Federal Court of Australia confirms that human genes are patentable

In Cancer Voices Australia v Myriad Genetics Inc ([2013] FCA 65 (15th February 2013)) – a landmark decision concerning the patentability of BRCA genes which are found in sufferers of breast and ovarian cancers – a single judge of the Federal Court of Australia has held that human genes are patentable.

Judge Nicholas relied heavily on the seminal Australian 1959 decision in National Research Development Corporation v Commissioner of Patents. This case set the test for patentable subject matter in Australia as being anything that is "an artificial state of affairs that has some discernible effect and is of utility in a field of economic endeavour". The judge highlighted the sweeping scope allowed to him under this precedent, stating that even if "an isolated nucleic acid... may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings", in the absence of human intervention naturally occurring nucleic acid does not occur outside the cell and "isolated" nucleic acid does not exist inside the cell; thus, it is itself even an "artificial state of affairs". The applicants did not challenge that the subject matter of the claims in suit had either a "discernible effect" or "utility in a field of economic endeavour".

The judge distinguished this case from the US Court of Appeals decision in Association for Molecular Pathology v United States Patent and Trademark Office (689 F3d 1303 (2012)), stating that:

  • The evidence in each case was different.
  • The law is different in the United States and Australia.
  • The constitutional setting in which patent legislation operates in the United States is different from that in Australia.

The application was dismissed with costs. The applicant, Cancer Voices of Australia, has disbanded, and in any event was a body of persons unlikely to have the commercial wherewithal to pay the costs awarded, and united only by their common interest in having genes declared unpatentable. It seems improbable that the respondent will press for costs; more so because in Australia, due to an antagonistic relationship between Myriad and the health sector, negative publicity is likely to be seen as acutely undesirable. This situation may also mitigate against the likelihood of any appeal to the Full Federal Court.


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