tag:theconversation.com,2011:/id/topics/gene-patenting-1558/articlesGene patenting – The Conversation2016-12-19T02:22:31Ztag:theconversation.com,2011:article/671132016-12-19T02:22:31Z2016-12-19T02:22:31ZObama administration’s big science and tech innovation: Socially engaged policy<figure><img src="https://images.theconversation.com/files/150616/original/image-20161218-26137-6n65ta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Obama annually welcomed students to the White House with their Science Fair projects.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Science/cdaa4cbaea9e4d03b9c54f898d9da404/2/0">AP Photo/Susan Walsh</a></span></figcaption></figure><p>When President Barack Obama gave his <a href="https://www.whitehouse.gov/blog/2009/01/21/president-barack-obamas-inaugural-address">inaugural address</a> in 2009, he promised to “restore science to its rightful place and wield technology’s wonders to raise health care’s quality and lower its cost.” For the previous eight years, scientists had protested that the Bush administration <a href="http://www.washingtonpost.com/wp-dyn/content/article/2005/08/31/AR2005083101271.html">ignored</a> their expertise and <a href="http://www.livescience.com/9574-scientists-bush-stifles-science-lets-global-leadership-slip.html">restricted</a> research freedoms. So they were heartened when the new president <a href="https://www.whitehouse.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells">removed barriers</a> to federal funding for human embryonic stem cell research and <a href="https://www.whitehouse.gov/the-record/climate">took serious steps</a> to mitigate climate change. </p>
<p>But President Obama should be remembered – and praised – for much more than his renewed support for science. As a scholar of science and technology policy, it is clear to me that this president and his advisers recognized that policy could be carefully crafted to maximize the social and economic benefits of research and innovation. </p>
<p>They designed intellectual property policies, for example, that enhance scientific collaboration and in turn accelerate research progress, and also improve the availability of important technologies. And by including average citizens in developing research projects and priorities, they increased the usefulness and public legitimacy of science and technology. </p>
<h2>Modernizing patents’ power</h2>
<p>For decades, the United States government had <a href="http://www.press.uchicago.edu/ucp/books/book/chicago/P/bo25338584.html">largely accepted</a> the idea that patents were a necessary incentive for innovation. With the promise of a temporary monopoly if they were successful, inventors would work hard to develop new, transformative technologies. The potential benefits were significant: access to technologies that could transform societies for the better. Ultimately new industries, new jobs and economic growth would result.</p>
<p>Over time, though, it became clear that patents can <a href="http://science.sciencemag.org/content/280/5364/698">stifle research</a> and make important new technologies <a href="https://mitpress.mit.edu/books/building-genetic-medicine">prohibitively expensive</a>. The Patent and Trademark Office (PTO) and its traditional stakeholders, such as patent lawyers, <a href="https://www.uspto.gov/web/offices/com/sol/comments/utilguide/index.html">dismissed</a> such problems as minor and temporary, suggesting that only those who misunderstood how the system worked were concerned.</p>
<p>But in 2010, the Obama administration took the unprecedented step of breaking with its own PTO to side with physicians and scientists, as well as civil liberties and patient advocacy groups, who raised these issues in the context of patents covering human genes. A case brought in federal courts focused on whether genes were products of nature, but the plaintiffs <a href="https://www.aclu.org/legal-document/brca-complaint">were clearly motivated</a> by concerns that patents on human genes were stifling important research and limiting access to potentially lifesaving genetic testing.</p>
<p>The Obama administration argued alongside these plaintiffs publicly when the Supreme Court heard the case in 2013. And in a unanimous decision, the Supreme Court agreed with the plaintiffs and the administration. Today, isolated human genes are not patentable. </p>
<p>As a result, there is greater competition in the genetic testing market; more tests are <a href="http://www.nytimes.com/2015/04/21/business/more-accurate-affordable-tests-for-detecting-breast-cancer-genes.html?_r=0">available</a> for common diseases including breast cancer, and at lower costs.</p>
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<span class="caption">Announcing the Precision Medicine Initiative, Obama shares the podium with a model of DNA.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Budget-Precision-Medicine/d3d0e8db587843fb82f29d2fcab56563/11/0">AP Photo/Carolyn Kaster</a></span>
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<h2>Removing IP roadblocks</h2>
<p>The Obama administration’s concern that intellectual property could be hurting biomedicine and ultimately patients is also clear in the research programs it established.</p>
<p>Both the <a href="https://www.whitehouse.gov/share/brain-initiative">Brain Initiative</a>, designed to develop a more dynamic understanding of brain function, and the <a href="https://www.whitehouse.gov/precision-medicine">Precision Medicine Initiative</a>, focused on designing individually tailored treatment and prevention strategies, <a href="https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative">emphasize</a> data sharing and collaboration. While previous efforts viewed competition among individuals and proprietary interests as central to the development of biomedicine, the Obama administration has come to see these as potential obstacles. </p>
<p>This <a href="https://medium.com/cancer-moonshot/report-of-the-cancer-moonshot-task-force-executive-summary-e711f1845ec#.xc01cmmi8">skepticism</a> is perhaps clearest in the 2016 <a href="https://www.whitehouse.gov/CancerMoonshot">Cancer Moonshot</a> initiative. </p>
<p>Decades of significant government expenditures for cancer research – from President Nixon’s <a href="https://dtp.cancer.gov/timeline/flash/milestones/M4_Nixon.htm">War on Cancer</a> to an <a href="http://www.healthline.com/health/breast-cancer/state-of-awareness-and-research#3">over 2,000 percent increase</a> in yearly breast cancer research funding since the 1980s – have improved scientists’ understanding of the disease and reduced <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">cancer deaths</a>. But cancer incidence <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">remains high</a>, and there are still significant disparities in <a href="http://link.springer.com/article/10.1007/s10903-014-9991-0">diagnosis</a> and <a href="http://jnci.oxfordjournals.org/content/94/5/334.short">treatment.</a> </p>
<p>The Cancer Moonshot aims to address these problems through increased data sharing. </p>
<p>For example, it includes a first-of-its-kind, open access, public data platform, the <a href="https://www.whitehouse.gov/the-press-office/2016/06/06/fact-sheet-vice-president-biden-launches-open-access-data-resource-part">Genomic Data Commons</a>. This allows researchers not just to store and analyze the genomes of cancer tumors, linking that information to data about how the disease appears and spreads in the body, but also to share all of this information with colleagues. The platform also provides privacy and security protections for patients and researchers. </p>
<p>Before 2008, policymakers seemed to assume that the competitive ethos and monopoly incentives provoked by patent policies were the most likely to stimulate important scientific research. But the Obama administration’s nuanced approach to patents and investment in data-sharing initiatives have created a legacy that emphasizes openness and collaboration as the best avenue for producing scientific progress.</p>
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<a href="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=394&fit=crop&dpr=1 600w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=394&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=394&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=495&fit=crop&dpr=1 754w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=495&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=495&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Protocols for patient consent were ripe for an update.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Informing-Patients/e6d3408332164573b4969bdafc0abe7d/8/0">AP Photo/Brian Kersey</a></span>
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<h2>More voices in the research conversation</h2>
<p>The Obama administration also took important steps toward including citizen perspectives in science and technology development.</p>
<p>The Precision Medicine Initiative – which aims to gather data (genomic, medical, metabolic, microbial, environmental and lifestyle) from at least one million Americans to produce better medical diagnostics and therapies – emphasizes transparency, citizen representation and patient autonomy in its core principles. It is dedicated to keeping participants informed throughout the research process, and emphasizes the importance of culturally appropriate interactions.</p>
<p>It has created <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/infographics">a new model of research</a> that treats informed consent as ongoing and interactive, and gives research subjects the option to withdraw at any time.</p>
<p><a href="http://www.nature.com.proxy.lib.umich.edu/nature/journal/v478/n7369/full/478312a.html">Customarily</a>, participants in similar research projects provide consent only once, at the beginning. This traditional approach has become controversial in recent years because blood and tissue samples are often <a href="https://theconversation.com/if-we-dont-own-our-genes-what-protects-study-subjects-in-genetic-research-56003">used for a variety of projects</a>, and citizens <a href="http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0">want more control</a> over how their samples are used. </p>
<p>The PMI also includes “<a href="https://www.whitehouse.gov/precision-medicine">substantial participant representation</a>” in all aspects of the process, including program design and implementation. This means research subjects will serve on the policy committees that develop data-sharing, privacy and recruitment guidelines, among others, and also help to determine research priorities. Previous scientific research initiatives have <a href="http://www.lancaster.ac.uk/fss/journals/gsp/docs/volume1number3/mlgspvol1no32005.pdf">included</a> citizen perspectives occasionally in the research process, either in funding decisions or identifying overarching goals. But the PMI approach is more ambitious and systematic. </p>
<p>The Obama administration’s enthusiasm for considering citizen perspectives is not limited to scientific research. We’ve seen this approach in its energy policy as well, including in decisions on the <a href="http://america.aljazeera.com/articles/2015/2/9/how-climate-activists-turned-a-pipeline-into-a-green-movement.html">Keystone XL</a> and <a href="http://www.latimes.com/nation/la-na-dakota-access-deadline-20161204-story.html">Dakota Access</a> pipeline.</p>
<p>After massive protests and millions of citizens <a href="https://www.youtube.com/watch?v=0BdjszfbIDw#t=19">submitting</a> public comments, President Obama <a href="https://www.nytimes.com/video/multimedia/100000004023322/obama-rejects-keystone-pipeline.html">rejected</a> the Keystone XL. Similarly, months of protests in Standing Rock, North Dakota, led the Army Corps of Engineers to halt development of the Dakota Access pipeline and <a href="https://www.theatlantic.com/science/archive/2016/12/the-historic-victory-at-standing-rock/509558/">request an environmental impact statement</a> that would assess the environmental and social implications of the project and provide extensive additional opportunity for public input. </p>
<p>At this moment, when there is great concern that the priorities of scientists and engineers do not align with those of the public, and there is growing <a href="https://www.bostonglobe.com/metro/2016/10/09/the-rise-biorights-donors-are-demanding-control-and-sometimes-cash-exchange-for-genetic-samples/jCbaQ2E5t6c0Qs1kcITMRM/story.html">desire</a> among citizens to be treated as “partners” rather than “subjects” in research, these kinds of initiatives are particularly important. They can lead to the development of science and technology that is more directly beneficial to the population – and also enhance the legitimacy of scientific and technological establishment.</p>
<h2>Will Trump build on the groundwork laid by Obama?</h2>
<p>There is a great deal of <a href="http://www.nature.com/news/the-ultimate-experiment-how-trump-will-handle-science-1.20971">uncertainty</a> about President-elect Trump’s approach to science and technology policy, and so far his cabinet appointments <a href="http://www.freep.com/story/opinion/columnists/stephen-henderson/2016/12/10/betsy-devos-trouble-data/95207844/">do not provide</a> much reassurance to the scientific community. Some of these appointments have <a href="http://www.newyorker.com/tech/elements/donald-trumps-war-on-science">even explicitly denied</a> the scientific consensus on climate change.</p>
<p>But there is a path forward that could allow Trump to remain true to those who voted him into office while building upon President Obama’s approach. Pundits tell us Trump’s victory is largely the <a href="https://www.washingtonpost.com/politics/a-rancorous-campaign-begets-huge-problems-for-the-winner/2016/11/08/0fcea580-a20d-11e6-8d63-3e0a660f1f04_story.html?utm_term=.0b0d12e81ec4">result</a> of a populist wave and deep frustration toward elites; many Americans feel that policymakers do not adequately consider the realities of their everyday lives.</p>
