D'Arcy v Myriad Genetics - High Court hears appeal on gene patentability On 16 and 17 July 2015, the High Court of Australia heard an appeal from the Full Federal Court concerning the patentability of isolated genetic material. The case concerned patent claims by Myriad Genetics, Inc in relation to isolated nucleic acid in the human gene BRCA1, which is said to indicate an increased risk of breast and ovarian cancer. Cancer Voice Australia, together with Ms Yvonne D'Arcy, filed an application in the Federal Court in 2013 for revocation of the patents. In September 2014, the Full Federal Court ruled that isolating nucleic acid was a valid "manner of manufacture" under section 18(1) of the Patents Act 1990 (Cth) and in this case isolated genetic material could constitute a patentable invention in Australia. In so ruling, the Court reached a contrary conclusion to the US Supreme Court, which decided that the corresponding Myriad patent in the US was invalid, as naturally occurring DNA is a product of nature and not patentable merely because it has been isolated. However, the US has a vastly different patent system to Australia, including a common "laws of nature" exception, requiring US courts to compare isolated DNA directly against naturally occurring DNA. In its judgment, the Full Federal Court pointed to the fact the BRCA1 gene could not be used to identify a mutation or polymorphism (linked to cancer risk) until it was isolated. The act of isolating the gene facilitated the further analysis necessary to assess cancer risk, and therefore was a valid manner of manufacture. Furthermore, the Court considered that since the legislature had chosen not to exclude gene sequences from patents under applicable legislation, it was open to the Court to validate Myriad's patent. It is anticipated that the High Court will overturn the Full Federal Court's decision on appeal, particularly given its judgment in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1. In that case, the High Court diverged from the Full Federal Court's stance on judicial intervention, and held that any changes regarding patentability of methods of medical treatment should come from the legislature and not from the judiciary. Given the fact that the US is a leader in this field, it may also be the case that the High Court will consider whether international conformity is appropriate (despite the differences between the approach to patents in each jurisdiction). The Myriad patent is limited in scope because it relates only to isolated nucleic acid defined by specific mutations or polymorphisms that the patent teaches could indicate a predisposition to breast cancer. Thus the process of isolating the genetic material under the patent could be seen to meet the threshold requirement for a valid "manner of manufacture" under s 18. Other gene sequences may not meet this threshold requirement, and as such, the High Court's decision (expected to be handed down later this year) may not apply to all genetic sequences and will not necessarily settle the issue of gene patentability in Australia. Watch this space. For more information, please contact Anne-Marie Allgrove, Toby Patten, Jarrod Bayliss-McCulloch or Grace Loukides.