The Australian High Court in Yvonne D'Arcy v Myriad Genetics Inc & Anor [2015] HCA 35 (7 October 2015) has held that an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not patentable subject matter in Australia. The decision did not specifically address claims to methods of using isolated nucleic acid sequences for diagnosing or treating conditions and it may be that claims restricted to such methods will remain patentable. 

This decision will clearly impact on existing Australian patents and patent applications. Any granted patents in Australia that include claims directed specifically to isolated nucleic acid sequences will need to be reviewed in the light of the High Court’s decision and appropriately amended. With regard to existing patent applications, IP Australia has already said that:

“The decision provides clarification of the law as applied to the patenting of isolated nucleic acid sequences and we will move quickly to ensure that patent examination practices are consistent with the findings of the Court. We are considering the decision and its implications and will provide a response in due course. In the interim, we have suspended examination of patent applications claiming nucleic acid sequences.” [1]

The impact of the Australian High Court’s decision on patents and patent applications in New Zealand is less clear. While persuasive, Australian decisions are not binding on New Zealand Courts. We will provide further analysis of the Australian High Court’s decision and its impact shortly.