<p>President-elect Trump could address these concerns by bringing the needs and perspectives of rural and working-class Americans explicitly into the development of science and technology policies. His administration could consider <a href="http://delinkage.org/">new kinds of policy frameworks</a>, including intellectual property regimes, that could help to lower drug prices. It could bring these “forgotten” Americans directly into policy discussions about how to tackle the unemployment triggered by <a href="http://www.businessinsider.com/united-tech-ceo-says-trump-deal-will-lead-to-more-automation-fewer-jobs-2016-12">increasing automation</a>. And it could <a href="http://www.bmj.com/content/316/7129/463?variant=full-text">include them</a> in discussions about biomedical research priorities, perhaps leading to increased funding for practical solutions to the <a href="http://aese.psu.edu/directory/smm67/Election16.pdf">opioid epidemic</a>. </p>
<p>Such efforts could ultimately strengthen the legitimacy of the new administration among both the scientific community and the public, while continuing the work towards a socially engaged science and technology policy.</p><img src="https://counter.theconversation.com/content/67113/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shobita Parthasarathy sits on the Board of Directors for Breast Cancer Action, a health justice advocacy group.</span></em></p>The outgoing president leaves behind some solid accomplishments in the world of science, tech and medicine. But the biggest departure from his predecessors might have been in his approach.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/438122015-07-31T10:49:21Z2015-07-31T10:49:21ZAn early expression of democracy, the US patent system is out of step with today’s citizens<figure><img src="https://images.theconversation.com/files/90139/original/image-20150729-30871-1u1dkq.jpg?ixlib=rb-1.1.0&rect=23%2C26%2C2132%2C1106&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Started with high democratic ideals, how does the U.S. Patent Office work for the 21st century?</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/streetsofdc/4011978857">StreetsofWashington</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>Last month, the U.S. Patent and Trademark Office issued its <a href="https://10millionpatents.uspto.gov">10 millionth patent</a>. But are all of these patents helping society? The American patent system was designed initially to stimulate innovation, but some citizens now argue that it’s actually <a href="http://www.teslamotors.com/blog/all-our-patent-are-belong-you">hurting innovation</a>, <a href="http://thehill.com/blogs/congress-blog/healthcare/244728-tpp-is-designed-to-make-medicines-more-expensive-reforms-more">limiting access to technology</a> and <a href="http://www.icta.org/patent-watch/">promoting unethical areas of research and innovation</a>. These critics are <a href="http://pubpat.org/">making their voices heard</a> through courtroom challenges, legislative hearings and even street protests.</p>
<p>This grassroots activism might seem strange. After all, the patent system is a highly specialized technical and legal domain, seemingly of interest only to inventors seeking exclusive rights to commercialize their new technologies for a limited period of time. Why has it become such a controversial site, and what can policymakers and citizens do about it?</p>
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<a href="https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=403&fit=crop&dpr=1 600w, https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=403&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=403&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=506&fit=crop&dpr=1 754w, https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=506&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/90142/original/image-20150729-30886-e8u3hr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=506&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">1869 patent drawing of a flying machine.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/usnationalarchives/5574345706">The U.S. National Archives</a></span>
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<h2>We the people and our patents</h2>
<p>When first developed in the late 18th and early 19th centuries, the U.S. patent system was <a href="http://www.cambridge.org/us/academic/subjects/history/early-republic-and-antebellum-history/democratization-invention-patents-and-copyrights-american-economic-development-17901920?format=HB">designed</a> to be democratic – particularly in comparison to the European patent systems of the time.</p>
<p>European royal courts <a href="https://eh.net/encyclopedia/an-economic-history-of-patent-institutions/">bestowed patent “privileges”</a> upon entrepreneurs for a high price. By contrast, the U.S. system issued patent “rights” to inventors. And it encouraged widespread participation in the system by <a href="http://www.jstor.org/stable/40971878?seq=1#page_scan_tab_contents">keeping patent application fees low</a> and creating public displays of patented technologies to inspire future innovation.</p>
<p>The U.S. system, in other words, put patents, innovation and entrepreneurship in reach for every citizen. Policymakers thought this <a href="http://heinonline.org/HOL/LandingPage?handle=hein.journals/jpatos76&div=94&id=&page=">would increase innovation</a>, which would produce economic and eventually social benefit.</p>
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<a href="https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/90145/original/image-20150729-30854-6x31oa.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>
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<span class="caption">An 1812 patent, signed by President James Madison.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/nationalmuseumofamericanhistory/9407060033">National Museum of American History</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
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<p>By many measures, these efforts were successful. Patent application rates grew throughout the 19th and 20th centuries, and in 2017, the U.S. issued over <a href="https://www.uspto.gov/sites/default/files/documents/USPTOFY17PAR.pdf">300,000</a> patents on innovations ranging from photocopies to solar panels. Indeed, many industries – from <a href="http://www.jstor.org/stable/3106161?seq=1#page_scan_tab_contents">railroads</a> to <a href="http://www.press.uchicago.edu/ucp/books/book/chicago/M/bo17212890.html">pharmaceuticals</a> – have credited their success to the modern patent system.</p>
<p>And this approach has also gone global, buoyed by <a href="https://doi.org/10.1111/j.1747-1796.2004.tb00260.x">international legal agreements</a> designed to create a uniform patent regime that would make it easier for inventions to travel, for inventors to reap rewards across borders and for markets to become transnational.</p>
<p>This centuries-old system, which continues to this day, assumes widespread public agreement on the idea that stimulating innovation through patents will <a href="http://www.uspto.gov/about-us">ultimately benefit everyone</a>. It envisions every citizen as a potential inventor and expects that if legislators and the courts serve the interests of inventors, they automatically serve the interests of the public. And it assumes the public will trust its decisions because the patent system is guided by scientific knowledge and the law.</p>
<h2>Patents, persecuting rather than protecting?</h2>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=1003&fit=crop&dpr=1 600w, https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=1003&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=1003&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1261&fit=crop&dpr=1 754w, https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1261&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/90185/original/image-20150729-30851-11vnvbo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1261&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">What’s driving individuals to protest patents?</span>
<span class="attribution"><span class="source">Shobita Parthasarathy</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>But the dynamics of the patent system have changed in recent decades. Public health activists have filed lawsuits stating that, rather than increasing access to technology, patents create monopolies that <a href="http://www.bcaction.org/our-take-on-breast-cancer/gene-patenting/">make good health unaffordable and inaccessible</a> for many. In 2013, a coalition of patients, health care professionals and scientists challenged patents covering genes linked to breast and ovarian cancer at the U.S. Supreme Court. They argued the patents had led to expensive and poor-quality genetic tests available <a href="https://mitpress.mit.edu/books/building-genetic-medicine">only through one company</a>: Myriad Genetics, the patent holder.</p>
<p>Meanwhile, small farmers have <a href="http://www.pubpat.org/monsanto-seed-patents.htm">organized protests against seed patents</a>, suggesting they accelerate the corporate control of agriculture in ways that are damaging for their livelihoods, for innovation, for consumers and for the ecosystem. </p>
<p>And civil society groups have instigated legislative hearings and media campaigns arguing that patents implicitly provide moral certification for the development and commercialization of ethically controversial areas of research and development. Such campaigns began as early as the 1980s, when environmentalists, animal rights organizations and religious figures <a href="https://www.jstor.org/stable/20027762">challenged the patentability of genetically engineered animals</a>. They worried that by turning these animals into commodities, the patent system would transform people’s understanding of ownership and our relationship with the natural environment. </p>
<p>Patent system officials and lawyers tend to <a href="https://doi.org/10.3152/030234210X501180">view this activism as seriously misguided</a>. They argue that these citizen challengers lack the expertise to understand how the patent system works: It is a limited domain focused merely on certifying the novelty, inventiveness and utility of inventions. This technical and legal orientation is also embedded in the rules and processes of the system, which make it virtually <a href="http://heinonline.org/HOL/LandingPage?handle=hein.journals/ncjl15&div=19&id=&page=">impossible for average citizens to participate</a>, except by submitting patent applications.</p>
<h2>How to reform a system from 1790</h2>
<p>In my 2017 book “<a href="http://press.uchicago.edu/ucp/books/book/chicago/P/bo25338584.html">Patent Politics: Life Forms, Markets, and the Public Interest in the United States and Europe</a>,” <a href="https://scholar.google.com/citations?user=-x17iNgAAAAJ&hl=en&oi=ao">I</a> suggest that these responses from the usual participants in the patent system, as well as the structure of the U.S. patent system itself, are out of step with modern democratic politics. </p>
<p>Citizens are playing a more active role in science and technology policymaking in a variety of ways. They are now trying to ensure that the systems that regulate the development, availability and use of innovation <a href="http://nyupress.org/books/9780814762387/">better reflect their values and concerns</a>. For instance, patient advocacy groups have forced their way <a href="https://doi.org/10.2190/HPXB-9RK8-ETVM-RVEA">onto the review panels that distribute government funding</a> for biomedical research, in order to maximize not just scientific but public benefit. </p>
<p>In the case of the patent system, traditional participants miss that the patent system’s scope and structure were originally built with a different kind of public – and public interest – in mind. The country’s founders targeted their patent policies to a small, white and male citizenry. But today, America’s multi-ethnic population is far more critical and makes a diverse set of demands of science and technology policy institutions. </p>
<p>Is it possible to reform the system to accommodate the newly engaged public? Indeed, there is no natural definition of what the patent system is, what citizens should expect of it, or who should participate and how they should do so.</p>
<p>Consider, for example, the pan-European patent system, which by most accounts is <a href="http://www.cambridge.org/us/academic/subjects/history/early-republic-and-antebellum-history/democratization-invention-patents-and-copyrights-american-economic-development-17901920?format=HB">quite similar to its U.S. counterpart</a>. In recent years, it has demonstrated <a href="https://doi.org/10.1007/s11077-011-9133-7">openness to civil society participation</a> in its bureaucratic and court proceedings, and incorporated <a href="http://documents.epo.org/projects/babylon/eponet.nsf/0/63A726D28B589B5BC12572DB00597683/$File/EPO_scenarios_bookmarked.pdf">attention to moral and socioeconomic concerns</a> into its decision-making. It has been particularly sensitive to citizen concerns regarding patents on software and biotechnology. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/90143/original/image-20150729-30854-10ufgd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">A 2005 protest against software patents in the EU.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/nathelbiya/10986865">Nath el Biya</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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</figure>
<p>In 2007, the European Patent Office invited a variety of its critics to participate in developing an unprecedented report, entitled “<a href="http://www.epo.org/news-issues/issues/scenarios.html">Scenarios for the Future</a>,” that identified the challenges and opportunities it would face over the next 30 years. It noted, for example: </p>
<blockquote>
<p>“Whether or not the patenting system is at fault for a failure to get drugs to those who need them is immaterial. Blame is laid at the door of the IP system by many forces in society.”</p>
</blockquote>
<p>In response, institutions across Europe have taken steps to limit patent-based monopolies that might hurt <a href="http://www.eolss.net/sample-chapters/c17/E6-58-10-05.pdf">public health</a> and <a href="https://no-patents-on-seeds.org/en/information/news/german-parliament-prohibits-patents-plants-and-animals-conventional-breeding">agriculture</a>. </p>
