07 March 2013

Yvonne D’Arcy Appeals Decision Upholding Patenting of Genes

Cancer definitionOn 4 March 2013 the law firm of Maurice Blackburn filed an appeal to a Full Bench of the Federal Court of Australia, on behalf of cancer survivor Yvonne D’Arcy, challenging the 15 February ruling of Justice Nicholas, in which the court confirmed the patent-eligibility of isolated gene sequences.

The original challenge was launched by Ms D’Arcy, along with Cancer Voices Australia Pty Ltd, asking the Federal Court to revoke 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.

Other claims of the patent, directed to related subject matter such as ‘probes’, ‘cloning vectors’, ‘expression vectors’, ‘transformed host cells’, along with methods of testing and diagnosis, have never been challenged in these proceedings.

The recent decision of the court was therefore directed to a very narrow single issue: whether isolated genes are inherently eligible for patent protection (assuming that they meet all of the other requirements, such as novelty, inventive step, utility and so forth).  Justice Nicholas essentially ruled that since an isolated gene, removed from its natural environment with a cell, and separated from the remainder of a DNA molecule, can only occur as a result of human intervention, it constitutes an ‘artificial state of affairs’ which is eligible, in principle, for patent protection.

Maurice Blackburn principal, Rebecca Gilsenan, who has been running the case from the outset, has been reported stating that the appeal ‘is directed towards saying that having held that the gene is not relevantly different inside or outside the body, it was then an error to say that when it is outside the body it constitutes an artificial state of affairs that is therefore patentable subject matter.’

The appeal has been assigned number NSD 359 of 2013, and has been scheduled for a ‘callover’ on 17 April 2013 before Justice Emmett, at which time it is likely that a date for the appeal hearing will be set.

Irregularities

In contrast with a corresponding case progressing through the US courts (currently pending before the Supreme Court), in which the parties involved, and their interests, have been transparent, the Australian proceeding has been plagued by irregularities and opacity from the outset.

For one thing, the law firm of Maurice Blackburn (slogan: ‘We Fight for Fair’) is best known for handling compensation cases in areas such as personal injury and workplace law.  While it certainly has an interest in social justice matters, it does not claim expertise in any area of intellectual property law – much less the highly specialised field of patent law – among its practice areas.  As I reported at the time of filing of the initial challenge, the case was supported by Dr Luigi Palombi from the Australian National University and Sydney University, and run on a pro bono basis by Maurice Blackburn partner Rebecca Gilsenan and experienced patent barristers David Catterns QC and Peter Cashman.

The original court proceeding was filed in the name of Ms D’Arcy along with Cancer Voices Australia (‘CVA’).  The legal status of CVA is, however, unclear.  The entity had an Australian Business Number (ABN) registered, however this was cancelled on 14 August last year (after the hearing in the original case, but before the decision was issued).  A company Cancer Voices Australia Pty Ltd (ACN 155 467 164) appears to have been registered on 2 February 2012 (shortly before the hearing commenced, but long after the proceeding was filed).  The company was deregistered, also on 14 August 2012.  A New South Wales organisation, Cancer Voices Australia Incorporated, existed from 2006, but was also deregistered in August 2012.

Following cancellation of CVA’s ABN and deregistration of the company, Maurice Blackburn withdrew its representation of CVA in the Federal Court proceedings.  This conveniently avoids any liability to CVA for costs awarded by the court, presumably leaving Ms D’Arcy carrying the can (though I doubt, somehow, that Myriad Genetics Inc will risk the bad publicity that would certainly result if it were to seek to enforce the costs order).

Despite enjoying no formal legal status, CVA continues to exist in the form of ‘spokespeople’, and a website, on which it claims to be ‘the national network of state Cancer Voices organisations representing Australians affected by cancer.’  However, a search of records at the Australian Securities and Investments Commission (ASIC) for organisations including the words ‘cancer voices’ reveals that state bodies exist only in New South Wales and South Australia, with organisations in Queensland, Tasmania and Western Australia all having been deregistered.

Is Yvonne D’Arcy a ‘Puppet’ Litigant?

