Gene patent debate in Australia — into injury time?

By Peter Kerr 29/02/2012 6


A guest blog – Doug Calhoun’s recent sticK blog on potentially crippling effects of intended patent law changes (see here) encouraged some healthy discussion (including on SciBlogs). In the interests of helping to ensure that upcoming legislation gets it right for New Zealand, Doug continues to enlighten.

The opponents of gene patents in Australia are a determined lot. Having failed in their attempts to persuade senators (twice) and an advisory committee that gene patents should be banned – they are continuing with their case in the Australian courts.

The debate on gene patents has been aired three times on SciBlogs’ Code for Life blog, see here, here, and here:

As Grant Jacobs noted (in a comment added to his third post on 21 February) the validity of the Australian patent (equivalent to those being contested in the US) was being tested in a courtroom. The outcome will be known in a few weeks (months).

(I apologise for hijacking Grant’s blog with a couple of lengthy comments I made on his third post. But readers interested in the topic might find them a useful background to this post.)

Over nearly 2 years the Australian senate Community Affairs Committee considered the broader social consequences of gene patents before issuing its report in November 2010. While the committee expressed its frustration that it did not have much hard evidence about gene patents and their relevance to the delivery of diagnostic testing, it did not find any systematic adverse effects. It therefore did not recommend any outright ban of gene patents.

The link to that inquiry is here:

Not to be deterred, Senator Heffernan and his followers introduced a bill into the senate (the day after the first report was published) that would have banned patents for ‘biological materials’ that were substantially the same as those materials found in nature. That very sweeping ban would not only have caught human DNA sequences but inventions such as microorganisms, non-human DNA sequences, proteins and many others – that have been patented in Australia since the modern biotechnology industry came into flower.

There were a total of 120 written submissions on that bill made to the Legal and Constitutional Affairs committee of which 37 were in favour, 78 were against and the remainder either confidential or neither clearly for or against. There were two days of oral hearings. The majority of that committee recommended against the bill proceeding.

The link to all the material of that inquiry is here:

At the same time, the Advisory Committee on Intellectual Property (ACIP) was conducting its own much broader review of what ought to be patentable subject matter in Australia. Naturally, in the course of their deliberations they considered the patentability of DNA sequences as well. ACIP recommended that there should be no exclusions of any specific subject matter from being eligible for patents. Rather they recommended (in February 2011) that the existing definition, ‘manner of manufacture’, should be replaced by the contemporary wording ‘an artificially created state of affairs in the field of economic endeavour.’

The link to that review is here:

And in November 2011 the Australian government reacted both to the challenges put to it by the first senate committee and to the recommendations made by ACIP. Its response to the main ACIP recommendation was:

‘The Government accepts these recommendations in principle, and will develop legislation to define patentable subject matter using clear and contemporary language. The Government recognises the important role of patents in commercialising health research and the need to provide industry with certainty within the patent system. The development of this legislation will be subject to considered and comprehensive public consultation. This will enable an opportunity to consider benefits and impacts on the health sector.’

The link to that report is here:

So the opponents of gene patents will have a challenging time persuading the court that two senate committees and ACIP got it wrong. And if the court were to rule in their favour, the government has signalled that it does not intend to ban gene patents in its proposed changes to the law.

Looking at it from a New Zealand point of view it is apparent that the policy review process involved in changing Australian patent law is a far more exhaustive and inclusive than is the case in New Zealand. The Senate Community Affairs Committee hinted that the review process was so comprehensive that it had become paralysis by analysis — but now that log jamb is to be broken if the government’s intention becomes action.

~ Doug Calhoun
IP Mentor


6 Responses to “Gene patent debate in Australia — into injury time?”

  • Doug,

    Excuse me for belabouring a point or two, but I suspect you have misread what I was saying. I was not suggesting you were hijacking my blog.

    For clarity: I when I wrote in a comment on my blog that “you might have more luck if you offered your thoughts to readers in general rather than just me” I wasn’t meaning to suggest that you write in another forum, as you have done here, but that you might have more luck engaging with readers on my blog rather than just me, who your comments were addressed to, as I was too busy at that point have the time to address a topic that needs some thought and precision. As I wrote at the time “As much as I’d like to I haven’t time to “defend” myself, which leaves me a little frustrated.”

    I increasingly feel your position is less than neutral – you appear to be championing a particular viewpoint. I think it would be helpful for readers to know that Doug previously wrote on my blog that:

    “The government accepted the 2001 GM Royal Commission’s recommendation that there should be no ban on the patenting of isolated DNA sequences. (Disclosure of interest – I appeared before the Commission and advocated in favour of that recommendation.)”

    [My emphasis added.]

    I’m still fairly busy. When I have time I will try write something explaining my position. (No promises, but I will try. I’ll likely use an article on my blog as it will likely be a bit long for a comment—I tend to be wordy!—and it may be useful to include illustrations, which I can’t do in comments.)

    That said, two quick comments. You wrote

    “That very sweeping ban would not only have caught human DNA sequences but inventions such as microorganisms, non-human DNA sequences, proteins and many others – that have been patented in Australia since the modern biotechnology industry came into flower”

    This, to my reading, conflates DNA sequences with ‘things’, something I tried to suggest to you needs care: “it might pay to be careful about considering the DNA molecule and it’s sequence to be conceptually the same thing.” Furthermore, I’d like to note that just because something has been done for some time, or for other purposes, doesn’t in itself make it right! 😉

    (I’d also like to add I’ve already said my objections are not related to the DNA sequences being human: “My own concerns are based on [the] science involved and the general area of industry (of gene-based diagnosis). That human genes are involved is not ‘of the essence’.”)

