D'Arcy v Myriad Genetics Inc

The High Court of Australia considered an appeal by D'Arcy against Myriad Genetics Inc concerning the patentability of isolated nucleic acid sequences that indicate a susceptibility to cancer. The dispute centred on whether these isolated DNA sequences, which code for the BRCA1 protein and contain specific mutations or polymorphisms, constituted a patentable invention under the *Patents Act 1990* (Cth).

The core legal issue before the High Court was whether the claimed invention, specifically isolated nucleic acid sequences coding for the BRCA1 protein with mutations indicative of cancer susceptibility, was a "manner of manufacture" within the meaning of s 6 of the *Statute of Monopolies*. This required the Court to determine whether the "artificially created state of affairs" criterion, as established in previous case law, was satisfied, and what factors were relevant to assessing whether a new class of claim fell within this concept.

The High Court reasoned that while the isolation of nucleic acids involves an artificial process, the resulting product, an isolated DNA sequence, was not fundamentally different in its essential characteristics from the naturally occurring sequence. The Court found that the claims encompassed molecules that, in their essential nature, were products of nature, even if they had been extracted from their natural cellular environment. The Court distinguished between the discovery of a gene and the isolation of a gene, noting that the claims were directed to the isolated gene itself, not a new use or application of it.

The High Court allowed the appeal, setting aside the orders of the Full Court of the Federal Court. The Court ordered that claims 1, 2, and 3 of Australian Patent No 686004 be revoked, finding that the isolated nucleic acid sequences claimed were not patentable subject matter.