In March, we blogged on the decision of a US district judge which held that patents directed to the detection of inheritable breast cancer were invalid (click here to read our earlier post). Hot on the heels of the US decision comes an attack on the validity of Myriad Genetics’ Australian patent for the gene mutation BRCA1 (commonly known as the breast cancer gene).
The action was initiated in the Federal Court on 8 June 2010 by Cancer Voices (an advocacy group) and Ms Yvonne D’Arcy (who was diagnosed with breast cancer in 1998). The respondents include Genetic Technologies Ltd, the exclusive Australian licensee, and Myriad Genetics. The first directions hearing is scheduled for 8 July 2010.
Ms Gilsenan, from Maurice Blackburn Lawyers, has indicated that the applicants will be arguing that the patent should not have been granted as the gene is naturally occurring, which is a similar argument to that which was successfully run in the US. Therefore, it will be argued that the subject matter of the patent is merely a discovery and not a patentable invention. There will, doubtless, also be many arguments made about the morality and ethics relating to the patenting of a gene which may restrict research and development in the breast cancer arena.
It is interesting to note that the applicants have instituted proceedings despite the fact that Genetic Technologies does not currently charge royalties for use of the patented technology in Australia. It is possible that the case is being used, following the US decision, as a launching pad to challenge the validity of gene patents in general. This will be the first time that the Australian Federal Court will rule on the validity of human gene patents.
On a related note, we noted in our earlier post that the Australian Senate Community Affairs Committee is conducting an Inquiry into Gene Patents. This inquiry is still ongoing, and the reporting time has been extended to 17 June 2010 due to “the extensive evidence received and the complex nature of many issues associated with this inquiry”.