The first half of 2010 saw three events shake the landscape of gene patenting as we know it. As a medical student with research experience, my interest rests in the clinical impact of these developments and its long-term potential benefits to patients. So far, the aftermath continues to have far-reaching consequences for the fields of personalized medicine, biotechnology and intellectual property – which will no doubt carry into 2011.

Myriad and Monsanto

In March, a U.S. district court invalidated (http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf) several of Myriad Genetic’s patent claims, notably those on isolated BRCA1-2 DNA sequences. Judge R. Sweet ruled that the BRCA gene mutations linked to breast and ovarian cancers do not differ from genes found in nature, and thus were not innovations. Since ‘products of nature’ cannot be patented, this verdict undermines the fundamental basis on which companies file patents: that the act of isolating and purifying the genes makes them different from what is found in nature. This runs contrary to the previously held standpoint of the U.S. Patent and Trademark Office; that individual unmodified genes can be patented. As expected, the biotech industry lobbied against this verdict. They argued that if upheld, the resulting shockwaves would nullify all naturally-occurring gene patents and be detrimental to corporations that have invested heavily in the development of tests for hundreds of diseases. Unsurprisingly, in June, Myriad filed an appeal (http://www.genomicslawreport.com/wp-content/uploads/2010/11/Myriad-Appellant-Brief.pdf) to challenge Judge Sweet’s ruling in a case headed for the U.S. Supreme Court.

Following this, in another suit over a gene patent, the Court of Justice of the European Union ruled against Monsanto Technology LLC, stating reasons similar to those presented by Judge Sweet (http://www.genomicslawreport.com/index.php/2010/07/28/european-court-issues-gene-patent-ruling-against-monsanto-a-myriad-connection/#more-4036). In September, the U.S. Department of Justice also published an amicus brief (http://www.genomicslawreport.com/wp-content/uploads/2010/11/Myriad-Amicus-Brief-US-DOJ.pdf) that threw their weight behind Judge Sweet’s verdict, except for patents which clearly require human ingenuity (such as those used for complementary DNA in therapeutic molecules or DNA-based vectors for therapy). These, they argue, should be retained.

Key Developments in Australia

Myriad’s story is different in Australia. In September, the Cancer Voices Australia v Myriad Genetics litigation took an unexpected turn when (faced with a case that had no upside and significant downside for them) (http://www.genomicslawreport.com/index.php/2010/06/21/myriad-litigation-goes-down-under/) Myriad offered to surrender its BRCA2 patent. Presumably, they sought to preclude a ruling that would prohibit gene patenting altogether. Their stratagem was unsuccessful, and the case is on its way to the Australian Federal Court (although it is now focused specifically on the BRCA1 gene patent). In addition, a private member’s bill (http://www.theaustralian.com.au/news/health-science/unlikely-challenge-to-human-gene-patents/story-e6frg8y6-1225952333147) was introduced last month with the aim of making genes unpatentable. Shortly after, the Australian Senate finally published their long-awaited report on gene patenting (http://www.aph.gov.au/senate/committee/clac_ctte/gene_patents_43/report/index.htm). Containing sixteen recommendations, the report drew on reasoning similar to that of Judge Sweet’s and suggested amendments not dissimilar to those we advocated in our last update. Like us, they proposed that:

·         Patents be restricted to DNA sequences which are in a form that 1) did not previously exist and 2) are an inventive solution to a real world, practical matter.

·         The use of naturally occurring genetic sequences for medical research be exempted from infringement liability.

This ensures that IP Australia are “patenting cures, not DNA” and protects patient interests. The Senate also recommended the formation of an independent patent audit committee and a “transparency register” to outline who owns what biological material. The report will hopefully prevent years of litigation over where the line lies between what is and what is not eligible for patents. A separate inquiry into the private member’s bill is scheduled in mid-2011.

Concerns over Patentable Materials and Synthetic Life

In June, a second significant international development took place – the much-anticipated conclusion to the Bilski v. Kappos case. In an anticlimactic Court ruling (http://www.supremecourt.gov/opinions/09pdf/08-964.pdf), the Supremes supported the Federal Circuit’s judgment that Bilski’s business method was not patent-eligible, but stated that the Federal Circuit’s “machine-or-transformation” test was not the sole test of patentable subject matter. In short, the ruling helped disperse fears that overzealous patent enforcement inhibits innovation, given that the Court has “substantial discretion … to interpret and implement the patent eligibility doctrine in a manner that fosters innovation”. On the other hand, it did little to clear up the confusion over how to evaluate patent eligibility.

