</a>. Unfortunately, the system appears to impose a <a href="https://dx.doi.org/10.2139/ssrn.2278255">net cost on most other technologies</a>, especially in high-tech industries.<br>
Opportunistic patent owners, often called patent trolls, surprise inventors with patent claims about inventions that are minor or distantly related to the technology that is the target of the suit. <a href="https://www.cato.org/sites/cato.org/files/serials/files/regulation/2012/5/v34n4-1.pdf">Economics research</a> shows such trolling activity slows innovation. </p>
<p>[<em>Over 100,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p>
<p>The patent system can be improved to deliver a net gain to all inventors even without being drastically reworked. A good start would be to rigorously enforce existing standards about information disclosure. Courts should push inventors to clearly describe and explain their inventions. </p>
<p>The flood of patents on minor technical advances could be ended if patent <a href="https://www.ftc.gov/system/files/documents/public_events/1494697/21_mark_schankerman.pdf">fees were increased and if the nonobviousness standard</a>, which screens out minor advances, was made stronger. Reducing the number of patents and increasing the amount of information about each patent would go a long way toward making the patent system work the way it was intended.</p><img src="https://counter.theconversation.com/content/148075/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael J. Meurer receives funding from the Technology and Policy Research Initiative at BU Law. The current funders are Google.org
Ewing Marion Kauffman Foundation
Charles Koch Foundation
Schmidt Futures
<a href="https://sites.bu.edu/tpri/about/funders/">https://sites.bu.edu/tpri/about/funders/</a> </span></em></p><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>Too many patents and too little information about them makes it hard for the system to weed out patents that unfairly block inventors.Michael J. Meurer, Professor of Law, Boston UniversityJanet Freilich, Associate Professor of Law, Fordham UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1453722020-12-08T13:14:58Z2020-12-08T13:14:58ZThe iconic American inventor is still a white male – and that’s an obstacle to race and gender inclusion<figure><img src="https://images.theconversation.com/files/372362/original/file-20201201-19-rbhm6a.jpg?ixlib=rb-1.1.0&rect=0%2C1%2C1024%2C818&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Thomas Edison remains the poster child of American invention 89 years after his death.</span> <span class="attribution"><a class="source" href="https://www.loc.gov/resource/cph.3c10811/">Underwood & Underwood via the Library of Congress</a></span></figcaption></figure><p>When President Barack Obama <a href="https://www.uspto.gov/learning-and-resources/newsletter/inventors-eye/president-obama-signs-america-invents-act">signed the America Invents Act</a> in 2011, he was surrounded by a group of people of diverse ages, genders and races. The speech he delivered about the legislation, which changed the technical requirements for filing a patent, highlighted this diversity by emphasizing that today anyone can become an inventor in the United States.</p>
<p>Despite Obama’s optimism about women and people of color inventing and patenting the nation’s new and innovative technologies, both groups still lag considerably behind their white male counterparts in <a href="https://www.bbc.com/news/technology-49843990">being recognized as inventors</a> and <a href="https://iwpr.org/publications/equity-in-innovation-women-inventors-and-patents/">owning patents</a>, in the U.S. and globally. Women and people of color possess the same intellectual capacities as their white male counterparts. Yet <a href="https://doi.org/10.1111/ablj.12159">empirical studies</a> consistently show that patent law overwhelmingly rewards white men for their labor and skill. </p>
<p>This is in part because <a href="https://ngcproject.org/statistics">women</a> and <a href="https://www.pewsocialtrends.org/2018/01/09/blacks-in-stem-jobs-are-especially-concerned-about-diversity-and-discrimination-in-the-workplace/">people of color</a> join science, technology, engineering and math (STEM) fields in much lower numbers than white men. In 2017, women made up over half of the workforce, but held only <a href="https://www.catalyst.org/research/women-in-science-technology-engineering-and-mathematics-stem/">29% of STEM jobs</a>. But even women and people of color who go into STEM fields invent and patent far less often than their white male counterparts. </p>
<p>The question is why. </p>
<p>As a researcher who <a href="https://scholar.google.com/citations?user=ugCKmdMAAAAJ&hl=en">studies race, rhetoric and intellectual property law</a>, I can say that the U.S.’s race and gender invention and patent gap results partly from a failure of imagination. The stories that people tell about invention in the U.S. continue to focus on white men – the Benjamin Franklins, Thomas Edisons and Elon Musks – without affording women and people of color the same larger-than-life status. </p>
<p>National myths about inventorship and political barriers to patenting set up women and people of color for failure by normalizing <a href="https://www.pewsocialtrends.org/2018/01/09/women-and-men-in-stem-often-at-odds-over-workplace-equity/">entrenched discrimination</a> even when they join STEM fields.</p>
<h2>The stories we tell about inventors</h2>
<p><a href="https://www.britannica.com/topic/critical-race-theory">Critical race theorists</a> show how legal terms and everyday narratives can look as if they create a level playing field while allowing implicit bias to thrive. In my new book, “<a href="https://www.sup.org/books/title/?id=27831">The Color of Creatorship</a>,” I look at how intellectual property law has evolved racially over 200 years. </p>
<p>Black and brown people are no longer legally prohibited from owning patents and copyrights, as they were in the 1700s and 1800s. However, seemingly colorblind patent and copyright laws continue to practically favor white male inventors and creators by using legal definitions and tests that protect inventions and creations that tend to match Western conceptions and expectations of, for instance, <a href="https://doi.org/10.1038/d41586-020-03056-z">expertise</a> and <a href="https://www.theatlantic.com/entertainment/archive/2010/03/how-to-make-a-documentary-about-sampling-legally/38189/">creativity</a>. </p>
<p>From the now cliché “think outside the box” to Apple’s slogan “<a href="http://www.thecrazyones.it/spot-en.html">think different</a>,” innovation, a central component of invention, is associated with breaking limits. Yet Americans have largely failed to change the ways that they think and talk about invention itself. </p>
<p>Even Obama’s speech about the America Invents Act begins by explaining how Thomas Jefferson epitomized the nation’s mythic spirit of invention and innovation. Yet Jefferson held the racist view that Black people <a href="https://www.washingtonpost.com/archive/lifestyle/2002/03/26/henry-louis-gates-a-wheatley-reader/e7a097ac-8d42-4432-abf0-8366e5ea4528/">lacked the capacity to be truly imaginative creators</a>, let alone citizens of the nation. Breaking limits, it turns out, is most often <a href="https://www.theatlantic.com/business/archive/2013/08/entrepreneurship-the-ultimate-white-privilege/278727/">a privilege afforded to white people</a>. </p>
<p>The current historical moment, in which facts are negotiable, white nationalism is on the rise and the nation is weathering a pandemic, is an important time to redefine American mythologies of invention. Celebrating the inventive capacity of women and people of color matters. Recognizing their innovative genius, in films like “<a href="https://www.newyorker.com/culture/richard-brody/hidden-figures-is-a-subtle-and-powerful-work-of-counter-history">Hidden Figures</a>,” helps transform what had been marginalized stories into narratives that are central to history. </p>
<p>Obama’s reference to Jefferson reinforced powerful, limiting conventional wisdom about invention and innovation. Popular cultural narratives frequently invoke the contributions of white men while erasing those of women and people of color. For example, the History Channel’s <a href="https://www.realclearhistory.com/articles/2012/11/09/who_are_the_men_who_built_america_40.html">The Men Who Built America</a> focuses on the inventions and innovations of Cornelius Vanderbilt, John D. Rockefeller, Andrew Carnegie and Henry Ford, business titans who achieved tremendous success via dubious ethics. </p>
<p>The show’s use of the Great Man theory of inventorship and entrepreneurship leaves out the many women and people of color, including Thomas Jennings, Elijah McCoy, Miriam E. Benjamin and Sarah E. Goode who, as legal scholar Shontavia Johnson shows, not only <a href="https://theconversation.com/americas-always-had-black-inventors-even-when-the-patent-system-explicitly-excluded-them-72619">invented and patented during the same period</a> but, as legal scholar Kara Swanson shows, used their work to <a href="https://www.cambridge.org/core/journals/journal-of-the-gilded-age-and-progressive-era/article/inventing-the-woman-voter-suffrage-ability-and-patents/B698232F40C9E4AF0E817097CA4F1987">lobby for suffrage rights for women and people of color.</a> </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/gQo1cZtEpgY?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">A brief listing of notable Black American inventors.</span></figcaption>
</figure>
<h2>Attacking Asian innovation</h2>
<p>America’s white-male-centered imaginings of inventorship and patenting extend beyond the nation’s borders, in xenophobic pronouncements frequently directed at Asian nations. Apple co-founder Steve Wozniak <a href="https://economictimes.indiatimes.com/opinion/interviews/success-in-india-is-based-on-studying-having-a-job-wheres-the-creativity/articleshow/63065361.cms?from=mdr">recently proclaimed</a>: “Success in India is based on studying, having a job … where’s the creativity?” </p>
<p>Similarly, President Trump claimed to be “<a href="https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-protecting-america-chinas-efforts-steal-technology-intellectual-property/">protecting the innovations, creations, and inventions that power our country</a>” from Chinese graduate students, who are part of a racial group that has long <a href="https://asiasociety.org/blog/asia/how-asian-graduates-and-executives-boost-us-economy">boosted America’s economy</a>, <a href="https://www.forbes.com/sites/johnmauldin/2018/09/19/china-is-building-the-worlds-largest-innovation-economy/#76f52ae66fd4">fueled global innovation</a> and <a href="https://www.reuters.com/article/us-health-coronavirus-usa-hcq/trump-thanks-india-for-decision-on-anti-malaria-drug-idUSKCN21Q2ZC">offered pandemic assistance</a>. </p>
<p>Refusal to recognize diversity in inventorship is a bipartisan affair. Then-presidential candidate and current President-elect <a href="https://www.bloomberg.com/news/articles/2014-05-29/biden-makes-a-habit-of-dissing-chinese-innovation">Joseph Biden made a shocking assertion</a> about innovation in China: “I challenge you, name me one innovative project, one innovative change, one innovative product that has come out of China.” </p>
<h2>Inventing new ways to talk about invention</h2>
<p>Racist, sexist and xenophobic inventorship and patenting norms are not immutable facts. They are practices built on exclusionary stories and feelings, transformed into familiar myths, including that of the American dream. These exclusionary stories frequently function as <a href="https://www.chicagoreporter.com/dog-whistle-politics-is-gops-longtime-political-weapon-of-choice/">dog whistles</a> that have long been used to fuel white anxieties about people of color and men’s anxieties about women. They make it difficult for women and people of color to prove they have the expertise needed to invent and patent.</p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p>However, as films like “Hidden Figures” emphatically show, it’s possible to tell inclusionary stories. I argue that telling them is an ethical act because it ensures that society recognizes the genius of people of all identities – race, gender, nationality, religion, ability, age – in contributing to invention and innovation, current and historical.</p>
<p>Rhetoricians frequently proclaim that “words mean things.” This is certainly true when imagining who has the capacity to perform certain tasks, such as inventing and patenting. At a moment in which the U.S. faces threats to democracy, environment and economy, it is more important than ever to invent new ways of talking about invention. People of all identities deserve the opportunities to create and own their innovative solutions for solving the world’s most pressing problems. More importantly, they deserve to be treated as full citizens in the realm of intellectual property and innovation.</p><img src="https://counter.theconversation.com/content/145372/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anjali Vats is affiliated with Microsoft Research New England's Social Media Collective. </span></em></p>The story of invention in America typically features larger-than-life caricatures of white men like Thomas Edison while largely ignoring the contributions of women and people of color.Anjali Vats, Associate Professor of Communication and African and African Diaspora Studies and Associate Professor of Law (By Courtesy), Boston CollegeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1194942019-06-26T19:25:13Z2019-06-26T19:25:13ZTrademark scholar says FUCT’s victory at Supreme Court is a win for free speech<figure><img src="https://images.theconversation.com/files/281458/original/file-20190626-76743-1cq4cuj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Erik Brunetti had good reason to be optimistic after the court heard his case in April.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Supreme-Court-Scandalous-Trademarks/903225524c2e4df8b15e39981f490dbe/2/0">AP Photo/J. Scott Applewhite</a></span></figcaption></figure><p>When is a brand too scandalous to register as a <a href="https://www.uspto.gov/trademarks-getting-started/trademark-basics">trademark</a>? According to the Supreme Court, there may be no such thing. </p>
<p>In a case that tested the constitutional limits of free speech, the <a href="https://www.npr.org/2019/06/24/732512169/supreme-court-strikes-down-ban-on-trademarking-immoral-scandalous-words-symbols">high court struck down a ban</a> on registering “immoral” or “scandalous” words and symbols. The <a href="https://www.scotusblog.com/2019/06/long-time-prohibition-on-registration-of-scandalous-and-immoral-trademarks-is-struck-down/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+scotusblog%2FpFXs+%28SCOTUSblog%29">ruling</a> was 6-3.</p>
<p>As a <a href="https://scholar.google.com/citations?user=T_SiGdwAAAAJ&hl=en&oi=a">trademark attorney and scholar</a>, I believe the Supreme Court made the right call in forcing the government to stop enforcing an impossible-to-apply moral standard in trademark law – as it has in many other legal domains.</p>
<p>I attended the oral argument on April 15, when lawyers representing streetwear clothing label FUCT <a href="https://www.washingtonpost.com/politics/courts_law/he-wants-to-trademark-a-brand-name-that-sounds-like-the-f-word-the-supreme-court-is-listening/2019/04/12/17426e44-5d29-11e9-a00e-050dc7b82693_story.html?utm_term=.b8767c55ecbb">argued the company has a right</a> to register its brand as a trademark, which helps protect against copycats. The United States Patent and Trademark Office had <a href="https://www.npr.org/2019/04/16/713632552/supreme-court-dances-around-the-f-word-with-real-potential-financial-consequence">rejected it</a> on the grounds that FUCT is “immoral” and “scandalous.” </p>
<p>Let me explain why the office got it wrong.</p>
<h2>An outlaw ethos</h2>
<p>It is perhaps appropriate that this case arose from a streetwear label famous for testing the limits. </p>
<p>While it’s commonplace today for clothing labels to adopt a provocative ethos and image, FUCT founder Erik Brunetti was a <a href="https://www.gq.com/story/fuct-erik-brunetti-supreme-court-case">trailblazer of edgy streetwear fashion</a> when <a href="https://www.grailed.com/drycleanonly/fuct-history">he started the company</a> in 1990. The name was meant to embody the company’s outlaw image – a corporate-looking logo with an anti-authoritarian pronunciation and subversive message. </p>
<p>A popular style involved prints of the brand name in the font style of the Ford logo, which can be found on <a href="http://www.defunkd.com/forum/what-worth-f20/vintage-fuct-ford-logo-shirt-t2930.html">T-shirts</a> and <a href="https://www.google.com/search?q=fuct+ford+logo+hat+original&rlz=1C5CHFA_enUS754US754&source=lnms&tbm=isch&sa=X&ved=0ahUKEwjD4szWwMvhAhVimuAKHfI1Av4Q_AUIDygC&biw=1412&bih=736">hats</a>. The brand quickly became a cultural icon, with its gear worn by skateboarders, punk rockers and even <a href="https://www.pinterest.com/pin/555420566539029843">members of the band Nirvana</a>. </p>
<p>As the popularity of the label grew, it engendered fake FUCT merchandise. In order to protect his mark more effectively around the world, <a href="http://www.abajournal.com/magazine/article/too-tasteless-to-trademark">Brunetti applied to register</a> it with the U.S. Patent and Trademark Office in 2011.</p>
<p>Trademark registration <a href="https://www.uspto.gov/trademarks-getting-started/trademark-basics">confers significant benefits</a>, including nationwide protection from confusingly similar products, enhanced monetary damages in litigation and priority for foreign filings. It also enables U.S. Customs agents to stop counterfeit goods from entering at the border. </p>
<p>In rejecting Brunetti’s application, examiners argued he ran afoul of a more than century-old provision in trademark law. </p>
<h2>‘Offensive to the conscience’</h2>
<p>The prohibition on registration of immoral and scandalous trademarks has been in existence since Congress <a href="https://www.ipmall.info/sites/default/files/hosted_resources/lipa/trademarks/PreLanhamAct_086_Act_of_1905.htm">passed the Trademark Act of 1905</a>. It says any mark that “consists of or comprises immoral or scandalous matter” will be rejected. </p>
<p>Today, scandalous <a href="https://tmep.uspto.gov/RDMS/TMEP/Oct2012#/Oct2012/TMEP-1200d1e3054.html">is defined</a> as “shocking to the sense of propriety, offensive to the conscience or moral feelings or calling out for condemnation.” </p>
<p>I and other scholars <a href="https://kb.osu.edu/bitstream/handle/1811/64637/OSLJ_V54N2_0331.pdf">have long questioned the wisdom</a> of having the trademark office as an arbiter of a collective and ever-evolving moral standard. That’s because trademarks <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/branlaj49&div=25&id=&page=">serve a valuable function</a> in the marketplace by identifying the source of a good or service, helping consumers trust where something they buy comes from and preventing deception. </p>
<p>What matters is source quality – not moral quality. </p>
<p>And because the prohibition affects registration but not use, I have found that <a href="https://scholars.unh.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1309&context=law_facpub">it is ineffective</a> at keeping offensive trademarks out of the marketplace. In addition, decisions based on this provision are wildly inconsistent. </p>
<h2>If FCUK is fine, why not FUCT?</h2>
<p>While the U.S. <a href="https://www.jstor.org/stable/1339557?seq=1#page_scan_tab_contents">has moved away</a> from regulating morality in other areas such as broadcasting – and in other forms of intellectual property such as copyrights and patents – the government continues to do so when it comes to granting <a href="https://freibrun.com/trademarks-valuable-intellectual-property-assets/">valuable legal rights</a> through trademark registration. </p>
<p>The primary evidence used by examiners to determine whether to reject a mark on these grounds is the <a href="https://ssrn.com/abstract=2715104">dictionary</a>. If a dictionary indicates that a term is “vulgar,” that is sufficient evidence to reject a mark. </p>
<p>Trademark examiners evaluate the meaning of a mark in the context of the current attitudes of the day. For example, in 1938, the <a href="https://casetext.com/case/in-re-riverbank-canning-co">trademark office rejected</a> a request to trademark Madonna as a wine brand on grounds that the word is religious in nature. A half-century later, the office apparently no longer had a problem with granting such trademarks when <a href="http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4809:d6j8vq.2.29">it approved one</a> for Madonna rosé wine. </p>
<p>Since the perception of what is and isn’t scandalous is constantly changing, it’s difficult for the trademark office to keep up. And trademarks that are considered scandalous or immoral to one examiner may be acceptable to another. </p>
<p>As a result, the trademark office records <a href="https://ssrn.com/abstract=2715104">are rife with inconsistencies</a>. In recent years, examiners <a href="https://www.uspto.gov/trademarks-application-process/search-trademark-database">have approved trademarks</a> containing words such as “whore,” “bitch,” “penis” and “pothead” while rejecting others with the same terms. </p>
<p>And the office has even approved clothing trademarks remarkably similar to FUCT, including FCUK, the F word and Fvck Street Wear. </p>
<p>In the case of FUCT, the rejection was based on the idea that the homonym <a href="https://www.supremecourt.gov/DocketPDF/18/18-302/95141/20190402150636686_18-302rbUnitedStates.pdf">would be perceived as equivalent</a> to the vulgar word it sounds like. </p>
<h2>A terrible message</h2>
<p>Two years ago, the Supreme Court cited the First Amendment <a href="https://www.npr.org/sections/thetwo-way/2017/06/19/533514196/the-slants-win-supreme-court-battle-over-bands-name-in-trademark-dispute">in striking down</a> a prohibition against <a href="https://theconversation.com/is-the-slants-racist-court-ruling-on-band-name-could-upend-trademark-law-48413">trademark registration for marks that disparage</a> individuals or groups.</p>
<p>That case arose when Simon Tam <a href="https://theconversation.com/is-the-slants-racist-court-ruling-on-band-name-could-upend-trademark-law-48413">sought to register the name</a> of his Asian American dance rock band, “The Slants,” as a trademark. The Supreme Court held that trademarks are private – not government – speech, and an examiner may not refuse to register trademarks based on the particular viewpoint the trademarks express. This case considered whether “scandalous” and “immoral” trademarks also discriminate on the basis of viewpoint. </p>
<p>In the FUCT case, several justices expressed concern that allowing trademark registration of offensive terms could be perceived as some sort of government endorsement of that language. Fortunately, however, a majority disagreed. </p>
<p>Trademark law shouldn’t police morality. It is terrible at doing so. </p>
<p><em>This is an updated version of an article originally published on April 23, 2019.</em></p><img src="https://counter.theconversation.com/content/119494/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Megan M. Carpenter 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 high court struck down a ban on trademarking ‘immoral’ or ‘scandalous’ words and symbols. A trademark scholar explains why that’s a good thing.Megan M. Carpenter, Dean, University of New HampshireLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1055082018-11-06T05:32:28Z2018-11-06T05:32:28ZMānuka honey: who really owns the name and the knowledge<figure><img src="https://images.theconversation.com/files/244004/original/file-20181105-74775-rw2dak.jpg?ixlib=rb-1.1.0&rect=880%2C485%2C5101%2C3449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In the case of mānuka honey, there are serious questions about what authenticity actually means. </span> <span class="attribution"><span class="source">from www.shutterstock.com</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p><a href="http://theconversation.com/how-better-tests-and-legal-deterrence-could-clean-up-the-sticky-mess-left-behind-by-fake-honey-row-102973">Adulterated honey</a> and <a href="http://www.stuff.co.nz/sunday-star-times/latest-edition/6784835/Fake-manuka-honey-threatens-industry">fake mānuka honey</a> have repeatedly made headlines in recent years. </p>
<p>The arguments around adulterated honey are relatively simple. These honeys are diluted with cheaper syrups and their lack of authenticity is unquestionable. The discourse around mānuka honey is different, as there are serious questions about what authentic mānuka honey actually means. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/honeygate-deepens-as-new-tests-reveal-27-of-brands-are-adulterated-104139">'Honeygate' deepens as new tests reveal 27% of brands are adulterated</a>
</strong>
</em>
</p>
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<h2>Two warring families</h2>
