Myriad cancer patent upheld in Australia

Companies in Australia will be able to continue to patent human genes after a court rejected an appeal by a breast cancer survivor.

The decision, on Friday (September 5), upheld the validity of Myriad Genetics’ BRCA1 gene patent, used in the treatment of breast cancer, after it was challenged by cancer survivor Yvonne D'Arcy.

The case D’Arcy v Myriad Genetics Inc, heard by the full bench of the Federal Court of Australia, ruled that isolating a DNA sequence from the gene’s surrounding genetic material involves structural and functional changes that create a new composition, meaning it can be patented.

Law firm Maurice Blackburn, which argued for D’Arcy, had claimed that mutations in the BRCA1 gene were naturally occurring components of the human body that had been discovered, rather than an invention that could be patented.

It feared that fewer tests and research could be carried out as a result of the ruling.

But, in a statement, law firm Jones Day, which acted for Myriad, said patents drove innovation.

"Myriad invested hundreds of millions of dollars in research and development, patient and physician education … which has resulted in a gold standard test, BRACAnalysis, for the testing of predisposition to hereditary breast and ovarian cancer risk at an affordable cost," it said.

The decision reaffirms a ruling from February last year when Federal Justice John Nicholas ruled at the same court that isolating the gene from the body constituted something new.

Cases at the Federal Court are heard in the first instance by single judges but if a decision is appealed against it can be referred to the Full Court, where it is heard before all the court’s judges.

The court’s five judges unanimously ruled that the patent claims something other than subject matter that had previously existed and, as such, constitutes patentable subject matter.

Writing on the Patently-O blog, Ben McEniery, a senior lecturer in law at the Queensland University of Technology and an IP barrister, said while it was difficult to fault the court’s reasoning it is unlikely to be the final chapter.

“It is likely that the unsuccessful applicant in this instance will appeal to the High Court of Australia, Australia’s final court of appeal, and that that the High Court will give leave to hear the appeal given the importance of the subject matter concerned,” he wrote.