The Australian High Court has allowed Yvonne D’Arcy’s special leave application from the Full Federal Court decision in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115. As a result, the patent claims directed to the gene BRCA1 (which has been found to exhibit particular mutations in women with an enhanced risk of developing breast and ovarian cancer) will be considered by the High Court sometime this year.
The Full Federal Court had upheld that patent claims directed to particular BRCA1 genes (which had been associated with an enhanced risk of developing breast and ovarian cancer in women) were considered to be patentable subject matter. The Full Federal Court decision was not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability, but was about whether, under Australian law and the concept of patentable invention as discussed by the courts, the challenged claims are patentable subject matter. Our analysis of the Full Federal Court judgment is here.
Today’s decision is important since it means the High Court will now decide once and for all if isolated genetic material is patentable subject matter (i.e. a ‘manner of manufacture’). Of course, Australia has a research exemption from patent infringement (by virtue of Section 119C of the Patents Act), so irrespective of the High Court decision, this will have no impact on the ability of Australian medical researchers to do what they do best – research.