Myriad Genetics Inc. ("Myriad") owns Australian Patent Number 686004 which includes claims to an isolated nucleic acid (e.g., DNA or RNA) encoding mutant or polymorphic BRCA1 polypeptides, as well as claims to methods for diagnosing a predisposition for breast or ovarian cancer by detecting the mutant nucleic acid. Related US patents held by Myriad are subject to well publicised litigation pending before the US Supreme Court.
In Australia, Cancer Voices Australia and cancer sufferer Yvonne D'Arcy challenged the patent arguing that claims defining isolated nucleic acids ("the disputed claims") related to unpatentable subject matter (i.e., not a "Manner of Manufacture"). The method of diagnosing cancer claims were not challenged.
The decision in this case was handed down by Justice Nicholas on 15 February 2013 (Cancer Voices Australia v Myriad Genetics, Inc  FCA 65).
Justice Nicholas made it very clear in his decision that the only question presented to him was whether the claims defining isolated nucleic acid encoding mutant/polymorphic BRCA1 related to a Manner of Manufacture under Australian law.
The Consideration and Decision
Under Australian practice, an invention is considered to satisfy the requirement of being a Manner of Manufacture if it defines (i) an artificially created state of affairs, and (ii) in a field of economic endeavour (1). The second requirement was not disputed, meaning that the only question related to whether the disputed claims defined an "artificially created state of affairs".
Justice Nicholas made what he considered some important points regarding the claims:
- The disputed claims are not to genetic information per se;
- The disputed claims are to â€œa chemical compositionâ€; and
- "[B]ecause each of the disputed claims is to an isolated chemical composition, naturally occurring DNA and RNA as they exist in cell [sic] are not within the scope of any of the disputed claims and could never, at least until they have been isolated, result in infringement of any such claim" (emphasis in original).
It was held that claims defining isolated nucleic acid define patentable subject matter in Australia because:
- Australian courts apply an expansive definition of what is a Manner of Manufacture;
- Without human intervention, naturally occurring nucleic acids do not exist outside the cell, and â€œisolated nucleic acid does not exist inside the cell; and
- It would be a mistake and inconsistent with the purpose of the Patents Act and previous decisions to exclude from patentability subject matter that was the result of skill and effort and that was practically useful and economically significant.
The Judge also highlighted that there had been previous Government inquiries which addressed whether isolated genes should be excluded from patentability which all recommended that such an exclusion not be made. In addition, it was recognised that the Australian Government accepted recommendations to increase patentability thresholds and to introduce a new "experimental use" defence (2).
The decision affirms the long standing practice of the Australian Patent Office of granting patents claiming isolated nucleic acids.
Cancer Voices Australia and/or Yvonne D'Arcy may still appeal the decision by a deadline of 15 March 2013.
There is also the possibility that the "gene patenting debate" will be re-invigorated once again in the Australian Parliament. However, with the count down to the Australian Federal election to be held on 14 September 2013 having begun, presumably Australian politicians will be distracted by other issues in the short term.
(1) National Research Development Corporation v Commissioner of Patents  HCA 67; (1959) 102 CLR 252
(2) Experimenters breathe a sigh of relief; Intellectual Property Laws Amendment (Raising the Bar) Act