09 November 2010

Gene Patents Back on the Australian Political Agenda

It appears that the issue of so-called "gene patents" is maintaining some political momentum in Australia.  We had thought that it might fall by the wayside when the Senate Committee considering the issue declined to deliver a comprehensive report following the calling of the Federal election, which then resulted in a hung parliament and the formation of a minority government.  However, it seems that we may have been wrong!

By way of background, we have previously reported on the Myriad cases in Australia and the US (here, here and here), on the Australian Senate enquiry into gene patents (here) and its demise (here), on opinion in the Australian press (here), and on the coverage of this issue on the ABC's Four Corners program (here, here and here).

SHADOW MINISTER WEIGHS IN

Last week, the Honourable Member for the Federal seat of Wentworth (also former leader of the Opposition, and current Shadow Minister for Communications and Broadband), Malcolm Turnbull, contributed an opinion piece to the Melbourne Age newspaper, dramatically entitled Humanity Fights for Ownership of its Soul

Earlier in the week the Age had republished a New York Times report on the amicus brief filed by the US Department of Justice in the Federal Circuit appeal of Association for Molecular Pathology v USPTO (ie the US Myriad BRCA gene patent case), arguing against the patentability of isolated genomic DNA sequences.  For a more informed discussion than we are able to provide of the implications of the DOJ intervention in this case, we suggest this article from the PharmaPatents blog.

In any event, the issue of whether or not genes should be patentable remains in the public eye, and is continuing to receive political and media attention.

As far as we are aware, Turnbull is stepping outside his areas of expertise (and his portfolio) in commenting on the gene patents issue.  His article is presented in his capacity as MP for Wentworth, and therefore represents perhaps 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.  Arguments based upon unjustified hyperbole, flawed logic and inaccurate "facts" do nothing to advance informed debate, or the cause of those who agree with Turnbull's general conclusion that isolated "naturally-occurring" genes should not be patentable.

"INVENTION" vs "DISCOVERY"

Turnbull argues that "...an invention is different from a discovery.  When we discover something new in nature we cannot claim to have invented it.  Newton did not invent gravity any more than Marie Curie invented radium."  It is clear, however, that this appealing colloquial use of the term "invention" differs from its meaning in patent law.  We should not forget that 35 USC 101 provides that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter..." shall be entitled to a patent, assuming that the other requirements of Title 35 (eg novelty, nonobviousness, and so forth) are satisfied.  Patentability arises out of a nexus between inventing or discovering something, and devising a novel practical (ie "new and useful") application.

The corresponding provision of the Australian Patents Act 1990, requiring a patentable invention to be a "manner of manufacture", has similarly never drawn a "bright line" between "invention" and "discovery" across all fields of human endeavour.  Pharmaceutical compounds are a clear case in point, where it is now largely uncontroversial that the discovery of a new therapeutic application for a molecule, whether that molecule was previously known and/or naturally-occurring or not, entitles the discoverer to a patent on the molecule for at least the purpose of the new therapy, but possibly (depending upon the circumstances) more broadly.

IS IT ENOUGH TO ALLOW PATENTS ONLY ON "TESTS" AND "THERAPIES"?

In this context, much of Turnbull's argument falls down, as can be seen by drawing a simple analogy between gene therapies and conventional chemical treatments.  For example, he contends that "[t]here is plenty of potential for people to develop and patent innovative tests and therapies, but the underlying genetic code must be public property."  The chemical analogy would be that "there is plenty of potential for people to develop and patent innovative drug synthesis and delivery techniques, but the underlying molecule must be public property."  This is demonstrably untrue. 

A new drug might be made commercially by known (and therefore unpatentable) synthesis methods, and delivered in a conventional manner (eg as a known pill/formulation or via injection).  Its value as a new therapy is independent of whether or not a novel synthesis or method of delivery must be developed.  Similarly, a method of genetic testing or therapy based on a newly identified and isolated gene may be identical with those used in relation to previously isolated genes.  Turnbull would deny the developers of such tests and therapies any patent protection as a return on their investment.

DO PATENTS STIFLE OR ENCOURAGE RESEARCH?

Turnbull's main problem seems to lie with his acceptance of the argument that allowing patents on isolated genes potentially stifles the use of those genes in research that may lead to the development of still further tests and therapies with positive public health benefits.  While this may sometimes be true, it is not apparent that it provides a basis for denying protection to an entire class of inventions.  We should not forget that while basic research may lead to an initial invention or discovery, any new medical treatment or therapy may require years of further development and trial before it is approved for wider use on human patients.  This work is generally not conducted, or paid for, by the "medical scientists" cited by Turnbull as leading a "chorus of opposition" to the contrary argument that removing patent protection would stifle research.  Regardless of the impact on medical scientists' freedoms, it is difficult to imagine that denying patents would not result in a reduction in private investment and funding, not only of clinical trials, but also of more basic public research.

Turnbull does not discuss any alternatives to an exclusion on patentability in order to address the research "problem", to the extent that it exists.  What about an exception to infringement for research purposes?  Or (at least for publicly-funded research) some form of compulsory licensing regime?

APPEAL TO RELIGIOUS TEXTS UNHELPFUL

Perhaps, after all, Turnbull's true motivation is to be found in his concluding paragraph:

But for all of the scientific progress there remains a mystery at the heart of every organism. Reflecting on this, I turned up the passage in Mark where Jesus asks: "For what shall it profit a man, if he shall gain the whole world, and lose his own soul?" But it is the next line that reaches across time to touch this issue. "Or what shall a man give in exchange for his soul?"
This kind of religious appeal is utterly unhelpful.  If we do have souls, as many believe, they cannot be encoded in our DNA, otherwise they would be no more immortal than our bodies, once we have turned to dust.  And, in any event, we do not infringe any patent granted on isolated DNA sequences merely by existing with corresponding genes encoded in our own cells.  A "gene patent" does not grant its proprietor "ownership", in any meaningful way, over any part of our selves.  The ability to prevent any one of us from sourcing a cheap, unauthorised, genetic test or therapy, to the economic detriment of the patentee who developed it (whether by "invention" or "discovery") is no greater (or lesser) a right than is conferred by any other patent monopoly.

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