In a decision issued on October 7, 2015, the High Court of Australia (High Court) ruled unanimously in D’Arcy v. Myriad Genetics Inc.,  HCA 35, that three BRCA1 patent claims held by Myriad Genetics, Inc. under Australian Patent 686,004 were invalid. While Myriad’s patent had actually expired on August 11, 2015, the court decision set important precedent relevant to intellectual property in genetics/omics and precision medicine.
The D’Arcy case itself, along with other litigation in the U.S. involving Myriad’s gene patents, has been discussed previously on Genomics Law Report (See generally here). Mutations in the BRCA1 gene confer increased risk of breast and ovarian cancer. The Myriad scientists were first to clone and sequence BRCA1, the gene that Mary-Claire King had linked to cancer susceptibility in a landmark paper in Science in 1990. Myriad identified several BRCA1 mutations. Myriad’s Australian Patent 686,004 contains 30 separate claims. Yvonne D’Arcy challenged the validity of the first three claims in Myriad’s patent, which claimed the isolated BRCA1 sequences with mutations conferring increased risk of breast and ovarian cancer.
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