- In an important decision for the biotechnology industry, the High Court has rejected certain patent claims to BRCA1 genes on the basis of these claims defining patent ineligible subject matter.
- The extent to which genes and other natural products are susceptible to patent protection is now unclear.
- The Australian Patent Office has now taken the position that it cannot presently accept patent applications containing patent claims covering naturally occurring nucleic acids that encode polypeptides, cDNA or naturally occurring RNA.
There has been much interest in whether claims to nucleic acid molecules are patentable subject matter under Australian law, in part due to the policy, social and moral issues at play.
The issue was last contested in 2014 before a specially constituted five-member bench of the Full Court of the Federal Court of Australia in D’Arcy v Myriad Genetics  FCAFC 115. The particular patent at issue was directed to mutations in the breast cancer gene BRCA1, which is associated with an increased risk of breast and ovarian cancer, and a diagnostic test to detect the presence of the BRCA1 gene.
Only the claims directed to nucleic acids were considered and the Full Federal Court held that isolated nucleic acids, either DNA (eg genomic DNA or cDNA) or RNA, were patentable in Australia. The appellant, Ms D’Arcy subsequently appealed to the High Court.
On 7 October this year, the High Court delivered its decision in D’Arcy v Myriad Genetics Inc (Myriad)  HCA 35. The Court rejected Myriad’s (the respondent’s) claims to ‘[a]n isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide’, for lack of patentable subject matter ie lack of ‘manner of manufacture’ under Australian law. Accordingly, many now consider that nucleic acid molecules are not patentable in Australia. However, in our view, the answer is not that straightforward.