<p>It is worth observing that while the U.S. system was initially conceived as a democratic improvement upon the European systems of the time, today’s pan-European patent system is far ahead of its U.S. counterpart in terms of both its public engagement and its attention to the implications that citizens care about.</p>
<p>If the U.S. patent system wants to maintain public trust, it has to realize that the 21st-century citizen is quite different from her 18th-century forebears. Today’s citizen cares about the ethical and socioeconomic implications of patents and the technologies they cover and is not content to assume that the system’s benefits eventually trickle down. And she seeks to have an active role in decision-making.</p>
<p>Taking this citizen seriously will require serious patent system reforms. Possible reforms include increasing opportunities for the public to participate in patent decision-making, allowing more legal and bureaucratic challenges on behalf of the public interest, and incorporating more emphasis on ethical and socioeconomic implications into our patent and innovation policies.</p>
<hr>
<p><em>This is an updated version of an article originally published on July 31, 2015.</em></p><img src="https://counter.theconversation.com/content/43812/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shobita Parthasarathy has received funding from the National Science Foundation, Wellcome Trust, and the Max Planck Institute for Intellectual Property, Competition, and Tax Law. She is on the Board of Directors for Breast Cancer Action.</span></em></p>Founded in 1790, the Patent Office aimed to put innovation and entrepreneurship within reach of every citizen. Now, 10 million patents later, critics say an out-of-touch system is doing the opposite.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/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/151952014-09-05T07:06:55Z2014-09-05T07:06:55ZFour things you should know about gene patents<figure><img src="https://images.theconversation.com/files/31511/original/zzhb3j8m-1379470053.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A gene patent means only the patent-holder has the right to undertake research and development involving that gene.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The Federal Court’s decision that gene patenting is permitted in Australia will have ramifications for all gene patents, even though the case involved only one gene associated with breast cancer.</p>
<p>A gene patent means only the patent-holder has the right to undertake research and development involving that gene. These patents generally last for 20 years.</p>
<p>The full bench of the Federal Court heard <a href="http://www.abc.net.au/news/2013-08-07/federal-court-appeal-begins-as-human-gene-patent-challenged/4870874">the appeal</a> against a ruling that private companies could patent genes in August 2013, after a Federal Court justice dismissed a challenge to the patent for a breast cancer gene, BRCA1, in February.</p>
<p>A landmark ruling by the <a href="http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf">US Supreme Court</a> in June 2012 declared that naturally occurring DNA sequences were ineligible for patents in a case that involved the same breast cancer gene, and the same patent holder. </p>
<h2>The BRCA1 and BRCA2 controversy</h2>
<p>It’s about 20 years since Myriad Genetics patented two genes associated with a significantly increased risk of developing breast cancer. Known as BRCA1 and BRCA2, the genes are also associated with an increased risk of ovarian cancer.</p>
<p>When functional, BRCA1 and BRCA2 produce tumour suppressor proteins that help repair damaged DNA. But when they are altered, the protein is either not made or doesn’t function correctly, leaving DNA damage unrepaired. The cells may then develop additional genetic alterations that can lead to cancer.</p>
<p>Breast cancer affects approximately one in ten women at some time in their lives, although not all cases result from these genetic mutations. <a href="http://www.ncbi.nlm.nih.gov/pubmed/10359546">Studies have estimated</a> that the frequency of BRCA1 and BRCA2 changes in the community is approximately one in 500.</p>
<p>Identifying these gene carriers is an important step in reducing disease in the community and in preventing transmission into subsequent generations. Indeed, any measure that can reduce breast cancer figures and help women avoid an incurable disease is something any reasonable society would aim for.</p>
<p>The BRCA1 and BRCA2 patents have generated significant controversy because Myriad has effectively monopolised the market for screening these genes to identify the alterations, or mutations, that render them non-functional. </p>
<h2>Four things you should know</h2>
<p>Here are four things you should know about gene patents that will provide some context for understanding the Federal Court decision.</p>
<p><strong>1. Genetic patents hinder, or don’t foster, innovation.</strong> </p>
<p><a href="http://www.theguardian.com/commentisfree/2013/apr/24/gene-patents-scientific-research-innovation">The argument</a> that gene patents foster innovation is often used to defend gene patenting, but it’s actually addressing the wrong question. </p>
<p>When considering gene patenting, we need to ask whether a gene is an invention, which is grounds for granting a patent, or a discovery. Isolating the actual gene itself is a discovery and, as such, should not be the focus of patent attention. </p>
<p>Surely only the process of how information is obtained from a gene can be the subject of a patent, and then only if it’s new. Developing new ways to interrogate a gene sequence can and should be patented as this leads to commercial drive and (hopefully) re-investment in new resources to improve testing strategies. </p>
<p><strong>2. Patents have traditionally been granted for isolated genes rather than for any kind of innovation.</strong> </p>
<p>Until recently, patent offices viewed the isolation of genes as enough to declare the gene more than just a product of nature and a discovery. </p>
<p>In the United States, patents are also granted on a first-to-invent basis. This contributed to the gene patent rush as the human genome project gathered pace in the 1990s and gene discoveries became almost a weekly event. There are now an estimated 4,000 gene patents in the United States.</p>
<p>The US Supreme Court ruling against gene patents hinged on a decision that isolating a human gene or part of a human gene is not an act of invention, reversing the traditional patent office practice. The decision allows for synthetically produced DNA sequences to be patented.</p>
<p><strong>3. Gene patents for tests create monopolies that lead to high prices.</strong></p>
<p>Commercial genetic testing has been a contentious issue and few companies undertake testing for single gene disorders. But companies engaged in commercial genetic testing have tended to ensure they’re the sole provider of such tests. </p>
<p>This gives them a monopoly and they can set whatever price they like for the test. This is clearly not a desirable outcome for society because it means we fail to protect vulnerable people who fear they have an illness from exploitation. </p>
<p><strong>4. Monopolies lead to a lack of quality assurance.</strong></p>
<p>Of particular concern is a monopoly’s inability to orchestrate a quality assurance program because this would require samples to be sent to third parties for verification.</p>
<p>Not only does it prevent monitoring of whether internal processes are producing the correct result, it disallows people from seeking a second opinion.</p>
<p>The decision of the High Court of Australia to uphold its previous decision now puts Australia out of step with the US Supreme Court and raises the question of just how much knowledge it has on matters it does not routinely deal with. </p>
<p>But what it means for Australia is probably very little; the current patent held by Myriad Genetics will expire within a relatively short period of time.</p><img src="https://counter.theconversation.com/content/15195/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rodney Scott does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The Federal Court’s decision that gene patenting is permitted in Australia will have ramifications for all gene patents, even though the case involved only one gene associated with breast cancer. A gene…Rodney Scott, Professor of Genetics, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/184512013-10-11T03:38:50Z2013-10-11T03:38:50ZFor Myriad Genetics, the gene patent fight isn’t over yet<figure><img src="https://images.theconversation.com/files/32734/original/nms44rq9-1381296564.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Most companies protect their core technologies with a set of patents, in case something goes wrong with one or more of them.</span> <span class="attribution"><span class="source">Flickr/Oak Ridge National Laboratory</span></span></figcaption></figure><p>Whether sequences of genetic material can be patented has been a matter of heated debate for the past decade or more. </p>
<p>In many countries, patents have been granted for isolated gene sequences, methods of isolating sequences, methods of using sequences for diagnosing genetic diseases, and a whole range of other gene-related products and methods.</p>
<p>Many thought this debate was drawing to a close earlier this year (June 2013), when the US Supreme Court handed down a <a href="http://theconversation.com/top-us-court-blocks-patents-on-breast-cancer-genes-15193">pivotal decision</a> in a test case on the patentability of genes associated with hereditary forms of breast cancer. </p>
<p>The decision, that the BRCA1 and BRCA2 genes were not patentable subject matter, was greeted with widespread enthusiasm. Mutations of these genes considerably increase the risk of developing breast cancer.</p>
<p>The US decision signalled the end of fears that patents could impede genetic research as well as the <a href="http://www.nytimes.com/2013/06/14/business/after-dna-patent-ruling-availability-of-genetic-tests-could-broaden.html?pagewanted=all&_r=0">provision of diagnostic genetic tests</a>. Or so many thought.</p>
<p>But the patent landscape around genetic testing for the BRCA genes is, in fact, far more complex than this. </p>
<p>Myriad Genetics, the company that owns the BRCA patents, was hardly going to sit by and watch its competitors move into the lucrative diagnostic testing space it had jealously guarded for so long. So it’s fighting on.</p>
<h2>More than one patent</h2>
<p>Most companies protect their core technologies with a set of patents, in case something goes wrong with one or more of them. Like the majority of patent owners, Myriad has various other patents in its armoury. It’s a smart business strategy.</p>
<p>Following the Supreme Court decision, <a href="http://www.ambrygen.com/">Ambry Genetics</a> and <a href="http://www.genebygene.com/">Gene-by-Gene</a>, two of Myriad’s closest competitors, provocatively announced that they would start offering BRCA diagnostic genetic tests. </p>
<p>In response, in July this year, Myriad instituted proceedings in the US District Court of New York alleging that both Ambry Genetics and Gene-by-Gene were infringing a number of its remaining patents. </p>
<p>Since then, various applications have been put to the court as part of the usual litigation process. </p>
<p>In particular, Ambry Genetics has counterclaimed that Myriad’s remaining patents are invalid and that the way it has acted amounts to patent misuse, as well as <a href="http://www.patentdocs.org/2013/08/ambry-responds-to-myriad-lawsuit.html">other matters</a>. </p>
<p>But this has not deterred Myriad, which has also been actively pursuing its case for patent infringement. <em>It has already</em> applied for a preliminary injunction requiring other companies to cease offering BRCA and other tests until the case has been decided. </p>
<p>And <a href="https://www.counsyl.com/">Counsyl Genetics</a>, another of Myriad’s competitors has independently applied to the US District Court for the Northern District of California for a declaration that it is not infringing any of Myriad’s remaining patents.</p>
<h2>Method and sequence</h2>
<p>Myriad’s <a href="http://www.patentdocs.org/2013/07/myriad-genetics-files-suit-against-ambry-genetics-for-genetic-diagnostic-testing-of-brca-genes.html">remaining patents</a> cover a range of claims for methods of diagnosis, and claims for DNA sequences.</p>
<p>The Supreme Court’s decision invalidating some of Myriad’s sequence claims probably make the validity of its other, similar claims doubtful. </p>
<p>The method claims are more problematic. In simple terms, a claim relating to a method of diagnosis might describe a method for screening for a gene mutation by comparing the gene sequence taken from a tissue sample with a reference sequence. </p>
<p>The Supreme Court did not get the opportunity to rule on Myriad’s method claims, but the lower courts dealing with that litigation were less than impressed with some of what the company claimed.</p>
<p>The Supreme Court has also indicated in another case (<a href="http://www.genomicslawreport.com/index.php/2012/03/21/prometheus-patents-struck-down-9-0-mayo-collaborative-services-v-prometheus-laboratories-inc-analysis/">Prometheus Labs. Inc. v Mayo Collaborative Services</a>) that it takes a dim view of claims that merely recite a method for comparing reference data (data that has been identified by prior experimentation and is disclosed in the patent) with patient data. </p>
<p>In the above case, the court decided that a method of measuring metabolites (what makes a drug able to be absorbed by the body) of a drug and comparing them with reference data to work out the correct dosage was not patentable.</p>
<p>It’s difficult to predict the direction that the court might take in the lawsuit between Myriad, Ambry and Gene-by-Gene in advance. But whatever happens in the District Court, more likely than not the case will be heading for protracted appeals to higher courts; don’t expect a clear outcome in the next year or more.</p>
