Gene patenting controversy reaches the Australian Federal Court

A controversial patent over a common genetic mutation is accused of being tantamount to privatisation of the human body. This is the argument being put forward by lawyers representing patient advocacy group Cancer Voices who, for the first time in Australia, are asking the Federal Court to decide if patents granted over segments of DNA are valid.

The US biotech company Myriad Genetics and the exclusive Australian licensee, Genetic Technologies, have a monopoly right to control the use of the BRCA1 mutation sequence (linked to breast cancer) for commercial R&D as well as diagnostic testing. It was granted on the basis that the process of isolating the gene from the human body in a laboratory constituted an "invention". It is worth noting that patenting gives no rights to genes inside the human body.

However, Cancer Voices claim that the key characteristic of the gene mutation relevant to the test – its ability to code for particular proteins – is identical inside the body and out, and should thus not be patentable. The spark for this case being brought before the courts began when the licensee sought to assert its patent rights over a number of public laboratories who were effectively performing the patented breast cancer diagnostic test “in-house” and without paying for a license.

Early last year, UWS Innovation prepared a submission to the Senate Inquiry on behalf of the S7 group of Universities, as did many other research bodies, arguing against a private members bill seeking to restrict the patenting of genes and other biological material. We argued then, and still believe, that restricting the ability to patent biological materials, including isolated genes, would have far-reaching and unintended consequences across the biotechnology industry, impacting on the development and ultimately the generation of diagnostics, novel therapies, tests, vaccines and drug delivery platforms while not solving the issue at hand.

UWS researchers who have questions on how this could affect their research should contact UWSI on ip@uws.edu.au