Australia’s highest court has issued its decision in D’Arcy v Myriad Genetics Inc, allowing the appeal and holding that claims directed to the BRCA1 gene be revoked on the basis that the substance of the claim “is information embodied in arrangements of nucleotides” and not a “manner of manufacture.”
The Court unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a manner of manufacture. The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. 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.