7 October 2015

The High Court has unanimously ruled that the first three claims of Myriad’s patent for the isolated gene sequences relating to BRCA1:

1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19[7].

are not patentable subject matter in Australia, falling outside the concept of “manner of manufacture”.

According to the High Court’s summary:

While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed. A plurality of the Court considered that to attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination. (emphasis supplied)

High Court’s summary here.

Link to pdf of the judgment here.

D’Arcy v Myriad Genetics Inc [2015] HCA 35