<p>The term mānuka carries with it a <a href="https://www.eater.com/2016/8/25/12644050/manuka-honey-why-so-expensive">premium</a>. Mānuka honey is made from the nectar of the <em>Leptospermum scoparium</em> flower. This plant is native to New Zealand and south-east Australia. It is, thus, not surprising that much of the war around the term mānuka has played out between Australian and New Zealand producers.</p>
<p>There are many registered trademarks in Australia and New Zealand that include the word mānuka and relate to honey-based products. In July, the Australian Manuka Honey Association filed to <a href="https://search.ipaustralia.gov.au/trademarks/search/view/1939743?fs=PENDING&fst=WORD&q=manuka">protect its name</a>. </p>
<p>The parallel New Zealand entity, the Mānuka Honey Appellation Society Inc, has filed for a <a href="https://www.stuff.co.nz/business/farming/102477715/nz-accepts-mnuka-honey-as-trademark-term-as-australian-government-funds-objection">certification trademark</a> for the term mānuka honey. If granted, traders in New Zealand would only be able to market their products as mānuka honey if they satisfy a certain standard and are certified as such. </p>
<p>The Mānuka Honey Appellation Society Inc sought the same certification trademark in <a href="https://search.ipaustralia.gov.au/trademarks/search/view/1752903?s=511a7039-d065-4b6b-b91c-a837171eebe5">Australia</a> and the <a href="https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/4/EU017285421">UK</a>. The New Zealand Ministry of Primary Industries has a <a href="https://www.mpi.govt.nz/growing-and-harvesting/honey-and-bees/manuka-honey/">definition for authentic mānuka honey</a>, which includes a certain DNA marker and four chemical compounds. Comvita have separately <a href="http://www.umf.org.nz/%7Bhttps://patents.google.com/patent/WO2017099612A1/en">filed patent applications</a> for marker compounds to <a href="https://www.comvita.co.nz/purest-source/manuka-honey/rangeNZ00001">identify true mānuka honey</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-fake-honey-and-why-didnt-the-official-tests-pick-it-up-102573">What is fake honey and why didn’t the official tests pick it up?</a>
</strong>
</em>
</p>
<hr>
<h2>What’s in a name</h2>
<p>Despite the value embodied in the term mānuka, Māori interests are often left out of the discussion. Similarly, little attention is given to the disagreement within Māoridom about who has jurisdiction over mānuka. </p>
<p>This is despite the glaringly obvious fact that mānuka is the <a href="http://www.maoritelevision.com/news/national/foma-disagrees-australias-claim-manuka-honey-trademark">Māori term</a> for <em>L.scoparium</em>. Put another way, a war of words is playing out. And, while the war is over a Māori word, Māori are not seen as a key player. Instead, it is industry and government that we see on the field.</p>
<p>The fact that Māori are often left out from the conversation around the authenticity of mānuka honey reflects a long history of western law and science ignoring indigenous peoples, at best, or treating them as non-stakeholders or sources to be mined for information, at worst. The issue runs deeper than simply the use of a Māori word.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=499&fit=crop&dpr=1 754w, https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=499&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/244005/original/file-20181105-74778-11f0gf4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=499&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Māori have long used the mānuka plant for medicinal purposes.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>From ancient grudge break to new mutiny</h2>
<p><em>L.scoparium</em> is near endemic to New Zealand. Māori have long used the plant and honey derived from it for various purposes, from brewing beer to <a href="https://collections.tepapa.govt.nz/topic/2988">multiple medicinal purposes</a>. The latter includes the treatment of urinary complaints, fevers, burns, dysentery, skin and muscle inflammations, eye and mouth problems, pain relief and as a sedative. Teas were made from the leaves of the plant to <a href="https://teara.govt.nz/en/rongoa-medicinal-use-of-plants">ease fevers</a>, or from the bark to treat dysentery and diarrhoea.</p>
<p>The use of <a href="https://www.newsroom.co.nz/@future-learning/2018/07/09/145825/patents-raise-concern-over-threat-to-maori-knowledge">Māori traditional knowledge</a> to further western science is not new. In a recent <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3209589">study of patent applications</a> filed in New Zealand, 25 applications were identified that used some aspect of the plant, honey or ingredient as a major component.</p>
<p>Half of the inventions were in the pharmaceutical industry. Many of these used the antibiotic properties of mānuka honey and were compositions including the honey or an extract. Several applied the antibiotic properties of the essential oil in <em>L.scoparium</em>. Three of the applications related to food or beverages. Two inventions were in the cosmetic industry.</p>
<h2>I take thee at thy word</h2>
<p>In 2013, New Zealand passed <a href="http://www.legislation.govt.nz/act/public/2013/0068/52.0/DLM1419043.html">new patent legislation</a>, which created a <a href="https://www.iponz.govt.nz/about-ip/maori-ip/maori-advisory-committees/">Māori Advisory Committee</a>. This has the role of advising the Commissioner of Patents on whether an invention is derived from Māori traditional knowledge or “indigenous plants or animals” and, if so, whether “the commercial exploitation of that invention is likely to be contrary to Māori values”. The commissioner uses this advice to determine whether the “commercial exploitation” of an invention would be contrary to “public order” or “morality”. </p>
<p>These provisions have the potential to introduce te ao Māori (the Māori world) into a western legal paradigm. It has yet to be seen if they will truly meet Māori concerns. Of the 25 inventions identified in the study, 13 appeared to be derivative of a known Māori use. However, only four of these came under the Patents Act 2013. </p>
<p>At the time of writing, none of the four had gone through full examination by the <a href="https://www.iponz.govt.nz/about-ip/trade-marks/process/">Intellectual Property Office of New Zealand</a>. Two were open for public inspection and two were recently filed. Indeed, no applications had gone to the Māori Advisory Committee. Thus, it remains to be seen what exactly the committee’s role will be and how it might affect applications for patents over inventions pertaining to mānuka in the future.</p><img src="https://counter.theconversation.com/content/105508/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jessica C Lai 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>While industry bodies fight over who can claim that their mānuka honey is authentic, Māori interests are often left out of the debate.Jessica C Lai, Senior Lecturer in Commercial Law, Te Herenga Waka — Victoria University of WellingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/840072017-11-20T15:54:42Z2017-11-20T15:54:42ZHow a Native American tribe came to own one of the world’s most valuable patents<figure><img src="https://images.theconversation.com/files/195449/original/file-20171120-18533-xdziwm.jpg?ixlib=rb-1.1.0&rect=125%2C278%2C5865%2C2955&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/263977949?src=UK9X2IIMyX0j7kM0oB3Gxw-1-4&size=huge_jpg">Tashatuvango/Shutterstock</a></span></figcaption></figure><p><a href="https://www.allergan.com/home">Allergan</a>, the drugmaker behind Botox, is using an unprecedented tactic to protect its valuable patents – angering lawyers and politicians, and keeping the price of its medicines high.</p>
<p>There has long been a debate about patents and traditional knowledge in developing countries. Pharmaceutical companies in the West, like Allergan, are often accused of “bio-prospecting”. They collect raw samples of traditional medicines and plants, whose healing properties have been known to locals for centuries, and patent modified extracts of the active ingredients. (Under patent law, existing natural materials such as plants and trees cannot be patented as they are not “novel”.)</p>
<p>Under international treaties, such as the <a href="https://www.cbd.int/convention/">Convention on Biodiversity</a>, companies need to ask permission before bio-prospecting. However, under patent law, pharmaceutical companies don’t have to share revenues from drugs developed in part from the exploitation of indigenous traditional knowledge. To add insult to injury, the patented medicines are often too costly for people in developing countries to afford.</p>
<h2>Bizarre twist</h2>
<p>The debate over patents and the rights of indigenous peoples has taken a bizarre new twist in recent months. Allergan transferred the ownership of the patents on one of its most valuable medicines – Restasis, a treatment for chronic dry eyes that had US$1.5 billion in <a href="http://www.newsweek.com/how-racism-fueling-pharma-scandal-over-billion-dollar-patent-680596">sales in 2016 alone</a> – to the Saint Regis Mohawk Tribe of New York State. It now plans to lease back the rights to the drug.</p>
<p>This may seem like a case of the pharmaceutical industry seeking to right historical wrongs by giving something back to an indigenous group that has long suffered from discrimination and dispossession – but it is not. The deal is purely a self-interested one on the part of Allergan. But there is no doubt that, in an inversion of the classic debate about using patents to exploit the knowledge of indigenous peoples, the Saint Regis Mohawk Tribe will also benefit from the deal.</p>
<p>So how did this come about? US law grants Native American tribes “sovereign immunity” in relation to their reservations, shielding them from some US federal laws. Since 2012 there has also been a system of challenging patents at the US Patents and Trademarks Office (USPTO) known as “<a href="https://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/inter-partes-review">Inter-partes Review</a>”. This allows competitors to argue at USPTO panels that a granted patent ought to be invalidated. It is quicker and more cost-effective than challenging a patent in court.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.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">US law grants Native American tribes sovereign immunity on reservations.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/116030641?src=hfFbyWvwgFQJgv3VD7Z-Pg-1-93&size=huge_jpg">Digital Media Pro/Shutterstock</a></span>
</figcaption>
</figure>
<p>This new system has <a href="https://www.bloomberg.com/news/articles/2017-09-20/apple-likes-the-patent-death-squad-allergan-pays-to-avoid-it">invalidated many pharmaceutical patents</a>. By transferring their patents to the Saint Regis Mohawk Tribe and leasing them back from the tribe for an annual fee of up to US$15m, Allergan is effectively paying the tribe to take advantage of its sovereign immunity, which also shields the patents from challenge. If this unprecedented legal strategy succeeds, it could prolong Allergan’s monopoly and stifle generic competition.</p>
<p>Meanwhile, the tribe, as quoted in the <a href="https://www.allergan.com/news/news/thomson-reuters/allergan-and-saint-regis-mohawk-tribe-announce-agr">Allergan press release</a>, said it viewed the deal as a way to benefit from the patent system, and that it would use the money for good causes in the community.</p>
<p>Unsurprisingly, there has been a great deal of opposition to this tactic. Shortly after the deal was announced in September 2017, several US senators asked the senate judiciary committee <a href="https://uk.reuters.com/article/us-allergan-patents/senators-want-probe-of-allergan-transfer-deal-with-tribe-letter-idUKKCN1C22VY?feedType=RSS&feedName=healthNews">to investigate</a> Allergan’s alleged “anti-competitive attempt to shield its patents from review and keep drug prices high”.</p>
<p>There is also an <a href="http://uk.businessinsider.com/allergan-restasis-patents-invalid-in-texas-district-court-2017-10?r=US&IR=T">ongoing court challenge</a> that may yet lead to a ruling that this strategy is an abuse of the sovereign immunity process. Yet if the Allergan-Saint Regis agreement survives legal challenge it will encourage further deals between US Native American tribes and pharmaceutical companies. </p>
<h2>Ingenious tactic</h2>
<p>There’s no doubt that the legal tactic is an ingenious one. Yet, even if we consider it a good thing that the tribe has found a new source of revenue, the deal should give us all pause for thought. </p>
<p>In addition to the competition concerns, this tactic subverts the protection given to Native American tribes under US law, in part to account for their historical dispossession. In other words, it uses the tribe’s status to boost corporate power and control of patented medicines. </p>
<p>It also, of course, does nothing to help other indigenous groups around the world, particularly those in developing countries. Although it turns the classic debate over patents and indigenous peoples on its head, the deal may end up doing more harm than good.</p><img src="https://counter.theconversation.com/content/84007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Luke McDonagh 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 Saint Regis Mohawk tribe has struck a multimillion-dollar deal with Allergan. But the deal may do more harm than good.Luke McDonagh, Senior Lecturer in Law, City, University of LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/768292017-07-19T06:43:00Z2017-07-19T06:43:00ZHow to make sure we all benefit when nonprofits patent technologies like CRISPR<figure><img src="https://images.theconversation.com/files/178710/original/file-20170718-10308-1vh9sh1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Are research nonprofits holding up their end of the tax-exempt bargain?</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/cthulhuwho1/3805687772">Will Hart</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Universities and other nonprofit research institutions are <a href="http://www.politico.com/interactives/2017/obamacare-cleveland-clinic-non-profit-hospital-taxes/">under increasing fire</a> about their commitments to the public interest. In return for tax-exempt status, their work is supposed to benefit society.</p>
<p>But are they really operating in the public interest when they wield their patent rights in ways that constrict research? Or when potentially lifesaving inventions are priced so high that access is limited? The public partially underwrites nonprofit discoveries via tax breaks and isn’t seeing a lot of benefit in return.</p>
<p>Questions like these arose recently in the case of CRISPR, the promising new gene-editing technology. After patenting it, the Broad Institute of MIT and Harvard sold the exclusive right to develop CRISPR-based therapies to its sister company <a href="https://www.bostonglobe.com/business/2016/12/19/editas-licenses-new-gene-editing-tool-raising-stakes-drug-development-race/VYRzmMHq4igAaBVrox1TsL/story.html">Editas Medicine</a>. <a href="https://www.statnews.com/2017/04/25/broad-institute-nonprofit-crispr/">Critics worry</a> that this monopoly could limit important research and result in exorbitant prices on emerging treatments.</p>
<p>We’ve seen this situation before: For example, Xtandi, a prostate cancer drug <a href="http://www.latimes.com/local/education/la-me-ucla-drug-royalties-20160304-story.html">developed and patented</a> by researchers at the University of California-Los Angeles, <a href="http://www.businessinsider.com/congress-taking-on-xtandi-price-2016-3">now costs</a> US$129,000 for a course of treatment. </p>
<p>Nonprofit research institutions <a href="http://www.latimes.com/local/education/la-me-uc-patents-20151011-story.html">usually argue</a> that any revenues they receive from their patents are reinvested in research and education. They contend this approach ensures that new technologies become widely available in the marketplace.</p>
<p>But I argue that nonprofit institutions can and should do better. At a moment of <a href="http://www.npr.org/sections/health-shots/2017/03/16/520390026/one-way-to-force-down-drug-prices-have-the-u-s-exercise-its-patent-rights">spiraling drug costs</a> and <a href="http://www.pewinternet.org/2015/01/29/public-and-scientists-views-on-science-and-society/">declining trust</a> in our science and technology policy institutions, they must develop a more sensitive and systematic way of thinking about the public interest in their intellectual property strategies. I offer one possible path.</p>
<h2>The logic of licensing</h2>
<p>Nonprofit research institutions’ understanding of the public interest is based on a <a href="http://press.uchicago.edu/ucp/books/book/chicago/P/bo25338584.html">U.S. innovation logic</a> that dates back to the country’s founding. <a href="https://theconversation.com/an-early-expression-of-democracy-the-us-patent-system-is-out-of-step-with-todays-citizens-43812">Early patent laws</a> encouraged all citizens to participate in the system. The more people who took advantage of the exclusive property rights afforded by a patent, the thinking went, the more robust the private sector, the more economic growth and the more new technologies available.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&rect=13%2C1155%2C4058%2C3001&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&rect=13%2C1155%2C4058%2C3001&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=603&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=603&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=603&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=758&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=758&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178282/original/file-20170714-14267-r2981q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=758&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 1980 Bayh-Dole Act clarified that nonprofits like the Broad Institute can own patents based on federally funded research.</span>
<span class="attribution"><a class="source" href="https://www.broadinstitute.org/photos-broad-institute/photos-broad-institute">Peter Vanderwarker</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>This logic guided passage of the 1980 <a href="https://doi.org/10.1016/j.respol.2009.07.007">Bayh-Dole Act</a>, which lets universities, small businesses and nonprofits own patents for inventions and discoveries that stem from federally funded research.</p>
<p>The law was triggered by <a href="http://press.princeton.edu/titles/9619.html">policymakers’ concerns</a> that companies were hesitating to commercialize federally funded inventions. Because the federal government paid for the research, it was unclear who – if anyone – owned the inventions that resulted. Companies worried that because the research results were in the public domain and unprotected by patents, they’d face competition and limited profits if they decided to develop a technology further. </p>
<p>But if nonprofits and small businesses could patent the inventions they developed, then they could exclusively license these inventions and defuse the threat of competition. Both the research institutions and companies would benefit. So too would the public because it would gain access to new technologies. It seemed like a win-win-win.</p>
<h2>Licenses are first step to profits</h2>
<p>In the wake of Bayh-Dole, many research institutions <a href="https://www.brookings.edu/research/university-start-ups-critical-for-improving-technology-transfer/">created technology transfer offices</a> to help faculty and staff patent and sell their innovations. These offices secure patents and then work to license the patented inventions and discoveries. The licenses come in two flavors. “Exclusive” means the company will have the sole license to develop the invention. “Non-exclusive” allows the university to sell multiple licenses on a single patented invention.</p>
<p>Exclusive licenses, like those negotiated by the Broad and UCLA in the cases of CRISPR and Xtandi, are common, but also controversial. Perhaps most famous is the exclusive license on <a href="http://som.yale.edu/case/2017/zerit">Zerit</a>, an important AIDS drug produced by researchers at Yale University. In 1998, Yale licensed its Zerit patent to Bristol Myers Squibb. The pharmaceutical company developed the drug further and eventually priced it so high that it was unaffordable for many in the developing world, where the AIDS crisis was severe.</p>
<p>Doctors without Borders, working with Yale students, successfully <a href="http://www.nytimes.com/2001/03/12/world/yale-pressed-to-help-cut-drug-costs-in-africa.html">pressured</a> the Yale administration to allow a South African company to create a generic version of the drug, and the price dropped by <a href="http://uaem.org/cms/assets/uploads/2013/03/UAEM_History_1_2011_Transition_DocumentFINAL.doc">96 percent</a>. This activism spawned the advocacy group <a href="http://www.uaem.org">Universities Allied for Essential Medicines</a>, which now operates 100 chapters in 18 countries across the world.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178275/original/file-20170714-3488-pmxzfy.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"></a>
<figcaption>
<span class="caption">Researchers in UAEM advocate for better access to medications, which means rethinking patent licensing on what comes out of their labs.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/lachiquita/3248063888">Gloria</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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</figure>
<h2>Holding back on some licenses</h2>
<p>Companies usually expect universities to sell them exclusive licenses to exploit their patents. They’re banking on the big profits that presumably come from having a monopoly on a valuable technology. Universities usually acquiesce because they too want to make the product available and generate maximum revenue.</p>
<p>But some universities have responded to UAEM’s activism. For instance, Harvard now <a href="http://otd.harvard.edu/upload/files/Sample_Global_Access_Language.pdf">reserves its right</a> to license patents nonexclusively for humanitarian purposes in low-income countries. It accepts the potential for a smaller revenue stream as a trade-off for lower drug prices and greater accessibility. Such provisions would come in handy for patents on <a href="http://www.msf.org/en/article/access-campaign-public-health-groups-welcome-johns-hopkins-university-and-medicines-patent">essential medicines</a> that could, say, cure Zika or HIV/AIDS. </p>
<p>Meanwhile, in other areas that raise significant moral, environmental and public health concerns, nonprofit research institutions are experimenting with “<a href="https://doi.org/10.1038/nbt.3756">ethical licensing</a>.” To prevent the abuse of their patented technologies, these licenses come with limits.</p>
<p>The Broad Institute’s exclusive licenses on the CRISPR technologies, for example, have multiple restrictions. Licensees may not use the gene-editing technology to modify human embryos, alter the ecosystem or <a href="http://gizmodo.com/monsanto-just-got-access-to-the-world-s-most-powerful-g-1786998287">grow stronger tobacco plants</a>. The Broad Institute’s approach is <a href="https://theconversation.com/crispr-dispute-raises-bigger-patent-issues-that-were-not-talking-about-56715">not a systematic or transparent one</a>, though. It’s not clear, for example, how or why the organization decided on these restrictions, and under what circumstances it would decide to issue restrictions on its other patents.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178731/original/file-20170718-10341-1mp7ith.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&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 proposal to make sure the public interest retains a seat at the table.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/143842337@N03/32590257662">thoroughlyreviewed.com</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>A better solution</h2>
<p>While promising, these efforts are still rare and ad hoc. I propose a better, more methodical, solution. Stand-alone nonprofit research institutions, universities and university-based hospitals should create intellectual property governance committees that would review pending patents and licenses. These committees would include not just patent lawyers, but also experts on innovation in its social, economic and historical context, ethicists and members of the public. </p>
<p>There’s a good precedent for this approach. In the latter part of the 20th century, in response to revelations of unethical biomedical research conducted by university faculty, the federal government began to require that all institutions getting federal funds <a href="http://press.uchicago.edu/ucp/books/book/chicago/B/bo12182576.html">develop a research ethics infrastructure</a>. Now all federally funded research in the U.S. involving human subjects – no matter what kind of institution conducts it – must be approved by an <a href="https://www.ncbi.nlm.nih.gov/pubmed/18811996">institutional review board</a>. These are made up of scientists, lawyers, at least one member of the public and others with expertise in the responsible conduct of research. </p>
