Federal Court of Australia confirms that human genes are patentable

15-Feb-2013

In 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 decided in Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013) that human genes are patentable.

The seminal Australian 1959 decision in National Research Development Corporation v Commissioner of Patents is heavily relied upon by Nicholas J. 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'. Nicholas J  highlights the very 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, and it is thus 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 The Association for Molecular Pathology & Ors v United States Patent & Trademark Office and Myriad Genetics Inc. 689 F3d 1303 (2012) stating that

·         the evidence in each case was different,

·         the law as between the US and Australia is different, and

·         so too the constitutional setting in which patent legislation operates in the US when compared to 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 likely without any commercial wherewithal to pay the costs now 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 it and the health sector, negative PR is likely to be seen as acutely undesirable. This situation may also mitigate against the likelihood of any appeal to the Full Federal Court.

By Karen Sinclair