Intellectual Property in Genetic Material.

Abstract

On October 7, 2015, the High Court of Australia unanimously ruled that isolated pieces of the BRCA1 gene code containing a cancer-causing mutation cannot be patented. It has been hailed in the media as a significant development for medical research, public health policy, and patient access to genetic testing and treatment (see, for example, Corderoy 2015). The decision echoes a 2013 ruling by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 186 L. Ed. 2d 124 (2013), in which the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated” ([10]). Mutations within the nucleic acid that encodes the production of a protein called BRCA1 indicate increased susceptibility to both breast and ovarian cancer. Myriad Genetics, Inc. (Myriad), a U.S. company, held a patent in Australia over the isolated nucleic gene coding of the mutation. The Australian High Court was required to consider whether the isolated genetic material containing this mutation was a “patentable invention” within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth).