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Gene patents in Australia: where do we stand? David P Simmons & Mark E Wickham The provision of a patent system that protects innovators and researchers while ensuring reasonable access to emerging technologies and medical treatments are the key objectives of the Australian government’s response to three important reports concerning Australia’s patent system and gene patents.
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n recent years, the protection of biological materials through the patent system has been the subject of considerable debate, both in the community and at various levels of government in Australia. The question essentially boils down to, “Should genes be patentable?” The position in Australia regarding the patentability of genes is based largely on the 1995 decision by the Australian Patent Office (IP Australia) in Kirin-Amgen Inc v Board of Regents of University of Washington1. In this it was held that a claimed isolated gene can essentially constitute an “artificially created state of affairs” that is not “a mere chemical curiosity or a mere discovery” and is therefore capable of satisfying the requisite considerations of being in itself a “manner of manufacture” under patent law to ensure it is worthy of patent protection. At appeal2, the Federal Court of Australia further held the view that the isolation of a gene is fundamentally akin to the discovery of a class of chemical compounds, and by analogy, entitles the patentee to broad protection for genes and the products related to those specifically isolated genes. Accordingly, provided that the applicant can point to some difficulty in reaching a particular result, isolated genes and any biological or genetic material derived therefrom were considered subject matter worthy of patent protection. One of the issues that arose subsequent to the formation of this position related to the question of patent scope and whether the isolation of a gene satisfying a particular purpose was sufficient to warrant patent protection of the gene for whomever isolated it. In Australia, David P. Simmons and Mark E. Wickham are at Phillips Ormonde Fitzpatrick, Melbourne, Victoria, Australia. e-mail:
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this provided considerable debate and discussion among interested parties, for example, those who provided submissions to the Senate Committees inquiry on the Patent Amendment (Human Genes and Biological Materials) Bill 2010. Australia is, of course, not the first country to consider the question of whether genes (and their biological products) should be allowable subject matter worthy of patent protection. This issue has been addressed in both the United States and Europe. The concerns of the Australian community toward the patenting of biological materials did not arise in isolation and were indeed fueled by the international debate concerning these same issues. It was considered by many that any decision outlawing the patenting of genes (or biological materials) would be likely to have a detrimental impact on innovation and investment in medical research in Australia. This would have a fundamental follow-on effect across a broad range of industries, including the biotech, healthcare, agriculture and food technology sectors. In response to the groundswell of concern on both sides of the debate, the Australian government authorized several inquiries4–6 to review the current position on intellectual property rights over biological materials (including human and microbial genes and noncoding sequences, proteins and their derivatives, and those materials in isolated forms) and whether the Australian patent system should remain as it stands (and allow for the protection of biological materials), or whether such patent protection should be prevented by amending legislation in an attempt to curtail patent claims directed to such materials. Because those involved in industries strongly connected to the patenting of biological materials, such as the biotech research community, needed certainty on this issue, a decision on
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where the government and Australia at large stood was desperately needed. The government’s response On November 23, 2011, the Australian government issued its combined response to the inquiries, vehemently rejecting an absolute ban on the patenting of genes and other biological materials7. In taking its position, the government promulgated its view that the patent system is central in promoting innovation and investment in medical research or any other research involving biological materials. In forming this position, the Australian government has taken steps to aid in restoring certainty and confidence in the biotech sector in Australia. To its credit, the Australian government has also attempted to include future ethical considerations by recommending that legislative reflections on contentious matters be provided through the introduction of potential ethical exclusions to the patenting of technologies where the effect of providing patent protection is not in accordance with community values. For the moment, these have not been enacted in the current legislation. Where do we stand? Due largely to the concerted response of the Australian government, the Australian research environment and the rewards offered to those who invest in it by the patentable protection of the biological materials that may subsequently be generated remain unfettered. It was difficult to believe that the Australian government would seek to move significantly away from the positions adopted by many of its major trading partners, in particular the United States and Europe. As a signatory of TRIPS (the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights), Australia also has an obligation to 323
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Future developments Although the Australian government has made clear its stance in the protection of inventions relating to biological materials, the outcome of a case recently heard in the Federal Court of Australia may have something different to say. In a landmark Australian case8, the validity of patent claims directed to the gene BRCA1 (which has been found to exhibit particular mutations in women with an enhanced risk of developing breast and ovarian cancer) is being closely scrutinized. This Australian patent9 additionally includes claims directed to a method for diagnosing a predisposition to these cancers based upon testing BRCA1 for any of the identified mutations. Of note is that this patent is the Australian equivalent of the US patent held by Myriad
Genetics that concerned BRCA1 and BRCA2. In July 2011, the US Court of Appeals for the Federal Circuit (CAFC)10 ruled that patent claims directed to DNA molecules that are ‘isolated’ cover subject matter capable of patent-eligible protection under 35 USC §101 (which is the US equivalent to the “manner of manufacture” requirements under Australian law). In essence, the CAFC viewed that the claimed molecules in question “do not exist in nature.” Regardless of the present US position, the outcome of this Australian case has the potential to again cause further uncertainty in the Australian biotech community. The hearing of this case before the Federal Court of Australia finished on February 24, 2012, with judgment currently reserved but anticipated to be handed down shortly. The decision by the Court will hopefully provide significant judicial insight into whether Australian patent law, as it currently stands, is appropriately equipped to weather any challenges faced in the patent-eligible protection of genes and their related biological materials. COMPETING FINANCIAL INTERESTS The authors declare no competing financial interests.
1. Kirin-Amgen Inc v Board of Regents of University of Washington (1995) 33 IPR 557. 2. Genetics Institute Inc v Kirin-Amgen Inc (1996) 34 IPR 513. 3. Senate Committees inquiry on the Patent Amendment (Human Genes and Biological Materials) Bill 2010. Submissions received by the Committee. 4. Australian Law Reform Commission. ALRC Submission to Senate Standing Committee on Community Affairs Inquiry into Gene Patents (ALRC, 18 March 2009). 5. Australian Law Reform Commission. Advisory Council on Intellectual Property Review of Patentable Subject Matter (ALRC, December 2010). 6. Australian Law Reform Commission. Genes and Ingenuity: Gene Patenting and Human Health (ALRC, 30 August 2004). 7. Anonymous. Australian Government Response to Senate Community Affairs References Committee Gene Patents Report (23 November 2011) 8. Cancer Voices Australia & Anor v Myriad Genetics Inc & Ors, Federal Court of Australia, NSD643 (2010). 9. Myriad Genetics, Inc. In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene. Australian patent no. 686004 (1995). 10.
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provide patent protection in all technology areas. The outlawing of patentable protection of biological materials would be largely viewed as a contravention of this international obligation. By responding in support of gene patenting, the Australian government has taken a committed position to protecting medical innovation and research to ensure consistency with global opinions.
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