The third major development in the first half of this year, touted as more significant than the cloning of Dolly the sheep, was the world-first creation of a synthetic life form. In May, the J. Craig Venter Institute (http://www.guardian.co.uk/science/video/2010/may/20/craig-venter-new-life-form) produced the first living cell to be controlled entirely by a synthetic genome. These custom-designed life forms can be instructed to produce plastics, medicines, fuels or even absorb greenhouse gas emissions and could be the key to combating climate change. They are exactly the types of innovation that fit the criteria for a patent grant. Certainly, the Institute’s US patent (http://portal.uspto.gov/external/portal/pair) reflects the innovative applications of the new technology, specifically for a set of essential genes that produce a synthetic “free-living organism that can grow and replicate” and make either hydrogen or ethanol for industrial fuels. Naturally, this development has reignited the debate over the ethics of gene patenting. The Canadian ETC Group (http://www.telegraph.co.uk/news/uknews/1553919/Man-made-microbe-to-create-endless-biofuel.html), which tracks developments in biotechnology, raised familiar concerns about companies receiving exclusive intellectual rights to the building blocks of life.

Commentary by Rachel Goh:

In my view, business and biotechnology fuel each other. We’ve never questioned whether this is different for gene patenting. Some would have us believe that complete proprietary protection is critical in encouraging biotech companies to invest in genetic innovation. They argue that should limits be placed on gene patenting, the advancement of research and the future of personalised medicine would be stilted. However, it is unclear how much evidence actually supports this concern. The competition among researchers to find diagnostic mutations for cystic fibrosis and other common diseases flourishes, even though no company has exclusivity. Furthermore, few companies actually go to court when claims to gene sequences are violated. It is controversial that firms are claim rights over genetic data that were obtained partly due to open access to the scientific research accomplished by others and often funded by taxpayers.

Thorough assessments are still needed to examine how important gene patents really are for incentivising the development of diagnostic tests. The role of gene patents is also changing within the biotech industry. Diagnostic laboratories are moving away from a dependence on individual gene patenting and towards multiple-genome analyses, with prominent articles (published as early as March, 2010) reporting that: “when hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur” (http://www.nytimes.com/2010/03/31/business/31gene.html?_r=1&hp). As we begin to move closer towards developing gene therapy and personalized medicine, a multi-genomic approach will become increasingly important and we will face greater concerns about whether the patenting of individual genetic sequences will inhibit follow-on and systemic innovations.

Related Sites

CBS’ 60 Minutes ran a program on gene patents in April 4th 2010 covering the BRCA breast cancer gene test. You can view it here: http://www.cbsnews.com/video/watch/?id=6362525n

In the six months since June, a cornucopia of events urging both for and against gene patents have unfolded. Issues highlighted by IPRIA+CITE’s public forum in April continue to feature in government and media debate. Just last month, the Federal Circuit decided that the Supreme Court’s 2006 decision in eBay v. MercExchange eliminated the presumption of irreparable harm associated with the ongoing infringement of a patent. In the case of Prometheus v. Mayo, the Appeals Court ruled to restore diagnostic patent rights. This favors Myriad and the University of Utah; as of now, no party has prevailed in the BRCA1-2 gene patent lawsuit filed against the University of Utah and Myriad Genetics in May, and the District Court rejected a motion to dismiss the lawsuit. Bilski v. Kappos is still pending, expected to be decided by the Supreme Court in mid 2010. Until the crunch comes, we expect uncertainty to remain over the U.S. practice of granting patents on human genes.