<p>Similarly, the intellectual property governance committees I’m proposing would help ensure that society benefits from the patenting and licensing practices of these tax-exempt institutions. They would also build public trust, strengthening the case that these institutions deserve their tax breaks.</p>
<p>Suppose researchers at a nonprofit research institution develop a drug that treats opioid addiction. The drug would clearly have major societal benefit, since it could save some of the <a href="https://www.statnews.com/2017/06/27/opioid-deaths-forecast/">500,000 Americans</a> the disease is projected to kill within 10 years. An intellectual property governance committee could recommend that the institution negotiate only nonexclusive licenses on the drug – in turn fostering research, competition and lower prices. In addition, the committee might advocate a narrowly written patent to encourage related innovation.</p>
<p>Whether or not they embrace this idea, universities and nonprofit biomedical research institutions need to hold up their end of the societal bargain more carefully. If they don’t, they’re likely to face greater controversy and even more questions about whether they really deserve their special status.</p><img src="https://counter.theconversation.com/content/76829/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shobita Parthasarathy 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>Holding patents can be a lucrative and powerful position to be in. Here’s a proposal for how nonprofit patent holders can do more for the common good – and live up to their end of the tax break bargain.Shobita Parthasarathy, Associate Professor of Public Policy and Women's Studies, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/776012017-07-12T00:35:00Z2017-07-12T00:35:00ZWhy can’t we fix our own electronic devices?<figure><img src="https://images.theconversation.com/files/176259/original/file-20170629-16051-lydbvr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Fixing electronics devices doesn't need to be difficult.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/electronics-repair-607246958">Krashenitsa Dmitrii/Shutterstock.com</a></span></figcaption></figure><p>Traditionally, when a car breaks down, the solution has been to fix it. Repair manuals, knowledgeable mechanics and auto parts stores make car repairs common, quick and relatively inexpensive. Even with <a href="http://blog.caranddriver.com/automakers-agree-to-fix-your-car-anywhere-in-right-to-repair-pledge/">modern computer-equipped vehicles</a>, regular people have plenty they can do: change oil, change tires and many more advanced upgrades.</p>
<p>But when a computer or smartphone breaks, it’s hard to get it fixed, and much more common to <a href="https://doi.org/10.1016/j.jclepro.2015.09.119">throw the broken device away</a>. Even small electronic devices <a href="https://unu.edu/media-relations/releases/e-waste-in-east-and-south-east-asia-jumps-63-percent-in-five-years.html">can add up</a> to <a href="https://motherboard.vice.com/en_us/article/americas-television-graveyards">massive amounts of electronic waste</a> – between <a href="http://www.electronicstakeback.com/wp-content/uploads/Facts_and_Figures_on_EWaste_and_Recycling1.pdf">20 million and 50 million metric tons</a> of electronic devices every year, worldwide. Some of this waste is recycled, but most – including components <a href="https://www.engadget.com/2017/01/16/e-waste-levels-surge-in-asia/">involving lead and mercury</a> – goes into landfills.</p>
<p>Bigger equipment can be just as difficult to repair. Today’s farmers often can’t fix the <a href="https://motherboard.vice.com/en_us/article/farmers-right-to-repair">computers running their tractors</a>, because manufacturers claim that farmers <a href="https://copyright.gov/1201/2015/comments-032715/class%2021/John_Deere_Class21_1201_2014.pdf">don’t actually own them</a>. Companies argue that specialized software running tractors and other machines is <a href="https://www.wired.com/2015/04/dmca-ownership-john-deere/">protected by copyright and patent laws</a>, and allowing farmers access to it would harm the companies’ intellectual property rights.</p>
<p>Users’ <a href="https://motherboard.vice.com/en_us/article/farmers-right-to-repair">right to repair</a> – or to pay others to fix – objects they own is in jeopardy. However, in our surveys and examinations of product life cycles, my colleagues and I are finding that supporting people who want to repair and reuse their broken devices can yield benefits – including profits – for electronics manufacturers.</p>
<h2>A corporate quandary</h2>
<p>At least eight states – Nebraska, Kansas, Wyoming, Illinois, Massachusetts, Minnesota, New York and Tennessee – <a href="https://www.wired.com/2017/03/right-to-repair-laws/">are considering laws</a> that would require companies to let customers fix their broken electronics. The proposals typically make manufacturers sell parts, publish repair manuals and make available diagnostic tools, such as scanning devices that identify sources of malfunctions. In an encouraging move, the U.S. Copyright Office suggested in June that similar rules should <a href="https://motherboard.vice.com/en_us/article/d3zbnz/the-government-wants-to-permanently-legalize-the-right-to-repair">apply nationwide</a>. And the U.S. Supreme Court recently ruled that companies’ patent rights <a href="https://www.nytimes.com/2017/05/30/business/supreme-court-patent-rights-lexmark.html">don’t prevent people from reselling</a> their electronics privately.</p>
<p>Seen one way, these regulations put manufacturing companies in a tough spot. Manufacturers can <a href="http://www.smithsonianmag.com/innovation/fight-right-repair-180959764/">earn a lot of money</a> from selling authorized parts and service. Yet to remain competitive, they must constantly innovate and develop <a href="https://qz.com/1011782/iphone-8-apples-aapl-next-iphone-may-have-new-full-screen-design-new-video-shows/">new products</a>. To keep costs down, they can’t keep making and stocking parts for old and <a href="https://9to5mac.com/2017/05/27/apple-moving-macbook-pro-air-and-iphone-to-obsolete/">outdated devices forever</a>. This leads to what’s called “<a href="http://dx.doi.org/10.1080/19397038.2015.1099757">planned obsolescence</a>,” the principle that a company designs its items to have relatively short useful lives, which will end roughly around the time a new version of the product comes out.</p>
<p>However, our research suggests that companies can take a different approach – designing and building products that can be refurbished and repaired for reuse – <a href="https://doi.org/10.1016/j.resconrec.2016.02.014">while building customer loyalty and brand awareness</a>. By analyzing surveys of hobbyists and the repair industry, we’ve also found that there are barriers, such as a lack of repair manuals and spare parts, that <a href="https://doi.org/10.1016/j.resconrec.2016.09.013">impede the growth of the repair industry</a> that can be improved upon.</p>
<h2>Consumers want to fix their devices</h2>
<p>Even as machines and devices have become less mechanical and more electronic, we have found that customers still expect to be able to repair and continue using electronic products they purchase. When manufacturers support that expectation, by offering repair manuals, spare parts and other guidance on how to fix their products, they build customer loyalty.</p>
<p>Specifically, we found that customers are more likely to buy additional products from that manufacturer, and are more likely to <a href="https://doi.org/10.1016/j.resconrec.2016.02.014">recommend that manufacturer’s product</a> to friends. The math here is simple: More customers using a company’s products, whether brand-new or still kicking after many years, equals more money for the business.</p>
<p>Our research also shows that the <a href="https://doi.org/10.1016/j.resconrec.2016.02.014">failure of most electronic devices</a> is due to <a href="https://doi.org/10.1016/j.resconrec.2016.09.013">simple accidents</a> such as dropping a device or spilling water on it. The most common problem is a broken screen. There are other issues, too – such as batteries that no longer hold their charges or circuit boards that just stop working.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/176258/original/file-20170629-16091-cq0ywx.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">Simple repairs don’t require much work, nor many tools.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/smartphone-broken-small-screwdrivers-repair-on-521520520">arrowsmith2/Shutterstock.com</a></span>
</figcaption>
</figure>
<p><a href="http://www.consumerreports.org/cro/magazine/2014/02/repair-or-replace/index.htm">Even nontechnical users</a> often want to pay someone to clean their devices and replace parts such as damaged screens and old batteries. If manufacturers provided access to replacement parts, more damaged items could be repaired, extending their usefulness. Apple could seize an opportunity here: It has just begun <a href="http://appleinsider.com/articles/17/05/17/apple-commences-iphone-se-production-in-india-with-assembly-partner-wistron">assembling older iPhone models in India</a>, which means it is still making parts that others could use to fix the devices they already have.</p>
<h2>Helping consumers, companies and the environment</h2>
<p>Technology manufacturers should take steps to promote customers’ right to repair their broken devices, which helps cut down on electronic waste and boost brand loyalty. But if they won’t, laws and regulations can help.</p>
<p>In France, for example, a 2015 law requires manufacturers to tell customers – before they purchase an item – for <a href="https://www.fastcompany.com/3043252/this-new-french-law-is-designed-to-make-products-easier-to-repair-so-th">how long repair parts will be available</a>. That lets consumers decide how much they want to factor in the possibility for repairs when deciding whether to buy something new.</p>
<p>Supporting repair rights can also bring economic benefits to more than just the technology sector. There were 4,623 consumer electronic repair and maintenance companies in 1998 in the U.S. By 2015, that number <a href="https://doi.org/10.1016/j.resconrec.2016.09.013">had dropped to 2,072</a>. Independent vendors are creating online marketplaces where people can buy and sell used <a href="https://www.newegg.com/Refurbished/Store">and repaired</a> gadgets. Other companies like <a href="https://www.ifixit.com/">iFixit</a> and <a href="https://repaircafe.org/en/">Repair Cafe</a> are creating networks of people who share information on repairing electronics, and even <a href="https://www.ubreakifix.com/">getting groups of people together in person</a> to work on their devices. </p>
<p>Meanwhile 3-D printing continues to make it easier and cheaper for people to produce <a href="http://www.ubergizmo.com/2016/08/asus-3d-print-parts-for-motherboard/">replacement parts</a> for older devices. </p>
<p>Companies shouldn’t fear people taking too much into their own hands, though: While it’s been possible for a few years to 3-D print and hand-assemble <a href="http://www.telegraph.co.uk/technology/news/11217005/Make-your-own-computer-worlds-first-3D-printed-laptop.html">entire computers</a>, they’re <a href="https://www.theverge.com/circuitbreaker/2017/2/3/14501812/olimex-teres-i-open-source-diy-laptop">not very good</a>. People are much more likely to buy corporate-made devices; they just <a href="https://www.bostonglobe.com/business/2017/02/22/you-gotta-fight-for-right-repair-your-digital-devices/rEDZDfIAdMeRejijuprdIO/story.html">want to be able to repair them</a> when they break down.</p><img src="https://counter.theconversation.com/content/77601/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sara Behdad receives funding from National Science Foundation. Any opinions, findings, and conclusions or recommendations expressed in this article are those of the authors and do not necessarily reflect the views of the National Science Foundation. </span></em></p>Many companies are working to prevent customers from fixing broken smartphones and tractors. By doing so, they’re missing out on an opportunity to build customer loyalty and boost profits.Sara Behdad, Assistant Professor of Mechanical and Aerospace Engineering, University at BuffaloLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/771442017-05-15T12:04:42Z2017-05-15T12:04:42ZHow an open approach to patents could help build a sustainable future<figure><img src="https://images.theconversation.com/files/168757/original/file-20170510-21623-1y5wofm.jpg?ixlib=rb-1.1.0&rect=640%2C41%2C3359%2C2137&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/humpolec-czech-republic-october-2016-tesla-549421732?src=Q_pbkfZpAU3Ilg7QhPOg1Q-1-54">Nadezda Murmakova/Shutterstock</a></span></figcaption></figure><p>To sustain a population of <a href="http://www.un.org/en/development/desa/news/population/2015-report.html">9.7 billion people by 2050</a> the world is going to need innovations that make careful use of the available resources, human and environmental. Key industry sectors such as energy, water, agriculture and transport are already under pressure to move to more sustainable methods of production and consumption. However, there are barriers in the way.</p>
<p>One of these lies in how the world manages the creation and ownership of inventions and ideas. A protectionist approach to intellectual property is designed to protect and prolong the lifecycle of existing technologies, and allow innovators to capture the profits from their creations. In a paper published with colleagues from universities in Germany and India, we examined how this also <a href="http://www.ifm.eng.cam.ac.uk/research/ctm/ctmpublications/ctmworkingpapers/open-ip-strategies-for-enabling-sustainability-transitions/">makes it harder</a> for new and more sustainable technologies to be developed and adopted. That explains why there are now other approaches being used to move key sectors to more sustainable systems and end this status quo.</p>
<p>Electric car manufacturer Tesla, has been doing just that. Tesla CEO Elon Musk “shocked” the world in 2014 when he announced that his company was <a href="https://www.tesla.com/en_GB/blog/all-our-patent-are-belong-you">joining the open source movement</a> and giving away its patents for free.</p>
<p>It is important to understand the rationale here. Why would a company that had worked so hard to develop and protect its technology from its global car manufacturer competitors suddenly give its technology away for free?</p>
<h2>Switching track</h2>
<p>Tesla initially developed a patent portfolio to protect its technology. However, Tesla’s concern that it would be overwhelmed once established car makers ramped up their production of electric cars never came to pass.</p>
<p>Instead, it saw the electric car market stagnate at <a href="https://www.iea.org/publications/freepublications/publication/Global_EV_Outlook_2016.pdf">less than 1% of total vehicle sales</a>. So Tesla changed its strategy from trying to prevent others from building electric cars to trying to encourage them <a href="https://www.tesla.com/en_GB/blog/all-our-patent-are-belong-you">into the market</a>.</p>
<p>Part of the reasoning here is that if more electric cars are built, then more battery recharging stations will be built too. This would make electric cars become more visible, and a more conventional choice. Tesla believes that an open intellectual property strategy can strengthen rather than diminish its position by building the size of the electric car market, and as a result, build its own share of the total automotive market.</p>
<p>This kind of careful management of intellectual property at company level, supported by policy-level awareness, can be a powerful way to support the same kinds of transitions to more sustainable technologies in other industries too.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/168759/original/file-20170510-21615-1s31acq.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">Power companies need to adapt.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/iloveboeing/27229292133/in/photolist-HuaeU2-GZsveG-HJeoFk-bB7cxt-vwnu5b-HW6E3H-cpSVnb-9S1bnf-3hHdwb-hQ3Ur6-jN2RA5-gM3aQS-ajnc9H-7xUT8Q-FZBDH6-bqhfed-769mE3-718Vn-5Vb4VG-6eMgcm-dnCzK1-dn5eUK-6eMegy-dgYzdu-6eMfoS-8TAGaW-boQKDG-dgYAA9-oP3jq6-4ZDeFM-dHFKjF-eSAFTM-iFkoNw-hQ2QqV-6FCAeQ-dgYEwY-dgYt7D-auzTHQ-dgYy3D-ajnc6T-ajpZjE-bBbXXH-hQ3v8y-x3dDg-5B51JB-bu7oWw-6KUBTi-bizbEe-d9YgnK-eSN1Tm">Chiu Ho-yang/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>Energy supply faces an array of difficulties: the depletion of natural resources; air pollution and greenhouse gas emissions; nuclear risks; and security of supply. The water supply sector is restricted by water scarcity, pollutants, extreme environmental events such as flooding and costs associated with supplying water to communities in poor countries and remote communities. The agri-food sector, meanwhile, is under pressure to sustainably produce more food and to address <a href="http://www.fao.org/3/a-i4646e.pdf">malnutrition in poor countries</a>. </p>
<p>For these industries to navigate a path around these problems, new knowledge and the innovations that follow will be essential. And in knowledge economies, intellectual property can either be an enabler or an inhibitor.</p>
<h2>Taking the medicine</h2>
<p>If the ownership of intellectual property is fragmented in an industry, it can slow down technology innovation and uptake, such as in the electronics industry where multiple players own complementary patents. However, firms can instead open up their innovation processes and move away from jealously guarded, internal cultures, where intellectual property is used to protect and prolong lifecycles. This change may see knowledge sharing that leads to accelerated innovation cycles and a more rapid uptake of sustainable alternatives throughout a sector: just what Tesla was hoping for in electric vehicles.</p>
<p>This approach to intellectual property, so-called “open IP”, is well advanced and mature in the software industry and healthcare. It has given access to life-saving medicines to millions of people, particularly in developing countries through patent pools, such as the <a href="http://www.medicinespatentpool.org/">Medicine Patent Pool</a>. This kind of project relies on multinational pharmaceutical companies sharing their intellectual property, but small companies can also play a strategic roles in creating these new, more sustainable systems, and it’s not all about open IP.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/168760/original/file-20170510-21598-1fxaizh.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">Plumpy'Nut is handed out in Kenya.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/dfid/33140342933/in/photolist-SuuVmZ-Turv6S-fQ7sWG-dCeA5e-dCezHk-atBkZt-cMCRCd-dCk2Db-ieaX7q-dYfe8h-TJnhQg-ieaFqY-dCk1os-7pYKg8-fQ7teG-d8Wv5f-ifyvyb-qe1yqF-ie9mnE-ie7aFc-ie8YUi-TwT8dZ-iea6S4-ieaaKT-iea5Qc-ie3T4i-ieatqW-ieaxSG-SuuWnM-ie6r8B-TEKyAW-ie2dog-neNZrD-ie4SUE-fQ7vK7-77Ghsz-ie9PDo-ie2wAE-ie4nNy-ie1bPp-idZRjz-ieadpG-SrQxQm-fTremr-fPPWzM-ie1f7X-fPPWCx-fQ7sj5-e37dje-ie7Qm6">DFID /Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>As progress in technology is cumulative, there will always be phases of “closed IP” for small companies to build up their portfolio. This can also be a strategy designed to make a social impact. Take Nutriset, which manufacturers food for famine relief. It protects both its invention, Plumpy’Nut, and its entire business model by patents. Plumpy’Nut is a peanut-based paste for the <a href="http://www.independent.co.uk/news/world/africa/plumpynut-the-lifesaver-that-costs-well-peanuts-8783650.html">treatment of severe malnutrition</a> and can be administered at home rather than through a supervised hospital treatment. As a result it can treat more patients.</p>
<p>Nutriset says that it uses patents to enable the development of <a href="http://www.nutriset.fr/en/access/patents-for-development/">local production plants</a> for Plumpy’Nut and to protect those in emerging nations from being taken over by global manufacturing sites in more developed countries. The local production of Plumpy’Nut helps with creating skills and employment in the regions where Nutriset’s product is most needed.</p>
<p>An open approach to intellectual property has clear advantages in popularising and establishing new and widespread sustainable technologies, but there is a rationale in some cases for sticking to the more traditional approach. The trick now is to discover when and where different sectors and innovators deploy each strategy. The grand open IP gestures in the mould of Tesla can force through rapid structural advances; a small peanut paste supplier shows that patent protection can still help put the building blocks in place.</p><img src="https://counter.theconversation.com/content/77144/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Frank Tietze 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>Elon Musk struck a blow for open IP, so should other sustainable industries go the same way?Frank Tietze, Lecturer in Technology and Innovation Management, University of CambridgeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/726192017-02-15T02:02:43Z2017-02-15T02:02:43ZAmerica’s always had black inventors – even when the patent system explicitly excluded them<figure><img src="https://images.theconversation.com/files/157436/original/image-20170219-10209-10w0f9l.gif?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A New York Times article from 1910 describes founding of Mound Bayou, a town founded on the wealth of a steamboat patent.</span> <span class="attribution"><a class="source" href="http://www.sundaymagazine.org/wp-content/uploads/19100612-4-ex.pdf">SundayMagazine.org</a></span></figcaption></figure><p>America has long been the land of innovation. More than 13,000 years ago, the Clovis people created what many call the “<a href="http://www.thirteen.org/programs/first-peoples/the-clovis-point--the-first-american-invention_clip/">first American invention</a>” – a stone tool used primarily to <a href="http://www.uwyo.edu/surovell/pdfs/qi%202008.pdf">hunt large game</a>. This spirit of American creativity has persisted through the millennia, through the <a href="http://cambridge.dlconsulting.com/cgi-bin/cambridge?a=d&d=Sentinel19420926-01.2.46">first American patent granted</a> in 1641 and on to <a href="http://www.usnews.com/opinion/economic-intelligence/articles/2016-01-08/5-reasons-the-us-is-great-for-innovation">today</a>.</p>
<p>One group of prolific innovators, however, has been largely ignored by history: black inventors born or forced into American slavery. Though U.S. patent law was created with color-blind language to foster innovation, the patent system consistently excluded these inventors from recognition.</p>
<p>As a law professor and a licensed patent attorney, I understand both the importance of protecting inventions and the negative impact of being unable to use the law to do so. But despite patents being largely out of reach to them throughout early U.S. history, both slaves and free African-Americans did invent and innovate.</p>
<h2>Why patents matter</h2>
<p>In many countries around the world, innovation is fostered through a patent system. Patents give inventors a monopoly over their invention for a limited time period, allowing them, if they wish, to make money through things like sales and licensing.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=838&fit=crop&dpr=1 600w, https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=838&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=838&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1053&fit=crop&dpr=1 754w, https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1053&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/156704/original/image-20170214-25992-15ubfe4.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1053&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 Office relief on the Herbert C. Hoover Building.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Patent_Office_relief_on_the_Herbert_C._Hoover_Building.JPG">Neutrality</a></span>
</figcaption>
</figure>
<p>The patent system <a href="http://dx.doi.org/10.1287/mnsc.32.2.173">has long been the heart</a> of America’s innovation policy. As a way to recoup costs, patents provide strong incentives for inventors, who can spend millions of dollars and a significant amount of time developing a invention.</p>
<p>The history of patents in America is <a href="https://ssrn.com/abstract=2473390">older than the U.S. Constitution</a>, with several colonies granting patents years before the Constitution was created. In 1787, however, members of the Constitutional Convention opened the patent process up to people nationwide <a href="https://ssrn.com/abstract=559145">by drafting</a> what has come to be known as the Patent and Copyright Clause of the Constitution. It allows Congress:</p>
<blockquote>
<p>“To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”</p>
</blockquote>
<p>This language gives inventors exclusive rights to their inventions. It forms the foundation for today’s nationwide, federal patent system, which no longer allows states to grant patents.</p>
