High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

The decision turned on whether the relevant claims related to a class of chemical compounds (as had been found by an enlarged bench of the Full Court, which had upheld the validity of the claims) or alternatively, ‘genetic information’ (as argued by Ms D’Arcy). The High Court found that the information stored in the sequence of nucleotides, coding for the mutated or polymorphic BRCA1 polypeptides, was the same information as contained in the DNA of the person from whom the nucleic acid was isolated. The information was therefore not “made” or “artificially created”.

The High Court’s decision is consistent with the United States Supreme Court’s decision that similar claims were invalid because they fell within a ‘product of nature’ exception to patentability.

The High Court’s decision overturns the judgment of Nicholas J at first instance and of a five judge bench of the Full Court, which had found the claims were valid. We have previously blogged about the Full Court’s decision (here), as well as Ms D’Arcy’s application for special leave to appeal to the High Court (here) and the granting of Ms D’Arcy’s special leave application (here).

We will provide a more detailed analysis of the High Court’s decision shortly.

¹D’Arcy v Myriad Genetics Inc [2015] HCA 35 (http://www.austlii.edu.au/au/cases/cth/HCA/2015/35.html)