On 7 October 2015 the High Court of Australia (HCA) issued its decision in D’Arcy v Myriad Genetics Inc [2015] HCA 35. The decision is a significant driver for legislative reform to deal with the issue. The court’s judgement summary of the decision is available .

In short, HCA held that the particular manipulated genetic material was not capable of being registered as a patent because the use and manipulation of genetic material was not a “manner of manufacture” within the meaning of the patent legislation, despite however clever the invention was.

The Court’s reasoning that to extend patentability to genetic system and markers in question (to do with identifying breast cancer susceptibility) was not possible because it “would involve an extension of the concept of manner of manufacture in a way not appropriate for a court”, so squarely raising the need for legislative reform.