D'Arcy v Myriad Genetics Inc & Anor

The High Court of Australia considered an appeal from the Full Federal Court concerning the patentability of isolated human genes. The applicant, D'Arcy, sought to challenge the validity of Myriad Genetics Inc's patent over the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. D'Arcy argued that the gene, being a product of nature, was not a patentable invention under Australian law.

The central legal question before the High Court was whether isolated DNA sequences, specifically the BRCA1 gene, constituted a manner of manufacture for the purposes of section 6 of the Statute of Monopolies, and therefore were eligible for patent protection. This involved determining whether such sequences, once isolated from the human body, were sufficiently distinct from their natural state to be considered an invention.

The High Court, by majority, held that isolated DNA sequences, including the BRCA1 gene, were not patentable inventions. The Court reasoned that these sequences were essentially discoveries of naturally occurring substances and did not involve a "manner of manufacture" in the sense contemplated by patent law. The majority distinguished between the discovery of a gene and the creation of a new and useful product or process, concluding that the isolation of a gene, while scientifically significant, did not transform it into an invention. The Court affirmed that patent law is intended to protect human ingenuity and the creation of new things, not the mere discovery of what already exists in nature.

The High Court allowed the appeal, setting aside the decision of the Full Federal Court and declaring the patent invalid.