The High Court of Australia has granted special leave to Yvonne D’Arcy to appeal the high profile Full Federal Court decision1 affirming the patentability of naturally-occurring genes in an isolated form.
The Full Federal Court affirmed last year that patent claims directed to isolated BRCA1 genes were considered to be patentable subject matter in Australia. The reasoning of the Full Federal Court relied heavily on the principles set down in the NRDC decision2, which has guided Australian law on patentable subject matter for over 50 years. The decision of the High Court to grant special leave may be part of recent activity by the High Court to affirm what has long been held to be patentable subject matter in Australia. Just over a year ago the High Court held that methods of medical treatment indeed constitute patentable subject matter3 and it may be that by hearing the “Myriad” appeal, the High Court will give its imprimatur to the patentability of isolated genes.
A transcript of the hearing for the special leave application published today did not give much away about how the High Court justices might decide the appeal. There was discussion about the US Supreme Court Myriad decision and the Federal Court’s criticism of that decision , the structure and the information of content DNA and whether a “law of nature” patentable subject matter exclusion could apply under Australian law. It is clear from the transcript that the central issue to be decided by the High Court is whether naturally-occurring DNA in an isolated form constitutes an artificially created state of affairs according to the principles set down by NRDC. The substantive appeal will be heard in April 2015 and we expect a decision late 2015. The Australian biotechnology industry awaits the High Court’s decision with bated breath.