<p>Though the language itself was race-neutral, like many of the rights set forth in the Constitution, the patent system didn’t apply for black Americans born into slavery. Slaves were not considered American citizens and laws at the time prevented them <a href="https://lawreview.law.ucdavis.edu/issues/40/3/distributive-justice-and-ip/DavisVol40No3_Aoki.pdf">from applying for or holding property</a>, including patents. In 1857, the U.S. commissioner of patents officially ruled that slave inventions <a href="https://www.bloomberg.com/view/articles/2013-02-08/how-the-patent-office-helped-to-end-slavery">couldn’t be patented</a>.</p>
<h2>Slaves’ inventions exploited by owners</h2>
<p>During the 17th and 18th centuries, America <a href="http://www.history1700s.com/index.php/articles/14-guest-authors/1084-the-inventions-of-18th-century-which-transformed-agriculture.html">was experiencing rapid economic growth</a>. Black inventors were major contributors during this era – even though most <a href="http://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1040&context=jgspl">did not obtain any of the benefits associated with their inventions</a> since they could not receive patent protection.</p>
<p>Slave owners often took credit for their slaves’ inventions. In one well-documented case, a <a href="http://atlantablackstar.com/2014/02/11/5-inventions-by-enslaved-black-men-blocked-by-us-patent-office/4/">black inventor named Ned</a> invented an effective, innovative cotton scraper. His slave master, Oscar Stewart, attempted to patent the invention. Because Stewart was not the actual inventor, and because the actual inventor was born into slavery, <a href="https://books.google.com/books?id=Wz-DTSXeLRYC&pg=PA31&lpg=PA31&dq=Oscar+Stewart+Ned+patent&source=bl&ots=4AuokDOGVw&sig=p_jIR4bYZPFDk0tnNh74gSae-mI&hl=en&sa=X&ved=0ahUKEwi3i-vq5oHSAhUD5YMKHXoeDVQ4ChDoAQgxMAg#v=onepage">the application was rejected</a>. </p>
<p>Stewart ultimately began selling the cotton scraper without the benefit of patent protection and made <a href="http://www.uh.edu/engines/epi1076.htm">a significant amount of money</a> doing so. In his advertisements, he openly touted that the product was “the invention of a Negro slave – thus giving the lie to the abolition cry that slavery dwarfs the mind of the Negro. When did a free Negro ever invent anything?” </p>
<h2>Reaping benefits of own inventions</h2>
<p>The answer to this question is that black people – both free and enslaved – <a href="http://www.infoplease.com/spot/bhmscientists1.html">invented many things</a> during that time period.</p>
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<p>One such innovator was <a href="http://nkaa.uky.edu/record.php?note_id=648">Henry Boyd</a>, who was born into slavery in Kentucky in 1802. After <a href="https://www.arcadiapublishing.com/Products/9781467111560">purchasing his own freedom</a> in 1826, Boyd invented a corded bed created with wooden rails connected to the headboard and footboard. </p>
<p>The “Boyd Bedstead” was so popular that historian Carter G. Woodson <a href="https://books.google.com/books?id=zF6J8Zge4XgC&pg=PA119&lpg=PA119&dq=Henry+Boyd+corded+bed&source=bl&ots=3U6YlDDtfB&sig=aDbhOuxCX_KQdUdXuiqVB2PQzbY&hl=en&sa=X&ved=0ahUKEwiU-ZHT1IHSAhXl7YMKHfBRAB0Q6AEIOTAG#v=onepage&q=Henry%20Boyd%20corded%20bed&f=false">profiled his success</a> in the iconic book “The Mis-education of the Negro,” noting that Boyd’s business ultimately employed 25 white and black employees. </p>
<p>Though Boyd had recently purchased his freedom and should have been allowed a patent for his invention, the racist realities of the time apparently led him to believe that he wouldn’t be able to patent his invention. He ultimately decided to <a href="https://books.google.com/books?id=qjWDoxwT6fIC&pg=PA11&lpg=PA11&dq=Henry+Boyd+patent&source=bl&ots=BRUsY-wjc_&sig=u-q8LbCuHm4pvav2ExPRJj3kvYg&hl=en&sa=X&ved=0ahUKEwiAkcn-04HSAhUJ5oMKHSz8AygQ6AEIOTAI#v=onepage&q=Henry%20Boyd%20patent&f=false">partner with a white craftsman</a>, allowing his partner to apply for and receive a patent for the bed.</p>
<p>Some black inventors achieved financial success but no patent protection, direct or indirect. Benjamin Montgomery, who was born into slavery in 1819, <a href="http://theblackhistorychannel.com/2013/benjamin-montgomery-slave-inventor/">invented a steamboat propeller designed for shallow waters</a> in the 1850s. This invention was of particular value because, during that time, steamboats delivered food and other necessities through often-shallow waterways connecting settlements. If the boats got stuck, life-sustaining supplies would be <a href="http://blackinventor.com/benjamin-montgomery/">delayed for days or weeks</a>. </p>
<p>Montgomery <a href="https://en.wikipedia.org/wiki/Ben_Montgomery">tried to apply for a patent</a>. The application was rejected due to his status as a slave. Montgomery’s owners tried to take credit for the propeller invention and patent it themselves, but the patent office also rejected their application because they were not the true inventors. </p>
<p>Even without patent protection, Montgomery amassed significant wealth and become one of the <a href="http://www.maricopa-az.gov/web/featured-contributors/1963-benjamin-montgomery-inventor-of-the-steam-operated-propeller">wealthiest planters</a> in Mississippi after the Civil War ended. Eventually his son, Isaiah, was able to purchase more than 800 acres of land and found the town of Mound Bayou, Mississippi after his father’s death.</p>
<h2>A legacy of black innovators</h2>
<p>The patent system was ostensibly open to free black people. From Thomas Jennings, the first black patent holder, who <a href="http://www.reunionblackfamily.com/apps/blog/show/40925874-thomas-l-jennings-was-the-first-black-man-to-receive-a-patent-the-patent-awarded-on-march-3-1821">invented dry cleaning</a> in 1821, to Norbert Rillieux, a free man who invented a revolutionary <a href="http://blackinventor.com/norbert-rillieux/">sugar-refining process</a> in the 1840s, to Elijah McCoy, who obtained <a href="http://www.historychannel.com.au/this-day-in-history/the-real-mccoy-patents-ironing-board/">57 patents</a> over his lifetime, those with access to the patent system invented items that still touch the lives of people today.</p>
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<p>This legacy extends through the 21st century. Lonnie Johnson generated more than <a href="http://finance.yahoo.com/blogs/the-exchange/bulls-eye---super-soaker-inventor-scores-huge-payday-232255648.html">US$1 billion in sales</a> with his Super Soaker water gun invention, which has consistently been among the <a href="http://www.biography.com/people/lonnie-g-johnson-17112946#synopsis">world’s top 20 best-selling toys</a> each year since 1991. Johnson now owns more than 80 patents and has since developed different <a href="https://www.vice.com/en_us/article/the-super-soakers-unlikely-role-in-the-green-energy-revolution">green technologies</a>.</p>
<p>Bishop Curry V, a 10-year-old black inventor from Texas, has already applied for a patent for his invention, which he says <a href="http://www.theroot.com/10-year-old-texas-boy-invents-device-to-stop-hot-car-de-1791880974">will stop accidental deaths of children in hot cars</a>. </p>
<p>Black women are also furthering the legacy of black inventors. <a href="http://www.blackenterprise.com/event/inventor-lisa-ascolese-talks-creating-invention/">Lisa Ascolese</a>, known as “The Inventress,” has received multiple patents and founded the <a href="http://www.aowie.com/about-aowie">Association for Women Inventors and Entrepreneurs</a>. <a href="http://inventors.about.com/od/blackinventors/a/bashen.htm">Janet Emerson Bashen</a> became the first black woman to receive a patent for a software invention in 2006. And <a href="http://nytlive.nytimes.com/womenintheworld/2016/01/09/black-female-physicist-pioneers-technology-that-kills-cancer-cells-with-lasers/">Dr. Hadiyah Green</a> recently won a $1 million grant related to an invention that may help treat cancer. </p>
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<p>True to the legacy of American innovation, today’s black inventors are following in the footsteps of those who came before them. Now patent law doesn’t actively exclude them from protecting their inventions – and fully contributing to American progress.</p>
<p><em>This article was updated on Feb. 19, 2017 to replace a photo that incorrectly identified Thomas Jennings.</em></p><img src="https://counter.theconversation.com/content/72619/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shontavia Johnson owns and consults for Jackson Johnson LLC, a business and innovation consulting firm.</span></em></p>American slaves couldn’t hold property – including patents on their own inventions. But that didn’t stop black Americans from innovating since the beginning of the country’s history.Shontavia Johnson, Associate Vice President for Academic Partnerships and Innovation, Clemson UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/700312016-12-08T19:30:16Z2016-12-08T19:30:16ZSupreme Court: Design patents are worth less, but we won’t tell you how much<figure><img src="https://images.theconversation.com/files/149307/original/image-20161208-31405-1gcezdq.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://upload.wikimedia.org/wikipedia/commons/d/d8/USSupremeCourtWestFacade.JPG">Matt Wade</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>When the Supreme Court took up Apple’s case alleging Samsung had stolen its patented iPhone designs for Samsung’s own smartphones, product designers, lawyers and corporate executives were paying close attention. The case promised to shed new light on a relatively unexplored area of patent law – design patents. </p>
<p>As distinct from what are called “utility patents,” design patents don’t protect how a device functions, but rather <a href="https://theconversation.com/do-you-buy-a-smartphone-for-its-curves-do-you-buy-a-car-for-its-cup-holders-66970">what it looks like</a>. A federal jury had declared in 2012 that <a href="https://www.supremecourt.gov/opinions/16pdf/15-777_7lho.pdf">Samsung had in fact infringed on Apple’s design patents</a> by copying elements of the iPhone’s design, including <a href="http://www.scotusblog.com/wp-content/uploads/2016/01/Apple-v-Samsung.pdf">rounded corners of the device and the “chiclet” layout</a> of icons on the screen. When someone infringes a design patent, the law requires that person to pay the patent owner “the extent of his total profit” of the “<a href="https://www.law.cornell.edu/uscode/text/35/289">article of manufacture</a>” found to be infringing.</p>
<p>Last year, a <a href="http://www.scotusblog.com/wp-content/uploads/2016/01/Apple-v-Samsung.pdf">federal appeals court had ruled</a> that the law required Samsung to turn over to Apple all the profits it had made on its smartphones – <a href="https://www.supremecourt.gov/opinions/16pdf/15-777_7lho.pdf">a whopping US$399 million</a>. That ruling was despite the obvious fact that the design patent violations formed only part of the phones’ attraction to consumers, and therefore only part of the basis for Samsung’s profits. The appellate court felt constrained by the language of the statute, however.</p>
<p>Samsung appealed to the Supreme Court, and, despite a rough few months with other problems – including <a href="http://www.cnn.com/2016/10/11/tech/samsung-note-7-fire-risks/">exploding phones</a> and a <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1171.Opinion.9-30-2016.1.PDF">reinstated patent infringement verdict in another case</a> – came out a winner. On Dec. 6, the court ruled that it was unreasonable to require Samsung to fork over all its smartphone profits. </p>
<p>But the justices deliberately “<a href="https://www.supremecourt.gov/opinions/16pdf/15-777_7lho.pdf">declined to lay out</a>” any guidance for how to calculate a reasonable amount. As such, they reduced the value of design patents to their owners, which could encourage third parties to go ahead and risk infringing these patents. Minimally, the ruling’s ambiguity ensures the case will drag on for years more, potentially even ending up back in the Supreme Court.</p>
<h2>Leaving a major question unanswered</h2>
<p>The Supreme Court was asked to decide, effectively, what an “article of manufacture” is. Is it the entire final product – Samsung’s smartphone with preinstalled software, as sold to the consumer? Or is it something less, such as the screen?</p>
<p>Instead, they ducked the question except in its broadest and vaguest form. The justices ruled that the article of manufacture could be something other than the entire product, but did not tell us how much less. In the court’s own words, “the term ‘article of manufacture’ is broad enough to encompass <a href="https://www.supremecourt.gov/opinions/16pdf/15-777_7lho.pdf">both a product sold to a consumer as well as a component of that product</a>.”</p>
<p>And that’s all it said.</p>
<p>The Supreme Court offered no suggestion as to how other courts in this case or future ones should divide a product to assess what is the relevant portion of the product. All we know is that they will have to do so.</p>
<h2>A two-part problem</h2>
<p>There are two distinct issues with which the the lower courts will have to wrestle. And if they get it wrong, it could end up back at the Supreme Court again. First, the courts will have to determine what exactly is the “article of manufacture” relating to patented designs. If it isn’t the entire phone, then what part of the phone is relevant?</p>
<p>Second, once the courts have drawn that difficult line, they will then have to figure out how much of Samsung’s profits can be attributed to that slice of the product. In other words, how much value does that portion of the product have? </p>
<p>It is not clear how either of those apportionments will take place. The courts may look to the cousin of design patents – utility patents. Although the analysis in the design patent context is technically different, the result is the same: The court must determine how much value the patented design added to the product. In the context of utility patents, courts have made similar analyses when determining the value of an invention that is a component of a broader product.</p>
<p>For example, in one case, an appellate court had to determine how much value the <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/08-1485.pdf">graphical “date picking” function in Microsoft Outlook</a> added in terms of the entire software product. But guidance from those cases remains elusive as well because every invention and market is likely different. The value added from the invention will depend on myriad factors, such as the importance of the invention to the product and what aspects of the product drive consumer demand. These fact-intensive inquiries do not lend themselves to standardized rules that will be easy for courts to apply uniformly in multiple cases.</p>
<h2>Design patents’ value drops</h2>
<p>At best, there are two clear takeaways from the Supreme Court’s decision. First, patent holders are not necessarily entitled to the infringer’s profits from the actual product sold. A court may divide the product up into different articles of manufacture in order to assess the appropriate damages. In some cases, patent owners still may be able to get profits for the entire product, but it is no longer a guarantee. </p>
<p>Second, somewhat ironically, design patents have now lost some value. This is specifically because patent holders are not entitled to the profits from the entire infringing product. At times, they may get only a fraction of that amount. Consequently, on average, this case reduces the value of design patents.</p>
<p>This outcome is a bit ironic because, as the Supreme Court itself recognized, Congress long ago – in 1887! – passed the profits statute precisely because courts had <a href="https://www.supremecourt.gov/opinions/16pdf/15-777_7lho.pdf">gutted the value of design patents</a> by awarding insufficient damages.</p>
<h2>Interpreting a lack of guidance</h2>
<p>At the time Congress adopted the forfeiture of the design patent infringer’s profits as the measure of damages, there generally was a one-to-one correspondence between a design and a product. For example, a design patent on a carpet corresponded to the actual product itself.</p>
<p>In the modern era, a single product can have a number of patentable design features. Think about cars: The car itself can have various design shapes, along with aspects of the interior, the arrangement of a computer screen in the car and even the cup holders. Any one of these affect the value of the car to some degree.</p>
<p>Congress likely did not foresee this development when it tried to reinvigorate design patents by providing the infringer’s profits as the remedy. Nevertheless, the Supreme Court reasonably believes the efforts of Congress to breathe value into design patents are no longer appropriate in a world of complex products. The statute, in essence, is a product of a time long since gone. Interestingly, though, the court decided to make this adjustment; it did not leave it to Congress to adapt the statute to modern markets.</p>
<p>How much damage has been done to design patents’ value? It will depend on how willing courts are to “slice and dice” an infringing product to determine what the relevant “article of manufacture” is.</p>
<p>It will also depend on how much courts attribute the value of the product to that slice of the product. If the courts permit large slices of the profits to be handed over to the patent owner, then the value of design patents will remain high, if somewhat reduced. But if the ruling means the penalty for infringement is reduced, competitors may be more willing to take the risk of infringing someone else’s design.</p>
<p>There is no doubt that the Supreme Court’s decision reduces the value of design patents. We will have to wait and see – perhaps for another case to come to the highest court in the land – to find out just how much.</p><img src="https://counter.theconversation.com/content/70031/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Timothy Holbrook joined an amici brief at the Supreme Court in this case.</span></em></p>The ruling in the Apple-Samsung case is ambiguous, ensuring the case will drag on for years more, potentially even ending up back in the Supreme Court.Timothy Holbrook, Professor of Law, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/571752016-11-21T20:53:54Z2016-11-21T20:53:54ZHow changing drug patent rules will affect developing nations<p><em>After years of legal battles, a global agreement has been reached for developing countries to buy – and for drug manufacturers to produce or import – generic medicines without <a href="http://www.pharmaceutical-journal.com/news-and-analysis/news/worlds-poorest-countries-dont-need-to-protect-drug-patents-until-2033-agrees-wto/20200017.article">breaching patent rules</a>. The Conversation Africa’s Health and Medicine Editor Candice Bailey asked Natalie Schellack to explain what this means for the developing world.</em> </p>
<p><strong>Are drugs about to become cheaper for poor people in developing countries? Why?</strong></p>
<p>Through the World Trade Organisation an agreement was reached in November 2015 for the world’s poorest countries to buy –- and for drug manufacturers to produce or import –- generic medicines without breaching patent rules until <a href="http://www.pharmaceutical-journal.com/news-and-analysis/news/worlds-poorest-countries-dont-need-to-protect-drug-patents-until-2033-agrees-wto/20200017.article">January 1 2033</a>. The decision was taken by the organisation’s Council for Trade-Related Aspects of Intellectual Property Rights <a href="http://www.ip-watch.org/2016/10/31/brazil-china-india-south-africa-put-un-high-level-panel-medicines-access-trips-council-agenda/">(TRIPS)</a>.</p>
<p>Put simply, the need of a nation trumped the right to derive protected benefit from a patent. This initiative will help developing countries come up with better policies. It will provide legal certainty, which should lead to better access and more affordable drug prices. </p>
<p>The agreement is good news for all countries in the Southern African Development Community as members of the World Trade Organisation (with the exception of the Seychelles). They’ll be able to incorporate the TRIPS agreement into their national laws. The community’s protocol on Trade confirms this <a href="https://www.wto.org/english/thewto_e/countries_e/south_africa_e.htm">position</a>. </p>
<p>South Africa, as a signatory to the TRIPS agreement, is allowed to pass intellectual property legislation, inclusive of patent laws, so that intellectual property rights do not become barriers to legitimate trade while ensuring the technology is transferred and disseminated in line with <a href="http://apps.who.int/medicinedocs/documents/s18249en/s18249en.pdf">social and economic welfare</a>.</p>
<p>If South Africa actively participates in this opportunity for more generic trade, medicines should be more affordable. </p>
<p>South Africa has been fighting for access to generic drugs for some time. In the late 1990s around 40 big pharmaceutical companies such as GlaxoSmithKline and Boehringer Ingelheim filed a lawsuit to the Pretoria High Court against the South African government due to the importation of generic anti-retroviral medicine to treat the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1119675/">HIV/AIDS pandemic</a>.</p>
<p>Millions of people were suffering from HIV/AIDS and could not afford the original brand-name medicines. The South African state was trying to find a way to guarantee their health. After three years the court overruled the patent law in this case and recognised the right to health as a basic human right of <a href="http://i-base.info/htb/4380">South African patients</a>. </p>
<p><strong>How do patents affect prices?</strong> </p>
<p>A patent in this context is when a pharmaceutical company develops a new drug for a disease. The company sells it under a “brand name”. The patent protects the pharmaceutical company’s right to manufacture and market the drug to profit from it. This helps recover the costs that have gone into developing the drug. </p>
<p>In most cases the drug patent is awarded for around 20 years. Once the patent has expired other companies can “copy” and manufacture the drug. </p>
<p>Generic drugs have to be near-identical “copies” of the branded drug. For example, they must be identical– or “bioequivalent”–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. In South Africa this is regulated by the <a href="http://www.mccza.com/documents/d259816c2.30_Biosimilars_Aug14_v3.pdf">Medicine Control Council of South Africa</a>.</p>
<p>For a developing country like South Africa, the most effective and sustainable way to bring down the price of a drug is by driving competition between different generic manufacturers. This can’t be done if a medicine is still under patent and the patent owner is not willing to allow competition. Preventing competition can drive up the price to an artificially high level. </p>
<p>Developing countries can’t afford this. Life-saving treatments for diseases such as HIV/AIDS, tuberculosis and malaria are needed. The price of medicine for people with these diseases is a matter of life or death. </p>
<p><strong>What changes and challenges has South Africa made to patent laws and how could they affect people?</strong> </p>
<p>South Africa’s draft Intellectual Property Protection Policy of 2013 is designed to reform the country’s patent law and to address various shortcomings that hamper access to medicine. The <a href="http://ip-unit.org/wp-content/uploads/2013/09/DRAFT-IP-POLICY.pdf">draft policy</a> provides public health safeguards and promotes cooperation between ministries. And more recently, South Africa’s cabinet approved a new <a href="http://www.thedti.gov.za/news2016/IPConsultativeFramework.pdf">Intellectual Property framework</a>. </p>
<p>The three-year delay in finalising the policy first set out in 2013 has affected the health of certain patients adversely. Two examples stand out. Patients with multidrug-resistant tuberculosis (MDR-TB) struggle to pay for one of the medications they need called linezolid. The hepatitis B medication, entecavir, is another example. It remains inaccessible to most people because it’s so expensive – while generic products are available outside South Africa at prices that are around <a href="http://www.fixthepatentlaws.org/?p=1080">84% lower</a>.</p>
<p>Once the policy becomes law, South Africa could be a role model for the rest of the world in prioritising people’s health over profit. </p>
<p><strong>What more needs to be done?</strong> </p>
<p>The process of finalising the Intellectual Property Protection Policy needs to be treated with urgency. The Department of Trade and Industry and all ministries involved must continue to prioritise turning it into law. </p>
<p>This will mean more affordable medicines can become available. </p>
<p>But there are other steps that can be taken too. </p>
<p>The most effective and sustainable way to bring down the price of a drug is through competition between manufacturers. </p>
<p>Investment is also needed. This can be promoted by having large pharmaceutical companies invest directly in South Africa to boost local production of medicines.
