Editor's note: since the publication of Tarishi's blog, the Full Federal Court and the High Court of Australia have ruled on the appeal from this case. The Full Federal Court upheld the first instance ruling. On appeal from the Full Federal Court, the High Court overturned the ruling and revoked Myriad's patent on the BRCA1 gene. The High Court ruling can be found here.
Should human cancer disposing genes be considered patentable inventions? What exactly is an ‘invention'? What impact would this have on patient healthcare and cancer research? How does Australia's patent law system operate? These were some of the questions I had to consider when analysing the Federal Court of Australia's historic ruling on the practice of ‘gene patenting' in Cancer Voices Australia v Myriad Genetics Inc during my internship with the McCabe Centre for Law and Cancer, undertaken earlier this year in partnership with the Melbourne Law School.
The case centred on the breast and ovarian cancer susceptibility gene, BRCA1 which had been extracted from the human body and was therefore considered an ‘isolated' gene. Myriad Genetics Inc., a US biotechnology company, had been granted a patent - an intellectual property right conferring exclusive rights for a specific time to exploit new inventions - over the ‘isolated' BRCA1 gene.
Although Australian patent law prohibits patents over products of nature, including naturally occurring genetic sequences existing inside the human body, the issue before Justice Nicholas was whether the ‘isolated' gene outside of the body was an ‘invention' according to the Patents Act 1990. The plaintiffs, support group Cancer Voices Australia and Yvonne D'Arcy, a breast cancer survivor, challenged the validity of Myriad's patent on the basis that the isolated gene was a product of nature and therefore not a patentable invention because there was no material difference between the isolated and naturally occurring gene.
Myriad Genetics argued that by virtue of the process of extracting the gene from the body, it had satisfied the requirements of an ‘invention' according to section 18(1)(a) of the Patents Act which states that an invention must be a ‘manner of manufacture'. Based on previous case law, the Court held that a ‘manner of manufacture' requires an ‘artificial state of affairs' of some discernable effect that is of economic significance. Justice Nicholas rejected the plaintiffs' arguments and upheld Myriad's patent concluding that the necessary ‘artificial state of affairs' existed for the following reasons:
- Previous case law binding on the court emphasised that the ‘manner of manufacture' requirement was to have a ‘broad sweep';
- Isolated genetic material cannot exist without human intervention. This intervention created an ‘artificial state of affairs' rendering the isolated genetic material a ‘manner of manufacture' despite the fact that there was held to be no significant difference chemically between the isolated and naturally occurring DNA; and
- The isolation of genetic material requires significant research and intellectual effort which should be rewarded by patent protection.
Although the ruling was consistent with the limited relevant case law, it was a broad reading of the ‘artificial state of affairs' test and the ‘manner of manufacture' concept. Consequently the ruling reignited long-standing concerns about the practice of gene patenting and the exclusive rights it provides patent holders, including potentially restrictive effects on access to genetic testing and genetic research, not to mention ethical concerns that the practice commodifies human beings. Indeed, the case was brought following attempts made by Genetic Technologies Ltd, the exclusive licence holder of Myriad's Australian patent, to restrict access to genetic testing of BRCA1. Genetic Technologies Ltd ultimately withdrew its attempts due to community backlash, however Myriad has enforced its monopoly rights elsewhere, most notably in the USA. Curiously, this fact and discussion of these important public policy concerns was largely absent in the judgment. It is perhaps unsurprising then, that an appeal against the decision was lodged and recently heard before the Full Federal Court, making the impact of the trial decision uncertain at this stage.
It is also unclear what influence the recent unanimous US Supreme Court ruling that invalidated Myriad's US BRCA1 patent will have in Australia. There are differences between the tests for patentability - the US Supreme Court's threshold for whether a matter is a product of nature rests on whether it is markedly different from that which exists in nature, whereas Australian patent law turns on whether an ‘artificial state of affairs' exists. Still, the Supreme Court ruling, while not binding on Australian Courts, may be persuasive. Regardless, the judgment of the Full Federal Court will be eagerly anticipated in the hope that it clarifies the boundaries of a patentable invention and therefore the practice of gene patenting in Australia.
Critiquing this case was one of many highlights during my time at the McCabe Centre. From attending a workshop on 'Making the Law Work Better for People Affected by Cancer' to contemplating the incursion of the 'cab-rank principle' in civil tobacco litigation cases, to learning about global health law and the WHO Framework Convention on Tobacco Control and researching the potential impact of privacy laws on cancer research, my time at the McCabe was always interesting and thought provoking.
My internship enabled me to put into practice and thereby solidify the analytical and logical reasoning skills developed during my law degree. I was warmly welcomed as part of the team, given substantive and rewarding legal work and exposed to areas of the law I had not been exposed to before including privacy, patent and anti-discrimination laws and was able to further my understanding and interest in international and human rights law. I gained important insights into public health law reform and policy, a particular area of interest of mine given my background in medical research.
Attending seminars and workshops organised by the McCabe Centre, as well as meetings of the Cancer Council Victoria provided me with a better sense of the role that lawyers play in public health policy reform, development and advocacy. I came to understand some of the challenges involved in the field and the importance of collaborative, multidisciplinary work in achieving successful public health outcomes. It was a privilege to work with such motivated and experienced individuals whose work has significantly impacted public health outcomes related to cancer control and to have had the benefit of their advice, guidance and support.
I would highly recommend an internship with the McCabe Centre to students interested in public interest law, policy development or law reform. The diverse work of the Centre provides you opportunity to explore your particular interests and to also learn about areas of the law you may not have previously encountered. The work encourages you to consider how these areas interact and impact those affected by cancer. Interning at the McCabe Centre is a great way to be involved in the policy development and advocacy work of a domestic and international public health NGO and to be part of a great team whose work positively impacts many. To the team at the McCabe Centre and Cancer Council Victoria - thank you!
References
CVA v Myriad Genetics Inc [2013] FCA 65
National Research Development Corporation v Commissioner for Patents (1959) 102 CLR 252
Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health, Report no 99 (2004)
Patents Act 1990 (Cth)
Association for Molecular Pathology v Myriad Genetics, Inc. 569 US ___ (2013)