Ms D’Arcy is, of course, the ‘face’ of the campaign.  She is a highly sympathetic figure, being a grandmother who has survived breast cancer twice, and ovarian cancer once.  Following the judgment, she was reported as being ‘in tears as she left court’, and as saying ‘I'm very disappointed.  We were doing this for future generations, and I'm just so disappointed.’  Upon the announcement of her appeal, Ms D’Arcy has been quoted as vowing that she will not give up the fight, and stating that ‘we need to continue for future generations of people who at some point in their life may need treatment for cancers and other diseases’.

While I do not for one moment doubt Ms D’Arcy’s sincerity, or her commitment to the cause, it is worrying that these statements appear to demonstrate a poor understanding of what is actually at stake in this case.  There is no challenge to the patentability of processes using isolated genes, or other genetic technologies, for testing, diagnosis or treatment.  As I have stated above, and in previous articles, the question before the court is a narrow one – all else aside, can an isolated genetic sequence be patented in principle?  While this is not an unimportant question from a legal perspective, and to the biotechnology and chemical industries generally, the answer will have no impact on the availability or cost in Australia of genetic tests and treatments for breast or ovarian cancers.

The question of whether gene patents will stifle research is also effectively a dead duck in Australia.  The Raising the Bar patent reforms established a statutory defence to infringement of a patent in cases of ‘experimental use’.  In any event, there has never been an actual instance of a patent-holder attempting to sue on the basis of research use of a patented gene in Australia.

Additionally, the Myriad patent is not being actively enforced in Australia, due to a public backlash when Genetic Technologies Limited, the exclusive licensee in Australia, last attempted to charge licence fees to organisations performing genetic tests for the mutant BRCA1 gene.

As for concerns for ‘future generations’, the Myriad BRCA1 patent will expire on 11 August 2015, after which the technologies it discloses and claims will forever belong to the public.  Any other currently existing gene patents will follow suit in less than a single generation.  And advances in technology have made is much harder to establish that isolating a gene and determining its function involves any inventive step any more, so the number of new gene patents that might be validly granted must now be very small.

If Yvonne D’Arcy is aware of any of these facts, it is not apparent from her public appearances and statements.  Ms D’Arcy has had to overcome great challenges in her life, and more power to her for her success.  Unfortunately, however, the only two possibilities that present themselves here are either that she is a terrific actor, or that she is the unwitting puppet of some unseen parties who are pushing their own agenda.

Call for Transparency

I have said before (most recently just last month) that the moral and legal issues around the patenting of human genes are an important subject for public debate, and consideration of possible law reform, if appropriate.  We live in a democracy, after all, and that is how democracy is supposed to work.

However, democracy is not supposed to work (even though it often does) according to the machinations of unseen forces operating in the shadows of media-friendly figureheads.  There is a behind-the-scenes agenda here – indeed, from what I hear it is all largely the work of a handful of individuals with big egos, although one should obviously be careful of putting too much credence in industry gossip!  One thing is pretty clear for anyone to see – Yvonne D’Arcy is not the driving force behind the legal challenge, however willing a participant she may be.  And she almost certainly does not have the financial resources to be pursuing the case by herself, even if many of the legal services have been provided pro bono.  For example, who is paying the Federal Court fees, which will have run into the tens of thousands of dollars by the time the appeal is done?

The case is ostensibly being run for reasons of social justice and public interest.  And yet the public has no idea who is really behind it, and where their interests lie.  The law, and the courts, belong and apply to all of the people of Australia.  We have a right to know who uses them in our name, and why.

If anyone would care to answer, this enquiring mind would like to know:
  1. Is Maurice Blackburn still acting pro bono, and if not, who is paying their fees?
  2. Will David Catterns QC and Peter Cashman be involved in the appeal, and will they (or any alternate counsel) continue to act pro bono?
  3. Is Dr Luigi Palombi continuing to provide input and advice in relation to the proceedings?
  4. Who is paying the Federal Court fees for the appeal?
  5. Who will pay Myriad’s costs of the original proceeding and appeal, if the appeal is unsuccessful, and Myriad elects to enforce the court’s costs orders?
  6. To what extent is Yvonne D’Arcy actually providing instructions to Maurice Blackburn, and if these are limited then on whose instructions is the firm truly acting?
  7. What exactly is the role of the non-existent entity known as Cancer Voices Australia, and/or what part is being played by Cancer Voices South Australia and Cancer Voices New South Wales?
Please, someone, let us all know – the comments system below does not make you provide a real name or contact email if you do not wish to do so!

Image Copyright (c) 123RF Stock Photos

4 comments:

JimC said...

