An Exorbitant Monopoly: The High Court of Australia, Myriad Genetics, and Gene Patents

<i>"It's not the size of the dog in the fight, it's the size of the fight in the dog.\ud And I'm only a little person, but I fight."</i>--Yvonne D’Arcy \ud \ud <b>Introduction</b>\ud \ud In 2015, the High Court of Australia handed down a landmark ruling in respect of Myriad Genetics Inc. and its patents in respect of genetic testing for breast cancer and ovarian cancer. This brought to a conclusion a long-running legal and political controversy over gene patents in Australia. \ud \ud The dispute – a ‘dog-fight’ according to its protagonist, Yvonne D’Arcy - has a long genesis. In June 2010, Cancer Voices Australia and Yvonne D’Arcy launched an action in the Federal Court of Australia against the validity of a BRCA1 patent – held by Myriad Genetics Inc., the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy – a Brisbane woman who has had treatment for breast cancer – maintained: ‘I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body.’ She observed: ‘For my daughter, I've her have mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me.’ \ud \ud The applicants argued: ‘The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention’. The applicants also argued that ‘the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies 1624’. The applicants argued that ‘the alleged invention is a mere discovery’. Moreover, the applicants contended that ‘the alleged invention of each of claims 1–3 is not a patentable invention because they are claims for biological processes for the generation of human beings’. The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. \ud \ud In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows:\ud \ud 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’. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) (the Act), a valid patent may be granted for a claim that covers naturally occurring nucleic acid – either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) – that has been “isolated”. In this context, the word “isolated” implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there.\ud \ud The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer. \ud \ud The judge held that Myriad Genetics’ patent claims were a ‘manner of manufacture’ under s 6 of the Statute of Monopolies and s 18 (1)(a) of the Patents Act 1990 (Cth). The matter was appealed to the Full Court of the Federal Court of Australia. \ud \ud In September 2014, five judges of the Full Court of the Federal Court of Australia dismissed the appeal by Yvonne D’Arcy in favour of Myriad Genetics Inc. The joint judgment by Allsop CJ, Dowsett, Kenny, Bennett, and Middleton JJ provided several justifications for their position. First, the judges held ‘the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age; rather, the boundaries must be such as to be apt to encompass the development of science and technology, and human ingenuity’. The judges emphasized: ‘This explains the broadening concept of patentability since the first quarter of the 17th century.’ Second, the judges maintained that ‘human intervention that creates an artificial state of affairs that has some discernible effect is essential.’ Third, the judges commented that ‘whilst notions of utility, ingenuity and invention have their place after one concludes that the claim is within the field of s 6, such notions also inform the context of analysis of patentability by assisting in describing the claims to processes or products that are claimed new results of principles carried into practice through human intervention and that create some claimed useful result by involving an artificial state of affairs’. Fourth, judges insisted that ‘expressions such as “the work of nature” or “the laws of nature” are not found in the statute; nor are they useful tools of analysis’. Fifth, the judges held that ‘the distinction between discovery of a scientific principle or fact and a deployment of such to a useful end by a procedure is real.’ The Full Court of the Federal Court of Australia concluded: ‘The isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit’. The judges insisted: ‘The claimed product is properly the subject of letters patent.’ The Full Court of the Federal Court of Australia observed: ‘The claim is to an invention within the meaning of s 18(1) of the Act’. The decision generated public discussion and debate. \ud \ud Yvonne D’Arcy appealed to the High Court of Australia. Myriad Genetics Inc. sought to defend the decisions of the Federal Court of Australia and the Full Federal Court of Australia. The Institute of Patent and Trademark Attorneys of Australia sought to intervene in the matter as an amicus curiae. The Attorney-General of the Commonwealth, George Brandis, also sought to intervene in the matter. In contrast to the Supreme Court of the United States, the High Court of Australia was reluctant to accept a wide range of submissions about the policy implications in respect of gene patents.\ud \ud The High Court of Australia heard oral argument over the matter in June 2015. There were epic, high-quality battles between leading intellectual property barristers, David Catterns QC and David Shavin QC. There was significant media coverage of the case – including by the flagship current affairs programme, the 7:30 Report. The matter was well-attended in the High Court of Australia in Canberra. I was an eyewitness to the oral argument, along with Professor Ann Monotti from Monash Law School. In October 2015, the High Court of Australia handed down a landmark decision in respect of gene patents held by the Utah biotechnology firm, Myriad Genetics Inc. The ruling was an unanimous decision – supported by French CJ, Kiefel, Bell, Gageler, Keane, Nettle and Gordon JJ. The High Court of Australia’s Registry sought to summarise the decision thus: ‘The High Court held that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, was not a "patentable invention" within the meaning of s 18(1) (of the Patents Act 1990 (Cth).’ The ruling attracted significant media attention. \ud \ud Drawing upon the framework of human rights, this chapter provides a systematic analysis of the debate over gene patents in Australia. In particular, this chapter focuses upon the landmark decision by the High Court of Australia in D’Arcy v. Myriad Genetics Inc. in respect of gene patents. This Chapter focuses upon three key themes. First, it explores the debate between Australian jurists over the history of patent law, the meaning of such key terms as a ‘manner of manufacture’, ‘products of nature’, and ‘an artificial state of affairs.’ Such a discussion has taken place against the backdrop of a long history of intellectual property and biotechnology. Second, this Chapter examines the discussion over the respective roles of the patent administration, the judiciary and the Australian Parliament in resolving disputes in respect of gene patents. It critically analyses the aftermath of the High Court of Australia decision – with the debate over IP Australia’s proposed examination guidelines. Third, this piece investigates how the High Court of Australia considered the international context of the debate over gene patents – and the comparative approaches to the topic. The conclusion foreshadows future developments – such as the push for higher standards of intellectual property protection under the Trans-Pacific Partnership