Patents and Information in Genes: Australia, Policy and the Distinction between DNA and cDNA

As in the United States, a prohibition on patenting isolated genetic sequences has now been recognized in Australia. On 7 October 2015, the High Court of Australia in D'Arcy v Myriad Genetics Inc., ruled unanimously that an isolated nucleic acid coding for mutant or polymorphic forms of the BRCA1 polypeptide is not a patentable invention [1]. As a consequence, it invalidated Myriad's BRCA1 patent which claimed an isolated mutated BRCA1 gene sequence. The Australian court's decision largely follows that of the Supreme Court of the United States in Association for Molecular Pathology v. Myriad Genetics, Inc., which found Myriad's US patents invalid [2]. In that case, the Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that synthetic complementary DNA (cDNA) sequences produced in laboratory but determined by the natural order of gene exons are patent eligible because they are not naturally occurring.