22 February 2012

As Myriad Gene Trial Starts, Are Cancer Advocates Being Misled?

Judging DNAOn Monday 20 February 2012, ‘landmark’ legal action over the patenting of human genetic material got underway before Justice Nicholas in the Federal Court in Sydney.  Hearings are expected to last at least a week, which is quite remarkable for a case which rests entirely upon a single provision of the Australian patent law.  Much of the time will be taken up with scientific testimony from experts called by both sides of the dispute.

We have written before about this case, which will determine whether isolated genetic material is patentable subject matter (i.e. a ‘manner of manufacture’) under Australian law.  (See Myriad Gene Patent Challenged in Australia, More on Australian Gene Patent Challenge, Review: Four Corners – "Body Corporate").

The court application challenging various claim in a patent held by Myriad Genetics, Inc and two co-developers, which is exclusively licensed in Australia to Genetic Technologies Limited, has been brought on a pro bono basis by Maurice Blackburn lawyers on behalf of patient advocacy group Cancer Voices Australia, and breast cancer survivor Yvonne D'Arcy. 

While Maurice Blackburn is better known for its work on compensation claims, it is supported in the patent action by experiences IP barrister David Catterns QC and Professor Peter Cashman of Sydney University.  We understand that Dr Luigi Palombi, who was the principal author of the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which sought to outlaw the patenting of human genes, is also involved.

The patent – which is Australian patent no. 686004 – includes claims directed to isolated genes known as BRCA1, which have been found to exhibit certain mutations in women having an enhanced risk of developing breast and ovarian cancer.  The patent also includes claims directed to a method for diagnosing a predisposition to these cancers based upon testing the BRCA1 gene for the identified mutations.

Our understanding is that only the claims directed to the isolated genes are being challenged.  However, this does not seem entirely consistent with some statements reportedly made this week by Cancer Voices Australia and Ms D’Arcy.  We are therefore caused to wonder whether these advocates have a sound appreciation of exactly what is at stake in the case.

OBJECTIONS TO MYRIAD PATENT

The main concern about the Myriad patent, as expressed by Maurice Blackburn Principal Rebecca Gilsenan, is that:

The granting of the patent means that Myriad Genetics and companies to which it sells licenses - such as Genetic Technologies in Australia - have a right to stop anyone else from isolating, testing, researching or otherwise using [the BRCA1] gene.

Ms Gilsenan has also been quoted in an ABC News article as saying:

There's a philosophical and ethical issue about commercialising the human body and its genetic material.

Beyond that though, there's a practical concern and that is that the patent owner has a right to prevent people from studying and testing for the gene mutation.

Gene patents can have the effect that they stifle research, they can stifle the development of treatments that researchers might otherwise develop and they can impede access to diagnostic testing for that gene mutation.

The ABC article further cites Ms Gilsenan as indicating that the patent monopoly could lead to Australian women paying significant sums of money to test for BRCA1 and 2, which are responsible for up to 10 per cent of cases of breast cancer.

Meanwhile, Ms D’Arcy has been quoted as stating that she does not believe biological material should be used for profit, and:

If you're really sick and its a genetic form of cancer, then everyone female down the line should be able to get the testing done at a price they can afford and if its patented, it won't be.

However, this concern appears somewhat tangential to the issues to be addressed in the present case, considering that the claims directed to the diagnostic test for predisposition to breast and ovarian cancer remain unchallenged.  Whatever the outcome, therefore, Genetic Technologies will retain a potential monopoly on the test, although it has previously bowed to public pressure and undertaken not to enforce the patent in any event.

Executive Director of Cancer Voices Australia, John Stubbs, appears to have a better grasp on the issues at stake in the court proceedings, but when pressed for a sound-bite outside the Federal Court buildings, has been quoted as saying:

More and more research is leading to the genetic diagnosis of cancer.  They are our genes, we want to make sure they and the diagnostic tests that go along with them are protected.

By ‘protected’, we presume that Mr Stubbs means exactly the opposite of what a patent lawyer would understand by the term, i.e. that they are not ‘protected’ for the exclusive use of one patent-holder, but rather are freely available to the general public.  But, again, the patentability of diagnostic tests based upon genetic technology is not, as we understand it, under challenge in the present proceedings.

WILL THE COURT’S DECISION LIBERATE DIAGNOSTIC TESTING?

Cancer advocates, the general public, and indeed all those unfamiliar with the detailed working of the patent system, could be forgiven for thinking that the challenge to the Myriad patent is somehow about ensuring that potentially life-saving tests are widely and cheaply available to all, unencumbered by pesky patent monopolies. 

Of course this is a desirable result, but denying patent protection to those companies that invest large sums of money in developing such tests is not the appropriate mechanism for achieving this outcome.  In Australia, we already have a perfectly workable system for providing affordable healthcare, including government subsidies under the Pharmaceutical Benefits Scheme, which has been making approved patented drugs affordable to all Australians for many years. 

However, liberating the diagnostic test for the shackles of Myriad’s patent monopoly is not an available outcome from the case, which is directed only to the validity of the claims directed to the isolated gene sequence.  So even if the challenge succeeds, it may leave some people feeling let down and misled when they realise that nothing has changed regarding Myriad’s potential monopoly over testing.

