Maurice Blackburn

Biotech company monopoly on cancer genes is unlawful: Australian test case over patents

In an Australian first, law firm Maurice Blackburn together with national consumer organisation Cancer Voices Australia and a Brisbane woman with breast cancer will today launch legal action against four biotech companies to challenge a patent over human genetic material.

The case in the Federal Court will focus on the patent over a gene mutation known as BRCA1. The mutation is associated with an increased risk of breast and ovarian cancer in women. Maurice Blackburn will argue that the patent held by companies including Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd (known as Patent 686,004) is invalid.

In March, the Federal District Court in New York ruled that patents were improperly granted to Myriad Genetics on two human genes, including BRCA1.

In Australia, the test case is supported by patent law expert Dr Luigi Palombi from Australian National University and Sydney University and will be run on a pro bono basis by Maurice Blackburn partner Rebecca Gilsenan and barristers David Catterns QC and Peter Cashman.

"There is a philosophical and ethical issue about the commercialisation of the human body. Beyond that, there is a practical concern - the patent owner has a right to prevent people from studying and testing for the gene mutation, so gene patents can stifle research, the development of treatments, and access to diagnostic testing," said Ms Gilsenan.

"Patents protect inventions, not discoveries. What Myriad has done is discovered and isolated the gene from the human body. We will argue that that does not and can not amount to a patentable invention," said Ms Gilsenan.

Cancer Voices, the first applicant in the case, has a strong interest in ensuring that all cancer patients receive access to the best available treatments. Executive officer John Stubbs said: "Cancer diagnosis is a time of stress for all people affected by cancer. We want control over our disease and treatment options. Patents have the potential to increase the cost of treating all cancers and perhaps denying a vital pathway to good treatment outcomes."

Yvonne D'Arcy, the second applicant in the case, believes patents over human genes are morally wrong. "It's just not right that a company can come along and say that it owns a gene and then control how you get tested for it and who can test you. A company shouldn't be able to own genes - they belong to everybody," she said.

Around 5-10% of women with breast cancer have a known gene mutation and many others have a strong family history. At least 20% of human genes are patented and the outcome of this test case will have implications for status of other patents on other genetic material.