Gene patenting: recent debate
Much of the debate around gene patenting in Australia has been prompted by the case of the BRCA genes. BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumour suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer. Patents for these genes are held by Myriad Genetics, an American company, which has granted Genetic Technologies exclusive rights to BRCA1 and BRCA2 testing in Australia.
In 2002-3, and again in 2008, Genetic Technologies sought to enforce its rights in relation to the BRCA genes in Australia, including through demands that public hospitals and other laboratories cease to offer the tests. Genetic Technologies later withdrew these demands. However, the episode prompted the establishment of a Senate Community Affairs Inquiry into Gene Patents in 2008 (following an earlier report from the Australian Law Reform Commission in 2004), as well as legal action initiated by Cancer Voices Australia and Yvonne D’Arcy. In 2010, a private member’s bill was introduced into the Senate (the Patent Amendment (Human Genes and Biological Materials) Bill 2010) to prevent the patenting of human genes and biological materials existing in nature. A Senate Inquiry was also established to consider this bill.
The Senate Inquiry into Gene Patenting reported in 2010 and made 16 recommendations, none of which specifically aimed to ban gene patenting. In 2011, the Inquiry into the Patent Amendment Bill recommended that the bill should not be passed, noting that some of the issues raised in the Inquiry would be addressed by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which was passed in March 2012. It made amendments that aimed to, among other things, raise patent quality and provide free access to patented inventions for regulatory approvals and research.
In February