D'Arcy v Myriad Genetics Inc & Anor

The High Court of Australia considered an appeal concerning the patentability of isolated human DNA sequences. The appellant, D'Arcy, sought to challenge the validity of Myriad Genetics Inc's Australian patent over isolated nucleic acid sequences encoding the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. The dispute centred on whether these isolated DNA sequences were mere discoveries or inventions eligible for patent protection under Australian law.

The primary legal issue before the High Court was whether isolated nucleic acid sequences, which occur naturally in the human body, could be considered "inventions" for the purposes of the *Patents Act 1990* (Cth). Specifically, the Court had to determine if the isolation and identification of these naturally occurring sequences constituted a manner of manufacture within the meaning of section 6 of the *Statute of Monopolies* (as incorporated into Australian patent law).

The High Court, by majority, held that isolated human gene sequences were not patentable subject matter. The Court reasoned that the mere isolation of a naturally occurring substance, without further modification or application, did not transform it into an "invention" in the sense of a "manner of manufacture." The Court distinguished between a discovery of something that exists in nature and the creation of something new through human ingenuity. While acknowledging the utility of the isolated sequences, the Court found that their isolation did not involve sufficient inventive step to qualify as patentable.

The High Court allowed the appeal, setting aside the earlier decisions of the Federal Court and the Patent Office. Consequently, Myriad Genetics Inc's patent was declared invalid.