Lawsuit to be launched over breast cancer gene patent

By Dr. Ananya Mandal, MDJun 7 2010

Dr Ananya Mandal, MD

BRCA1 and BRCA2 are two genes that have been identified to hold a key to women’s susceptibility to get breast or ovarian cancer. Changes also known as mutations in these genes are significant in women who go on to develop breast or ovarian cancer. Melbourne-based company Genetic Technologies Limited (GTL) has the exclusive license from American biotechnology company Myriad Genetics to carry out testing for the genes in Australia. Myriad holds a patent for these genes. After many women complained of the cost of the genetic tests which could be done only by the patent holding company, many law firms came forth to argue that genes occur in nature and could not be patented. For example In the US the tests cost about $3,700 and the company does not allow a second opinion. In March, the Federal District Court in New York ruled that patents should not have been granted to Myriad Genetics on BRCA1 and 2.

Now law firm Maurice Blackburn is filing a case in the Federal Court in Sydney, upholding the same issue. They will try to remove the monopoly of GTL on testing the genetic mutations. The lawsuit will be launched today, Tuesday. The case is undertaken on behalf of national consumer group Cancer Voices and Yvonne D'Arcy, a Brisbane woman with breast cancer.

Lawyer Rebecca Gilsenan feels strongly against these exclusive rights held by GTL. She also feels this can hamper research. She said in a statement, “There's a philosophical and ethical issue about commercializing the human body and its genetic material… Beyond that though, there's a practical concern and that is that the patent owner has a right to prevent people from studying and testing for the gene mutation…Gene patents can have the effect that they stifle research, they can stifle the development of treatments that researchers might otherwise develop and they can impede access to diagnostic testing for that gene mutation.” She also explained the practical time, cost and quality problems saying, “The patent owner has the right to be the exclusive tester, if you like, and therefore it can drive up the cost, it can create delays… It means there's no competition and therefore nobody could develop an improved test so there's all sorts of consequences - mainly cost and quality.”

GTL had sent legal notices to Westmead Hospital and the Peter MacCallum Cancer Institute in Victoria in 2003 and 2008 asking them to stop testing for the genes citing patent issues. The threat was hastily withdrawn after the public protested.

According to patent law expert at the Australian National University, Dr Luigi Palombi, this lawsuit is very significant. “It is important because for the first time in Australian legal history, the Australian courts are going to rule on whether an isolated biological material, such as the human gene which has been removed from the human body, is an invention…For the last 20-odd years the Australian patent office [IP Australia] has been granting patents on all manner of genes and biological material such as plants, plant genes, viral genes - all manner of biological material…. It will mean a message will go out to the patent office immediately that it can no longer continue to pursue a policy that's led to the grants of these kind of patents. It will force biotechnology companies to start innovating in different ways,” he explained.

At present at least 20 percent of genes come under patent law and this lawsuit could determine their fate.