Amidst fears that a rising number of human gene patents may be impeding medical advance as well as rights to their results, the Australian Parliament launched a Senate Inquiry. Up for examination in early August was the way companies have been filing “umbrella” patents and – allegedly – abusing the patent system in a bid to control the “blueprints of life”. While the Committee digests the Senate inquiry’s 75 submissions, the Biotechnology Industry Organization (BIO) took issue with the Secretary’s Advisory Committee’s (SACGHS) draft report examining how patenting and licensing affect access to clinical genetic testing in the US. The SACGHS reported that patents neither greatly hinder nor facilitate patient access to genetic testing, but added that problems do occur when patents are exclusively licensed to a single provider and no alternative is available. However, courts have been changing the thresholds for what can be patented, and how strongly patents can be enforced. Ultimately, the report may signal that the US government is taking action to foster beneficial uses of genetic testing while preserving intellectual property incentives. In claims contrary to this, BIO derided the report’s recommendations as over-reaching and restrictive, disregardful of research which shows that without patent protection, commercial investment in biotechnology research would falter and medical advances would be impeded. November came and went, along with the due date for the Senate report. The Committee has extended its reporting deadline to March 18, 2010.

Interviews with twenty researchers early last year showed divided opinions about the impact patents have on the research environment. In the last decade, studies have been similarly inconsistent about whether gene patents impede the development and availability of diagnostic testing. A recently published study by Murray and Huang provides the first large-scale systematic evidence for the negative impact of patent grant on downstream public knowledge; the negative impact is especially severe for disease-linked genes as they have greater commercial potential, stronger patent enforcement and exhibit ownership fragmentation. Since then, an empirical study by van Overwalle et al. on the granting for litigation of gene patents has reported that, though this is true, not many blocking gene patents exist and thus, a blanket ban on human genes is not a plausible solution. This view was supported by Holman in Science. These two studies, among others, suggest that reforming patent laws may be a better alternative. The most important change proposed is to ensure each patent is of appropriate scope and strength, rather than absolute patent protection, such as “patenting cures and not DNA” and exempting the use of naturally occurring genetic sequences for medical research from infringement liability. Thus far, research indicates that this may preserve commercial interests in biomedical research as well as availability of genomic diagnostics for public health.

Stay tuned for future updates.

]]> http://genepatents.info/2010/02/02/update-on-gene-patents-june-dec-2009/feed/ 2 kwanghui http://genepatents.info/2009/04/26/ipriacite-public-forum-on-gene-patents/ http://genepatents.info/2009/04/26/ipriacite-public-forum-on-gene-patents/#comments Sun, 26 Apr 2009 13:48:31 +0000 kwanghui http://genepatents.info/2009/04/26/ipriacite-public-forum-on-gene-patents/ ]]> In April, 2009, IPRIA and CITE organized a panel debate and public discussion on “should genes be patented?”. Here is a summary of the event, including video podcasts. More details about the event are on the ipria website. If you have comments or thoughts to share about the discussion, please add them to the “comments” section at the end of the page.

NEW: Transcribed text for the event is now available: IPRIA+CITE Public Forum on Gene Patents-final.

The event began with a welcome address by Beth Webster, director of IPRIA.

Dr. Kwanghui Lim then presented an introduction (created with Dr. Chris Dent) on the current situation with regards to gene patenting and its pros and cons.

Then, each of the panelists made a brief presentation. First up was Dr. Gillian Mitchell, a leading oncologist in Australia and Head of Familial Cancer Centre, Peter MacCallum Cancer Centre, Melbourne.

Next was Professor Gregory Mandel from Temple University, USA:

He was followed by Professor Dan Peled, an Economist from Haifa University, Israel.

Professor Dianne Nicol from the University of Tasmania provided a legal perspective:

An open discussion involving both the panel and members of the audience. The discussion was moderated Professor Joshua Gans, Professor of Information Economics at Melbourne Business School and Director of CITE. The first topic discussed was the effect of gene patenting on scientific research.

This was followed by a discussion on the tradeoffs and legality of gene patents, spearheaded by Luigi Palombi and Hazel Moir from the Australian National University who were in the audience:

The discussion then moved to possible solutions, triggered by another audience member, David Thorburn from the Murdoch Childrens Research Institute and President of the Human Genetics Society of Australasia.

Finally, Joshua Gans wrapped up the event with a funny and insighful presentation.

We thank the panel speakers and several audience members for allowing us to include them in this video podcast, as well as for their contributions to the debate.

If you have thoughts or comments about the issue, feel free to post them in the “comments” section below. We do not moderate or censor any submissions, except for spam and those containing obscenities.

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