And the approval process for new medicines should be streamlined by the <a href="http://www.mccza.com/">Medicine Control Council</a>.</p>
<p>Another market in South Africa that should get more attention is clinical trial research. This would not only allow research into conditions inherent to South Africa, it would also be an investment in local specialists.</p>
<p>The distribution of medicines throughout South Africa by the National Department of Health should be streamlined to avoid medicines being unavailable. One solution could be to transfer logistical and distribution costs of medicines to the suppliers to avoid delays, additional transport costs and stock-outs.</p><img src="https://counter.theconversation.com/content/57175/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Natalie Schellack 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>After nearly two decades of legal battles and negotiations, South Africa is moving to cut the cost of medicines with policies to increase imports and local production of generic drugs.Natalie Schellack, Associate Professor and Course Leader: Post Graduate Programmes in Clinical Pharmacy in the Department of Pharmacy, Sefako Makgatho Health Sciences UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/669702016-10-14T01:54:34Z2016-10-14T01:54:34ZDo you buy a smartphone for its curves? Do you buy a car for its cup holders?<figure><img src="https://images.theconversation.com/files/141656/original/image-20161013-3958-qwdrk1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">How much did Samsung's phone sales depend on it looking like an iPhone?</span> <span class="attribution"><a class="source" href="https://www.youtube.com/watch?v=eBRGHazii6U">Comparison Smartphone/YouTube</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>On Oct. 7, Samsung found itself facing an unpleasant result in one of the many patent lawsuits it’s a part of: A federal appellate court <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1171.Opinion.9-30-2016.1.PDF">reinstated a jury verdict of US$119 million against Samsung in favor of Apple</a>. </p>
<p>In that case, Samsung was found to have infringed three Apple utility patents on how smartphones function. The first related to a smartphone’s ability to create links automatically to webpages and phone numbers, so the user need only press the link to jump to the webpage or call someone. Another covered the “slide to unlock” screen function. The third related to the phone providing autocorrect recommendations when the user was typing. Samsung’s smartphones all incorporated these features, without Apple’s permission.</p>
<p>But not all of the patent law news was bad for Samsung. In a different chapter of the <a href="http://www.digitaltrends.com/mobile/apple-vs-samsung-patent-war-timeline/">Apple v. Samsung smartphone patent saga</a>, the U.S. Supreme Court on Oct. 11 heard arguments over a $400 million verdict against Samsung for infringing several Apple iPhone design patents. Aside from the enormous amount of money at stake, this is the first time the Supreme Court has addressed design patents in more than a century. This generally sleepy area of intellectual property has awoken. And, reading the tea leaves from the oral argument, it seems that Samsung will likely win at the Supreme Court.</p>
<p>The key to this case, as contrasted with the other loss, is that the Supreme Court case is about design patents, not utility patents. What is the difference? Utility patents, like the “slide to unlock” patent, cover new inventions that have some sort of practical use – like the proverbial “better mousetrap.” Design patents, like those at issue in the Supreme Court case, protect the <a href="https://www.law.cornell.edu/uscode/text/35/171">“ornamental design” of an item</a> rather than the way a product works.</p>
<h2>Understanding design patents</h2>
<p>Design patents typically cover how things look, like shoes or furniture. The three design patents at the Supreme Court cover different aspects of the appearance of smartphones: the rectangular front face with rounded corners, the surrounding rim and the colorful grid arrangement of 16 icons on the screen. None of these has any effect on how the phones work.</p>
<p>What is fascinating – and seemingly troubling for the Supreme Court – is exactly what happens when someone infringes a design patent. A design patent holder is entitled to get the profits made by the infringer. Specifically, an infringer of a design patent must pay to the patent’s owner <a href="https://www.law.cornell.edu/uscode/text/35/289">“the extent of his total profit” of the “article of manufacture”</a> found to be infringing. The lower courts interpreted this to mean that Samsung should be required to pay Apple all of the profits Samsung made from selling its infringing phones, a whopping $400 million.</p>
<p>But, is that the right outcome? Why should Apple get all of Samsung’s profits just because the phones look the same? Surely Samsung customers bought the company’s devices not only because of how they looked, but also, to some degree, because of what they can do, like making telephone calls, surfing the internet and playing “Pokemon Go.” Those functions are not at issue in this patent case.</p>
<p>I personally think making Samsung give up all its profits is not the correct outcome, which is why <a href="http://www.scotusblog.com/wp-content/uploads/2016/06/15-777-tsac-50-Intellectual-Property-Professors.pdf">I joined a brief</a> at the Supreme Court arguing for a different outcome. Based on how the oral argument went, I’d wager the Supreme Court thinks that outcome was wrong, too.</p>
<h2>Finding useful parallels</h2>
<p>To the lay reader, the design patent statute may seem clear: The owner of the design patent gets the infringer’s profits from what it made. It may seem harsh for Samsung, but what is the problem?</p>
<p>Here is where the lawyers step in. The question is about what constitutes the “article of manufacture” on which the patented design is applied. Is it the entire phone, or just part of it?</p>
<p>Think about wallpaper. The primary reason a consumer wants the wallpaper is how it looks, its design. In that context, the design and the article are basically the same thing. Infringement in this context likely would require payment of the profits for selling the wallpaper.</p>
<p>At the other extreme, think about a patented design for a cup holder used in a car. If a car company built a vehicle with that cup holder design, without permission, what should be the remedy? </p>
<p>The lower court’s decision in this design patent case suggests the owner of the cup holder patent should get the car company’s total profits from selling the entire car. But the product being sold – on which the profits are being calculated – is much more than a cup holder: It’s a car.</p>
<h2>How much is design worth?</h2>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=390&fit=crop&dpr=1 600w, https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=390&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=390&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=490&fit=crop&dpr=1 754w, https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=490&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/141671/original/image-20161013-3953-1wyouie.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=490&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Buy it for its looks or its functions?</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Volkswagen_Beetle_.jpg">IFCAR</a></span>
</figcaption>
</figure>
<p>Those two examples are extreme, easy ones. In the argument at the Supreme Court, the justices used a somewhat more complex hypothetical about the Volkswagen Beetle. The design of the Beetle is ornamental: It does not have to be shaped that way to operate as a car. The shape has nothing to do with the engine or the interior of the car. </p>
<p>Some people may buy the Beetle because of the body design, but others may be more interested in its fuel efficiency, or the power of the engine. Would someone copying the Beetle’s shape be liable for the entire profits from selling the car?</p>
<p>The answer isn’t entirely clear. Nor is it in the context of the the smartphone designs at the Supreme Court. All of the parties – even Apple – agree that what’s in dispute here is not the entire phone. What, then, is the appropriate article of manufacture?</p>
<p>Most likely the Supreme Court will send the case back to the lower courts to sort that out. We legal scholars can hope the court will give some specific guidance about how to draw the line. Once the line is drawn – once the article of manufacture is identified – the courts will have to determine the second question: How much of Samsung’s profits from the phones is a result of that part of the phone?</p>
<p>It seems likely that Samsung will not have to pay the entire $400 million original judgment. But it is also clear that this case is far from over. And of course, Apple and Samsung could settle, as they have done before in their multiyear, multicountry battle. </p>
<p>These disputes are not even the largest problems facing Samsung at the moment. The patent cases are about hundreds of millions of dollars, but the company is reeling from having to end production of its Galaxy Note 7 on Oct. 11 because the phone’s battery had a tendency to burst into flames. That move, including recalling devices already sold, is projected to cost the company <a href="http:/www.nytimes.com/2016/10/12/business/international/samsung-galaxy-note7-terminated.html?_r=0">as much as $10 billion</a>.</p><img src="https://counter.theconversation.com/content/66970/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Timothy Holbrook joined an amicus brief at the Supreme Court in favor of Samsung. </span></em></p>Design patents cover how products look – but how much does appearance contribute to profits?Timothy Holbrook, Professor of Law, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/587852016-05-04T20:17:35Z2016-05-04T20:17:35ZIt’s time to future-proof Australia’s copyright laws for the 21st century<figure><img src="https://images.theconversation.com/files/121145/original/image-20160504-1305-opof0a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Copyright is currently skewed in favour of producers, not consumers.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The award-winning Australian author <a href="http://www.jackiefrench.com/">Jackie French</a> is wrong. In her <a href="http://blog.harpercollins.com.au/wp-content/uploads/2016/04/Open-Letter-from-Jackie-French_Theft-and-Failure-of-Economics-101.pdf">open letter</a>, she blasts the Productivity Commission’s <a href="http://www.pc.gov.au/inquiries/current/intellectual-property/draft/intellectual-property-draft.pdf">report on intellectual property</a>, released last month.</p>
<p>The report, though, makes a number of sensible recommendations that will help modernise Australia’s copyright laws for the 21st century. Economically, the report is rigorous and comprehensive. </p>
<p>Morally, the study shows a subtle and nuanced appreciation that copyright law is designed ultimately to promote the public interest of the Australian community.</p>
<p>The proposed reforms will enhance consumer rights, competition policy, access to knowledge and Australia’s ambitious <a href="http://www.innovation.gov.au/page/agenda">National Innovation and Science Agenda</a> and “ideas boom”. </p>
<p>The report also makes some helpful suggestions regarding Australia’s process for treaty-making in respect of intellectual property.</p>
<h2>Competition policy</h2>
<p>The Productivity Commission has recommended the repeal of parallel importation restrictions for books, which supports the position of <a href="http://www.smh.com.au/federal-politics/political-news/harper-review-government-faces-stoush-with-authors-over-removal-of-parallel-book-imports-20151124-gl6u5d.html">Prime Minister Malcolm Turnbull and Treasurer Scott Morrison</a>.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/121146/original/image-20160504-22761-wk2o6b.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">Allowing parallel imports will make books cheaper, potentially boosting sales and the number of active readers.</span>
<span class="attribution"><span class="source">J Brew/Flickr</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Australia’s <a href="https://theconversation.com/au/topics/parallel-imports">parallel importation</a> restrictions are an anachronistic hangover from British imperial publishing networks and are anti-competitive. </p>
<p>Over the past 40 years, the High Court of Australia, the <a href="http://catalogue.nla.gov.au/Record/635382">Prices Surveillance Authority</a>, the <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_committees?url=ic/itpricing/index.htm">Australian Parliament</a>, the <a href="https://www.accc.gov.au/media-release/accc-report-points-way-for-cheaper-books-and-software">Australian Competition and Consumer Commission</a>, the <a href="http://www.pc.gov.au/inquiries/completed/books">Productivity Commission</a> and the <a href="http://competitionpolicyreview.gov.au/final-report/">Harper Competition Policy Review</a> have highlighted how Australian consumers are paying more than they should for books. </p>
<p>Parallel importation restrictions largely benefit multinational publishing networks and foreign authors rather than local authors. As the Productivity Commission comments:</p>
<blockquote>
<p>Most of the additional income from higher book prices goes to overseas authors and publishers whose works are released in Australia. The Commission estimated the additional income flowing overseas is around 1.5 times that retained by local copyright holders. In effect, PIRs impose a private, implicit tax on Australian consumers that largely subsidises foreign copyright holders. Indeed, none of the authors with top ten titles in the sample provided by HarperCollins are Australian.</p>
</blockquote>
<p>The removal of parallel importation restrictions would be beneficial for Australian readers. Cheaper books for Aussie kids would be a great policy outcome.</p>
<p>In response to the Productivity Commission, publishers and authors have been running a scare campaign against the commission’s recommendations. The multinational publishing empire HarperCollins has grimly defended the restrictions.</p>
<p>Authors <a href="http://www.afr.com/business/media-and-marketing/publishing/productivity-commission-recommendation-threatens-livelihood-of-book-industry-20160429-goi2zq">Thomas Keneally</a>, Richard Flanagan, Peter Carey, Tara Moss and Jackie French have railed against the report. However, their emotive arguments are weak, inaccurate and unconvincing. </p>
<p>Parallel importation laws are not an effective means of protecting local culture or creative livelihoods. The removal of the restrictions will not destroy the local publishing industry. Indeed, opening up the book market may well be beneficial for publishers and authors by removing age-old distortions in the marketplace.</p>
<p>The Productivity Commission also supported the <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_committees?url=ic/itpricing/index.htm">Australian Parliamentary Inquiry into IT Pricing</a> and recommended that Australian consumers should be able to circumvent <a href="https://theconversation.com/au/topics/geoblocking">geoblocking</a>. </p>
<p>Australian consumers deserve a fair deal in the digital economy. It has been concerning that Australian internet users are paying much more for IT works than our counterparts overseas.</p>
<p><a href="http://www.afr.com/business/legal/foxtel-hits-out-at-proposed-copyright-reforms-20160429-goibht">Foxtel has opposed these recommendations</a>. However, consumers such as <a href="https://t.co/ishokLhFMn">Mark Serrels</a> have complained that Foxtel’s service provides a poor distribution system for TV shows such as Game of Thrones.</p>
<h2>Innovation</h2>
<p>The Productivity Commission was concerned that “Australia’s copyright system has progressively expanded and protects works longer than necessary to encourage creative endeavour, with consumers bearing the cost”.</p>
<p>The commission also recommended that Australia should adopt a broad defence of “<a href="https://theconversation.com/the-only-way-to-fix-copyright-is-to-make-it-fair-23402">fair use</a>”, supporting the previous inquiry by the <a href="http://www.alrc.gov.au/publications/copyright-report-122">Australian Law Reform Commission Into Copyright Law and the Digital Economy</a>. </p>
<p>The defence of fair use in the United States has enabled innovative start-ups to flourish in hot-spots such as Silicon Valley, Boston and New York. Indeed, the US courts recently recognised that <a href="https://www.eff.org/deeplinks/2016/04/case-closed-supreme-court-refuses-hear-authors-guilds-challenge-google-books">Google Books was protected under the doctrine of fair use</a>.</p>
<p>Professor Peter Jaszi has noted that fair use is the “<a href="https://academeblog.org/2014/01/31/house-hearings-on-intellectual-property-and-the-internet-and-the-issues-related-to-fair-use-part-2-peter-jaszis-testimony/">secret sauce</a>” of US competitiveness.</p>
<p>Australia is at a competitive disadvantage because it has only a much more limited, purpose-specific defence of fair dealing. Start-ups may well be reluctant to base themselves in Australia because of fears of copyright litigation by incumbent industries. </p>
<p>The Productivity Commission recommended:</p>
<blockquote>
<p>A new system of user rights, including the introduction of a broad, principles-based fair use exception, is needed to help address this imbalance. </p>
</blockquote>
<p>The commission observed:</p>
<blockquote>
<p>One of the key advantages of a fair use over a fair dealing exception is that the law can adapt to new circumstances and technologies.</p>
</blockquote>
<p>The Australian Law Reform Commission has already highlighted how a <a href="https://www.alrc.gov.au/publications/4-case-fair-use-australia/summary">defence of fair use</a> could future-proof Australia’s copyright laws.</p>
<p>In addition, the Productivity Commission has recommended that all Australian governments should implement an <a href="https://theconversation.com/au/topics/open-access">open access</a> policy for publicly funded research. </p>
<p>The policy should provide free access through an open access repository for all publications funded by governments, directly or through university funding, within 12 months of publication. This proposal will help boost <a href="http://www.innovation.gov.au/start/agenda?tid=1">Australia’s Ideas Boom</a>. </p>
<p>The open access sharing of research will support the creative industries, as well as science and technology. <a href="https://creativecommons.org/board/#ryanmerkley">Ryan Merkley</a>, CEO of the Creative Commons project, has highlighted the <a href="http://www.wired.com/2016/04/stealing-publicly-funded-research-isnt-stealing/">benefits of open access publishing</a>. </p>
<p>In particular, public health research could benefit. As US Vice President Joe Biden recently observed, <a href="https://www.washingtonpost.com/news/to-your-health/wp/2016/04/20/biden-to-cancer-researchers/">there is a need to get cancer research out from behind pay-walls</a>.</p>
<h2>Fair trade</h2>
<p>The Australian government has been involved in a flurry of negotiations over intellectual property and trade, with the <a href="http://dfat.gov.au/trade/agreements/ausfta/pages/australia-united-states-fta.aspx">Australia-US Free Trade Agreement</a>, the <a href="https://ustr.gov/acta">Anti-Counterfeiting Trade Agreement</a>, the <a href="http://dfat.gov.au/trade/agreements/tpp/pages/trans-pacific-partnership-agreement-tpp.aspx">Trans-Pacific Partnership</a> and various trade agreements with Chile, Japan, China and South Korea.</p>
<p>The Productivity Commission noted that the Mickey Mouse copyright term extension under the Australia-US Free Trade Agreement was incredibly expensive for the Australian community. Australia is a net importer of copyright works, and there was a need to mitigate against the costs of exorbitant copyright term extensions.</p>
<p>Reflecting upon such hectic activity, the Productivity Commission has been critical of the government entering into trade agreements without openly and fully assessing the benefits and costs of intellectual property obligations. </p>
<p>The commission warned:</p>
<blockquote>
<p>Agreements embodying provisions on the scope and term of IP protection necessarily involve a ‘wrestle for rents’ – Australia should not capitulate too easily. </p>
</blockquote>
<p>Moreover, the commission was concerned about the “spaghetti bowl” of trade agreements that Australia had been involved in: </p>
<blockquote>
<p>Further, in more recent times, there has been a tendency to favour bilateral and regional initiatives over multilateral ones, resulting in overlapping and complex rules.</p>
</blockquote>
<p>The commission’s report will provide a salutary caution for the Australian Parliament as it evaluates the Trans-Pacific Partnership.</p>
<p>Rather than let the Productivity Commission’s report be lost <a href="https://theconversation.com/productivity-commissions-recommendations-on-ip-reform-likely-to-be-lost-in-election-haze-58576">in the tumult of the 2016 election</a>, Australian politicians should pay heed to the popular interest in the study. </p>
<p>The Australian public has been <a href="http://www.cnet.com/au/news/choice-takes-campaign-against-internet-filter-to-canberra/">crying out</a> for copyright reforms to our anachronistic laws to bring them up to date with the digital age of the 21st century.</p>
<p>There is a great opportunity for political leaders to capitalise upon this public interest in competition, innovation, access to knowledge and fair trade.</p><img src="https://counter.theconversation.com/content/58785/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Matthew Rimmer has previously received grants from the Australian Research Council.</span></em></p>The Productivity Commission’s report into copyright reform will be good for the public, good for innovation and good for Australia.Matthew Rimmer, Professor in Intellectual Property and Innovation Law, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/555892016-03-08T00:32:56Z2016-03-08T00:32:56ZBiopiracy: when indigenous knowledge is patented for profit<figure><img src="https://images.theconversation.com/files/113440/original/image-20160301-31050-1bol1g5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/ciat/3887465932/in/dateposted/">CIAT</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>As genetic research becomes more sophisticated, so does our ability to use plants and animals to develop new drugs or modify crops to meet food security needs.</p>
