On 7 October 2015, the High Court of Australia unanimously allowed an appeal from a decision of the Full Court of the Federal Court of Australia concerning the issue of whether an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, was a “patentable invention” within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth) (‘the Patents Act’). The High Court held that it was not.
In the early 1990s Myriad Genetics Inc, in collaboration with the University of Utah, the National Institute for Environment Health Sciences, McGill University and Eli Lilly, announced that they had sequenced the Breast Cancer 1 (BRCA1) gene, which was associated with familial breast and ovarian cancer.
In a subsequent US patent, Myriad Genetics Inc, claimed the isolated BRCA1 gene, protein, associated mutations and the use of the sequence in diagnostics. The US patent was granted, and, through international patent filing, the firm also received Australian patent 686004.
The US patent was subsequently challenged, and on June 13, 2013, in Association for Molecular Pathology v Myriad Genetics (No. 12-398), the US Supreme Court unanimously ruled that ‘a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’.
- Note the US Supreme Court also held that manipulation of a gene to create something not found in nature—such as a strand of synthetically-produced complementary DNA could still be eligible for patent protection.) ↩