<p>Broader questions about the lessons to be learned from the Myriad cases for diagnostic genetic testing remain unanswered. But the optimism resulting from the Supreme Court decision in June should not turn to pessimism quite yet.</p>
<h2>Australian scene</h2>
<p>The patentability of genes sequences also remains unresolved in Australia. The Full Court of the Federal Court of Australia recently heard an appeal from the decision of Justice John Nicholas in February this year relating to Myriad’s local BRCA patent. </p>
<p>Justice Nicholas decided that the gene sequence in question was patentable subject matter, because it was an “artificially created state of affairs”. The Full Court decision is imminent.</p>
<p>Meanwhile, a <a href="http://search.informit.com.au/documentSummary;dn=354215339633258;res=IELHEA">survey of Australian diagnostic laboratories</a> offering BRCA and other genetic tests completed in late 2012 indicate that few Australian laboratories are facing demands from gene patent owners either to stop offering tests or to pay licence fees for the provision of tests. </p>
<p>In contrast, owners of US patents appear more willing to enforce their patents against diagnostic laboratories. </p>
<p>It seems that there’s currently more leniency in granting gene patents in Australia than in the United States, but that diagnostic testing laboratories probably have less to fear from patents holders.</p><img src="https://counter.theconversation.com/content/18451/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 the National Health and Medical Research Council</span></em></p>Whether sequences of genetic material can be patented has been a matter of heated debate for the past decade or more. In many countries, patents have been granted for isolated gene sequences, methods of…Dianne Nicol, Professor of Law, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/152122013-06-14T14:36:14Z2013-06-14T14:36:14ZSupreme Court BRCA patenting decision: experts respond<figure><img src="https://images.theconversation.com/files/25592/original/gkwwz66y-1371219058.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Angelina Jolie has a double mastectomy after discovering she carried a mutation of the BRAC1 gene.</span> <span class="attribution"><span class="source">Dominic Lipinski/PA Wire</span></span></figcaption></figure><p>Millions of women in the US will have access to affordable genetic screening for cancer after the US Supreme Court ruled that a commercial company cannot patent human genes.</p>
<p>The screening tests for mutations in the BRCA1 and BRCA2 genes that increase someone’s risk of developing breast cancer. Actress Angelina Jolie recently revealed that she had undergone a double mastectomy after the test revealed she had an 87% chance of getting breast cancer. </p>
<p>But since the 1990s, the BRCA1 and BRCA2 genes have been patented by Myriad, a Utah-based company, which charged at least US$3000 (£1,900) a time for the test. It argued that removing the patents would stifle innovation.</p>
<p>But after a successful legal challenge to the company’s monopoly - unanimously upheld by judges - US labs will now be able to carry out the tests for less than US$200 (£127) a time.</p>
<p>The <a href="http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf">court upheld patents</a> for synthetic cDNA “because it is not naturally occurring”.</p>
<p>What does the ruling mean for women who may be at risk of cancer? And will it stifle research leading to less? A panel of experts responds below</p>
<hr>
<p><strong>Professor Anneke Lucassen, Clinical Geneticist, University of Southampton:</strong></p>
<p>Looking at the reaction to the news and on Twitter the decision is seen as a victory. The reason health professionals and patients are happy is because you can’t do genetic tests on those genes without paying a fee to Myriad.</p>
<p>But companies can still patent synthetic DNA, and I wonder what this will mean in practice. In order to do DNA tests you have to copy it first. Because you can’t sequence it directly, you have to copy the naturally occurring [DNA] compound to analyse it. Those copies aren’t covered by the ruling as far as I can see. If that’s the case then they can still patent those and this isn’t as big a victory as the headlines are making out. There’s still a loophole. </p>
<p>In the UK and Europe the decision wasn’t so eagerly awaited as we weren’t strangled by Myriad. In the US they had to pay around $3000, whereas here it costs some £500 a go because the European Patent Office doesn’t observe US rules. In practice we haven’t had to pay Myriad for testing. But the principle of not being able to patent people’s genetic code is of course as welcome here as in the US.</p>
<hr>
<p><strong>Professor Marcus Pembrey, Emeritus Professor of Paediatric Genetics, University of Bristol</strong></p>
<p>It’s good news. I’m a clinical geneticist in paediatrics and I’ve dealt with families with inherited disorders. We were involved in early work on haemophilia and other types of monogenic conditions, which are genetically determined and only involved only one altered gene, to help families who had this problem running through them. It was a great surprise at the time that companies were able to patent. </p>
<p>I’m not against patents. But it might be in the clever way someone comes up with for analysing it - as happened with polymerase chain reaction which was a clever idea of taking a bit of DNA and amplifying it so you could look at lots of DNA at the same time. That was a good example of a patent and a clever idea that pushed the research field forward very quickly.</p>
<p>Trying to patent gene sequences and the fault in them - it’s a naturally occurring thing and not patentable. You might argue that it’s a legal issue not an ethical one but there’s an element of ethics. It’s trying to extract additional profit from what to some extent is a human right.</p>
<hr>
<p><strong>Professor Alan Ashworth, head of the Institute of Cancer Research and part of the team who discovered BRCA2:</strong></p>
<p>The argument that innovation will be stifled if there are no rewards for “invention” is particularly pernicious. Commercial organisations can be exceptionally innovative and it is only right that this is rewarded. But patenting is not the only way to ensure innovation. </p>
<p>Tests for potentially fatal BRCA mutations are already saving lives by diagnosing women at highest risk of developing breast and ovarian cancer. By identifying women who carry high-risk BRCA mutations, doctors can help them make decisions on their future treatment, for example by offering a preventative mastectomy.</p>
<p>When we found the BRCA2 gene our aim was that our discovery was used to help cancer patients.</p>
<hr>
<p><strong>Professor Julian Savulescu, Uehiro Chair in Practical Ethics and Director, Institute for Science and Ethics, Oxford University:</strong></p>
<p>I don’t think it is clear at the moment whether this decision is good or bad. Patents are there for a period of time and the misunderstanding people have is that these genes are owned by the company. The patents are held for seven years to enable companies to recoup investment. So during that seven years you could say research is restricted.</p>
<p>Create mechanisms to make it worthwhile. It may be that patenting isn’t the best way but it’s an empirical issue. The legal system might be irrational but it is very important to know what the consequences are. It’s very easy to say it should be free.</p>
<p>Patents are all of limited timespan. It could be that in the longer term this is the best way to maximise investment. I do think you need to provide a mechanism. We don’t live in a Communist state and I’m concerned you have very long term consequences on research.</p>
<p>On the other hand we want as many people as possible to access these tests and make decisions on the basis of them. Angelina Jolie did a good thing in raising public awareness of these possibilities. But it’s hard to know at this point whether this ruling will have an impact.</p><img src="https://counter.theconversation.com/content/15212/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alan Ashworth is Chief Executive of the Institute of Cancer Research and receives a number of relevant grants through the organisation</span></em></p><p class="fine-print"><em><span>Julian Savulescu has received funding from the Wellcome Trust for a Hinxton Collaboration group meeting on patents and intellectual property</span></em></p><p class="fine-print"><em><span>Marcus Pembrey receives funding from the Medical Research Council</span></em></p><p class="fine-print"><em><span>Anneke Lucassen 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>Millions of women in the US will have access to affordable genetic screening for cancer after the US Supreme Court ruled that a commercial company cannot patent human genes. The screening tests for mutations…Alan Ashworth, Chief Executive, Institute of Cancer Research, LondonAnneke Lucassen, Professor of Clinical Genetics, University of SouthamptonJulian Savulescu, Sir Louis Matheson Distinguished Visiting Professor, Monash UniversityMarcus Pembrey, Emeritus Professor of Paediatric Genetics, University of BristolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/151932013-06-14T04:32:47Z2013-06-14T04:32:47ZTop US court blocks patents on breast cancer genes<figure><img src="https://images.theconversation.com/files/25541/original/8tb4hsz8-1371182126.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The decision may impact on an impending Australian appeal.</span> <span class="attribution"><span class="source">Image from shutterstock.com</span></span></figcaption></figure><p>All nine members of the US Supreme Court have ruled that isolated genetic material cannot be patented – unless the material is markedly different to what exists in nature. </p>
<p>The court ruled against Myriad Genetics’ patents on the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer. The primary plaintiff was the Association for Molecular Pathology, although the case was brought on behalf of a range of other stakeholders including medical associations, and breast cancer and women’s health groups.</p>
<p>The US decision may impact on the impending appeal in an Australian in which a Federal Court judge ruled patent claims to isolated genetic sequences were valid.</p>
<h2>The US decision</h2>
<p>The Association for Molecular Pathology argued that patent claims to “isolated” genomic DNA were not eligible for patent protection because they are products of nature. It is a fundamental tenet of modern patent law that natural phenomena and products of nature cannot be patented. Products of nature are reserved as the basic tools of scientific and technological work.</p>
<p>In the United States, the legal test that courts apply to determine whether a patent claim is a product of nature or not, is that the invention has “markedly different characteristics from any found in nature”.</p>
<p>In a quite simple judgement, the Supreme Court emphasised that brilliant discoveries may not receive patent protection because they are laws of nature. Albert Einsteins’ formulation E=mc2 (the finding that energy and mass are different forms of the same thing) is a good example. </p>
<p>In this case, the Supreme Court stated that Myriad Genetics Inc did not invent genomic sequence, they only isolated it.</p>
<p><a href="https://theconversation.com/patent-controversy-dont-let-breast-cancer-gene-genie-out-of-the-bottle-2616">Previous cases</a> on the same gene patents in the United States held that to isolate genomic DNA, chemical bonds were broken and this was sufficient to make the isolated genomic DNA “markedly different” from that in nature. The Supreme Court acknowledged bonds had been broken, but focused on the information content of the material (the genomic sequence) because that was the focus of the patent claims.</p>
<p>The Supreme Court did hint that artificially changing genomic DNA sequences may be sufficient to make isolated DNA markedly different from that in nature. Moreover, it stated that [cDNA](http://en.wikipedia.org/wiki/Complementary_DNA](http://en.wikipedia.org/wiki/Complementary_DNA), a laboratory-made form of (synthetic) DNA, that has very little chemical resemblance to what is found in nature, was patent eligible.</p>
<h2>What does it mean for Australians?</h2>
<p>The appeal in the Australian case will be heard by all three judges of the Full Federal Court on August 7 and 8. While the US case does not create a direct precedent, important elements of the case are the same and will have an impact. The test of patentability in Australia is similar to that in the United States, and the cases are about the same patents held by the same company.</p>
<p>Still, patents are territorial by design. This means that US patent law does not directly affect Australian patent law. In Australia, the legal test to determine whether a claim in a patent is a law of nature or not is whether it’s an “<a href="http://www.austlii.edu.au/au/cases/cth/HCA/1959/67.html">artificially created state of affairs</a>”. </p>
<p>This is probably a lower threshold test than the US test. In the recent Australia case over Myriad’s BRCA1 patent, <a href="http://www.austlii.edu.au/au/cases/cth/FCA/2013/65.html">the court was satisfied</a> that the test was met by isolating genomic DNA outside of a cell. </p>
<p>This is slightly different rationale to that applied by the US Supreme Court. While arguments citing the US Supreme Court decision will most likely be made in the Australian appeal case before for the full bench of the Federal Court later, the decision is not binding on Australian courts.</p><img src="https://counter.theconversation.com/content/15193/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John Liddicoat owns shares in Genetic Technologies Limited and Benitec Biopharma Ltd.</span></em></p><p class="fine-print"><em><span>Dianne Nicol receives funding from the ARC.</span></em></p>All nine members of the US Supreme Court have ruled that isolated genetic material cannot be patented – unless the material is markedly different to what exists in nature. The court ruled against Myriad…John Liddicoat, University of TasmaniaDianne Nicol, Professor of Law, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/128152013-05-10T01:19:22Z2013-05-10T01:19:22ZEnsure open access to genetic data to protect innovation<figure><img src="https://images.theconversation.com/files/23297/original/7pgbtz4n-1367889431.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Allowing patents that capture categories of unique genomic DNA damages the principle of open access.</span> <span class="attribution"><span class="source">Nestlé/Flickr</span></span></figcaption></figure><p>Public investment in the <a href="https://theconversation.com/explainer-what-is-the-human-genome-project-7559">Human Genome Project</a> was expected to deliver a global public good that would help generate scientific breakthroughs. But open access to our genetic blueprint is a precondition to achieving this and gene patenting – where companies have monopoly rights over genetic material – threatens to undermine it.</p>