    “The debate on gene patents”

    I believe this should more correctly read “The debate on the Myriad Genetics BRCA gene patents”, although the impact of that case may be broader.

  • Grant,

    Thank you for your explanation. My intention is to engage with other commentators – but that is a bit tricky when no one else is commenting! But I look forward to when you have a bit more time to put your thoughts together.

    While the court case is specifically about one Australian patent for BRCA gene sequences, it is apparent from the senate hearings, the ACIP inquiry, the US Patent Office hearings and the commentary on the internet and elsewhere that the Myriad gene patents are a test case for a much broader debate. The focal point of that debate is gene patents in general, but it is my impression that the gene patent debate is a proxy for a debate on the value of patents in general. My motivation is that I have been a card-carrying member of a profession that services the patent industry for most of my adult life.

    The dilemma I face is captured in the question posed by Alison Campbell:

    “How far should scientists, & those who communicate about science, go in ‘pushing’ against strongly-held beliefs? (These could include creationism, but also beliefs about ‘alternative therapies’ such as homeopathy & TCM.)”

    in her 21 February post:

    https://sciblogs.co.nz/bioblog/2012/02/21/here-be-dragons/

    Like Alison and the commentators, I’m not sure what the answer is – but I don’t think remaining on the sidelines is helpful. So I am tying to explain where patents fit into the broader scheme of things. Patent attorneys tend to become very engaged with what they are doing, and if they are not careful can get caught up on a treadmill of doing what they have to do without thinking beyond that. Retirement has a wonderful way of allowing you to lift your horizons!

    During the GM Royal Commission inquiry, many of those who held strong beliefs against genetic modification also expressed strong opposition to the concept of patenting “genes”. And some of their views on what was being patented and what were the legal effects of patents – were based on beliefs that either did not know of or ignored the checks and balances that exist in a patent system. My evidence to the Commission attempted to outline those checks and balances and how they applied to the concerns expressed by other witnesses.

    Your concern:

    “This, to my reading, conflates DNA sequences with ‘things’, something I tried to suggest to you needs care: “it might pay to be careful about considering the DNA molecule and it’s sequence to be conceptually the same thing.” Furthermore, I’d like to note that just because something has been done for some time, or for other purposes, doesn’t in itself make it right! ;-)”

    deserves an answer. Judge Bryson, as you noted, agreed with you and dressed up that belief in the conventional legal mumbo jumbo that many (with justification) find impenetrable. Judge Moore, in her judgement, more or less agreed with you, but looked at the consequences to a biotechnology industry that has invested billions of dollars with the belief that gene sequences are patentable. That consideration trumped the ethical one. Judge Lourie ignored the concern you have expressed.

    At least one patent blogger has expressed some sympathy with your comment. The blogger is Mark Summerfield. What he has stated is:

    “Many IP professionals (and we freely admit that we are far from being immune to this criticism) believe that these types of ethical concerns are irrelevant to the patent law, and therefore need not be taken seriously.”

    The full post is at:

    http://blog.patentology.com.au/2011/05/why-ip-professionals-must-take-gene.html

    So blog readers – keep those (digital) cards and letters coming.

    Doug

  • The area of what is and isn’t (should/shouldn’t be) patentable is a critical element in advancing innovation – noting that innovation is more than creativity; it is the process of turning new ideas into wealth.

    I for one am glad to see Doug engaging with the wider sci-tech and business communities to enlighten us on the arguments each way. Too often the patent legal fraternity keep their debates to their peers.

    It is my view that New Zealanders at all levels are especially naive in understanding the tools of intellectual property, including patents, and their criticality in converting our highly creative society into a markedly more prosperous one. I infer that this naivety has allowed successive governments to be complacent in transacting patent laws appropriate for today’s science and technology and our business environment.

    That we are still operating patent law that was written in 1953 is laughable; little wonder it struggles to cope with concepts like computing and gene technologies, technologies totally unknown when the law was written. Successive governments agree that patent reform is well overdue, yet accord no urgency to transacting its implementation. It is ironic that the (current) intention to reform was conceived at the end of last century (August 2000, yes I am one who asserts that the century starts at “1”), was released as a consultation draft in 2004, was then “consulted on” for at least four years, and has subsequently lain languishing totally unattended for two years awaiting its second reading. The elapsed time since the need for patent reform was triggered by MED amounts to 12 years and spans five government terms. This must be the longest gestation and birthing process in the history of the world!

    Ironically social law is tinkered with every term of government, but our parliamentary representatives do not see the same urgency in streamlining the patent law as the primary legal component of effecting innovation.

    I can only conclude that our elected representatives don’t “get” innovation, or that we as a society do not motivate them to be interested.

    Anyway, thank you Doug for rattling the cage and for triggering a debate in the sci-tech community at least. Here’s hoping that in turn leads to some action in actually enacting effective patent reform by our elected reps.

  • UPDATE

    The US Court of Appeal of the Federal Circuit has set a timetable for the rehearing of the American gene patent case. The details are here:

    http://www.patentlyo.com/patent/2012/04/gene-patent-debate-returns-to-the-federal-circuit.html

    The hearing on the challenge to the validity of the equivalent Australian patent wound up on 24 February. The decision had not been published as of the end of April:

    https://www.comcourts.gov.au/file/Federal/P/NSD643/2010/actions

  • […] The case was solely about whether or not the isolated nucleic acids claimed were “manners of manufacture” as required under the Australian Patents Act 1990. It was not about policy issues, such as access to medicines, or what the law ought to be in future. I discussed these issues in an earlier post: […]