Breast cancer gene patent test case: response to Federal Court ruling
15 February 2013
The Federal Court of Australia in Sydney, has today handed down its decision in the landmark case to determine the legal validity of Australian patent 686004 which covers mutations associated with breast and ovarian cancer.
The ruling by Justice Nicholas found that isolation of the gene from the human body is the product of human intervention and isolated gene sequences are therefore patentable. The result is that the patent of Myriad Genetics Inc and the licence to the patent held in Australia by Genetic Technologies Limited remain in place.
"We are disappointed in this ruling but it is not necessarily the end of the issue in a legal or policy sense. The case has given both sides the opportunity to air some very important issues about the ownership of human genetic material and the monopolies that can be created by patents.
"Our opposition to gene patents remains and has widespread support among medical researchers and health advocates.
"It will take us some time to read this judgment in detail and we will make an announcement about the likelihood of an appeal soon."
Yvonne D'Arcy, the applicant in the case who travelled to Sydney for the judgement said, "I won't give up the fight because this is too important for future generations of people who at some point in their lives, may need testing and treatment for cancers and other diseases."
The test case against two biotech companies including Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd was launched in June 2010 by Maurice Blackburn on behalf of Cancer Voices Australia and Yvonne D'Arcy, a Brisbane woman with breast cancer.
The case was heard by Justice Nicholas, over 5 days in February 2012. It centred on the patent (Patent 686,004) and in particular the claims in that patent to mutations of a 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.