The original (unsuccessful) challenge to the patent, owned by Myriad Genetics, Inc along with two co-patentees, was launched by cancer-survivor and ‘gene patent’ opponent Yvonne D’Arcy, along with advocacy group Cancer Voices Australia (which has since disbanded and withdrawn from the case). Ms D’Arcy is seeking revocation of claims 1 to 3 of Australian Patent no. 686004, each of which is directed to ‘an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide…’. Mutations in the BRCA1 gene are correlated with increased breast cancer risk, and can therefore be used as a basis for early detection of a predisposition towards development of cancer.
Corresponding claims in Myriad’s US patent have been found to be ineligible for patent protection by the US Supreme Court. However, the unanimous decision of the five judges sitting as a Full Bench of the Federal Court, which was issued in September last year, made it very clear that the ‘manner of manufacture’ test for patent-eligibility under Australian law is different from the test that applies in the US under 35 USC 101.
According to a media statement issued by Maurice Blackburn – the lawyers representing Ms D’Arcy – a hearing will take place in April. I would therefore expect that a final judgment will issue later in the year.
Why Has the High Court Granted Leave to Appeal?I am a little surprised that the High Court has agreed to take on this appeal. So far six Federal Court judges have looked at the claims in question, and every single one of them has reached the same conclusion: that the isolated genes defined by the claims are patent-eligible in Australia. It is almost inconceivable to me that a majority of the High Court would reach a different view, particularly considering that it was only back in December 2013 that the court upheld the patent-eligibility of methods of medical treatment of human beings by a 4-1 margin.
I assume that the court granted leave on the basis that the patentability of isolated genes is a matter of significant public interest, and that it is therefore desirable that the question be settled once and for all by the highest judicial authority in the land. There will then be no question that if the law is to be changed it will fall to parliament to make that decision. The transcript of the hearing on the application for special leave to appeal will be available in the next few days, and will presumably reveal the court’s reasons for granting leave.
Misinformation Campaign ContinuesIn the meantime, Ms D’Arcy’s lawyers are continuing to spread the misinformation that has characterised this case from the outset. In particular, the firm’s media statement quotes principal lawyer Rebecca Gilsenan saying that ‘It is important that there is legal certainty to allow scientists and others the freedom to study genes without fear of a patent holder taking legal action against them.’
As I have pointed out previously, a review conducted by the Australian Government’s Advisory Council on Intellectual Property (ACIP) in the early 2000’s found absolutely no evidence that patent rights had ever been a factor in restricting research in Australia (see report Patents and Experimental Use, October 2005). Nonetheless, to ensure certainty for researchers going forward, an express experimental use exception to infringement was introduced in April 2012, as part of the Raising the Bar package of IP law reforms.
This is a non-issue – ‘scientists and others’ already have ‘freedom to study’.
Conclusion – Further Disappointment for Yvonne D’Arcy?I am sympathetic to the views of people who are opposed to gene patents on ethical grounds. I am also sympathetic to Ms D’Arcy, whom I believe to be a pawn in a campaign by gene patent opponents who, for the most part, have different motivations and have managed to remain hidden in the background. Maurice Blackburn may be providing its services pro bono, but there are many other expenses in running such complex and high-profile litigation, and it is plainly apparent that Ms D’Arcy is not in a position to cover those costs. My personal view is that the public, whose interests are supposedly being served by the challenge to gene patents, is entitled to know who is paying the bills, and who has indemnified Ms D’Arcy for the costs that will be awarded against her if (or, as I believe, when) she is ultimately unsuccessful.
It is interesting to note that Myriad’s patent will expire on 11 August 2015. The race is therefore on to see whether the High Court can issue a judgment before the patent ceases to be in force. Of course, this case is about the principle, not the specific patent at issue (which is not being enforced in Australia, anyway), so the timing of the judgment is of no practical consequence.
Possibly, however, this will be of great personal importance to Ms D’Arcy. Although she faces further disappointment, in the event that the High Court does not find in her favour, the expiry of the BRCA patent will perhaps be some consolation.