08 May 2011

Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously

Professor Andrew Christie, who holds the Davies Collison Cave Chair of Intellectual Property at the University of Melbourne Law School, has been touring the country with his seminar Beyond Genes: What should and should not be patented and how to tell the difference

We were present at a packed house in Melbourne last week, and found it to be a most thought-provoking presentation.

Professor Christie is no supporter of the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which seeks to exclude biological materials which are ‘identical or substantially identical to such materials as they exist in nature’ from patentability.  He is one of the many opponents of the Bill who have made submissions to the Senate Enquiry (as previously reported here and here).  Professor Christie’s submission is available from the Senate Committee’s web page, in which he argues that:

The Bill does too little in the sense that it does not achieve its primary stated aim [i.e. to reinforce the applicability of a distinction between ‘discovery’ and ‘invention’]. The Bill does too much in the sense that it is likely to have a practical effect beyond (and possibly inconsistent with) its stated aim – i.e. have unintended consequences.

However, Professor Christie made it very clear that he believes that many of the key stakeholders in the Australian patent system – including members of the IP professions, such as IP lawyers and patent attorneys – should accept a fair share of the blame for the adverse publicity that the patent system has received in recent months (see, e.g., Review: Four Corners – "Body Corporate" and Gene Patents Back on the Australian Political Agenda), culminating in the introduction of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 into both houses of the Australian parliament.

ENGAGING WITH CRITICS OF ‘GENE PATENTS’

The Senate Committee conducting the enquiry into the ‘gene patents’ Bill has received 110 submissions from interested parties, most of whom are stakeholders in the patent system as end users, professional advisors, or administrators of the system.  An overwhelming majority of the submissions are opposed to the specific form of the Bill.  However, quite a number of these opponents are either wholly or partly supportive of the intent of the Bill.

Objections to the patenting of particular subject matter, as Professor Christie pointed out in his presentation, broadly fall into one of two categories.  The first category is economic, typically characterised by contentions such as that patents:
  1. unduly stifle competition;
  2. lead to higher prices;
  3. limit community access to technologies that are socially beneficial;
  4. are unnecessary in the field in question because innovation will occur anyway, even without a patent incentive; and/or
  5. actually reduce innovation by limiting competitors’ freedom to innovate.
By and large, IP professionals do a good job of engaging with these types of concerns.  This excerpt from the submission to the Senate Enquiry by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) is typical:

The concerns expressed by the community in relation to the risk that abusive monopolistic behaviour, stemming from the existence of patent rights, could proceed unchecked are legitimate concerns which must be seriously considered and appropriately addressed.

However, IP professionals do not engage so well when it comes to the second category of objections, which are ethical concerns.  Those who hold such concerns are often unable to articulate them any more clearly than as a general belief that certain things are ‘wrong’, for example:
  1. it is wrong for commercial entities to ‘own’ human genes;
  2. it is wrong for a company to use a patent to prevent women from gaining access to a genetic test that might enable an early diagnosis of breast cancer; or
  3. it is wrong to allow someone to obtain a monopoly over something that already exists in nature.
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 sentences following the one quoted above, in the IPTA submission to the Senate Enquiry, tellingly state:

However, dealing effectively with this issue is difficult within the context of the highly charged, emotive debate which has occurred to date. What is therefore now required is a sensible and responsible debate which is followed by a response that is enshrined in law, well understood, based on rational analysis…

In effect, IPTA is stating that there are reasonable, rational concerns of the community, primarily of the type that can be expressed and addressed in economic terms, and that these need to be taken seriously.  On the other hand, there are emotional, irrational views, perhaps those primarily driven by ethical concerns, which need to be set aside so that we can have a ‘sensible and responsible’ discussion about the issues. 

The problem with this attitude is that members of the community who have strong ethical convictions do not appreciate having their concerns dismissed, or their opinions ignored, on the basis that they are supposedly insufficiently well-informed about the rational basis of the patent system.

As Professor Christie pointed out in his presentation, it is no answer to a genuinely-felt concern to tell someone that if they only understood the patent system properly (as, of course,  we all do), then they would realise that their concern is unfounded.  At best this is unhelpful.  At worst it is offensive and condescending.

DO ‘ETHICAL CONCERNS’ BELONG IN PATENT LAW?

If you had asked us a few weeks ago, we might have told you that the Patents Act is no place for provisions based on ethical concerns.  We are on-record on this blog calling the proposal for an ‘ethical exclusion’ in the the recent Advisory Council on Intellectual Property (ACIP) review of Patentable Subject Matter (chaired by Professor Christie) ‘unnecessary, wasteful and impractical’ (ACIP Reports on ‘Patentable Subject Matter’).  We rejected ACIP’s contention that an ‘ethical exclusion’ is required because patenting ‘condones the invention’ or may ‘bring the patent system into disrepute.’

We now confess that we may have been a little hasty in passing judgement on this recommendation.  If you delete the word ‘patent’ from the above question, it becomes simply ‘do ethical concerns belong in law?’  Well, of course they do.  Why do we have a legal age of consent?  How do we decide which acts should be considered ‘criminal’?  Why do we have laws restricting publication in the media of the names of minors?  It is because, although each one of us individually might draw the lines slightly differently, as a society we are broadly in agreement that these are all issues in relation to which we can identify ‘right’ and ‘wrong’, and provide protections for the ‘wronged’ and punishments for the ‘wrongdoers’.

