High Court to hear breast cancer gene patent case

13 February 2015
The High Court of Australia will hear an appeal in a landmark case to challenge the validity of a patent over a gene that is associated with hereditary breast and ovarian cancer.

Social justice law firm Maurice Blackburn was today granted leave to appeal to the High Court in D’Arcy v Myriad Genetics Inc [2013] FCA 65 following a 2014 Full Federal Court judgment that upheld the validity of the patent in relation to the BRCA1 gene.

Rebecca Gilsenan, principal lawyer at Maurice Blackburn who has fought the case since 2010 said she was delighted that the High Court would examine an issue of such importance and widespread public interest.

“This matter has enormous significance for access to genetic testing, research and the development of treatments for diseases suffered by millions of Australians. It raises a number of ethical, philosophical and legal questions about the commercialisation of the human body. It is important that there is legal certainty to allow scientists and others the freedom to study genes without fear of a patent holder taking legal action against them.

Maurice Blackburn’s social justice practice began the case pro bono in June 2010 on behalf of Yvonne D’Arcy, a Brisbane woman who has suffered from breast cancer.

The High Court case will be heard in April 2015.



In a Federal Court decision in February 2013 Justice Nicholas 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.

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 are 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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