PARALLEL US LITIGATION

Last July, in a decision relating to an equivalent US patent held by Myriad, the US Court of Appeals for the Federal Circuit (CAFC) ruled that patent claims directed to ‘isolated’ DNA molecules cover patent-eligible subject matter under 35 USC §101 (i.e. the US counterpart to Australia’s ‘manner of manufacture’ test) because ‘the molecules as claimed do not exist in nature.’  (See US Appeals Court Rules Isolated Genes Patentable).  The challenging parties in the US case, The Association for Molecular Pathology and other interested groups and individuals, are in the process of asking the US Supreme Court to agree to hear an appeal of that decision.

ECONOMIC VERSUS ETHICAL OBJECTIONS

Patenting of genetic materials, and related procedures, processes and tests, remains contentious.  However, the impression that we have is that for many opponents of so-called ‘gene patents’ the objections are more substantially of a moral character, rather than economic.  Certainly a patent monopoly enables a patentee to maintain higher prices than might be the case with free competition, but this is the price we pay as a society of providing an incentive for companies to invest in expensive and risky medical research.  Other mechanisms exist to address issues of equitable access to healthcare.

We have no real issue with people having moral or ethical objections to the patenting of certain subject matter, and indeed this is a genuine issue worthy of intelligent public discussion (see Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously).  However, it might be more productive if people were to be up-front about their real concerns.  Presenting the argument as being economic (i.e. the availability and cost of testing) rather than ethical (i.e. a deeply-held conviction that there is something inherently wrong with a company holding a monopoly over use of genetic material) is not helpful in building a constructive dialogue. 

Patent professionals, and policy-makers, are very good at arguing the economic case.  Getting them to confront ethical issues – or even, in some cases, to admit that these exist – is a more difficult proposition.  Yet it needs to be done.

‘SPECIAL’ MOLECULES

The fact is that, for many people, the molecules that store our individual genetic code are special and unique, and cannot therefore be treated in the same manner as other molecules. Where there would be no objection to a patent claiming a molecule that had been found to have useful pharmacological properties, a different arrangement of atoms that has also been found to have valuable medical applications, but which happens to be a fragment of somebody’s DNA is, for some at least, a different matter.

The decision of the Federal Court in the Myriad case will determine whether the current Australian patent law is equipped to make the same distinction.  We do not think that it is, nor are we sure that it should be, however we know that there are many with a different view.

4 comments:

ozvic said...

Just because a company spends (possibly lots of) money on research should that make a discovery patentable? I believe the American judge's argument was was continually along those lines "but they spent so much money!". I believe the medical Institute in the USA couldn't even vary their doses to benefit patients because of 'license or patent infringement'!

Patentology (Mark Summerfield) said...

There's no particular reason why anything should be patentable, except that the legislature makes it so.  There is nothing new about a 'discovery' being patentable, so long as the applicant has identified at least one practical application of that discovery.  The real issue is over how broad the resulting patent right should be.

Since we are not in the United States, we cannot point to a constitution and argue that allowing patents on certain subject matter fails the test of 'promoting science and the useful arts'.  We have a patent law for the same reason the English first passed the Statute of Monopolies in 1623, which is to provide only limited circumstances in which a monopoly might be tolerated, in furtherance of economic policy objectives.

So if we believe that, on balance, our society will be better off if companies spend a lot of money on research, and we want to provide an incentive for them to do so, then that may be sufficient justification for permitting patents to be granted on the results, even if they are classified as 'discoveries'.

This is a perfectly legitimate topic for public debate.  In a democracy, the people have a right to be heard on important issues.  The problem at the moment, as I see it, is that the real motivations behind the Myriad court action are not necessarily those that are being presented to the public, or even to those who are being held up as the public faces of this campaign.

You might wonder why the politicians who get behind the anti-gene-patents movement tend to be associated with the religious right if, in fact, the issue is primarily the social cost of overpriced diagnostic tests, i.e. concerns that we might more normally associate with the left of politics.  You might otherwise expect that the conservative side of politics would be more inclined towards a position of rewarding investment in research through a 'user pays' model.

But these are strange times, and politics, as always, makes strange bedfellows.  Hopefully the court will be above all that!

Ricardonest said...

If it considered a non-patentable innovation, then what will happen to the already existing patents for gene engineering? I only ask because there is like over 8,000 patents related to human engineered genes in the US (you can see the number of gene patents here: http://bit.ly/AmCkZf ).  

Patentology (Mark Summerfield) said...

If the court rules that isolated genes cannot be patented, it will effectively be deciding that the Patent Office was wrong to have been granting such claims for many years.  Many similar types of claims in existing patents will be invalid, and thus unenforceable.

However, the Myriad patent, and many other genetic-technology patents like it, include claims that are directed to specific uses of the genetic discoveries, such as diagnostic testing, gene engineering, and so forth.  None of these types of claims will automatically become invalid because of any ruling in this case.  Just because some claims of a patent might be invalid does not necessarily invalidate the entire patent.

Any decision issued by Justice Nicholas is subject to an appeal to the Full Federal Court, and a Full Court decision is potentially appealable to the High Court, should it agree to hear the case.  The principle at stake here is important to both sides, and it is the kind of legal question that the High Court might well consider significant enough to take on.  So there is a very real possibility that this case could go all the way, so it could be some time before we have a final answer.

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