In his presentation, Professor Christie gave some (admittedly extreme) examples to illustrate the point that patent law is not so much different in this regard from other areas of the law.  Would any of us, he asked, wish to see the headlines that might follow the grant of a patent for a method and apparatus of inflicting torture?  Or the tabloid television coverage of the grant of a patent to a known paedophile covering a method or system for grooming children?  We might hope that such things would not be patentable under the existing law, but what if, in some particular instance, they are?  Should it not be possible to refuse, or invalidate, a patent on the basis that it seeks a monopoly over something for which society simply has no need or desire to grant exclusive rights?

It is not enough to argue that the use of such ‘inventions’ would be illegal, and therefore the grant of patents is of little consequence.  The simple fact is that if the government grants the privilege of a monopoly over an abhorrent ‘invention’, the public quite rightly wonder whether the patent system is worthy of support.

While we might not believe that isolated genes constitute abhorrent subject matter on the level of means of torture or paedophilia, there are others in society who feel more strongly about this issue.  They are entitled to be heard, and to be taken seriously.  That we in the IP profession have not adequately done so is a failing on our part, not theirs.

WHERE TO FROM HERE?

Professor Christie also reminded his audience that we (i.e. the IP profession) do not ‘own’ the Australian patent system.  It is a part of the laws that belong to all of the people of Australia and, as we all know, when people lack confidence in the law then they tend not to respect or support it.   Public concern about gene patents has been simmering for over a decade.  There have been a number of relevant enquiries in recent years – including the Australian Law Reform Commission (ALRC) enquiry into Gene Patenting and Human Health, and the ACIP review of Patentable Subject Matter – each of which has made a number of recommendations.  The total number of these recommendations that have been taken up for further action is precisely zero.

Governments are always preoccupied with the major public issues of the day, that impact upon their popularity and re-election prospects.  Patent law is rarely considered ‘sexy’ or important enough to grab the public’s attention.  If the main stakeholders in the patent system have been unwilling to encourage the government to act on the recommendations produced by the various reviews and enquiries, then who will?  As it turns out, the answer to this question is: the frustrated members of the public whose concerns have been ignored for too long, and who have finally built up the public profile of a specific issue – gene patents – to the point where it is now of sufficient community interest to gain the attention of parliament.

If the Patent Amendment (Human Genes and Biological Materials) Bill 2010 becomes law, the stakeholders in the system who are opposed to it – including IP professionals – will share some of the responsibility.  Not for anything we have done, but for the years of inaction and failure to engage meaningfully with the genuine ethical concerns of the wider community.

The time has come for those on both sides of this debate actually to listen to one another, and to take each other’s views seriously.  The Patent Amendment (Human Genes and Biological Materials) Bill 2010 is (in our opinion) bad legislation, for all of the reasons that we, and its many other opponents, have articulated.  But where is the compromise position – the viable alternative that might be acceptable to both sides?  This might be the ‘ethical exclusion’ proposed by ACIP, or it might be something else.  But it seems clear that doing nothing is no longer an option.

4 comments:

Robert Cook-Deegan said...

This is one of the most thoughtful pieces I have seen on the gene patent debate, and IP law more generally. 

Tim said...

The distinction between 'discovery' and 'invention' is a complete red herring.  Compare US and EP law.  In the latter, 'discoveries' are unpatentable.  In the former, 'inventions' are patentable: and 'invention' is defined to include 'discovery'.  So what you can patent in the two systems is completely different? - actually, not,  It's broadly the same (and the differences do not result from this apparent divergence). 

The point is quite simple.  A 'mere' discovery (which was what the old UK law said you couldn't patent) is simply new knowledge.  It makes explicit what before was implicit.  Knowledge isn't patentable.  However, new knowledge frequently suggests a new process or thing.  That (if unobvious, as it frequently is, in the light of what was known previously) is what is patentable.  There seems to be a feeling that to say 'discoveries aren't patentable' means that when discussing obviousness of the resulting new process or thing, you assume that the 'discovery' is prior art.  That is simply wrong.

Tim said...

I ought perhaps to say that my post above is concerned with a side-issue (if a significant one).  The main thrust of the discussion - that the patent system has to be acceptable to society as a whole, not just professionals - I do not disagree with.  

Patentology (Mark Summerfield) said...

Thanks for your comments Tim.

I agree with you completely.  That a 'discovery', in the sense of a practical application of new knowledge, is patentable in Australia is unquestionable.  The still-controlling decision of the High Court of Australia in NRDC v Commissioner of Patents is a case in point.  The patent was essentially directed to the 'discovery' that a known chemical compound, when applied for a previously unknown purpose in the treatment of crops, had unexpected beneficial effects.

It make no difference to the question of patent-eligibility whether the discovery was made by accident, by trial-and-error, or by the application of a particularly inspired line of research.

Of course, if a discovery is made as a result of routine steps, and the result is not surprising given the state of knowledge at the time, it may be unpatentable for obviousness.  But that is a separate issue.

Mark

Post a Comment