Great article Mark and I'll just add a couple of comments.
1.Federal Court Fees:- If these are being funded by we, the taxpayer, would it not be a matter of Public Record and as such available under the Freedom of Information Act?
2. Was Yvonne D'Arcy assisted in her successful battle against potentially fatal 3-time cancers by taking any of the very tests she is now essentially in dispute against - I've followed the case a little but not read anything on how her own survival came about.
3. The gene patent itself :- as this runs out in 2015 anyway, maybe it'd be a good gesture for Myriad to relinquish it a year early, ie August 2014 ?
All in the interest of Humankind but would also be very good for business to show such selflessness.
4. The lawer firm, Sheridan Ross,successfully represent Genetic Technologies in the US. Their speciality is Patent & Licensing Litigation. Maybe they'd be able to offer some comment on the situation ?

Mark Summerfield said...

Thanks for your comment, Jim.

The court fees I am referring to are the ones payable by the parties in the litigation. There are fees for filing applications and various other documents and requests with the court, and also (I believe) fees payable for each day of appearance. The records would show that Maurice Blackburn paid these fees on behalf of their client. Where the money comes from in the first place is not generally anybody else's business!

Of course, the fees do not cover the costs of operation of the Federal Court, so we taxpayers end up subsidising all civil litigation, as part of the price for living in a civilised society under the rule of law!

As far as I am aware, there are currently no therapies based upon the BRCA genes. They are useful as an early indicator of higher risk, which enables someone known to carry the mutation to be more closely monitored. This enables cancers to be caught early, which in turn improves the prognosis. I do not know whether Ms D'Arcy was tested prior to any diagnosis.

In Australia, the patent is licensed exclusively to Genetic Technologies, which is not actually enforcing or receiving any royalties from other parties conducting the test. Despite this, Myriad did offer to gift the patent to the Australian people, to settle the litigation (see http://blog.patentology.com.au/2010/09/myriad-offers-brca-gene-patent-as-gift.html ). It seems the offer was declined. The challengers wanted their day in court, to try to get all gene patents declared invalid. Myriad is just a means to an end, and settlement is not an option!

Finally, aside from the fact that the Myriad patent is something of a cause celebré, I am unaware of any connection between the Australian and US cases. There are some significant differences between the patent claims at issue, as well as the applicable laws and the approach taken by the courts. I doubt that Sheridan Ross have any insight into the Australian forces arrayed against their client. But even if they do, they would not comment publicly, especially while both cases are still before the courts (the US case is currently on appeal to the Supreme Court).

Cheers.

Mark

Bob Cook-Deegan said...

Please do post what you learn about the background for this case. Will it backfire? Given that the patents have been a "gift to the people of Australia," it does indeed seem there is little practical impact likely to result one way or the other. Despite the short-lived and ill-thought-out effort in 2008 to take back the "gift", it is indeed difficult to see the point of establishing a precedent a year from the expiration of the patent. And by the time the patent expires, the preferred clinical procedure will likely be multi-gene deep sequencing or all-exome or whole-genome sequencing, producing data on all 20+ genes associated with inherited risk of breast and ovarian cancer, not just BRCA1/2. Clearing out infringement liability from such testing is the one possible benefit of eliminating these patent claims, but would other claims be infringed (none of those methods entail probes or PCR primers, but they will by definition entail use of "isolated" nucleic acid molecules)? The orignal very broad method claims (original claims 17 and 18) would look to be infringed by any method of analysis. Are those claims challenged here, or just the composition of matter claims?

Even Myriad/GTG's BRACAnalysis would seem *not* to infringe claims 1-3, since no one makes the entire cDNA needed to encode the BRCA protein in a diagnostic test. The original claim 4 on "a portion of" the full-length DNA or RNA would be infringed, but is it included in the case?


I'm puzzled whether anyone could do BRCA testing without infringement liability even if Cancer Voices/Yvonne D'Arcy prevail.

For those who want good background on the relevant history, see Richard Gold and Julia Carbone: http://www.nature.com/gim/journal/v12/n1s/full/gim2010142a.html

Mark Summerfield said...

Thanks for your comment and insights, Bob.

I will certainly post anything I learn, though so far that is a big fat nothing! If anyone knows anything more, they are not telling me.

However, based on what I know, I agree with everything you say. The only claims being challenged are claims 1-3.

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