D’Arcy v Myriad Genetics  HCA 35
On 7 October 2015, the Australian High Court handed down a unanimous judgment finding that isolated genetic material is not patentable subject matter under s18(1) of the Patents Act 1990. This decision overturned a decision made last year by the Full Federal Court, in which five judges found that claims directed to isolated genetic material met the requirements of s18(1) and was patentable subject matter .
Brief History of the case
This has been a controversial, emotive and highly publicised case as it centres on the BRCA1 gene, mutations in which have been shown to predispose women to certain forms of breast and ovarian cancer. BRCA1 gene mutations are used as an indicator of a predisposition towards the development of hereditary breast and ovarian cancers. Yvonne D’Arcy sought revocation of claims 1 to 3 of Myriad’s Australian Patent AU 686004, directed to ‘an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide…’.
The Federal Court handed down its original decision in February 20131. In that decision, Justice Nicholas ruled in favour of Myriad, finding that isolated gene sequences are the product of human intervention and are thus patentable.
Later, in September 2014, five judges of the Full Federal Court handed down a unanimous decision that isolated genetic material is not the same as the naturally occurring product and, thus, claims directed to isolated genetic materials are patentable2. In making their decision, the Full Federal Court relied on the principles set down in the NRDC decision3, which requires an invention to be a manner of manufacture, that is ‘it must belong to the “useful arts”; it must provide a material advantage; and its value to the country must be in the field of economic endeavour’.
Following this decision in February 2015, D’Arcy was granted special leave to appeal to the High Court, Australia’s highest court.
The High Court Decision
In a unanimous decision, Justices French, Kiefel, Bell, Keane, Gageler, Nettle and Gordon have found isolated genetic material not to meet the requirements of patentable subject matter under s18(1) of the Patents Act 1990.
In a joint judgement, French, Kiefel, Bell and Keane JJ, referring to isolated nucleic acids, found that even though the invention as claimed ‘embodies a product created by human action’, it was ‘not sufficient to support its characterisation as a manner of manufacture.’  It was stated at  that:
“The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination. Further, to include this class of claim within that concept would not contribute to coherence in the law as was the case in Apotex4. Nor do Australia’s international obligations and the differently framed patent laws of other jurisdictions, which were referred to earlier in these reasons, support the conclusion that this class of claim should fall within the concept.”
In reaching this decision French, Kiefel, Bell and Keane JJ discussed the extension of the principles of NRDC , and highlighted that NRDC does not prescribe a “well defined pathway for the development of the concept of ‘manner of manufacture’ in its application to unimagined technologies with unimagined characteristics and implication. Rather it authorized a case-by –case methodology” 
Concern was also raised regarding the breadth of the monopoly provided:
“The boundaries of the class are not defined by a limiting range of chemical formulae. There is a real risk that the chilling effect of the claims, on the use of any isolation process in relation to the BRCA1 gene would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolation nucleic acids containing the sequences coding for the BRCA1 protein.” 
In a separate but concurring judgement, Gordon JJ also raised issue with the breadth of the monopoly, stating at  that ‘no single product is identified’ and that ‘Myriad did not and cannot delineate the bounds of the class of chemical compounds by reference to the chemical composition of every possible product.’
The concurring judgement of Gageler and Nettle JJ also explored the legislative history, including the practice of the Australian Patent Office since 1995 of accepting the patentability of isolated nucleic acid sequences. It was found at  that the practice of the Australian Patent Office did not go so far as to demonstrate a legislative endosement and ‘nor had the Patents Act been amended in a way which necessarily assumes the patentability of isolated nucleic acid sequences’. It was further found at  that:
“The most that can legitimately be drawn from the legislative history is a repeated legislative acceptance that, unlike the position in the European Union, issues of patentability in biotechnology and genetic engineering in Australia will continue to be resolved, consistently with NRDC, according to the principles which have developed for the application of s 6 of the Statute of Monopolies, except as otherwise specifically provided in s 18(2) and (3) of the Patents Act. That is to highlight the critical question, not to answer it.”
This has been a surprising decision which will have significant ramifications throughout the Biotechnology industry. The extent of these ramifications is not yet known. The High Court commented on the broad nature of the claims, which were not limited to specific nucleic acid sequences, but were instead directed to a large number of sequences encoding the BRCA1 protein. Thus, there is a possibility that the decision may be limited to its facts and interpreted narrowly in the future.
Interestingly, in finding the essential element of the claimed invention to be the information encompassed by the sequence and not the isolated genetic material, comments were made in the joint judgment of French, Kiefel, Bell and Keane JJ that this could also extend also to cDNA , . Thus, it is also possible that this decision may have an even greater impact than the corresponding decision in the United States5, where isolated genetic material was found not to be patentable, but cDNA with introns removed was considered patentable subject matter.
Finally, while the earlier decision of the Full Federal Court suggested that parliament had approved the patenting of genetic material by not legislating against it, this decision has turned the onus back onto the Australian Government to legislate in favour of gene patents, if that is its intention. Time will tell whether this occurs.
This article was written by Rosemary Manhire-Heath and Ellen Reid.
If you have any specific enquiries about this decision, or gene patents generally, please contact Debra Tulloch or Paul Jones.
- Cancer Voices Australia v Myriad Genetics Inc.  FCA 65
- D’Arcy v Myriad Genetics (2014) FCAFC 115
- National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 25
- Apotex v Sanofi (2013) 253 CLR 284
- Association for Molecular Pathology v. Myriad Genetics Inc., 569 U. S. (2013)