The High Court has granted Cancer Voices’ application for special leave to appeal a Full Federal Court finding that Myriad’s patent relating to the BRCA1 gene is patentable.
The case centred on Myriad’s patent covering mutations in the BRCA1 gene which have been linked to breast and ovarian cancer, as well as methods for detecting mutations in the gene. At trial, Cancer Voices argued that the invention was not a “new manner of manufacture” on the basis that the claimed isolated nucleic acid is not materially different to the nucleic acid that occurs in nature.
At first instance, Justice Nicholas found the patent claimed a product that consists of an artificially created state of affairs which has economic significance, and as such was patentable subject matter. The Full Court upheld this decision, finding that the claim was not to a mere discovery of the nucleotide sequence as it exists in nature but rather the sequence isolated from the cell. The Full Court also found that the claimed products were different to the DNA sequence as it exists in nature.
The US Supreme Court came to a different view about the patentability of similar claims in Myriad’s US patent. There the Court found that isolated nucleic acid sequences were not patentable subject matter. DNA was thought to be a product of nature that is not rendered patentable by virtue of being isolated.
For more on the Australian decisions see our posts here and here, and our article “Isolated nucleic acid sequences patentable in Australia: D’Arcy v Myriad Genetics”, 2014, 14(2) Bio-science Law Review 43.
The High Court’s grant of Cancer Voices’ application for special leave to Appeal means that the High Court will have an opportunity to consider the patentability of gene sequences and could potentially bring the Australian position in line with the US, where the Supreme Court decision has largely meant the end of patents claiming isolated but naturally occurring DNA sequences.