Breast cancer gene patent test case win: High Court of Australia rules patent is invalid

7 October 2015
In a landmark test case, the High Court of Australia has today unanimously upheld an appeal in the breast and ovarian cancer gene patent test case of Yvonne Darcy v Myriad Genetics Inc, bringing to an end a five year fight over the validity of a patent over the isolated BRCA1 gene.

The High Court decided that the patent over the isolated BRCA1 gene is invalid.

“We are thrilled that after this long and hard fought case, the High Court has found that a company cannot lay claim to ownership to our genetic information,” said Rebecca Gilsenan, principal at social justice law firm Maurice Blackburn which has fought the case since 2010.

“This judgment invalidates the patent on the BRCA1 gene. It provides certainty that testing and research on the BRCA1 gene cannot be monopolised in Australia and can be carried out widely and cost-effectively.”

“The High Court recognised that genetic information is not something that is “made” or “artificially created”.  Myriad did not ‘create, make or alter” the genetic code. This is what we have argued since the outset”. 

Justice Gordon stated that “That the specific mutations and polymorphisms are indicative of a predisposition to breast cancer and ovarian cancer is a fact. That fact existed before Myriad worked it out”.

The Court recognised the risk of a chilling effect of the patent upon legitimate innovative activity of medical practitioners, researchers and inventors.

“This is a contentious area of law and now Australia’s approach to granting patents on genetic mutations will be more in line with the US where the Supreme Court has ruled that companies cannot patent human genes.” 

This issue is of enormous public interest and has significance for access to genetic testing, research and the development of treatments for diseases suffered by millions of Australians.”

Maurice Blackburn’s social justice practice began the case in June 2010 on behalf of Yvonne D’Arcy, aged  69, a Brisbane breast cancer survivor. 

“I’m so thrilled with this news from the High Court. It’s been such a long hard fight and it means so much to so many people. I am so proud to have been part of this case,” said Ms D’Arcy.

Background

In February 2013 Justice Nicholas of the Federal Court ruled in favour of Myriad and agreed that isolated gene sequences are the product of human intervention and are therefore patentable.

Soon after, Maurice Blackburn lodged an appeal which was heard in August 2013 by the Full Federal Court. On 5 September 2014, the Full Federal Court upheld Justice Nicholas’ ruling. On 16 September 2014 Maurice Blackburn lodged an appeal with the High Court of Australia. The High Court heard the matter in June 2015.

The US Supreme Court has also considered the issues raised by the equivalent BRCA1 gene patent in the United States and ruled in June 2013 that the fact of isolation itself is not sufficient to render genes patentable.

The arguments mounted in the Australian case were similar to those in the US. The US decision confirms that information that is encoded in the gene is identical, whether the gene is inside the body or isolated from the body. 

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