<p>Allowing patents that capture <a href="http://www.guardian.co.uk/global-development-professionals-network/2013/mar/12/intellectual-property-genome-divide">categories of unique genomic DNA</a> damages the principle of open access. A related constraint – and one that can impact research and diagnostics – is the “ownership” of genetic samples from patients. </p>
<p>The potential and richness of this data could hold the key to developing cures, but opportunities are lost if this data is privatised or made inaccessible in some other way.</p>
<p>It’s difficult to find useful data on the number and scope of gene patents but <a href="http://weill.cornell.edu/news/releases/wcmc/wcmc_2013/03_25_13b.shtml">a recent report from Weill Cornell Medical College</a> in the United States delivers an interesting analysis. It estimates that almost all the human genome has been claimed through a series of complex and overlapping patents.</p>
<p>The most contentious genetic patents are those that are simply isolated and remain identical to DNA in the body. This category of patents blocks access to the original DNA and constrains innovation and research. </p>
<p>The legal status of such gene patents is now being addressed through test cases <a href="https://theconversation.com/who-owns-our-genes-myriad-genetics-monopoly-challenged-13489">in the United States</a> and <a href="https://theconversation.com/gene-patenting-australian-court-rules-brca1-patent-is-legal-12240">Australian courts</a>. </p>
<p>And it won’t just be companies that will be affected. The reduction in genetic sequencing costs has transformed the scope and access to genetic research and information for the scientific community. It also created a personalised genetic service industry that will have to take account of the legal wrangling over gene patents.</p>
<p>Public interest in understanding hereditary genome is a growth industry. Individuals contribute their DNA and pay for genetic analysis to services, such as 23andMe and similar companies offering assorted personalised <a href="http://www.guardian.co.uk/commentisfree/2013/mar/13/know-your-genome-personal-genetics">genetic services</a>.</p>
<p>How this genetic information is translated commercially – how it will be accessed and utilised, by whom and for what purposes – will have significant consequences, particularly in terms of health <a href="http://www.phgfoundation.org/news/4249/">insurance access</a> and notions of wellness.</p>
<p>The public also contribute to significant collections of individual genetic samples sourced through health-related services. But rarely do individuals seek an understanding of the use that might be made of their samples.</p>
<p>Patients’ clinical samples and genetic data collected by various genetic services are generally maintained by the service provider. That data often becomes part of privatised patented or copyright databanks, some used for important medical research, or <a href="http://www.reuters.com/article/2012/12/10/us-amgen-decode-idUSBRE8B90IU20121210">on-sold to other businesses.</a></p>
<p>UNESCO’s 2003 <a href="http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.htmll">Declaration on Human Genetics Data</a> provides some guidance about the ethics of genetic data but has little teeth. It promotes ethical practice in genetic data use and storage, with de-identification being the primary protection. </p>
<p>If unique but simply isolated DNA continues to be patentable, innovation will be affected and research options skewed. Private databanks will be permanently off limits. The issue of access to the human genome requires some clear thinking to develop appropriate governance and policy options to future-proof innovation.</p>
<p>The public is becoming more aware of the odd set of double standards applied to “accessing” genetic resources. Whether this will affect the current level of interest in understanding more about their genetic make-up or question what happens to their data is an open issue. </p><img src="https://counter.theconversation.com/content/12815/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anna George is affiliated with Murdoch University and Chatham House, Centre on Global Health Security.</span></em></p>Public investment in the Human Genome Project was expected to deliver a global public good that would help generate scientific breakthroughs. But open access to our genetic blueprint is a precondition…Anna George, Adjunct Professor , Murdoch UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/122402013-02-16T05:15:07Z2013-02-16T05:15:07ZGene patenting: Australian court rules BRCA1 patent is legal<figure><img src="https://images.theconversation.com/files/20320/original/h6r8nkdh-1360991583.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers.</span> <span class="attribution"><span class="source">Tips Times</span></span></figcaption></figure><p>“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of the Federal Court of Australia in <a href="http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2013/2013fca0065"><strong>Cancer Voices Australia v Myriad Genetics Inc</strong></a>, published on Friday.</p>
<p>This is the first Australian court decision on the patentability of isolated <a href="http://en.wikipedia.org/wiki/Dna">DNA</a> or <a href="http://en.wikipedia.org/wiki/Rna">RNA</a> sequences. Myriad Genetics, claiming a patent related to the <a href="http://en.wikipedia.org/wiki/Brca1">BRCA1</a> gene, won the case and the challenge to their patent was dismissed. </p>
<p>Three things will help understanding why.</p>
<h2>What is BRCA1?</h2>
<p>It’s a human breast and ovarian cancer-disposing gene. According to the disputed patent, mutation of the BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers.</p>
<h2>Can genes as such be patented?</h2>
<p>No. Patents cannot be granted for products of nature. There’s no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.</p>
<h2>Was this particular patent valid?</h2>
<p>This was the core of the debate. <a href="http://www.myriad.com/">Myriad Genetics</a> argued that its patent related to isolated DNA and RNA, extracted from cells removed from human body and purged of other biological material with which it is associated in the cell. </p>
<p><a href="http://www.cancervoicesaustralia.org/">Cancer Voices Australia</a> argued that there’s no significant or material difference between nucleic acid in its natural and isolated states. Scientific experts gave evidence on these issues, to assist the court.</p>
<h2>Key question</h2>
<p>In analysing the competing arguments, the Court said that a composition of matter may be patentable if it consists of an artificial state of affairs, with some discernible effect, of economic utility and the result of some human intervention. </p>
<p>The Judge said:</p>
<blockquote>
<p>The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.</p>
</blockquote>
<h2>The outcome</h2>
<p>Ultimately, the court decided that there was the necessary artificial state of affairs, explaining:</p>
<ul>
<li><p>earlier cases binding on the court regarding similar issues had used expansive language,</p></li>
<li><p>in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and isolated nucleic acid does not exist inside the cell, and</p></li>
<li><p>it would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent.</p></li>
</ul>
<h2>An appeal</h2>
<p>The Australian judicial system is transparent and reviewable. Transparent, so anyone can freely access online the full reasons for judgement in <a href="http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2013/2013fca0065">Cancer Voices Australia v Myriad Genetics Inc</a>. Reviewable, so dissatisfaction with the outcome may be tested in an appeal from the decision - perhaps even two appeals, should the issues warrant determination by the High Court.</p>
<h2>Changes to the law</h2>
<p>The <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/">Patents Act</a> is crafted by the Australian parliament. Should it wish, the parliament may amend the legislation to provide a different balance between private and public rights. Reform in this area has been considered in the past. </p>
<p>In its report <a href="http://www.alrc.gov.au/publications/report-99">Genes and Ingenuity: Gene Patenting and Human Health</a>, the <a href="http://www.alrc.gov.au/">Australian Law Reform Commission</a> recognised that concerns could be raised in relation to patents for isolated biological materials. </p>
<p>The <a href="http://www.alrc.gov.au/news-media/2011/government-response-alrcs-2004-report-genes-and-ingenuity-gene-patenting-and-human-h">Australian government’s 2011 response</a> accepted the recommendation that the legislation not be amended to exclude genetic materials and technologies from patentable subject matter, though some <a href="http://www.austlii.edu.au/au/legis/cth/num_act/iplatba2012517/">other amendments</a> to intellectual property laws have recently been made.</p>
<h2>What next?</h2>
<p>Similar arguments about gene patients are soon to be considered by courts elsewhere. <a href="http://edition.cnn.com/2013/02/15/world/asia/australia-breast-cancer-gene-patent/index.html">CNN quickly reported</a> the recent Australian decision, noting that that the same gene, along with <a href="http://en.wikipedia.org/wiki/BRCA2">BRCA2</a>, is at the centre of a high-profile lawsuit set to be heard by the United States Supreme Court in April of this year.</p>
<p>The frontier of genetic medical research seems likely to remain on the Australian and international judicial and parliamentary agenda for some time to come.</p><img src="https://counter.theconversation.com/content/12240/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Madden is also a lawyer in private practice with Slater & Gordon Limited, however that firm was not involved in the litigation referred to in this article.</span></em></p>“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of…Bill Madden, Adjunct Fellow, Western Sydney UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/75592012-08-07T03:10:46Z2012-08-07T03:10:46ZExplainer: what is the Human Genome Project?<figure><img src="https://images.theconversation.com/files/13918/original/mfb9397z-1344231826.jpg?ixlib=rb-1.1.0&rect=0%2C459%2C2048%2C1134&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The stories behind the Human Genome Project are themselves extraordinarily human.</span> <span class="attribution"><span class="source">widdowquinn</span></span></figcaption></figure><p>For many decades humans have pursued work to characterise the <a href="http://en.wikipedia.org/wiki/Human_genome">human genome</a>. Today, <a href="http://www.ncbi.nlm.nih.gov/RefSeq/">publicly available</a> references to genome sequences are available and have been instrumental in effecting <a href="http://www.futuremedicine.com/doi/abs/10.2217/pme.11.27?journalCode=pme">recent advances in medicine</a>, <a href="http://genome.wellcome.ac.uk/inthegenome/">genetics</a> and technology. </p>
<p>But interpretation of the human genome is in its early stages and large initiatives are now embarking on more complex pursuits to characterise the human genome that include understanding individual genome variation. </p>
<h2>What is the human genome sequence?</h2>
<p>The human genome sequence is contained in our DNA and is made up of long chains of “<a href="http://ghr.nlm.nih.gov/glossary=basepair">base pairs</a>” that form our 23 chromosomes. Along our chromosomes are the base pair sequences that form our 30,000 genes. </p>
<p>All humans share a great degree of similarity in their genome sequences - the same genes are ordered in the same manner across the same chromosomes, yet each of us is unique (except for identical twins) in terms of the exact base pair sequence that makes up our genes and thus our DNA/chromosomes. </p>
<p>It is this similarity that, in a genetic sense, defines us as “human” and the specific variation that defines us as individuals.</p>
<h2>Launching the Human Genome Project</h2>
<p>As early as the 1980s, momentum was gathering behind <a href="http://www.ornl.gov/sci/techresources/Human_Genome/project/alta.shtml">activities</a> that supported, and would eventually define, the Human Genome Project. </p>
<p>Conversations had turned into workshops that likened characterisation of the human genome to characterisation of the human anatomy that had centuries earlier revolutionised the practice of medicine. </p>
<p>In 1990, with continued support from the United States Department of Energy, the <a href="http://www.nih.gov/">United States National Institutes of Health</a> (NIH) and widespread international collaboration and cooperation, the $3 billion dollar Human Genome Project was launched. </p>
<p>The project aimed to determine the sequence of the human genome within 15 years. By 2000 (well ahead of schedule) a <a href="http://www.ornl.gov/sci/techresources/Human_Genome/publicat/hgn/v11n3/03draft.shtml">working draft of the human genome</a> was announced. This was followed by regular updates and refinements and today we all have access to a human “reference genome sequence”. </p>
<p>This sequence does not represent the exact sequence of the base pairs in every human, it is the combined genome sequence of a few individuals and represents the broad architecture of all human genomes that scaffolds current and future work aiming to characterise individual sequence variation. </p>
<p>The detail and stories behind the Human Genome Project are themselves extraordinarily human. This project benefited from our human drive for discovery and advancement and our human response to competition. </p>