<p>Often, in the search for new bioresources, researchers draw on local people’s traditional knowledge about the properties of a particular plant, animal or chemical compound. When researchers use traditional knowledge without permission, or exploits the cultures they’re drawing from – it’s called <a href="http://www.etcgroup.org/issues/patents-biopiracy">biopiracy</a>.</p>
<p>Biopiracy happens when researchers or research organisations take biological resources without official sanction, largely from less affluent countries or marginalised people.</p>
<p>Biopiracy is not limited to drug development. It also occurs in agricultural and industrial contexts. Indian products such as the <a href="http://news.bbc.co.uk/2/hi/science/nature/4333627.stm">neem tree</a>, <a href="http://www.business-standard.com/article/specials/patent-on-tamarind-adds-sour-to-indian-flavour-hanging-198022101076_1.html">tamarind</a>, <a href="http://www1.american.edu/ted/turmeric.htm">turmeric</a>, and <a href="https://www.wto.org/english/res_e/booksp_e/casestudies_e/case16_e.htm">Darjeeling tea</a> have all been patented by foreign firms for different lucrative purposes. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/113537/original/image-20160302-25912-1th8u8h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Turmeric: patented by the University of Mississippi in 1995.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/anantns/6679559665/in/photolist-bbfunP-7E7zWz-qFXZiX-6jHZSF-7TGVnK-ocKsr4-fzdFm-o51QTV-snh8h-dyerFp-ngKLy5-6WYaN3-8nrhNn-9AQUnF-4iNHRf-4zGsuV-cWMNUG-xa2ytM-zWTDyT-4gYa9p-otCd3-yQhakZ-z123t4-zUAoPQ-yZRLAS-HjWvv-cfDUG-6Ndfcv-fzdC9-nVhh8k-tcpfrb-555XZu-djHxww-9pw3D9-boPWKZ-zTkaw-7SYETu-z9h379-7QNzAi-8nrhQa-2Uwj5K-DqXsrZ-LvsCg-68s3Yi-4gJqPc-ARRYWh-7NdtK7-9mTeBZ-di6apN-iyskrw">Anant Nath Sharma</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>A less politically charged word for biopiracy is bioprospecting. This is more commonly used by research groups who attempt to search for biological resources in a legal and respectful manner. </p>
<p>Sadly, not many positive examples of bioprospecting exist. Ideally, it involves ethical considerations such as prior informed consent, access and benefit sharing agreements, and material transfer agreements before research commences. Earnings from any commercial products should go towards local conservation efforts and the construction of infrastructure. </p>
<h2>Scientific colonialism</h2>
<p>Although biopiracy might happen within a country, with elite groups or government officials taking resources from less influential citizens, it has more of a reputation for occurring between different countries. Biopiracy often accentuates power inequalities between wealthy, technology-rich countries and less affluent, yet bioresource-rich, countries.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=841&fit=crop&dpr=1 600w, https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=841&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=841&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1057&fit=crop&dpr=1 754w, https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1057&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/114133/original/image-20160307-31283-vkcdwc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1057&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Quinine.</span>
<span class="attribution"><a class="source" href="https://en.wikipedia.org/wiki/Quinine#/media/File:Cinchona_calisaya_-_K%C3%B6hler%E2%80%93s_Medizinal-Pflanzen-179.jpg">Franz Eugen Köhler, Köhler's Medizinal-Pflanzen</a></span>
</figcaption>
</figure>
<p>Historically, biopiracy has been linked to colonialism, with formerly colonised countries having many of their resources forcibly removed. Pepper, sugar, coffee, quinine, or rubber did, and still do, have significant impact on the world economies. All of them have a colonial past. </p>
<p>At the heart of the matter is the idea of ownership. Patents and trademarks are hotly defended by international trade organisations and multinational groups. But for many traditional farmers or indigenous groups, owning a constantly evolving and changing organism is illogical, as is assigning ownership to one person instead of a community of users.</p>
<p>Since 1994, the <a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a> has required WTO member countries to develop legal frameworks to protect varieties of plant and animal resources in two systems: one for agricultural contexts and the other for pharmaceutical, chemical, textile, or other commodity contexts. Several countries have considered this to be counterproductive for protecting their bioresources.</p>
<p>Since the early 2000s, many national governments have changed their laws to protect their bioresources, in accordance with the 1992 <a href="https://www.cbd.int/convention/text/">Convention on Biological Diversity</a>.</p>
<h2>The case of <em>Quassia amara</em></h2>
<p>Exactly what can be patented, for how long, and by whom, differs between legal frameworks, which causes much confusion for researchers, governments, and traditional local peoples. </p>
<p>Recently, a <a href="http://www.sciencemag.org/news/2016/02/french-institute-agrees-share-patent-benefits-after-biopiracy-accusations">biopiracy case</a> surfaced between the French Institute for Development Research (IRD) and local officials in French Guiana, an overseas department and former colony of France. This dispute exemplifies several common misunderstandings in biopiracy. </p>
<p>French researchers conducted interviews in French Guiana to find out about local antimalarial remedies. That preliminary research was published in 2005, and ten years later, a patent was granted for a new compound from the plant <em>Quassia amara</em> which had antimalarial properties. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/114138/original/image-20160307-31266-10hibju.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"><em>Quassia amara.</em></span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Flower_Quassia_amara.JPG">Pescov</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Researchers found the compound not from traditional preparations of the plant in a tea, but from alcohol-based extraction methods. Thus, in the European scientific tradition, the compound did not come from traditional Guianese methods but was discovered by the scientists. Nonetheless, it was the local Guianans and their plant knowledge that led the scientists to examine <em>Q. amara</em> and not thousands of others plants. </p>
<p>According to the newly implemented laws, agreements should have been made before the research even began. Now, French Guiana and the IRD are entering into discussions to form a retroactive agreement.</p>
<h2>The future is open</h2>
<p>Biopiracy is not likely to disappear any time soon. As climate change threatens, many large agribusinesses and researchers are patenting drought-resistant, heat-resistant, and salt-resistant genes from plants for future use in crop species. </p>
<p>To counter this, many researchers are attempting to collect genes and publish them in scientific domains (such as the NIH’s online <a href="http://www.ncbi.nlm.nih.gov/genbank/">GenBank</a> or various seed banks). By sharing genetic sequences, scientists can prevent big firms from claiming uniqueness and novelty, two criteria for patents. </p>
<p>While patents were first used to protect inventions and stimulate innovation, many anti-biopiracy activists and some academic and scientific circles are pushing for changes in the system, as it is now thought to hinder research in many important areas. For now, the issue of biopiracy remains at a stalemate.</p><img src="https://counter.theconversation.com/content/55589/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Janna Rose ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'a déclaré aucune autre affiliation que son organisme de recherche.</span></em></p>How scientists and corporations are plundering the developing world for new substances.Janna Rose, Chercheuse en développement durable, sciences sociales et technologie, Grenoble École de Management (GEM)Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/526652016-01-06T11:06:37Z2016-01-06T11:06:37ZHow 3D printing threatens our patent system<figure><img src="https://images.theconversation.com/files/107308/original/image-20160105-29000-s7kwnk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Stop printing all over my patent.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/edans/7187593954">Enrique Dans/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Remember Napster or Grokster? Both services allowed users to share computer files – usually digital music – that infringed the copyrights for those songs.</p>
<p>Now imagine that, instead of music, you could download a physical object. Sounds like something from a sci-fi movie – push a button and there’s the item! But that scenario is already becoming a reality. With a 3D printer, someone can download a computer file, called a computer-aided design (CAD) file, that instructs the printer to make a physical, three-dimensional object. </p>
<p>Because CAD files are digital, they can be shared across the internet on file-sharing services, just like movies and music. Just as digital media challenged the copyright system with rampant copyright infringement, the patent system likely will encounter widespread infringement of patented inventions through 3D printing. The problem is, however, that the patent system is even more ill-equipped to deal with this situation than copyright law was, posing a challenge to a key component of our innovation system. </p>
<h2>The factory at your fingertips</h2>
<p>Technically called “additive manufacturing,” 3D printing from a CAD file allows someone to “print” physical items at home. The printer follows a file’s instructions to generate a physical object. The printer head releases tiny squirts of material that, layer by layer, build up into the item. 3D printers can create incredibly complex objects, such as <a href="http://ngm.nationalgeographic.com/2014/12/3d-printer/smith-text">rocket engine parts</a>, <a href="http://www.nature.com/nbt/journal/v32/n8/full/nbt.2958.html">human tissue</a>, a <a href="http://ngm.nationalgeographic.com/2014/12/3d-printer/smith-text">bionic ear</a> and even a <a href="http://www.wired.com/2015/06/feds-restrict-3d-printed-gun-files">functional gun</a>. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/107315/original/image-20160105-28971-1ccn25l.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"></a>
<figcaption>
<span class="caption">Laser scan an object into the computer and you can then print out a new 3D replica.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/creative_tools/4530599701">Creative Tools</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>The CAD files <a href="http://3dprinting.com/what-is-3d-printing/#howitworks">can be created</a> by scanning in an object or by virtually designing an object on the computer. Once you have what are essentially the blueprints, the object is then just a press of a button away. Of course, if that object is covered by a patent, then pushing that button results in patent infringement. </p>
<h2>Potentially bypassing patent protection</h2>
<p>Patents are actual documents issued by the federal government. They’re awarded for inventions that are <a href="https://www.law.cornell.edu/wex/patent">nontrivial advances in the state of the art</a>. A patent allows the owner to prevent others from <a href="http://www.uspto.gov/patents-getting-started/general-information-concerning-patents#heading-2">making, using, selling or importing the invention</a>. These exclusive rights help keep competitors out of the market, allowing the patent owner to recover R&D costs. The owner also can use the patent to support efforts to commercialize the invention.</p>
<p>If people can evade the patent, however, then its value is reduced, undermining these important incentives. 3D printing presents this potential. It enables someone to “print” something that infringes a patent. Once someone prints the patented invention, they have “made” it, which violates the patent owner’s rights. </p>
<p>Each printed copy of an invention is a lost potential sale to the patent holder. But, to sue for infringement, the patent owner would need to be aware that someone is using a 3D printer to make the patented invention. And that’s a very tall order since these printers are widely dispersed across households and businesses. </p>
<p>Alternatively, patent owners could go after the people facilitating the infringement. The Patent Act permits a patent holder to sue parties <a href="https://www.law.cornell.edu/uscode/text/35/271">who induce others to infringe</a>. Potential inducers of patent infringement here could be the sellers of the 3D printers, someone providing CAD files of the patented device, or websites that sell or share various CAD files that instruct the 3D printer to make the patented invention.</p>
<p>Copyright law similarly prohibits inducement of infringement. Grokster did not make the infringing copies of the music itself, but it certainly helped other people make infringing copies. The Supreme Court held that Grokster likely induced copyright infringement, and <a href="http://www.nytimes.com/2005/11/08/technology/grokster-calls-it-quits-on-sharing-music-files.html?_r=0">Grokster shut down</a>. The same idea could apply in the patent context. </p>
<p>But there is a huge problem with this approach: inducement of patent infringement requires actual knowledge of the relevant patent. For music, everyone knows the songs are copyrighted. Not everyone is aware that a particular device is covered by a patent. There are hundreds of thousands of patents in existence. It’s highly unlikely that potential inducers would have actual knowledge of every patent that could be infringed by use of a 3D printer. </p>
<p>For example, suppose a dentist develops a brilliant new form of plastic braces, and she patents it. Independently, another dentist with some computer savvy comes up with the same idea via a CAD file. He shares the file with his dentist friends with 3D printers, who then all begin printing the plastic braces. The dentist’s friends start sharing the file with their friends, or someone places it on a file-sharing network. And so on. Anyone printing the braces is technically an infringer, but how can the patent owner find them all? And the dentist sharing his CAD file would have to be aware of the patent to be liable as an inducer, which may be unlikely.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=417&fit=crop&dpr=1 600w, https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=417&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=417&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=524&fit=crop&dpr=1 754w, https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=524&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/107316/original/image-20160105-28971-192yjt2.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"></a>
<figcaption>
<span class="caption">Does the infringement lie with the CAD files themselves?</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/creative_tools/13925075703">Creative Tools</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>Should the CAD files alone trigger infringement?</h2>
<p>Will 3D printing undermine the innovation incentives the patent system is designed to provide? Potentially, but <a href="http://law.campbell.edu/page.cfm?id=270&">Professor Lucas Osborn</a> of Campbell University School of Law and I have argued that courts can combat this problem by focusing on the CAD files, rather than the printed object.</p>
<p>Copyright provides a helpful contrast. Digital files themselves infringe. They are copies of the work. Not so in patent law. To infringe, one has to make a tangible version of the invention. But, if the infringing object is merely the press of a button away for someone with the CAD file and a 3D printer, should the CAD files themselves be viewed as <a href="http://dx.doi.org/10.2139/ssrn.2483550">digital patent infringement</a>, similar to copyright law? </p>
<p>We argue that if someone sells a CAD file that prints a patented item, that should be considered infringing. The CAD file has value because of the patented invention, so the seller is appropriating the economic value of the invention. </p>
<p>But what if someone is not selling the CAD file? Instead, they just possess it. Should that be infringement, too? We think not. The patent system encourages others to design around existing patents, which is often done in a virtual space. If the CAD file itself would be viewed as infringement, then the system could lose such beneficial improvement efforts. </p>
<p>It is unclear if courts or Congress will act to address these issues. What is inevitable, however, is that 3D printing will prove challenging to our patent system. There is a great irony here. One of the greatest innovations of our time may ultimately undermine a key engine of innovation, the patent system.</p><img src="https://counter.theconversation.com/content/52665/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Timothy Holbrook 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>Copyright law had to figure out how to deal with digital media. Now 3D printers – and their capacity for infringement – are poised to challenge the patent system in a similar way.Timothy Holbrook, Associate Dean of Faculty, Professor of Law, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/456482015-08-05T20:17:14Z2015-08-05T20:17:14ZHow the battle over biologics helped stall the Trans Pacific Partnership<p>Talks that were meant to finalise the Trans Pacific Partnership wound up in Hawaii late last week <a href="http://www.abc.net.au/news/2015-08-01/trans-pacific-partnership-delegates-fail-to-reach-final-deal/6665204">without reaching</a> a final deal. Over the last five years, 12 countries – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam – have been involved in negotiating the final text of the deal.</p>
<p>Despite the setback, there will be a strong push to sort out the remaining issues in August. After that the Canadian and US election cycles will make further progress in negotiating the trade deal next to impossible. And one of the most highly charged matters negotiators will be trying to resolve is intellectual property protections for medicines.</p>
<p>Over the next few weeks, Australia’s trade minister, <a href="http://www.andrewrobb.com.au">Andrew Robb</a>, will be under intense pressure to renege on the government’s oft-repeated commitment to <a href="http://trademinister.gov.au/releases/2013/ar_mr_131211.html">reject anything in the deal</a> that could undermine the <a href="http://www.pbs.gov.au/pbs/home">Pharmaceutical Benefits Scheme</a> (PBS) or increase the cost of medicines for Australians.</p>
<h2>Data exclusivity</h2>
<p>A key issue affecting drugs is the length of the data-exclusivity period for a class of medicines called biologics, which are produced from living organisms. Biologics include many new and very expensive cancer medicines, such as Keytruda, a melanoma drug <a href="http://www.pm.gov.au/media/2015-06-28/new-drug-listing-keytruda-treat-melanoma">recently listed on the PBS</a>. Without the PBS subsidy, it would cost over A$150,000 to treat a patient for a year.</p>
<p>Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors. It’s a different type of monopoly protection to patents. While a product is covered by data exclusivity, manufacturers of cheaper follow-on versions of the product can’t rely on the clinical trial data produced by the originator of the drug to support the marketing approval of their product. </p>
<p>Section 25a of Australia’s <a href="https://www.comlaw.gov.au/Details/C2015C00086">Therapeutic Goods Act</a> provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can’t be revoked or challenged in court. </p>
<p>The powerful biopharmaceutical industry lobby in the United States has been seeking <a href="http://phrma.org/note-media-elected-officials-support-12-years-data-protection-tpp">12 years of market exclusivity for biologics</a>. </p>
<p>Facing intense opposition from all other countries, the US trade representative fell back this week to eight years. While this was heralded as a new level of “flexibility” in the US position, in reality it remains <a href="http://www.ip-watch.org/2015/07/27/decision-time-on-biologics-exclusivity-eight-years-is-no-compromise/">a significant extension of intellectual property rights</a> in most of the TPP countries.</p>
<p>Thus far, the Australian delegation has apparently maintained the position that it will not go beyond existing domestic law. Days before the talks broke up, the trade minister indicated in <a href="http://www.abc.net.au/radionational/programs/breakfast/andrew-robb-on-the-trans-pacific-partnership/6655730">an interview on ABC Radio National</a> that he didn’t see the sense in accepting a longer monopoly for biologics.</p>
<h2>Good reasons to not budge</h2>
<p>Three factors are likely to be contributing to this resolve. The first is the costs of extending monopolies. These are likely to be <a href="http://dfat.gov.au/trade/agreements/tpp/submissions/Documents/tpp_sub_gleeson_lopert_moir.pdf">hundreds of millions of dollars a year</a> in the short term and could rise exponentially in the longer term as patents gradually expire on biologics already listed on the PBS.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/90718/original/image-20150804-15146-gcmhrq.jpg?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">
<figcaption>
<span class="caption">Without a PBS subsidy, some new medications could cost patients thousands of dollars for a course of treatment.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/the_smileyfish/4018251978/in/photolist-785Ajw-aZeeWr-aYKsUT-aYJjWz-ppcfho-rmg8NM-2Fpbw2-JcsvK-Jcmvo-Jcm7y-8bmupc-9iavuh-44Nbp-4cQ2kF-nLnHsk-nrTkA1-9wYiDe-9x2iEQ-PcucF-dNUoaq-4jyVng-8EGNH-5Xe6m-89nPNh-5ybjn2-Jcsd2-JcmoY-9kZQPN-a2No9t-4EG4Jr-rS6tuE-8BVyEV-Jcmem-oDJSem-3cqncc-4MEcz-7LdwMs-3qiSoa-4HcEMQ-3cuGyW-apMGH2-8i6Wky-6Hmb7b-5WHQvU-bcMb2t-6C7jw-8XQ8a1-8XQ82C-8XQ7rh-781G7c">Toni Fish/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Another pressing consideration is the degree of political opposition to longer medicine monopolies in Australia. Extending the period of data exclusivity would require an amendment to the <a href="https://www.comlaw.gov.au/Details/C2015C00086">Therapeutic Goods Act</a> – a move Labor, the Greens and many independents would strongly oppose. And the failure to get implementing legislation through the Senate could compromise the whole deal.</p>
<p>The third factor is the lack of progress in bargaining for access to US markets; the US reportedly <a href="http://www.afr.com/business/agriculture/us-sugar-paying-millions-to-shut-out-australia-from-tpp-20150803-giqrog">made only a token offer on sugar</a> and <a href="http://www.smh.com.au/federal-politics/political-news/transpacific-partnership-deal-in-doubt-20150731-gioyho.html">withdrew an earlier offer on dairy</a> products.</p>
