A full panel of the Federal Court of Australia has upheld its earlier ruling that an isolated but naturally occurring nucleic acid, BRCA1, can be patented. D’Arcy v Myriad Genetics Inc., FCAFC 115 (Fed. Ct. of Austl., decided September 5, 2014). The decision stands in contrast to the U.S. Supreme Court’s conclusion in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, No. 12-398 (2013), which determined that human genes and the information they encode are not patentable even if isolated, thus invalidating certain Myriad BRCA1 and BRCA2 claims based solely on isolation. Additional information on that decision appears in Issue 59 of this Bulletin.
After discussing the BRCA1 patent and the underlying science, the court compared the claims in the Australian patent to Myriad’s claims in its invalidated U.S. patent, finding them to be different. The court also noted that the U.S. Congress had not considered the issue, while “Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them.” To further distinguish the Australian and U.S. patent systems, the Australian court noted that the High Court has rejected an approach eliminating “products of nature” from patentability, while the United States prohibits the patenting of such material.
Explaining its reasoning, the Australian court responded to the U.S. Supreme Court and Federal Circuit decisions on BRCA1 and BRCA2 patentability, finding the circuit court’s opinion upholding the patents more persuasive. “What is being claimed is not the nucleic acid as it exists in the human body, but the nucleic acid as isolated from the cell. The claimed product is not the same as the naturally occurring product. There are structural differences but, more importantly, there are functional differences because of isolation,” the court said. “It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.”