<p>It forced us as individuals and communities to consider our personal, ethical and social attitudes towards the availability of human genome information, intellectual property protection (<a href="http://www.smh.com.au/opinion/society-and-culture/genetic-patenting-push-needs-to-keep-sight-of-public-interest-20100705-zxhv.html">especially gene patenting</a>) and public versus private/commercial enterprise in a broad sense.</p>
<h2>Advancing the project’s success</h2>
<p>In the years after the initiation of the Human Genome Project there were constant and significant advances in key areas that facilitated the enormous DNA sequencing effort. </p>
<p>These advances were achieved in all areas key to the efficient processing of DNA into electronic DNA sequence information. They included:</p>
<ul>
<li>improvements in the chemistries and instruments used to decipher the base pair sequences of prepared pieces of DNA </li>
<li>significant improvements in the capacity of computing facilities to manage the volume and nature of data generated from the instruments</li>
<li>perhaps most importantly, improvements in the analytical tools </li>
</ul>
<p>The then state-of-the-art DNA sequencing chemistry used in the Human Genome Project was <a href="http://www.dnalc.org/view/15479-Sanger-method-of-DNA-sequencing-3D-animation-with-narration.html">Sanger sequencing</a> – capable of sequencing single stretches of several hundred base pairs at a time. </p>
<p>Advances in analytical methods of putting these pieces back together into the 3.3 billion base pair human genome was fundamental to the progress of the project. </p>
<p>The Human Genome Project was also advanced by competition. In 1998 <a href="https://www.celera.com/celera/history">a privately funded project with similar aims</a> was launched in the United States by Celera Genomics. </p>
<p>Using a modification of the DNA sequencing technique and a smaller budget it was partly responsible for the accelerated progress of the Human Genome Project. </p>
<p>This competition brought forward other aspects of the project for ethical and legal scrutiny and discussion. </p>
<h2>Patent wars</h2>
<p>The issue of patenting genes formed a background to the Human Genome Project and many other similarly focused projects for some time. In the early 1990s it had been a serious issue of contention between <a href="http://en.wikipedia.org/wiki/James_D._Watson">James Watson</a> and <a href="http://www.theheart.org/article/1260905.do">Bernadine Healy</a> (then Director of NIH). </p>
<p>Competition between Celera Genomics and The Human Genome Project now brought the discussion into a different dimension.</p>
<p>The publicly-funded Human Genome Project released new data freely and in 2000 released the first working draft of the genome on the web. </p>
<p>In contrast, Celera filed preliminary patent applications on more than 6,000 genes and also benefited from the data provided by the publicly-funded project. </p>
<p>In March 2000, the US president Bill Clinton <a href="http://www.vjf.cnrs.fr/histrecmed/publications-electroniques/histoire-genetique/wikihistoryofhgp.html">announced</a> that the genome could not be patented and should be made freely available. </p>
<p>The stock market <a href="http://money.cnn.com/2000/04/06/companies/genomics/">dipped transiently because this announcement</a> did not reflect the <a href="http://www.nature.com/nrg/journal/v13/n6/full/nrg3255.html">tangible benefits</a> for biological research scientists. </p>
<p>Within 24 hours of the release of the first draft of the human genome, the scientific community downloaded half a trillion bytes of information from the University of California, Santa Cruz’s <a href="http://genome.ucsc.edu/">genome server</a> - a strong indication of the relevance of this information to the biological, biotechnological and medical research communities. </p>
<p>Interpretation of the genome sequence is in its early stages but has already improved our ability to offer genetic testing and clinical management of many diseases. </p>
<p>We are now embarking on more complex pursuits to characterise the human genome so as to understand individual genome variation. This work is supported by projects related to, and of the same magnitude as, the Human Genome Project, including projects characterising the genomes of other species, among them mice and yeast, <a href="http://hapmap.ncbi.nlm.nih.gov/abouthapmap.html">the International HapMap Project</a>, <a href="http://www.personalgenomes.org/">The Personal Genome Project</a> and the <a href="http://www.1000genomes.org/about">1000 Genomes Project</a>. </p>
<p>These projects are greatly enhanced by the next generation of sequencing methodologies, which will expedite the characterisation of the human genome at an individual level in coming years. </p>
<p><br>
<em>See more <a href="https://theconversation.com/topics/explainer">Explainer articles</a> on The Conversation.</em></p><img src="https://counter.theconversation.com/content/7559/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Melissa Southey receives funding from The National Institutes of Health, USA; The National Health and Medical Research Council of Australia; The Victorian Breast Cancer Research Consortium; The Cancer Council Victoria; The National Breast Cancer Foundation; The Komen Foundation,USA. She is affiliated with The University of Melbourne and The Cancer Council Victoria.
</span></em></p>For many decades humans have pursued work to characterise the human genome. Today, publicly available references to genome sequences are available and have been instrumental in effecting recent advances…Melissa Southey, Professor of Pathology, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/80342012-07-10T04:20:48Z2012-07-10T04:20:48ZIs it time to unlock biotech patents?<figure><img src="https://images.theconversation.com/files/12723/original/q2kdrynx-1341811230.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Biotech patents are worth big money, so companies would fiercely resist a compulsory licence.</span> <span class="attribution"><span class="source">sam d</span></span></figcaption></figure><p>We’re in for another round of the biotech <a href="https://theconversation.com/patent-wars-we-get-the-war-but-what-about-the-patents-2974">patent wars</a>, with announcement the Productivity Commission will <a href="http://pc.gov.au/projects/inquiry/patents">inquire</a> into the compulsory licensing of patents. If adopted, compulsory licensing could increase public access to patent-protected diagnostics and therapies, and foster research that has been inhibited by “<a href="http://www.researchoninnovation.org/thicket.pdf">patent thickets</a>”.</p>
<p>Biotech is the future. It’s about money – potentially very big money. It’s also about saving lives, whether from an early death or from discomfort and disability. The inquiry represents an effort to achieve a balance between public and private goods in a way that is consistent with Australia’s international obligations.</p>
<h2>How does the patent process work?</h2>
<p>The global biotech economy is founded on the interaction of research and patent law. That law enables patent holders - individual researchers, academic institutions, investors, pharmaceutical giants - to exclude the unauthorised use of an “invention”. </p>
<p>In order to gain protection under Australia’s <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/">Patents Act</a> and equivalent overseas legislation, that invention must have some degree of originality. The law accordingly protects innovative ways of doing things, devices and formulations. It does not protect facts or what is obvious and what is naturally occurring. </p>
<p>One consequence is that you cannot patent a human being. Another is that there is debate – often passionate debate – about the validity of attempts to patent parts of the human genome or uses of the genome in, for example, the diagnosis of cancer.</p>
<p>The ability of patent holders to legally exclude the unauthorised use of their invention means that the holders can sell the invention, licence the invention on a commercial basis (to generate ongoing revenue) or simply sit on the invention (so that it’s not used by anyone). </p>
<p>Although data is sketchy, many patent holders charge what they can get for use of the invention, meaning some pharmaceuticals and medical tests are expensive, at times prohibitively so. Other holders will discourage competition or, more egregiously, extort revenue by acting as “<a href="https://theconversation.com/the-art-of-war-know-your-enemys-patents-and-your-own-5489">patent trolls</a>” (threatening to litigate over purported infringement of their rights under patent law).</p>
<h2>What would a compulsory licence mean?</h2>
<p>The compulsory licence is one response to what critics see as a serious market failure. In essence, the licence overrides the patent holder’s ability to exclude others from using the invention. </p>
<p>The licence doesn’t involve confiscation of the patent, with the holder losing all rights and forgoing all revenue. Instead, the entity using the invention under a compulsory licence typically provides the patent holder with revenue that’s less than the market rate, which may not be commensurate with the investment required to develop the invention.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=387&fit=crop&dpr=1 600w, https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=387&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=387&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=487&fit=crop&dpr=1 754w, https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=487&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/12738/original/rzqjhx9j-1341822187.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=487&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Compulsory licencing could reduce the patent holders’ revenue.</span>
<span class="attribution"><span class="source">Steve Snodgrass</span></span>
</figcaption>
</figure>
<p>The Productivity Commission inquiry is to take nine months. It follows recent changes to Australian Law through the <a href="http://www.comlaw.gov.au/Details/C2012A00035">Raising The Bar</a> Act, promoted as modernising and simplifying the Australian regime in a way that balances the interests of intellectual property rights holders and users. </p>
<p>It also follows a succession of reports by parliamentary committees, industry advisory bodies and the Australian Law Reform Commission (ALRC), notably the Commission’s major <a href="http://www.alrc.gov.au/publications/genes-and-ingenuity-gene-patenting-and-human-health-alrc-report-99/27-compulsory-licens">Genes and Ingenuity report</a> and <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate_Committees?url=clac_ctte/gene_patents_43/report/index.htm">senate inquiries</a> into gene patenting. </p>
<p>Both reports claimed biotech patent holders were denying the Australian community ready access to diagnostic tools and therapeutic tests, such as tests for breast cancer. They also claimed that under Australian law, patenting of the genome cannot be valid because information about the genome is obvious and factual, rather than an invention. Nor should it be validated, giving investors a monopoly on isolated genes.</p>
<h2>Resistance to compulsory licensing</h2>
<p>Proponents of biotech patents have typically responded that protection results in social goods – patents foster the investment needed for the advancement of medicine. And if specific patents involve “overreaching”, that failure can be resolved using traditional litigation, with courts denying protection to patent claims that are overly broad or simply nonsensical.</p>
<p>Those proponents are likely to be wary about the Productivity Commission inquiry. The Commission - better funded than the ALRC, which has been recurrently cut - is a bastion of economic rationalism. It’s a foe of government intervention in the market and, more broadly, of regulation. Unlike bodies such as <a href="http://www.ipaustralia.gov.au">IP Australia</a> (the Patent Office) and the Advisory Council on Intellectual Property (<a href="http://www.acip.gov.au/library/Patentable%20subject%20matter%20-%20options%20paper.pdf">ACIP</a>) it has historically not been a fan of patents and other intellectual property.</p>
<h2>Scope of the inquiry</h2>
<p>The Commission’s <a href="http://ministers.treasury.gov.au/DisplayDocs.aspx?doc=pressreleases/2012/059.htm&pageID=003&min=djba&Year=&DocType=">terms of reference</a> are not restricted to biotech and, in principle, cover compulsory licensing of all inventions. But gene patenting is mentioned several times in the scoping document. </p>
<p>We can read the inquiry as an attempt to come up with recommendations that offer a middle ground between conflicting claims about the sacredness of private property and the necessity of commercial incentives in an era where governments are cutting support for research, a religious distaste for patenting God’s handiwork and arguments that the genome involves facts, not inventions, and therefore falls outside patent law. </p>
<p>That middle way may see the government reform the law and explicitly allow gene patents, thereby removing the uncertainty that’s vexed some investors (and many law students), but allow compulsory use for public health reasons. In an era where the patent-protected life sciences are increasingly important, that would be a positive outcome.</p><img src="https://counter.theconversation.com/content/8034/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>We’re in for another round of the biotech patent wars, with announcement the Productivity Commission will inquire into the compulsory licensing of patents. If adopted, compulsory licensing could increase…Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/52442012-02-27T04:06:43Z2012-02-27T04:06:43ZGenetic land-grab or reward for ingenuity? Australian court to rule on gene patents<figure><img src="https://images.theconversation.com/files/8096/original/qgkyy7vk-1330308782.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What the court decides in this case could potentially change the genetic research landscape for ever.</span> <span class="attribution"><span class="source">David/Flickr</span></span></figcaption></figure><p><strong>IDEAS AND OWNERSHIP: The concept of protecting ideas and innovation by legal means dates back to antiquity. But in the age of the internet and multinational business models, many of the existing laws are under strain, their suitability and ultimate purpose called into question.</strong></p>
