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.
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  HCA 35