<p>Eight years of data exclusivity won’t be an appealing option for any of the other TPP countries, with the exception of Japan and Canada, which already allow for eight years. New Zealand’s trade minister recently faced outrage at home over <a href="http://www.radionz.co.nz/news/political/279879/tpp-key-admits-medicine-costs-will-rise">admissions that the cost of medicines may be expected to increase</a> after the agreement. The country’s opposition, also Labor, has declared it won’t support a deal that raises the costs of medicines.</p>
<p>The US stance itself is contradictory as the Obama administration has been <a href="http://www.canberratimes.com.au/comment/tpp-could-force-australia-to-americanstyle-health-system-20150625-ghxdes.html">trying to reduce the exclusivity period for biologics</a> to seven years, to speed up the availability of cheaper alternatives and save an estimated US$16 billion in the next decade.</p>
<p>It seems clear to everyone except US negotiators – and biopharmaceutical industry lobbyists – that the demand for extending data exclusivity for biologics needs to be dropped if the TPP is to be finalised.</p><img src="https://counter.theconversation.com/content/45648/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Deborah Gleeson receives funding 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, including the TPP. She has represented the Public Health Association of Australia on matters related to the TPP, including at the recent TPP negotiations in Maui.</span></em></p><p class="fine-print"><em><span>Ruth Lopert 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>Over the next few weeks, the trade minister will be under intense pressure to renege on the government’s commitment to reject anything in the Trans Pacific Partnership that could undermine the PBS.Deborah Gleeson, Lecturer in Public Health, La Trobe UniversityRuth Lopert, Adjunct professor, Department of Health Policy & Management, George Washington UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/444992015-07-30T19:45:43Z2015-07-30T19:45:43ZGive existing reforms a chance to kill patent trolls<figure><img src="https://images.theconversation.com/files/89998/original/image-20150728-7671-cn596v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Watch out for trolls squatting on patents.</span> <span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Troll_Warning.jpg">Gil</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Two hundred twenty-five years ago, on July 31 1790, the first patent was issued in the United States. It covered a method of making a fertilizer ingredient, <a href="http://www.uspto.gov/about-us/news-updates/first-us-patent-issued-today-1790">potash.</a></p>
<p>How times have changed! Over <a href="http://www.uspto.gov/web/offices/ac/ido/oeip/taf/issuyear.htm">eight million patents</a> later, we’ve moved from fertilizer to a revolution in genetics and digital technologies. Thousands of patents have been issued on computer software and methods of doing business. </p>
<p>Patents are supposed to encourage such dramatic innovation by providing inventors a limited period of time where they can exclude others from using their invention. Nevertheless, the law can struggle to keep up with new technologies. Software and business-method patents have created strain on the way our patent system operates. In particular, these patents have been frequently used by what critics have dubbed the “patent troll.” </p>
<h2>Patent trolling for profit</h2>
<p>What exactly are “patent trolls?” Their less pejorative appellation is Patent Assertion Entities (PAEs). PAEs generally are business entities that have only one asset, a patent. Typically they buy these patents from small inventors or bankrupt companies. PAEs don’t manufacture anything. Their entire business model is to threaten to sue people for patent infringement in hopes of getting licensing fees for the patent. </p>
<p>The PAE model is effective. Patent litigation is expensive for companies, costing <a href="http://www.patentinsurance.com/custdocs/2013aipla%20survey.pdf">potentially millions of dollars</a>. Once sued by a PAE, many companies prefer to settle to avoid the cost, regardless of the merits of the case. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/89999/original/image-20150728-7641-1xyqwnp.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patents are meant to foster innovation by protecting inventions.</span>
</figcaption>
</figure>
<p>PAEs, on the other hand, have few litigation expenses. Their only asset is the patent, and often their lawyers take the case on a contingency fee basis, so the lawyer gets paid only if and when the money comes in. Settle the case, then move on to the next target.</p>
<p>A popular statistic thrown around is that <a href="https://www.whitehouse.gov/sites/default/files/docs/patent_report.pdf">60% of United States patent lawsuits filed in 2013 were brought by PAEs</a>, leading many to view PAEs as parasites. </p>
<p>Congress has reacted, with <a href="https://www.congress.gov/bill/114th-congress/house-bill/9">patent reform legislation</a> on the verge of passing. The legislation is targeted at trolls and contains myriad provisions: creating standards for pleading a case far beyond other forms of litigation, making the loser pay in patent litigation and limiting discovery until the court has interpreted what the patent covers. There seems to be much enthusiasm for such reform, with reform bills making it out of committee in both the <a href="http://www.washingtontimes.com/news/2015/jun/11/house-committee-approves-patent-reform-innovation-/">House</a> and the <a href="http://thehill.com/policy/technology/244039-senate-panel-moves-patent-bill-to-the-floor">Senate</a> in a surprising show of bipartisanship. </p>
<p>Except, we don’t need it, at least not yet.</p>
<h2>Legal changes already under way</h2>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/89996/original/image-20150728-13725-tg9wug.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Campaigns are under way to annihilate the trolls.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/hershco/13242953903">Hershco</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
</figcaption>
</figure>
<p>The patent system is already in the throes of dramatic change, the impact of which we are only now beginning to feel. </p>
<p>Even in the two years since that 60% statistic, we’ve seen a sea change in patent law. To alter the patent landscape yet again risks undermining the value of all patents, not just the PAEs’. The proposed reforms are intended to chill abusive PAE activity, but they would have the same impact on small inventors and universities, who are also entities that don’t manufacture anything. Yet we would not consider them “trolls.” </p>
<p>The changes that have already taken place came from both Congress and the courts. </p>
<p>The Supreme Court, in particular, decided numerous cases in 2014 that could alter dramatically the ability of PAEs to operate. The court made it easier, for example, to <a href="http://www.supremecourt.gov/opinions/13pdf/12-1184_gdhl.pdf">force PAEs to pay their opponents’ attorney fees</a> when the PAE loses, making trolls’ suits riskier and potentially less profitable. </p>
<p>Most importantly, the Supreme Court’s decision in <a href="http://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf">Alice Corporation v CLS Bank</a> has dramatically altered the law governing which types of inventions are eligible for patent protection. </p>
<p>Alice invalidated a particular business method – a way to reduce the risk in a financial transaction of one party not carrying through on the agreement. The Supreme Court concluded that the method was merely an “abstract idea.” The patent in essence claimed the idea of avoiding these risks and merely used conventional computer technology to achieve it. According to the Supreme Court, that is not enough to constitute a patentable invention.</p>
<p>The Supreme Court’s decision has created a flood of other decisions invalidating patents on similar inventions, along with those relating to computer software, because courts view them as merely abstract ideas that are being implemented through routine mechanisms. The US Court of Appeals for the Federal Circuit – the court hearing all patent appeals across the country – <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/13-1505.Opinion.12-3-2014.1.PDF">has found only one patent valid</a> on these grounds in the post-Alice world, invalidating <a href="http://www.law360.com/articles/662776/a-look-at-everything-the-fed-circ-has-said-about-alice">numerous others</a>. These are the areas in which PAEs often operate, and many of their patents are now likely dead.</p>
<p>For its part, Congress substantially reworked the patent system in 2011 when it passed the America Invents Act (<a href="http://www.aipla.org/advocacy/congress/aia/Pages/The-Act.aspx">AIA</a>). </p>
<p>Among other changes, the AIA created new procedures at the United States Patent and Trademark Office (<a href="http://www.uspto.gov">USPTO</a>) that provide alternatives for challenging patents that are faster and cheaper than litigation. </p>
<p>In particular, the AIA created the “Covered Business Method” (<a href="http://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/transitional-program-covered-business">CBM</a>) procedure that targets business-method patents, the favorite playground of PAEs. </p>
<h2>Changes need time to percolate through the system</h2>
<p>The CBM procedure began in September 2012. These proceedings can take some time, so we are only now beginning to see the fruits of this and other new procedures at the USPTO. Indeed, the Federal Circuit just decided its <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1194.Opinion.7-8-2015.1.PDF">very first appeal</a> from a CBM proceeding on July 9.</p>
<p>While these proceedings are proving to be <a href="http://www.law360.com/articles/581512/trends-from-2-years-of-aia-post-grant-proceedings">popular with parties seeking to challenge patents</a>, the cases are only now making their way through the USPTO and on to the Federal Circuit. Many uncertainties remain about their impact, but all signs suggest these proceedings are meeting, if not exceeding, expectations as a cheaper alternative to challenge bad patents, including those in the hands of PAEs.</p>
<p>As a result of these legislative and judicial actions, the patent system is already in a state of flux, and much of the change is directed to PAE abuses. So why mess with things now? </p>
<p>Of course, when litigants abuse the patent system, it is costly to everyone, and undoubtedly some PAEs <em>are</em> abusing the system. But Congress should be sure that new reforms don’t do more harm than good. Further congressional action now of the wrong kind could reduce the value of patents if it makes it too costly or risky to enforce legitimate patents. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/89995/original/image-20150728-7626-v4nemr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Be careful where you steer the car….</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/tamaleaver/6288497038">Tama Leaver</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>One of the first things we are taught in drivers’ education is that over-correcting the steering wheel can actually be worse than merely staying the course. Congress’ well-meaning legislative proposals run the risk of acting prematurely and over-correcting the patent system, potentially driving it off the road.</p><img src="https://counter.theconversation.com/content/44499/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Timothy Holbrook 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>Nobody loves patent trolls. But new legislation in Congress aimed at the trolls isn’t necessary, since the effects of recent patent reforms are only starting to be felt.Timothy Holbrook, Professor of Law, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/376322015-02-17T00:15:44Z2015-02-17T00:15:44ZGene patents may sound scary but soon they may no longer matter<figure><img src="https://images.theconversation.com/files/72198/original/image-20150217-4573-i71zpz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Challenges to the patents for BRCA mutation tests in Australia and the United States resulted in opposing conclusions.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/christianacare/6332853828/in/photolist-aDBwNY-aDB7U7-aDx8Ur-aDxJMZ-aDB9gL-aDBVvU-aDxmuk-aDxStF-aDxkyk-aDBa1u-aDBkDq-aDxjWx-aDyayF-aDxUhK-aDBShu-aDxxft-aDBUoU-aDxWV8-aDBGSf-aDBom1-aDBHVS-aDBFL3-aDxYPD-aDBak7-aDBCC9-aDxHMR-aDBHpo-aDxFZt-aDxoE8-aDxKrx-aDBc7U-aDy5Xe-aDBLr5-aDBYRy-aDBWuy-aDxxQc-aDxvFR-aDxPa4-eES1EY-eEKTTn-i2nSi5-i2ou66-i2nFpJ-i2otEX-i2otSa-i2nuVB-i2otBR-jA2pb5-i2oxan-i2otDz">Christiana Care/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p>Recent cases in Australia and the United States and a new case in Canada show how controversial the subject of gene patents is. But technological advances and the cost of patenting may soon mean gene patents no longer matter.</p>
<p>On February 13, 2015, the High Court of Australia <a href="http://www.mauriceblackburn.com.au/about/media-centre/media-statements/2015/high-court-to-hear-breast-cancer-gene-patent-case/">granted special leave</a> to hear an appeal against the Federal Court decision in <a href="http://www.austlii.edu.au/au/cases/cth/FCAFC/2014/115.html">D'Arcy v Myriad Genetics Inc</a>. The case centred on whether the BRCA gene, certain mutations of which predispose women to breast cancer, could be patented. The full Federal Court had decided late last year that <a href="https://theconversation.com/australian-federal-court-upholds-gene-patents-31350">patent claims for the isolated genes were valid</a>. </p>
<p>The special leave means the High Court has agreed to review the decision; we can expect its judgment towards the end of this year, or possibly next year.</p>
<h2>Different jurisdictions</h2>
<p>The Australian case is indicative of global concern about gene patenting. </p>
<p>In June 2013, the <a href="https://theconversation.com/top-us-court-blocks-patents-on-breast-cancer-genes-15193">United States Supreme Court</a> found patents for isolated genes were not valid, also based on a challenge to the BRCA patents. The relevant legal test in the United States is whether the invention is “markedly different” from what occurs in nature. The Supreme Court focused on the information content of the isolated gene, finding it was not sufficiently different. </p>
<p>The relevant test in Australia is whether an invention constitutes an “artificially created state of affairs”. On this point, the Federal Court found the term “isolated” as used in the patent had a specific meaning – that the genetic material had been removed from its native environment and undergone a series of chemical alterations.</p>
<p>The Federal Court accepted that genetic material claimed in the patent may well have the same informational content as that found in nature. What made it artificial was that it differed chemically, structurally and functionally. The court drew attention to the fact that the material would not function properly if re-inserted into human cells. </p>
<p>In Canada, the Children’s Hospital of Eastern Ontario <a href="http://www.cbc.ca/news/health/u-s-gene-patents-patient-care-stymied-in-canada-hospital-claims-1.2820211?utm_medium=twitter&utm_source=twitterfeed&cmp=rss">is also challenging</a> the patentability of isolated genes. While the Australian and US cases were directed to a gene associated with breast cancer, this case concerns long QT syndrome, a rare disease that can <a href="https://theconversation.com/explainer-can-you-just-die-suddenly-25423">lead to heart arrhythmia and sudden death</a>. </p>
<p>Onset of the disease has been linked with mutations in a number of genes. And every one of these genes has to be tested to ensure they perform their job properly. The owner of the Canadian patents is trying to prevent hospitals from doing some tests.</p>
<p>The Canadian case will also ask whether isolated genes are valid subject matter for a patent. But other important questions – including whether methods of analysing genes are patentable, whether aspects of the inventions were so obvious that patents should not have been granted, and whether the Canadian diagnostic organisation is actually infringing any patent claims – are also being raised by the case.</p>
<p>Answers to all these questions are vital to modern genetic diagnostic testing. But the infringement question is particularly interesting because diagnostic technology is constantly changing. </p>
<p>There are good arguments that new types of diagnostic testing and whole genome sequencing may not actually infringe patents claiming isolated genetic material because genes do not have to be chemically and structurally “isolated” to carry out the test.</p>
<p>It is possible for the Australian High Court to reach a different conclusion from both the Canadian and US courts on the patentability of genes. By itself, this does not mean that any one country’s laws are better than any other. What should and should not be patentable is a complex ongoing debate without a clear answer.</p>
<h2>Australian law and practise</h2>
<p>In light of this, there are three particular aspects of Australian patent law and practice that we would like to clarify to encourage informed discussion.</p>
<p>First, no patent can directly claim elements of any naturally occurring organism. Although some patents claim similar subject matter to that in nature, it must still be different. This means there are no valid patent claims to things as they exist in nature.</p>
<p>A patent provides the right to stop others from using the invention that it claims, but it does not provide ownership of tangible things. It’s the stuff of fiction that “corporations own your genes” and can exercise rights to them in your body.</p>
<p>Second, Australian patent law explicitly allows <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/s119c.html">experiments on inventions</a> claimed in patents aimed at improving or modifying them. Any concerns that patents significantly and negatively affect basic research in Australia are exaggerated or represent a misunderstanding of our patent laws.</p>
<p>Third, patents often lead to higher prices because they provide a period of exclusivity in the market. The system is specifically designed this way to encourage research and development. Despite this, our <a href="http://www.publish.csiro.au/view/journals/dsp_journal_fulltext.cfm?nid=270&f=AH13029">recent survey</a> shows that, aside from the cost of materials and reagents, there is no evidence of Australian public testing facilities paying a fee or royalty to provide BRCA genetic tests - or any other genetic test. And anyway, the BRCA patent in question expires on August 11, 2015.</p>
<p>That’s not to say the patent holder, Myriad Genetics, hasn’t pursued royalties or asked companies to stop testing for BRCA mutations around the world – it has. The company’s Australian licensee, Genetic Technologies, has also considered having all tests run through them but decided against it. Currently, any accredited testing organisation can perform the test for BRCA mutations in Australia. </p>
<p>Whatever the High Court ultimately decides in the D’Arcy case, it’s unlikely there will be a surge in gene patent applications. A recent government-sponsored investigation has found such applications have been significantly <a href="http://www.ipaustralia.gov.au/pdfs/IPA_Final_Report__Human_Gene_Patents_2013.pdf">decreasing in number</a>, following a global trend. The reason is not entirely clear, but commentators have <a href="http://www.nature.com/nrg/journal/v13/n6/full/nrg3255.html">suggested</a> that because patents have annual fees and many are not profitable or useful in other ways, they are now being discarded.</p><img src="https://counter.theconversation.com/content/37632/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dianne Nicol receives funding from the Australian Research Council and National Health and Medical Research Council.</span></em></p><p class="fine-print"><em><span>John Liddicoat 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>Recent cases in Australia and the United States and a new case in Canada show how controversial the subject of gene patents is. But technological advances and the cost of patenting may soon mean gene patents…John Liddicoat, Research Fellow, University of TasmaniaDianne Nicol, Professor of Law, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/290482014-07-13T19:51:34Z2014-07-13T19:51:34ZLOT network: how Google and friends aim to block patent trolls<figure><img src="https://images.theconversation.com/files/53604/original/3nb9p6gx-1405054720.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Patent trolls ... halt!</span> <span class="attribution"><a class="source" href="http://www.flickr.com/photos/rpenalozan/5842530609">Rafael Peñaloza</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p>Google, Canon and other information technology corporations last week announced they’re banding together in an attempt to fix an allegedly broken patent system and squash the wave of <a href="https://theconversation.com/a-quick-fix-solution-for-patent-trolls-probably-wont-work-18819">patent trolls</a> and privateers crippling innovation.</p>
<p>The License on Transfer (<a href="http://www.lotnet.com/">LOT</a>) Network <a href="http://www.lotnet.com/learn-more/news-events.cfm?nid=Asana%2C%20Canon%2C%20Dropbox%2C%20Google%2C%20Newegg%20and%20SAP%20Announce%20Formation%20of%20New%20Cooperative%20Patent-Licensing%20Agreement">describes itself</a> as “a new kind of royalty-free cross-license meant to address these growing systemic problems”. </p>
<p>In principle it could involve IT start-ups, universities and bodies such as CSIRO that we expect to gain revenue by actively commercialising creativity. </p>
<p>The LOT Network’s current participants “own almost 300,000 patent assets, generate more than US$117 billion in revenue and employ more than 310,000 people”, albeit many of those people are in China rather than Silicon Valley, Sydney or London.</p>
<p>A Google spokesperson characterises the LOT Network – entities that have agreed to cooperate with each other – as “a sort of arms control for the patent world”:</p>
<blockquote>
<p>By working together, we can cut down on patent litigation, allowing us to focus instead on building great products.</p>
</blockquote>
<p>But how exactly will patent trolls and privateers really be affected by this move?</p>
<h2>The problem at hand</h2>
<p><a href="https://theconversation.com/ip-patents-copyright-you-5421">Patent law</a> gives inventors and investors a legally enforceable right to commercially exploit an invention – in essence, a new device or process. </p>