<p><strong>Here, Dianne Nicol examines a court case that will decide whether human genes are patentable subject matter in Australia.</strong></p>
<p>The Federal Court of Australia will soon rule <a href="http://www.theaustralian.com.au/news/health-science/drug-company-defends-gene-mutation-patent/story-e6frg8y6-1226276389707">on a case</a> with significant implications for the multitude of gene patents granted in Australia. In a hearing that ended on February 24, the court was, for the first time, given the opportunity to decide whether genes are patentable subject matter in Australia.</p>
<p>Patient advocacy organisation <a href="http://www.cancervoicesaustralia.org.au/">Cancer Voices Australia</a> has challenged the validity of a patent owned by the US biotechnology company, <a href="http://www.myriad.com/">Myriad Genetics, Inc</a>. Myriad claims exclusive rights to exploit the so-called <a href="http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA">BRCA1 gene</a>, which is linked to increased susceptibility to breast and ovarian cancer. </p>
<p>Myriad Genetics has been exposed to negative publicity in many countries because of its patent claims to BRCA1 and <a href="http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA">BRCA2</a> (another gene linked with breast and ovarian cancer), and its method of detecting mutations in these genes associated with increased breast cancer risk. But there’s nothing out of the ordinary about Myriad making claims to both the sequences and their diagnostic tests. </p>
<p>The criticism is largely because of the way the company has chosen to use its patent rights. Myriad requires all BRCA testing to be done in its own laboratories. The biotech has been particularly vigilant in enforcing its patent rights in the United States (where it is facing the possibility of a Supreme Court challenge to the patents), but has been less successful in Europe and Canada.</p>
<p>In Australia, Myriad’s patents are exclusively licensed to Melbourne-based biotech company, <a href="http://www.gtglabs.com/">Genetic Technologies, Ltd (GTG)</a>. And there are concerns in some quarters that GTG could take the same approach as Myriad in enforcing the BRCA patents in Australia. </p>
<h2>Challenges elsewhere</h2>
<p>The validity of Myriad’s patents was <a href="http://www.lexology.com/library/detail.aspx?g=27cdfbc8-cf2b-43d9-8025-32f4785bf441">challenged in the United States in 2010</a> by the Association for Molecular Pathology and a number of other organisations and individuals. The patents were initially found to be invalid.</p>
<p>In a successful <a href="https://theconversation.com/patent-controversy-dont-let-breast-cancer-gene-genie-out-of-the-bottle-2616">appeal</a> by Myriad, a majority of judges decided the company’s claims to the BRCA gene sequences were valid, but claims relating to methods of detecting mutations (diagnostic tests that show if people have the gene mutation) were invalid. </p>
<p>The United States Supreme Court will soon decide if it will hear an appeal on the question of whether or not the gene sequence claims are valid. </p>
<h2>Here and there</h2>
<p>The US case and the Cancer Voices litigation in Australia are the first time in both countries that courts are being asked to decide on the fundamental question of whether isolated genes can be patented. </p>
<p>For many readers the answer may seem obvious, but in the eyes of the law, the judgement is far from clear.</p>
<p>The test for patentable subject matter in Australia is cast in curious legal language – proof of “manner of manufacture”. This phrase comes from the <a href="http://ipmall.info/hosted_resources/lipa/patents/English_Statute1623.pdf">English Statute of Monopolies of 1623</a>, and various law reform inquiries have considered whether the wording is appropriate in modern Australian patent law. </p>
<p>The most recent inquiry by the <a href="http://www.acip.gov.au/reviews_completed.html#psm">Advisory Council on Intellectual Property</a> has recommended the language be modernised but amendments have not yet been made. </p>
<p>The best explanation of the manner of manufacture requirement comes from a case in 1959, which says the condition is satisfied if the subject matter is:</p>
<ul>
<li><p>an artificially created state of affairs </p></li>
<li><p>in the useful rather than the fine arts </p></li>
<li><p>a material advantage</p></li>
<li><p>in a field of economic endeavour. </p></li>
</ul>
<p>It was easy for such requirements to be satisfied by inventions such as steam engines, electric cars, velcro, and the like. Everyone would probably agree that these are the very types of inventions that the patent system was designed to cover. </p>
<p>But things get more complicated for methods of medical treatment, computer software, business methods, living organisms and other material coming from the natural world, such as gene sequences. </p>
<p>In the Cancer Voices case, the court will doubtless seek assistance from decisions in other jurisdictions (such as the United States), but it must ultimately decide based on the peculiarities of the Australian “manner of manufacture” requirement. </p>
<p>While it’s difficult to predict the outcome, it’s worth noting that courts have tended to take an expansive view of what constitutes patentable subject matter, suggesting that the validity of this patent may be upheld. </p>
<p>Some will be disappointed by a decision not invalidating the Myriad patent; some will be concerned about the viability of the biotechnology industry if the decision goes the other way. But what’s more important is that we have a well-reasoned decision on this crucial aspect of patent law, based on sound legal authority. </p>
<p>It’ll be some months before we’ll have a decision on whether or not genes are patentable subject matter in Australia. And given the importance and impact of this issue, we can expect appeals. All we know with certainty is that what the court decides could potentially change the landscape for ever. </p>
<p><strong>This is part seven of Ideas and Ownership. To read the other instalments, click on the links below:</strong></p>
<ul>
<li><strong>Part One: <a href="https://theconversation.com/ip-patents-copyright-you-5421">IP, patents, copyright, you</a></strong></li>
<li><strong>Part Two: <a href="https://theconversation.com/do-patents-promote-innovation-5443">Do patents promote innovation?</a></strong></li>
<li><strong>Part Three: <a href="https://theconversation.com/the-art-of-war-know-your-enemys-patents-and-your-own-5489">The art of war: know your enemy’s patents, and your own</a></strong></li>
<li><strong>Part Four: <a href="https://theconversation.com/evergreening-patents-playing-monopoly-with-solar-fuels-and-medicine-innovations-5165">Evergreening patents: playing monopoly with solar fuels and medicine innovations</a></strong></li>
<li><strong>Part Five: <a href="https://theconversation.com/will-the-internet-kill-copyright-heres-hoping-5560">Will the internet kill copyright? Here’s hoping…</a></strong></li>
<li><strong>Part Six: <a href="https://theconversation.com/open-source-ditching-patents-and-copyright-for-the-greater-good-5302">Open source – ditching patents and copyright for the greater good</a></strong></li>
</ul><img src="https://counter.theconversation.com/content/5244/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dianne Nicol receives funding from the Australian Research Council.</span></em></p>IDEAS AND OWNERSHIP: The concept of protecting ideas and innovation by legal means dates back to antiquity. But in the age of the internet and multinational business models, many of the existing laws are…Dianne Nicol, Professor of Law, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/36142011-10-19T07:38:10Z2011-10-19T07:38:10ZEuropean court bans stem cell patents – what about Australia?<figure><img src="https://images.theconversation.com/files/4630/original/aapone-20040405000011304738-germany_greenpeace-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Part of a Greenpeace protest at the European Patents Office in Munich. Greenpeace brought the case that has resulted in the European ruling.</span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p>The European Court of Justice has <a href="http://bit.ly/r6Sjzg">today banned patenting</a> of stem cell inventions derived from human embryos which are capable of developing into a human being. </p>
<p>The court held that this exclusion from patentability is not limited to the use of human embryos for industrial or commercial purposes, but also includes the use of human embryos for the purposes of scientific research.</p>
<p>Although the ruling follows <a href="http://europa.eu/rapid/pressReleasesAction.do?reference=CJE/11/18&type=HTML">an earlier legal opinion</a>, it appears to have caused general dismay among scientists who now fear their research discoveries may not be commercialized into patentable inventions. </p>
<p>The test case was brought by Greenpeace against Oliver Brüstle, director of the Institute for Reconstructive Neurobiology at Bonn University, who holds patents on a technique involving stem cells. </p>
<p>The decision is sure to evoke passionate responses. But despite the criticism likely to follow, it’s useful to remember that the Court expressly left open the patentability of therapeutic or diagnostic uses for human embryos.</p>
<p>Here in Australia, the proposed ban on the <a href="http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22legislation%2Fbillhome%2Fs814%22">patenting of genes and biological materials</a> continues to be a live issue. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/4635/original/European_court_of_justice_in_luxembourg.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">The European Court of Justice in Luxembourg.</span>
<span class="attribution"><span class="source">Anders Gardebring via Wikimedia Commons</span></span>
</figcaption>
</figure>
<h2>Senate Inquiry into Patent Amendment</h2>
<p>The recent Australian Senate inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth), and its subsequent amendments, handed down its <a href="http://www.aph.gov.au/Senate/committee/legcon_ctte/patent_amendment/report/index.htm">final report</a> in late September, after <a href="http://www.aph.gov.au/hansard/">two days of public hearings</a> and sifting through an <a href="http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/submissions.htm">overwhelming number of submissions</a>. </p>
<p>Those who had hoped for the Senate Legal and Constitutional Affairs Committee to take an emphatic stance on this very important issue were left bitterly disappointed.</p>
<p>Unable to reach a consensus in its report, the members of the Committee managed to issue two diametrically opposed recommendations in its report – a majority and a dissenting view. </p>
<p>While the majority recommended the Bill not be passed, the dissenting section, sponsored by Senators Heffernan, Siewert, Xenophon and former Senator Coonan, took the opposite view. </p>
<p>Clearly, Senator Heffernan’s private bill hit some raw nerves. </p>
<h2>The Patent Amendment Bill</h2>
<p>The Bill seeks to <a href="http://theconversation.com/who-owns-the-rights-to-the-human-body-its-patently-obvious-835">amend</a> the <a href="http://www.comlaw.gov.au/Details/C2011C00263">Patents Act 1990 (Cth) </a>to prevent the patenting of human genes and biological materials existing in nature.</p>
<p>It was met with formidable <a href="http://theconversation.com/patent-amendment-bill-could-kill-access-to-new-medicines-637">opposition</a>, mainly from biotechnology and pharmaceutical companies, research institutions and universities, as well as by intellectual property and patent attorneys. </p>
<p>Given these competing interests and the strong views of the senators who supported the Bill, it’s unsurprising to find the divisions entrenched in the final report. </p>
<p>What <em>is</em> surprising are the markedly differing approaches adopted by the majority and dissenting groups.</p>
<h2>The report </h2>
<p>The dissenting report takes a staunchly partisan approach, focusing on submissions supporting the Bill as well as responding to some of the major criticisms.</p>
<p>Little attention is paid to the vast number of critical submissions received by the Committee. </p>
<p>This dismissive approach is ostensibly justified on the basis that these critical submissions are mainly from “sectorial interests associated with the biotechnology, pharmaceutical and agri-biotech industry”, who “are either holders of patents which contain claims to biological materials that are identical or substantially identical to those that exist in nature” or otherwise have a financial, or other interest in securing the procurement of such patents. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=907&fit=crop&dpr=1 600w, https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=907&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=907&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1140&fit=crop&dpr=1 754w, https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1140&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/4634/original/aapone-20090317000164301726-bill_heffernan_file-original.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1140&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Senator Bill Heffernan</span>
<span class="attribution"><span class="source">AAP</span></span>
</figcaption>
</figure>
<p>By contrast, the majority part of the report takes a far more evaluative approach. Indeed, the majority of the Committee dedicated the bulk of its report to a detailed review of the submissions. </p>
<p>In particular, it focused on 13 key issues raised in evidence. Chief among these were concerns about the need for the Bill as well as its drafting and efficacy.</p>
