The Federal Court trail will assess the legal validity of patents involving genetic material this week in the first Australian case of its kind.
Law firm Maurice Blackburn launched the test case in June 2010 with Cancer Voices Australia and a Yvonne D’Arcy, a Brisbane woman with breast cancer against four biotech companies to challenge a patent over human genetic material.
“This case is groundbreaking. No Australian court has considered the question of whether isolated human genes are patentable,” said Rebecca Gilsenan, Maurice Blackburn principal lawyer on the case.
The case launches in the Federal Court on Monday 19 February 2012 in Sydney.
The case is being run pro bono by the firm, barrister David Catterns QC and Professor Peter Cashman of Sydney University.
The case will be heard by Justice Nicholas, is expected to run for between five and eight days and will focus on the patent over mutations to an isolated gene known as BRCA1. When these mutations exist on the BRCA1 gene they are associated with an increased risk of hereditary breast and ovarian cancer.
The trial will hear from expert witnesses and the applicants will argue that the patent held by the companies is invalid.
Gilsenan said of the case: “Patents protect inventions, not discoveries. Myriad has isolated the gene from the human body. We will argue that can not amount to a patentable invention.”
In March 2010, the Federal District Court in New York ruled that patents were improperly granted to Myriad Genetics on two human genes, including BRCA1.
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 Gilsenan in 2010.