An Australian federal court has thrown out a lawsuit challenging a patent on the cancer-associated gene BRCA1. The decision, issued 5 September, is the latest setback for patient advocates who argue that the patent limits genetic-testing options for Australian cancer patients.
The patent, held by Myriad Genetics of Salt Lake City, Utah, is used to protect a genetic test for mutations in BRCA1 that may enhance the risk of cancer, particularly breast and ovarian cancer.
The Australian case is an echo of a previous legal challenge to patents on BRCA1 and BRCA2 in the United States. That case culminated last year in a unanimous, landmark Supreme Court decision that overturned decades of practice by the US Patent and Trademark Office, invalidating all patents on naturally occurring human genes. The implications of that decision for other US patents on natural products are still being worked out.
The Australian case began in 2010, and was brought by breast-cancer survivor Yvonne D’Arcy and a patient advocacy group, Cancer Voices Australia. But a federal judge dismissed the case on 15 February 2013, arguing that the patent’s reference to isolated DNA was enough to establish that it claimed a “manner of manufacture”, rendering the patent valid under Australian patent law. D’Arcy filed an appeal, which culminated in a second dismissal yesterday.
But that action may not spell the end of the patent challenge. In the wake of the decision, the non-governmental organization Cancer Council Australia called for legislative changes to prevent monopolies on diagnostic tests.
And D’Arcy may yet appeal today’s ruling. “The judgment has significance for access to genetic testing, research and the development of treatments for diseases,” wrote Rebecca Gilsenan, principal lawyer at the firm Maurice Blackburn, which represented D’Arcy, in a statement. “We will look at appealing the decision once we have considered the judgment in detail.”