<p>The majority seemed most concerned by submissions that characterised the Bill as containing “unclear or ambiguous provisions” that “would result in uncertainty for patent applicants and investors in research, and could result in unnecessary and costly litigation”.</p>
<p>Obviously perturbed by these possible “unintended consequences”, the majority then went on to narrow their concerns to nine “key issues” arising out of the patenting of human genes and biological matter.</p>
<p>Although the ethical, economic and health issues identified are of great importance, it is only the first issue — the distinction between discoveries and inventions — which calls for further attention.</p>
<h2>Patent law</h2>
<p>A bedrock principle of patent law is that inventions may be patentable, whereas mere discoveries are not. </p>
<p>Colin Bodkin, a leading commentator on Australian patent law, <a href="http://www.thomsonreuters.com.au/catalogue/productdetails.asp?id=8158">explains that while there are no clear lines in making this distinction</a>, the difference is said to lie in between:</p>
<ul>
<li><p>“observing a scientific fact for the first time” (not patentable) and, </p></li>
<li><p>“devising a new and useful result by the application of that fact”(may be patentable). </p></li>
</ul>
<p>In truth, the elephant in the room is really what “discovery” and “invention” mean in the context of biological materials. </p>
<p>As complex and as vexed as this is, we must ask whether it’s simply beyond us to define what these terms means in this context. </p>
<p>And – if it isn’t beyond us – are we content to reward people with a “eureka patent” for their efforts? In other words, are we content to reward someone for discoveries, such as identifying and isolating genetic mutations (such as <a href="http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA">BRCA1 and BRCA2</a>) that exist in nature? </p>
<p>The implied basis for granting a patent for this seems to be the recognition that the process leading to such a discovery is incredibly laborious and cost prohibitive, thus deserving of protection. </p>
<p>That seems to be the current practices of patent offices worldwide, but is it appropriate?</p>
<h2>Whose authority? </h2>
<p>Again, the differing approaches in the dissenting and majority reports are telling. </p>
<p>The dissenting report focused heavily on the discovery/invention distinction in making the case that identifying biological materials, whether new or unknown, is simply an “act of discovery, not an act of invention”. </p>
<p>It turned to the guidance proffered on this point by the 2000 <a href="http://www.ag.gov.au/www/agd/agd.nsf/Page/Publications_ErgasCommitteereport-September2000">Intellectual Property and Competition Review Committee report (Ergas Committee Report)</a>. </p>
<p>That report warns of the dangers of defining the scope of patent rights beyond “reasonable limits”. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=1227&fit=crop&dpr=1 600w, https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=1227&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=1227&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1541&fit=crop&dpr=1 754w, https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1541&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/4633/original/aapone-20040624000012116468-australia-biotech-cells-original.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1541&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A five-day old human embryo (top) and stem cells derived from it (below).</span>
<span class="attribution"><span class="source">AAP</span></span>
</figcaption>
</figure>
<p>It insists that “mere discoveries – that is, the identification and specification of the nature, structure, and properties of existing matter and its interaction – should continue to be excluded from the class of patentable subject matter”. </p>
<p>It suggests this principle “should exclude from the scope of patent protection the mere identification of a gene sequence”.</p>
<p>In stark contrast, the majority report seems to ignore the comprehensive <a href="http://bit.ly/oBSDuY">Ergas Committee Report</a>, preferring instead the recommendation by the <a href="http://www.acip.gov.au/">Advisory Council on Intellectual Property (ACIP)</a>.</p>
<p>ACIP would like to maintain the status quo in relation to the test for patentable subject matter as stated in its <a href="http://www.acip.gov.au/library/ACIP%20PSM%20final%20report%204%20Feb%202011.pdf">recent report</a>. </p>
<p>Although one may accept the majority’s view that the proposed amendments “will at best, not assist to clarify the distinction between discovery and invention in the patent system and, at worst, make the distinction more obscure”, it’s difficult to accept the report’s lack of engagement with the implications of the Ergas Committee Report.</p>
<p>To put it another way, in preferring a “technology neutral approach” to the fixing of the line between discovery and invention, the majority report simply doesn’t answer the fundamental question raised by this inquiry – whether, as a matter of principle, human genes and biological materials ought to be patentable subject matter.</p>
<p>Or, to borrow the <a href="http://www.billheffernan.com.au/news/default.asp?action=article&ID=259&Archived=true&Archived=true&Archived=true&Archived=true">words of Senator Heffernan</a>, whether “the materials that make us who we are and what we are can be monopolised and commoditised”.</p>
<h2>Wide world</h2>
<p>Perhaps the recognition of the Bill as “well-intentioned” by the majority of the Committee provides us with valuable insights into their views on this issue. </p>
<p>If we accept this, then surely we must accept that it’s not beyond the competencies of a skilled parliamentary draftsperson to translate these good intentions into legislation.</p>
<p>Meanwhile, even though s 18(2) of the Patents Act provides that “human beings, and the biological processes for their generation, are not patentable inventions”, the full implications of this prohibition in Australia are yet to be realised. </p>
<p>This latest move by the European Court of Justice may prove important in what is sure be an ongoing tussle over the patentability of human embryos, and, more generally, the patenting of genes and other biological materials.</p>
<p>With all this uncertainty abounding, decisive legislative action is required. Time will tell whether this will happen.</p><img src="https://counter.theconversation.com/content/3614/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Fady Aoun is a member of the NSW Law Society and a practising solicitor.</span></em></p>The European Court of Justice has today banned patenting of stem cell inventions derived from human embryos which are capable of developing into a human being. The court held that this exclusion from patentability…Fady Aoun, Law lecturer & doctoral student, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/36162011-09-29T02:58:09Z2011-09-29T02:58:09ZIs patenting crops really about feeding the hungry? A response<figure><img src="https://images.theconversation.com/files/3949/original/3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Feeding the world's poor may not really be the main concern of companies that take out gene patents on crops.</span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p><a href="http://theconversation.com/will-patenting-crops-help-feed-the-hungry-3405">Michael Gilbert’s article</a> starts with a title that poses a question - <a href="http://theconversation.com/will-patenting-crops-help-feed-the-hungry-3405">Will patenting crops help feed the hungry?</a> Fair enough, except he then proceeds to provide an answer, which as the posted comments below the article suggest, is incomprehensible.</p>
<p>Gilbert begins with an account of a variety of white rice developed by an organisation he runs. This rice, he says, contains much more iron and zinc than “conventional rice”, whatever that means. </p>
<p>Putting this qualitative issue to one side, what has patenting genes got to do with anything he says about this “new” rice? </p>
<p>First, Gilbert says this rice is “patented technology”, which begs a question about what the patentable part of it is since rice as such exists in nature. </p>
<p>Second, he refers to “very clever science” which his company used to “trick it into thinking” that it needs to absorb “a lot more iron from the soil than normal” (again, what is normal?). </p>
<p>The main problem with Gilbert’s answer to the question about feeding the hungry is that it digresses onto the subject of gene patents in the context of agriculture without any introduction. </p>
<p>Is the reader to assume that this “new” rice is the product of genetic manipulation? Is the genome of this rice patented? Is this rice really the answer to feeding the world’s poor and hungry? </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=333&fit=crop&dpr=1 600w, https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=333&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=333&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=418&fit=crop&dpr=1 754w, https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=418&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/3947/original/2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=418&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Eating a variety of grains could also solve the problem of nutrient deficiencies.</span>
<span class="attribution"><span class="source">AAP</span></span>
</figcaption>
</figure>
<p>You can be forgiven, if by the time you finish reading his article, you are unable to answer any of these questions.</p>
<p>Yes, patented crops will feed the hungry and if companies, such as Monsanto, had their way more and more patented crops would feed the world. But that’s only because, as is pointed out in the article: “gene patents are commonplace in agriculture”. </p>
<p>It’s not because there’s no other alternative. You see, feeding the world is one issue. How you feed the world is another. Unfortunately, Mr Gilbert confuses the two.</p>
<h2>Patents are not the answer</h2>
<p>For thousands of years humans have been able to feed themselves albeit not always successfully. Drought, war, civil unrest and, now, drastic and rapid climate change, are closely, or are being closely, associated with famine, population displacement and death. </p>
<p>History is littered with examples of humanity’s failure to provide adequate sustenance for all people at all times in all places. </p>
<p>But are gene patents the answer to this age old problem? Mr Gilbert would like us to believe that they are. I don’t agree.</p>
<p>Not to make too fine a point but since when is cutting and pasting genetic materials from one organism to another an inventive step when the materials themselves exist in nature in the first place?</p>
<p>What Mr Gilbert fails to explain is that gene patents are a legal aberration. The patent system is there to reward the act of invention and the dissemination of that act to the world through the publication of the patent. </p>
<p>The problem is that the rice Mr Gilbert refers to is just rice. Sure, it contains iron and zinc but then, what’s new about that? </p>
<p>And if people aren’t getting enough iron and zinc in their diets there are other grains such as amaranth, which contains 14 times the amount of iron, and wheat which contains 12 times the amount of zinc, than white rice. </p>
<p>So if people need more iron and zinc the solution isn’t just to eat Mr Gilbert’s rice but to eat a variety of grains. </p>
<p>Besides, the ability to provide essential minerals to humans through a variety of foods is important and, more to the point, it’s tasty. </p>
<p>Since when do we want to eat only one type of grain and expect it to provide all our daily vitamins and minerals? And since when is the development of such genetically modified foods able to solve the problem of world hunger anyway?</p>
<h2>Loss of biodiversity</h2>
<p>We already know through history that when a population relies on monoculture the risks of famine, population displacement and death are far greater. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=837&fit=crop&dpr=1 600w, https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=837&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=837&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1052&fit=crop&dpr=1 754w, https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1052&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/3948/original/1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1052&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Gene patents could see the rise of monoculture and the loss of biodiversity.</span>
<span class="attribution"><span class="source">AAP</span></span>
</figcaption>
</figure>
<p>Between 1845 and 1852 about one million people died from hunger in Ireland when a potato disease called potato blight affected a quarter of the potato harvest. </p>
<p>The implications of that tragedy on the entire world are well known. Yet, in forgetting the lessons from history agricultural research organisations are now working hand-in-glove with agri-biotech companies, like Monsanto, to ensure that patented plants and their products become the only source of the world’s food in the near future.</p>
<p>Mr Gilbert is right about one thing. Literally thousands of gene patents have been granted and are being applied for in regard to all forms of agriculture, not just plants. </p>
<p>What this means for the world has yet to be fully comprehended and I for one have grave doubts that those in the business of promoting gene patents really care if they feed the hungry.</p>
<p><br></p>
<p><strong><em>You can read Michael Gilbert’s article – <a href="http://theconversation.com/will-patenting-crops-help-feed-the-hungry-3405">Will patenting crops help feed the hungry? here.</a></em></strong></p><img src="https://counter.theconversation.com/content/3616/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Luigi Palombi 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>Michael Gilbert’s article starts with a title that poses a question - Will patenting crops help feed the hungry? Fair enough, except he then proceeds to provide an answer, which as the posted comments…Luigi Palombi, Director, Genetic Sequence Right Project, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.