The patenting of human genetic material – where does the law stand in Australia

27 October 2014
On 5 September 2014 the Full Federal Court of Australia upheld the validity of the patent over BRAC1, the gene that is associated with hereditary breast and ovarian cancer in the matter of D’Arcy V Myriad Genetics Inc and Genetic Technologies.

By Rebecca Gilsenan, NSW

This is an important judgment and there is considerable public interest in, and concern about, the broader issue of the patenting of human genetic material. Maurice Blackburn is now seeking leave to appeal the decision to the High Court of Australia (HCA).

We argued that the patent held by companies including Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd is invalid. The case raises philosophical and ethical issues about the commercialisation of the human body. It also exposes practical concerns around gene patents including access to the gene mutations for testing, research and, ultimately, the development of new treatments. It also has implications for other genetically-based chronic diseases.

Under current law only inventions which are considered a ‘manner of manufacture” or “manner of new manufacture” can be patented. In our case it is argued that isolated genetic material is not an invention because it is naturally occurring and is not relevantly different from nucleic acid that has not been isolated. The isolated nucleic acid that is the subject of the patent contains certain information and it is that information that has value, not fluid or acid itself.

The arguments mounted in D’Arcy v Myriad Genetics Inc are similar to those that form the basis of the unanimous US Supreme Court decision of June 2013 in which the Court held that the equivalent patent in the US was invalid. The US Supreme Court held that information that is encoded in the gene is identical, whether the gene is inside the body or isolated from the body.

It is hoped that the application for leave to appeal to the HCA will be heard later in 2014 or in 2015.