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 applicants, D'Arcy and others, sought to challenge the validity of Myriad Genetics Inc's Australian patent over the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. The core of the dispute revolved around whether isolated DNA sequences, which are naturally occurring and have been isolated from the human body, could be considered "inventions" or "artificially created or manipulated substances" for the purposes of the *Patents Act 1990* (Cth).

The central legal question before the High Court was whether isolated nucleic acid sequences, specifically the BRCA1 gene, were patentable subject matter under Australian patent law. This required the Court to determine whether such sequences, despite being isolated from their natural state, could be classified as "manner of manufacture" under section 6 of the *Statute of Monopolies* (as incorporated into the *Patents Act*), or whether they were merely discoveries of naturally occurring phenomena. The Court also had to consider whether the claims in Myriad's patent were directed to a physical product or to information.

The High Court, by majority, held that isolated nucleic acid sequences, including the BRCA1 gene, were not patentable subject matter. The majority reasoned that these sequences, even when isolated, were essentially the same as the DNA as it exists in the human body and were therefore discoveries of naturally occurring substances, not inventions. The Court distinguished between a discovery of a natural phenomenon and an invention, emphasizing that patent law is intended to protect human ingenuity and innovation, not the identification of pre-existing natural materials. The Court found that the claims were directed to the gene itself, not to a new or useful application or manipulation of it.

Consequently, the High Court allowed the appeal, finding that the patent claims were invalid for lacking patentable subject matter. The Court ordered that the patent be revoked.