<p>That right can be licensed to another entity, with the rights owner for example authorising several manufacturers to concurrently use the owner’s patent in return for a royalty. The right lasts for a finite period of years and is meant to encourage creativity and investment in order to benefit society. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/qpn53WS8maQ?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">An introduction to patent law, if you prefer it in video form.</span></figcaption>
</figure>
<p>The balance between social goods and rewards to the investors and inventors remains contentious. Controversy around the <a href="http://www.equilibri.net/nuovo/articolo/high-price-drug-patents-australia-patent-law-pharmaceutical-drugs-and-trans-pacific-partner">Pharmaceutical Patents Review</a> in Australia suggests there <em>is</em> cause for concern. </p>
<p>There is also disagreement about whether some patented innovation is truly <a href="https://theconversation.com/everything-but-the-squeal-researchers-steak-claim-with-beef-patent-13398">original</a> (and thus appropriately protected) and about the impact of large-scale litigation such as the “<a href="https://theconversation.com/apple-google-and-samsung-is-it-peacetime-in-the-patent-wars-26949">patent war</a>” between Apple and Samsung.</p>
<p>Recently we have seen the much-hyped (and less understood) <a href="http://www.teslamotors.com/blog/all-our-patent-are-belong-you">announcement</a> by CEO Elon Musk at Tesla – the electric car company – about patent licencing:</p>
<blockquote>
<p>We believe that applying the open source philosophy to our patents will strengthen rather than diminish Tesla’s position</p>
</blockquote>
<p>Rather than exemplary philanthropy that announcement can be seen as an indication that Tesla plans to exploit its rights on a selective basis. Nice media release; not the end of patent law or an intellectual property nirvana. </p>
<h2>Back to LOT</h2>
<p>The LOT agreement isn’t designed to eradicate patents or lawyers. It operates on the basis that inventors, such as Google, can continue to gain patents covering their innovation. </p>
<p>That is unsurprising, given that the real value of many corporations lies in trade marks and patents rather than in factories or offices. (Much manufacturing in the IT sector, after all, is done by agents such as <a href="http://www.foxconn.com/">Foxconn</a> rather than directly by rights owners.)</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=336&fit=crop&dpr=1 600w, https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=336&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=336&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=423&fit=crop&dpr=1 754w, https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=423&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/53605/original/cy6thyss-1405054996.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=423&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/mwiththeat/5562687410">Matt Wakeman/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Having gained a patent, each LOT entity can licence its invention to other entities within the group. Each entity retains the right to enforce the patent so long as it retains ownership. It can assign a value to the patent in its corporate accounts. It is not forced to licence or gift the innovation to a competitor. </p>
<p>But if the patent is sold to an entity outside the group, the members of the group gain a royalty-free license to use the patent. </p>
<p>The expectation is that the LOT Network agreement will accordingly prevent mischievous litigation by what are characterised as patent trolls or patent privateers, such as entities that critics claim engage in a form of extortion over supposed or substantive rights, but do not engage in innovation themselves. </p>
<p>In essence, there will be little point in buying a LOT patent in order to improperly assert rights through threats of litigation against members of the group. The buyer could of course litigate against infringement of the patent by an entity outside the group, so the LOT Network is not a comprehensive fix.</p>
<p>International patent lawyers, academics and investors will be checking the fine print in what is otherwise a positive development. There are carve-outs to “preserve a patent portfolio’s value”, including provisions regarding some takeovers and other deals affecting control of an entity within the group. </p>
<p>We might wonder whether competition watchdogs will also be watching LOT, which, as in some cross-licensing arrangements over the past 120 years, has the potential to be anti-competitive if you are outside the LOT club or one of the smaller entities dealing with a giant such as Google.</p><img src="https://counter.theconversation.com/content/29048/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Baer Arnold 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>Google, Canon and other information technology corporations last week announced they’re banding together in an attempt to fix an allegedly broken patent system and squash the wave of patent trolls and…Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/188192013-10-25T03:27:31Z2013-10-25T03:27:31ZA quick-fix solution for patent ‘trolls’ probably won’t work<figure><img src="https://images.theconversation.com/files/33774/original/3zs8z7vs-1382673016.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A new US proposal aimed at combating patent trolls is not likely to be effective</span> </figcaption></figure><p>In the US this week <a href="http://www.smh.com.au/it-pro/business-it/us-congress-to-consider-law-against-patent-trolls-20131024-hv280.html">there’s been another outbreak</a> of proposals to fix the “patent troll” problem. </p>
<p>A new bill from Representative Bob Goodlatte suggests changing the nation’s patent law to punish trolling or increase the resources of the USPTO (the patent registrar). </p>
<p>These proposals aren’t an effective solution, given the disagreement and general lack of consensus within the business community about what constitutes “trolling”. Instead, the proposals are likely to further complicate the law and add to the workload of US courts in interpreting that law.</p>
<p>Earlier in the year, New Zealand took a stab at combating excessive patent disputes surrounding software.</p>
<p>Their <a href="http://www.legislation.govt.nz/act/public/2013/0068/latest/whole.html?search=ts_act%40bill%40regulation%40deemedreg_patents_resel_25_a&p=1#DLM1419046">Patent Bill</a> received royal assent and is coming into effect. The legislation is attracting international attention, and some raised eyebrows, after <a href="http://au.ibtimes.com/articles/502780/20130901/new-zealand-parliament-bans-software-patent-information.htm">claims</a> that software patents would soon become a relic of the past. The reality is a little more complicated and a lot more interesting.</p>
<p>Patent law provides the holder with exclusive rights to exploit or use an innovation in any way they see fit. Those rights typically last for twenty years and are legally enforceable. They concern a specific “invention” – which might be a device or an original process – rather than a scientific discovery or what is deemed to be “obvious”. </p>
<p>In essence, <a href="http://www.ipaustralia.gov.au/get-the-right-ip/patents/">patent law</a> provides an incentive for creativity and investment. It is a central but controversial <a href="http://oami.europa.eu/ows/rw/resource/documents/observatory/IPR/joint_report_epo_ohim.pdf">feature</a> of the information economy. Some critics, for example, <a href="http://www.wired.com/insights/2013/07/patent-law-broken-abused-to-stifle-innovation/">argue</a> that patent protection, which often results in a short term monopoly that can be exploited by patent holders, stifles innovation. Other critics claim that protection is simply unnecessary, with manufacturers usually relying more heavily on exemplary service and rapid product redesign.</p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/32528/original/2bpxcswf-1381107440.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">When it comes to patent legislation, a quick-fix isn’t necessarily the best option.</span>
<span class="attribution"><span class="source">shutterstock.com</span></span>
</figcaption>
</figure>
<p>Advocates of <a href="http://www.acip.gov.au/reviews/all-reviews/review-innovation-patent-system/">protection</a> on the other hand <a href="http://www.law.unimelb.edu.au/melbourne-law-school/news-and-events/watch-online/francis-gurry">argue</a> patent law provides an incentive for the investment required for the development of <a href="http://www.ipaustralia.gov.au/pdfs/Draft_Report_PharmaReview.pdf">pharmaceuticals</a> and other products that are socially beneficial but involve substantial infrastructure and years of work.</p>
<p>One court famously <a href="http://www.nzlii.org/nz/cases/NZCA/1983/24.pdf">commented</a> that “Patent law is a rather artificial, highly complex and somewhat refined subject”. It is however an area of law that has been used by innovators in the development of products that range from zippers and children's’ toys to 3D printers, surgical stents, mobile phones, ABS brakes and Viagra.</p>
<p>So, this begs the question: is software – machine-readable instructions for the operation of a device – an invention?</p>
<p>Patent legislation in <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/">Australia</a>, Canada, the US, Europe and elsewhere typically does not specifically refer to software. However, our courts and patent registrars – the government bodies administering the patent system – have broadly accepted that software can be patented. Protection under that law specifically relates to the novel way of doing things rather than any specific code.</p>
<p>The emphasis on novelty means that individuals and organisations seeking protection for software face difficulties, because most software builds on previous products and thus is not sufficiently innovative. Software is thus comparable to scientific research, where most researchers are standing on the shoulders of giants and truly epochal breakthroughs are rare.</p>
<p>In Australia, consistent with the High Court’s interpretation of “invention” in the 1959 <em>NRDC v Commissioner of Patents</em> <a href="http://www.austlii.edu.au/au/cases/cth/HCA/1959/67.html">judgment</a>, software can be patented. That protection applies regardless of whether the software is freestanding or <a href="http://www.computer.org/csdl/mags/so/2009/03/mso2009030014.html">embedded</a> in a device via a computer chip – for example in office machines, cars and “smart” domestic appliances.</p>
<p>New Zealand has headed in a different direction, one that will presumably result in trade disputes with partners such as the US.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=425&fit=crop&dpr=1 600w, https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=425&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=425&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=534&fit=crop&dpr=1 754w, https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=534&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/32535/original/7ny3thxx-1381109884.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=534&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">New Zealand’s new patent legislation is out of step with the rest of the world.</span>
<span class="attribution"><span class="source">shutterstock.com</span></span>
</figcaption>
</figure>
<p>The new legislation is unique as it provides protection for “embedded” software, but excludes other software. Instructions that are not embedded - not specific to the particular device and not found on a chip - will not be protectable under patent law. They thus will <em>not</em> be subject to claims of patent infringement. </p>
<p>This type of software will still be protected under <a href="http://www.copyright.org.au/find-an-answer/browse-by-what-you-do/software-developers/">copyright</a> law. However, that law provides weaker protection than patents because copyright deals with expression rather than functionality. Essentially, if you rewrite the code you are no longer infringing the copyright.</p>
<p>This new legislation is a conundrum. It comes at a time when Australia and New Zealand are standardising their intellectual property regimes to strengthen the bi-national Trans Tasman Market, including standardisation of patent practice. The law means that what is able to be protected in Australia, is not able to be protected in the Land of the Long White Cloud. </p>
<p>Despite this, we are not likely to see software developers fleeing across the Tasman to Australia. Some will stay at home and register their innovative software developments in Australia, the US and other patent-friendly jurisdictions. Some will continue to embrace <a href="https://theconversation.com/open-source-ditching-patents-and-copyright-for-the-greater-good-5302">Open Source</a>, emphasising low cost or customisation for niche markets. </p>
<p>New Zealand’s exceptionalism in patent law takes it out of step with its trading partners, most of whom are strengthening rather than weakening patent protection. The benefits of the legislation for consumers and software developers are unclear. It is likely we will see a u-turn as NZ politicians recognise that global competiveness involves more than agriculture and tourism.</p>
<p>The global struggle surrounding patent disputes suggests Australia should be wary of calls for quick-fixes. A real solution is going to be much more complicated than the elimination of non-embedded software patents or special anti-troll provisions.</p><img src="https://counter.theconversation.com/content/18819/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Baer Arnold 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>In the US this week there’s been another outbreak of proposals to fix the “patent troll” problem. A new bill from Representative Bob Goodlatte suggests changing the nation’s patent law to punish trolling…Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/151902013-06-21T05:33:42Z2013-06-21T05:33:42ZEnd of an era for Viagra as rivals get ready to raid market<figure><img src="https://images.theconversation.com/files/25780/original/tbwqt4gh-1371573223.jpg?ixlib=rb-1.1.0&rect=34%2C82%2C1232%2C852&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Harder times ahead for Pfizer as Viagra patents end.</span> <span class="attribution"><span class="source">Flickr/kosare</span></span></figcaption></figure><p>Those for whom Viagra is indispensable might be a little surprised that the ubiquitous blue, diamond-shaped pill was a chance discovery by a group of research pharmaceutical chemists at Pfizer’s research laboratory in Sandwich, Kent. </p>
<p>The research scientists were investigating the properties of the “sildenafil citrate” compound for its suitability as a heart drug when they accidentally discovered that it could treat erectile dysfunction - or impotence. Pfizer promptly synthesised the compound, assigned it the trade name Viagra and applied for patents across the world to protect their new invention.</p>
<p>But today two of Pfizer’s Viagra patents come to an end - a process that will inevitably finish the company’s monopoly in the UK.</p>
<h2>Pfizer’s battles over patents and fake pills</h2>
<p>Since its commercial debut in 1998, Pfizer has made a fortune selling billions of Viagra pills - <a href="http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10095251/Viagra-maker-Pfizer-faces-competition-from-generic-rivals-as-patent-expires.html">a record 2.3m men</a> were prescribed the drug last year in the UK.</p>
<p>But the global popularity and commercial success of the little blue tablets also inevitably provoked the envy of competitors who challenged the validity of their patent. The European Patent (UK) 702,555 for Viagra was <a href="http://news.bbc.co.uk/1/hi/business/1013244.stm">invalidated by Justice Hugh Laddie</a> in 2000 on grounds that the use of sildenafil citrate - the key ingredient - was already in the public domain before the patent was granted in 1993. </p>
<p>In Canada, the Viagra patent was invalidated <a href="http://www.scc-csc.gc.ca/case-dossier/cms-sgd/sum-som-eng.aspx?cas=33951">for insufficient disclosure</a> by the Supreme Court of Canada in 2012.</p>
<p>Nevertheless, Pfizer still managed to preserve its monopoly on Viagra in the UK via two other patents based on its methods of manufacturing Viagra. These are the two UK patents that expire today.</p>
<p>It means that rival “generics” manufacturers will be legally able to produce the pills under the name sildenafil and the lack of patent cover could see a dramatic diminution in Pfizer’s Viagra sales and profits with a price drop from £10 <a href="http://www.guardian.co.uk/business/shortcuts/2013/jun/03/viagra-lose-patent-pfizer-generic">to as little as 85p a pill</a>.</p>
<p>Even before the official expiration of Pfizer’s Viagra patents in the UK and the recent weakening of Viagra patent in Canada by the Supreme Court judgement, <a href="http://www.guardian.co.uk/society/2004/sep/29/health.medicineandhealth1">counterfeit</a> and illegal generic copies of Viagra were being sold online. This undermined Pfizer’s monopoly and robbed the company of billions of pounds in annual sales of Viagra. </p>
<p>But in light of its waning patents around the world Pfizer’s new strategy for retaining its market share is to <a href="http://www.cbsnews.com/8301-500395_162-57582958/pfizer-to-sell-viagra-online-in-first-for-big-pharma-ap/">sell Viagra directly to customers</a> via its website, in direct competition with the expected new generic competitors and the online pharmacies which have peddled unauthorised generics and fake Viagra pills for years.</p>
<h2>A time to recoup</h2>
<p>Pfizer’s Viagra sums up the challenge facing drug manufacturers around the world: they need patents to secure a monopoly right (for 20 years) in order to recoup millions of investment in research and development (R&D) into new drugs. </p>
<p>However, not all new drugs are as serendipitous as Viagra has been for Pfizer. The R&D process for a new drug could take years and <a href="http://www.law.cf.ac.uk/researchpapers/4">can cost about $802m</a>, according to a 2003 study by the Tufts Centre for the Study of Drug Development, and not all R&D lead to new drugs. </p>
<p>Also, as amply demonstrated by Viagra, drugs patents are often challenged by competitors in courts in expensive and often lengthy litigations that can last the lifetime of the disputed patents. New drugs are also subject to mandatory and lengthy prior-market approval processes, which include clinical trials on animals and human subjects.</p>
<p>Pharmaceutical companies need patents as an incentive and a safeguard for their investments. Without them, it’s unlikely they would invest in unpatentable, albeit promising pharmaceutical compounds.</p>
<h2>Patents make for more expensive drugs</h2>
<p>Generic and out-of-patent drugs are notoriously cheaper than patented drugs. Inevitably drugs are more expensive in countries with relatively stronger pharmaceutical patents, such as the US, than in countries with weaker pharmaceutical <a href="http://www.bbc.co.uk/news/business-21991179">patents such as India</a>. In <a href="http://uk.reuters.com/article/2013/05/10/uk-usa-health-drugs-analysis-idUKBRE9490OA20130510?feedType=RSS&feedName=GCA-GoogleNewsUK&google_editors_picks=true">EC countries</a> and <a href="http://www.ohlj.ca/archive/articles/35_2_halewood.pdf.">in Canada</a> there are official price control mechanisms in place to counter the higher drugs prices caused by patent monopolies. </p>
<p>National health authorities across Europe often initially reject expensive drugs as one form of control. In the UK for example, the National Institute for Health and Clinical Excellence (Nice) routinely turns down patients’ demand for expensive drugs that lack corresponding clinical benefits. </p>
<p>Some of these make headlines. <a href="http://www.telegraph.co.uk/health/healthnews/9079213/Breast-cancer-sufferers-denied-two-drugs-on-NHS.html">There was Herceptin</a> in the case of breast cancer. Nice also refused to pay for Crizotinib, a lung cancer drug that costs £4,000 a month per patient, on the grounds that it was too expensive, <a href="http://www.dailymail.co.uk/health/article-2299655/NHS-watchdog-refuses-pay-lung-cancer-drug-Crizotinib-thats-twice-effective-chemotherapy.html">despite clinical benefits</a> that doubled the ones provided by chemotherapy. There are also rules on how much Viagra the NHS can prescribe.</p>
<h2>Drug companies bending the rules</h2>
<p>Drugs companies also often abuse the patents system by circumventing the limited monopoly conferred by patents. </p>
<p>This can be done in legitimate and illegitimate ways. For example, Pfizer could legitimately use Viagra’s trademark or trade name to extend or preserve their monopoly on the drug after their patents expire in the UK. It could do this by barring generic manufacturers of the drug from using the distinctive diamond-shaped and blue colour of Viagra and the name Viagra, which are all registrable trademarks in the UK and European Union. </p>
<p>Out-of-patents drugs manufacturers often pay generic manufacturers to delay entering the market in order to artificially preserve the monopoly price, indirectly and illegally extend their patent monopoly, and keep drugs prices artificially high. </p>
<p>US pharmaceutical company Solvay, which makes prescription testosterone gel AndroGel, agreed to pay generic manufacturers $42m (£27m) a year to delay making a generic copy of AndroGel by another nine years. The legality of this “pay to delay” payment is the <a href="http://www.politico.com/story/2013/06/scotus-gives-pay-for-delay-case-another-day-in-court-92897.html">subject of a legal challenge</a> by the US Federal Trade Commission in the US.</p>
<h2>A balancing act between cost and investment</h2>
<p>The essence of drugs patents is to incentivise innovation in new pharmaceuticals by allowing drugs makers a limited monopoly rights that lets them recoup their investments in pharmaceutical R&D. </p>
<p>It’s a societal quid pro quo for many life-saving drugs. However, a monopoly often leads to higher drugs prices along with affordability issues <a href="http://www.jltp.uiuc.edu/archives/oriola.pdf">for both poor and rich countries</a>. The main challenge for authorities around the world is how to achieve the right balance.</p><img src="https://counter.theconversation.com/content/15190/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Taiwo Oriola received funding from the Department of Trade and Industry in 2006 as part of a Cardiff University research team looking into the regulation of nanotechnology</span></em></p>Those for whom Viagra is indispensable might be a little surprised that the ubiquitous blue, diamond-shaped pill was a chance discovery by a group of research pharmaceutical chemists at Pfizer’s research…Taiwo Oriola, Lecturer in Law, Ulster UniversityLicensed as Creative Commons – attribution, no derivatives.