In a companion case to the “gene patenting” dispute presently before the U.S. Supreme Court, Myriad Genetics, Inc. successfully defended the patent-eligibility of “gene patents” in Australia. In Cancer Voices et al. v. Myriad Genetics Inc. et al. [Myriad] the Federal Court of Australia held that a claim that covers an isolated naturally occurring nucleic acid – either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) – is patentable provided that the other requirements for patentability have been met.  

The Challenged Claims

The challenged patent entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene” claims isolated polynucleotides comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus. The polynucleotides can be RNA, DNA, cDNA and synthetic forms. The invention also includes detection methods, isolated antibodies, and screening methods.

Legal Analysis

In reaching its holding, the Australian court reviewed the relevant case law in Australia and the United States and its application to the patenting of products of nature. The court highlighted prior decisions where the technology may depend on the operation of natural laws or the natural properties of the materials involved. Similar to Judge Lourie’s reasoning in the companion U.S. case [see prior post of August 16, 2012], the Australian court focused on the isolated nature of genetic material. Isolated or purified nucleic acids, the court reasoned, is the product of human intervention. Moreover, the court placed importance on the long standing practice of patenting isolated DNA in Australia and other countries. The court also determined that it would be difficult, on any rational basis, to confine the holding of this case to patenting in other fields, such as the patenting of pure and isolated chemicals that occur in nature; where the consequences of such are unknown.

Myriad and the biotechnology community now wait for the U.S. Supreme Court’s review of the patent-eligibility of human genes. Oral argument is expected in April. Stay tuned.