The gene patent controversy continues to enjoy political momentum in Australia, despite some recent indications that it may have been placed on the backburner. Significantly for companies involved in the development of genetic technologies, the case against gene patents appears to be gaining the upper hand in the ongoing public debate.
Following controversial moves by Australian company Genetic Technologies Limited, which holds an exclusive licence to the Myriad Genetics Inc patent covering the BRCA “breast cancer” genes, a Senate enquiry into gene patents and their effects on the Australian people was established in 2009. Notably, certain US members of this same patent family were the subject of a partially successful challenge by the Association for Molecular Pathology earlier this year in the Federal Court for the Southern District of New York (currently on appeal to the US Court of Appeals for the Federal Circuit). The Australian patent is currently the subject of a similar challenge, brought by lawyers on behalf of national consumer organisation Cancer Voices Australia and a Brisbane woman with breast cancer.
The Senate committee was originally due to report on the last parliamentary sitting day of 2009; however, this was extended three times until 2nd September 2010. An early federal election was called before the extended reporting date, in response to which the committee issued a brief report stating that it was "unable to provide a comprehensive report at this time" and would "reconsider the issues of this inquiry in the event that it is re-referred to the committee in the new parliament".
This report, and the preceding time extensions, gave the impression that the committee was having great difficulty in arriving at any meaningful conclusions or recommendations. The subsequent close election has resulted in a minority Labour government. Given the various competing interests of the members of Parliament, and other, higher-profile issues occupying public attention, it seemed quite possible that gene patents might disappear from the agenda altogether.
Recent developments in the public debate
On 6th September 2010 the Australian Broadcasting Corporation investigative journalism programme Four Corners aired a report entitled "Body Corporate", pitched as "the story of the battle that will decide who owns your body and the biological building blocks that make you the person that you are". The story appears to have been prompted, at least in part, by the challenges to the Myriad patents in the United States and Australia, and gave significant weight to the anti-gene patent side of the debate.
On 2nd November 2010 the honourable member for the federal seat of Wentworth (and former leader of the opposition and current shadow minister for communications and broadband), Malcolm Turnbull, contributed an opinion piece to the Melbourne Age newspaper entitled "Humanity Fights for Ownership of its Soul" (available at www.theage.com.au/opinion/society-and-culture/humanity-fights-for-ownership-of-its-soul-20101102-17c9d.html).
Acknowledging that "the patenting of genes is not the highest profile political issue today", Turnbull argued that while "there is plenty of potential for people to develop and patent innovative tests and therapies… the underlying genetic code must be public property", advocating that "this reform is something on which we should be able to find a common ground and speedily amend our patent laws to ensure nobody can own a part of us".
Turnbull appears to be stepping outside his areas of expertise (and his portfolio) in commenting on the gene patents issue. His article was presented in his capacity as member of Parliament for Wentworth, and therefore perhaps represents his personal opinion on the matter or views that have been expressed to him by constituents.
There is much to criticise in Turnbull's article, regardless of one's views on the issue. A number of his arguments are based on unjustified hyperbole, flawed logic and inaccurate "facts", which do nothing to advance informed debate or the cause of those who agree with his general conclusion that isolated “naturally occurring” genes should not be patentable.
Turnbull argues that genes are "discoveries", and therefore not "inventions", despite the fact that no such bright-line distinction exists in the test for patentable subject matter under Australian law (and completely ignoring the express provision in the corresponding US law, 35 USC 101, that "whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter" shall be entitled to a patent).
His argument that "there is plenty of potential for people to develop and patent innovative tests and therapies" also fails to justify a blanket exclusion on patenting of isolated genes. For example, the steps of a test or therapy may be known in the prior art, such that the novel contribution lies not in the development of the test or therapy, but rather in the discovery of a function and use of the gene and the applicability of the known method. As Turnbull would have it, a company responsible for such a discovery and its subsequent commercialisation would not be entitled to any protection for its investment.
While the question of whether patents stifle or encourage research will always be controversial (not least because, depending on specific circumstances and points of view, they can do both), Turnbull sides with a "chorus of medical scientists" who consider that there would be more research freedom in the absence of gene patents. However, he provides no justification for this position; nor does he appear to consider the possible consequences for corporate investment in both public and private research.
Finally, Turnbull quotes from the Gospel of Mark to imply a connection between allowing corporations to "own" our genes and selling our souls. Of course, this kind of religious appeal is irrelevant and unhelpful. Exclusions from patentability based on moral or ethical considerations are generally made in order to avoid providing a monopoly incentive to invest in developments that society does not wish to encourage (eg, human cloning). In this case, both sides of the debate are in favour of providing the best opportunities for development of new genetic tests and therapies. The disagreement is over how this might best be achieved, rather than its desirability. In almost all other fields of economic endeavour the current public policy position is that there is a role for patent monopolies, and there appears not to be a convincing case to establish that genetic technologies are exceptional in this regard.
Possible consequences for gene patentability
Turnbull is a prominent politician whose views on this matter may well be influential within opposition party ranks. It is also likely that the Greens and the Independents, who currently hold the balance of power in both houses of Parliament, would be inclined to side against gene patents should the issue of amending the Patents Act ever come up for formal debate. The case in favour of gene patents has not been clearly articulated and does not have high visibility in any public forum at this stage.
Overall, if the proponents of excluding isolated genes from patentability continue to make their case in public and in Parliament, there is a very real possibility that they will ultimately succeed in outlawing gene patents. Stakeholders that would be adversely affected by such a result should join in the public debate and ensure that their views are made known persuasively to Parliament and the wider population.
This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.