In the landmark Australian case Cancer Voices Australia (ABN 93 322 703 427) & Anor v Myriad Genetics Inc & Ors the Federal Court of Australia has today found that patent claims directed to the gene BRCA1 (which has been found to exhibit particular mutations in women with an enhanced risk of developing breast and ovarian cancer) are valid.
Costs have been awarded against patient advocacy group Cancer Voices Australia, and breast cancer survivor Yvonne D’Arcy. Reasons for judgment may be found here.
The decision affirms the existing position in Australia that isolated genetic material is patentable subject matter (i.e. a ‘manner of manufacture’).
The patent in question is the Australian equivalent of the US patent held by Myriad Genetics that concerned BRCA1 and BRCA2. In July 2011, the US Court of Appeals for the Federal Circuit (CAFC) ruled that patent claims directed to DNA molecules that are ‘isolated’ cover subject matter capable of patent-eligible protection under 35 USC §101 (which is the US equivalent to the “manner of manufacture” requirements under Australian law). In essence, the CAFC viewed that the claimed molecules in question “do not exist in nature.” Today’s judgement affirms the Australian position is in line with that of the United States.
Prior to today’s decision, the position in Australia regarding the patentability of genes is based largely on the 1995 decision by the Australian Patent Office (IP Australia) in Kirin-Amgen Inc v Board of Regents of University of Washington. In this it was held that a claimed isolated gene can essentially constitute an “artificially created state of affairs” that is not “a mere chemical curiosity or a mere discovery” and is therefore capable of satisfying the requisite considerations of being in itself a “manner of manufacture” under patent law to ensure it is worthy of patent protection.
At appeal, the Federal Court of Australia further held the view that the isolation of a gene is fundamentally akin to the discovery of a class of chemical compounds, and by analogy, entitles the patentee to broad protection for genes and the products related to those specifically isolated genes. Accordingly, provided that the applicant can point to some difficulty in reaching a particular result, isolated genes and any biological or genetic material derived therefrom were considered subject matter worthy of patent protection.
In the intervening period between the 1995 decision and today’s judgement, there were a number of government inquiries to review Australia’s position on intellectual property rights relating to biological materials. A discussion of the inquiries and previous decisions can be found here: http://www.nature.com/nbt/journal/v30/n4/full/nbt.2173.html