BRCA1 gene patent challenged in Australian court

A consortium has launched legal action against four biotechnology companies, including Genetic Technologies (GTG), challenging the validity of patents concerning genetic material.

This follows a ruling in March by the US Federal District Court that declared the patents belonging to US company, Myriad Genetics, for two human genes were improperly granted, on the grounds that they were more 'discoveries' than 'inventions'.

It's widely expected that this decision will be appealed and may end up in the US Supreme Court, the decision of which would be binding until such time as legislation can be changed.

The genes involved in this ruling were BRCA1 and BRCA2, which are strongly associated with breast and ovarian cancer risk. GTG has an exclusive licence from Myriad to these genes in Australia.

The group mounting the legal challenge consists of Cancer Voices Australia, an advocacy group for individuals with cancer, law firm Maurice Blacburn and a Brisbane woman, Yvonne D'Arcy, who has breast cancer.

They contest that isolating a gene constitutes a discovery of something pre-existing in nature rather than an invention, which is the normal purview of patents.

"There is a philosophical and ethical issue about the commercialisation of the human body," said Maurice Blackburn partner Rebecca Gilsenan.

"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."

In 2008, GTG, stirred up controversy by demanding several Australian labs cease performing a test for BRCA1 and BRCA2. The company later withdrew the threat and allowed testing for the genes to continue.

A Senate enquiry is currently underway into the validity of gene patents. It was expected to report earlier this year, but has since been delayed.

Industry groups assert that gene patents, and the protection of innovation, are crucial to the biotechnology industry.

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) suggests that the abolishment of gene patents could result in a "catastrophic" withdrawal of investment in biotechnology from the corporate sector.

The test case will be heard by the Australian Federal Court.