Australian court backs Myriad in human gene patent dispute

A judge at Australia’s Federal Court has upheld Myriad Genetics’ patent covering a human gene mutation linked to breast cancer, in the country’s first court ruling on whether isolated genes can be patented.

Myriad was granted a patent covering the isolated nucleic acid (RNA) coding for a mutation known as BRCA1 in 1996. In 2010, the patent was challenged by not-for-profit organisation Cancer Voices Australia and Yvonne D’Arcy, a Brisbane resident who was diagnosed with breast cancer.

D’Arcy said that patenting genetic material is morally wrong, while Cancer Voices said gene patenting will stifle research, the development of treatments and access to diagnostic testing (Myriad has exclusive rights to perform diagnostic testing on the BRCA1 gene).

Rebecca Gilsenan, a lawyer at Maurice Blackburn who represented Cancer Voices, argued that Myriad’s patent is a discovery, not an invention and that “the isolation of BRCA1 is no more than a medical or scientific discovery of a naturally occurring phenomenon”.

But in a ruling delivered on Friday, February 15, Justice John Nicholas said that Myriad’s patent is valid because it concerns isolated material that has been extracted from naturally occurring DNA and, as a result, consists of an “artificial state of affairs” – an essential requirement under Australia’s patent law.

“There is no doubt that naturally occurring DNA and RNA…cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated,” he concluded.

Myriad has also been successful in defending its cancer gene patents in the US: in 2012, the US Court of Appeals upheld its BRCA1 patent and another for BRCA2, a gene mutation linked to ovarian cancer. The US Supreme Court has since agreed to review this decision and a ruling is expected later this year.

John Fairbairn, a partner at Minter Ellison in Sydney, said the Australian Federal Court decision does not change Australia’s patent law but supports national patent office practice that isolated DNA and RNA sequences are patent-eligible, regardless of the species from which the biological material originates. “It reflects the status quo,” he said.

Kim O’Connell, partner at King & Wood Mallesons agreed, but added that the judgement would provide certainty for the scientific community. “Unless the decision is overturned… it appears that the law in relation to the patentability of biological material is settled," she said.

Both Fairbairn and O’Connell believe the ruling isn’t likely to be overturned unless it reaches the High Court. “It would require a reconsideration or reframing of the principles outlined in the landmark 1959 decision, National Research Development Corporation v Commissioner of Patents [cited by Nicholas in his decision]...that can only be done by the High Court,” said Fairbairn.

Chris Williams, special counsel at Gilbert + Tobin’s patent practice in Sydney, said that any appeal against the decision is unlikely, as Cancer Voices Australia has been de-registered since last year’s court hearing, leaving only Yvonne D’Arcy as plaintiff.

“[Both Cancer Voices and D’Arcy] were ordered to pay the costs of Myriad, as routinely occurs in Australian cases. This may prevent the individual from persisting with the appeal,” he said.