Australia’s highest court to hear Myriad gene patent case

The High Court of Australia is set to consider the Myriad Genetics case concerning whether isolated genetic material is patentable subject matter.

On Friday (February 13), the Full Federal Court of Australia granted a request by Yvonne D’Arcy, the plaintiff in the case, for special leave to appeal to the High Court. It means the High Court, the country’s most senior, will hear the case in April 2015.

Special leave is granted in cases where there is a question of law that is of public importance. The decision to grant it is determined by one or more justices of the Federal Court.

The case, D’Arcy v Myriad Genetics, which was filed by breast cancer survivor D’Arcy, centres on whether isolating a DNA sequence from a gene’s surrounding genetic material involves structural and functional changes that create a new composition—and can therefore be patented.

D’Arcy filed the case in partnership with the Cancer Voices Australia organisation against Myriad in 2010.

In February 2013 a judge at the Federal Court of Australia ruled in favour of Myriad, finding that isolated gene sequences are patentable as they are the product of human intervention.

D’Arcy appealed against the decision to the Federal Court in August 2013, and in September 2014 the court upheld the validity of the patent. The plaintiff later sought special leave to appeal.

The patent is related to the BRCA1 gene, mutations of which can increase an individual’s chance of developing breast or ovarian cancer. Myriad offers tests that examine the BRCA1 gene.

Australian law defines patentable subject matter as a “manner of manufacture”. D’Arcy argued that gene patents are not a manner of manufacture, as isolating a gene does not make a difference to it—the resulting product is identical to that found in nature.

In 2013, the US Supreme Court found that genes are not patentable subject matter simply because they have been isolated.

Rebecca Gilsenan, a principal at Australian law firm Maurice Blackburn, who is representing D’Arcy in the case, said that the matter has “enormous significance” for access to genetic testing, as well as research and development into treatments for disease.

“It raises a number of ethical, philosophical and legal questions about the commercialisation of the human body. It is important that there is legal certainty to allow scientists and others the freedom to study genes without fear of a patent holder taking legal action against them,” she added.

Myriad did not respond to a request for comment.