Commercialisation of human genetic material - breast cancer gene patenting

In an Australian first, in 2010 Maurice Blackburn began legal action to challenge a patent over human genetic material. On 7 October, 2015 the Australian High Court ruled that the gene BRCA1 cannot be patented, ending a five year legal battle. The case was on behalf of a Brisbane woman with cancer and was run by Maurice Blackburn's Social Justice Practice, led by Rebecca Gilsenan and barristers David Catterns QC and Professor Peter Cashman.

Maurice Blackburn argued that the patent held by companies including Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd was invalid. The case raised philosophical and ethical issues about the commercialisation of the human body. It also exposed practical concerns around gene patents including access to the gene mutation for research and testing purposes.

Under current law only inventions which are considered a ‘manner of manufacture or “manner of new manufacture” can be patentable. We argued that isolated genetic material is not an invention because it is naturally occurring.

The case has far reaching consequences for future medical research and genetic testing.

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, Maurice Blackburn sought leave to appeal to the High Court of Australia. The High Court of Australia ruled on 7 October 2015 unanimously in our favour.

In US developments, the US Supreme Court 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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