Team:Macquarie Australia/Outreach/Law

Australian legal scholarship has discussed synthetic biology for almost a decade – in particular, whether genes are patentable. The U.S. Myriad decision ruled that genes are not patentable in the U.S., as the isolated product's factor of interest was the code of the base pairs, an entirely natural element. This posed a challenge to Australian legal scholars; Australia allowed domestic patenting of genes on the basis that isolated genes are chemically distinct to that found in DNA. We have therefore undertaken this analysis as an Australian first to provide iGEM teams and researchers with an overview of how this landmark decision applies to Australia, coupled with a focused consideration of Australian patent law in relation to genes.

In July 2014, the D'Arcy case appealed this issue to the High Court, testing the Myriad reasoning in Australian courts. The High Court upheld the Australian reasoning over the US reasoning, on the basis of Australian statutory wording's emphasis on 'artificial', in contrast to the US emphasis on 'natural'. The Macquarie University iGEM team therefore has identified the need to review and provide a summary of Australian patent law in light of the new authority on the subject.

The Macquarie iGEM team urges the Australian Parliament to extend the exemption to patent regarding genes to commercial use of human genes, to ensure the best medical care is accessible to all Australians at an affordable cost. We believe that engagement and clear communication of legal issues is important, so researchers understand the legal framework in which they operate, particularly in clarifying positions of law and identifying areas of concern following landmark cases such as D'Arcy.