The High Court has unanimously allowed an appeal from the Full Federal Court on the validity of a gene patent. The patent relates to a particular DNA or RNA sequence named BRCA1 that has been isolated (or removed) from its ordinary cellular environment and is an indicator of breast or ovarian cancer. Dismissing the appeal from the trial judge’s decision, the Full Federal Court held that the isolated gene is an invention within the meaning of the Patents Act 1990 (Cth) and the Statute of Monopolies 1623, on the basis that the isolation process involved a new manufacture from and is different to the original natural material and produces an economically useful result (see [213]–[214]). The appeal to the High Court focused on the ‘manner of manufacture’ requirement.

The Court unanimously held that the invention did not fulfill the manner of manufacture requirements in the Patents Act. The joint judgment (French CJ, Kiefel, Bell and Keane JJ) held the claimed features of the invention in substance were related to sequencing information, did not pass the ‘manner of manufacture’ requirement and should not be brought within that concept (at [9]): the claimed invention, over the information embodied in arrangements of nucleotides, did not ‘make’ that information by human action, but rather allowed it to be discerned (at [6]):

[An invention] must be something brought about by human action. The requirement, in each claim, that the sequence in the isolate bear specified mutations or polymorphisms raises the same problem in a particular way. Satisfaction of that integer depends upon a characteristic of the human being from whom the nucleic acid is isolated, a characteristic which is not shared by all human beings. It has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence.

The joint judgment rejected the Full Court’s approach of taking ‘made’ to include being brought into existence by human action (at [87]) or as involving an ‘artificially created state of affairs’ (at [91]) and concluded that extending the concept of ‘manner of manufacture’ to include the isolation of nucleic acids was not appropriate for judicial determination (at [94]). Gageler and Nettle JJ agreed with the conclusions of the joint judgment, holding too that the while a procedure for detecting mutations and polymorphisms might be patentable, the claim was for a monopoly over fragments of naturally occurring DNA and thus extended too far (see at [168]–[169]). Gordon J likewise agreed with the orders in the joint judgment, holding that the claim failed because, amongother things, Myriad did not create, make or alter the genetic code, there was no idea, concept or principle as a new manufacture, and that the claim was too broad (see [244]ff).