20 February 2013

Myriad Revisited – Morality and the Patent Law

Got EthicsLast week’s decision by Justice Nicholas, in the Federal Court of Australia, regarding a patent covering the BRCA1 ‘breast cancer gene’, raises important questions about our patent laws, but has been much misunderstood, and misreported in the media.

Even sources which one might expect to provide a more informed and balanced view of the case, such as this article at The Conversation, have contributed to the general level of confusion and misinformation.  For example, the article quotes Cancer Council CEO, Professor Ian Olver, stating that ‘[d]iscovering and isolating genetic materials is not inventive, yet the current law gives licence to biotechnology companies to claim ownership of naturally occurring substances.’  However, the court was not asked to address the question of whether the processes of discovery and isolation were inventive.

Professor Dianne Nicol of the University of Tasmania is quoted as saying that Justice Nicholas ‘has given a broad reading of the “invention” requirement in Australian law (referred to as manner of manufacture).’  While the Professor’s desire to simplify the legal language of the Patents Act 1990 is understandable, this statement does little to help clarify what the case was actually about – which was not ‘invention’, in the everyday sense of the word, but more correctly the appropriateness of isolated genes as subject matter for a potential invention, independently of any assessment of inventiveness. 

Had the case been about the wheel, rather than an isolated gene, the question for the court would not have been whether a particular wheel, or even wheels in general, are patentably new and inventive.  Rather, the question would have been whether, as a general proposition, a wheel is the kind of thing for which a patent might be granted if it is also shown to be new and inventive.  And it is no answer to this analogy to say that genes are different in that they are naturally occurring, while wheels are not.  The end result of isolating a gene is no more ‘natural’ than the end result of cutting away all of the wood from a tree that is ‘not wheel’ in order to leave behind a wooden wheel!  Both processes result in a product that simply does not arise in the absence of human intervention, skill and effort.

Why are ‘Gene Patents’ Controversial?

In my view, it is a great pity that the case had to be argued on purely technical grounds.  The primary basis for objection to ‘gene patents’ seems not to be a desire to preserve the traditions of the patent law, but might be better characterised as moral, ethical and/or philosophical.  Yet many of the protagonists in the challenges to gene patents appear unable to step up and simply state that they want to see an end to the patenting of genes because they believe it to be wrong.  It seems a sad indictment on the state of the conversation (and The Conversation) that only legal, technical and economic arguments are considered to carry any weight.  Why can we not openly discuss whether the social or moral harm caused by granting monopolies over isolated genes outweighs the benefits that gene patents may provide?

The most honest reaction to the decision last week might have been that of cancer survivor, and figurehead of the legal challenge, Ms Yvonne D’Arcy.  As reported in The Age, and elsewhere, Ms D’Arcy was ‘in tears’ leaving the courtroom, where she was quoted as saying: ‘To tell the truth I'm very disappointed.  We were doing this for future generations, and I'm just so disappointed.’

‘Not Substantially Different’?

The patent at issue, owned by Salt Lake City based Myriad Genetics, Inc, was originally granted by the Australian Patent Office in 1998, and is due to expire in 2015.  While much of the media coverage of the decision suggests that it will result in more patents being granted on human genes, the reality is that the court has simply confirmed the validity of a practice that has been operating for over two decades.

It is important to appreciate that Justice Nicholas did not determine that the isolated BRCA1 gene sequence was inventive.  Indeed he specifically expressed no view on the matter. Advances in techniques for identifying and isolating genes mean that a process that may have involved inventive ingenuity in 1994, when the BRCA1 patent application was originally filed, would most likely not qualify for patent protection in 2013.  However, the case was not argued on the basis of whether isolation of the gene was inventive, but rather on the much narrower proposition that in no circumstances could a patent be granted on a molecule that happens to be ‘not substantially different’ from something which occurs in nature.

The case was perhaps always destined to fail on this technical ground.  The patent law does not recognise a definition of ‘substantially different’ where chemical compounds are concerned.  This would be, in any event, an issue of inventiveness, rather than one of whether molecules produced as a result of human intervention can be patented as a matter of principle.

The Patent and the Scope of the Challenge

A patent specification – the document which describes and defines an invention – is a chimera.  Neither purely legal nor purely technical in nature, it is required to perform two entirely distinct duties. Firstly, it must explain, in terms comprehensible to a person skilled in the relevant field of technology, how the invention may be put into practice.  Secondly, it must set out, in terms that are as clear and concise as possible (two sometimes conflicting requirements) exactly what it is that the patent protects. Anything done or produced, without authority of the patent owner, which falls within these terms (known as ‘claims’) constitutes an infringement of the patent.

The challenge, by advocacy group Cancer Voices Australia, and cancer survivor Yvonne D’Arcy, never sought to invalidate all of Myriad’s claims.  The case was focussed on just three of the 30 claims made in the patent.  Each of these three claims covers a molecule consisting of an isolated gene sequence which, as Justice Nicholas was at pains to point out in his judgment, is not something which occurs in nature, in the absence of human intervention.  Justice Nicholas also expressly stated that the claims do not encompass the genetic information represented by the molecule, nor do they encompass DNA or RNA as it occurs naturally in human cells.  In other words, in no legal sense does Myriad ‘own’ anybody’s genes, or genetic identity.

A number of other claims of the Myriad patent cover processes of extraction and testing for the BRCA1 gene.  Since these claims were not challenged, and despite reports to the contrary, the case would have had no impact on the cost or availability of genetic tests for cancer, even if it had been decided in the challengers’ favour.

A Place for ‘Morality’?

However, none of this means that opposition to the grant of patents on human genes is without merit.  As I have said here previously, the reality is that moral, ethical and social concerns about this issue are very much real, and deeply felt.  We must recognise that for many people the idea that private companies may hold rights over human genetic material is gravely abhorrent.  And while many intellectual property lawyers and patent attorneys would argue that morality has no place in patent law, there is no basis for such an assertion.

Moral values are pervasive in the law, whether it be in the selection of acts defined as crimes, the punishments considered appropriate, or even such matters as the age of consent.  The patent law is not specially immune from moral considerations, and supporters of the patent system may want to bear in mind that law considered to be out-of-touch with community values tend also to lose the respect and support of that community.

A Case for Reform?

In December 2010, the Australian Government’s Advisory Council on Intellectual Property (ACIP) published a review of ‘patentable subject matter’ in which it recommended that the law be revised to ‘exclude from patentability an invention the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public’. To date, the government has not sought to act on this recommendation.

The challenge to the Myriad BRCA1 gene patent claims was based on a doomed technical ground because the true reason for objection – genuine concern about the propriety of government-sanctioned monopolies over human genetic material – is not a recognised basis for denying a patent under our law. Hopefully this case can be the catalyst for a conversation about whether it is time for this to change.

Image Copyright (c) 123RF Stock Photos

4 comments:

Mark Summerfield said...

Hi David,

Thanks very much for your extensive and thoughtful comment!

I see what you mean about the distinction between morality of commercial use of the invention, and of the grant of the monopoly per se. I think, however, that reference to the use of the invention is necessary, otherwise the entire exercise is abstract.

In the case of isolated genetic material itself (as opposed to a claimed method of treatment or diagnosis) the claim necessarily covers all commercial use of the material for any purpose. The solution may therefore be to word the exclusion so as to encompass any reasonably foreseeable wholly offensive use. An applicant might then be compelled to claim more narrowly in order to cover only exploitation that is not objectionable.

As for 'who decides', ACIP covered that in its report. It reviewed the approach adopted in a number of other jurisdictions, and proposed that the Commissioner be given the power to seek appropriate non-binding expert input in the rare instances where the issue might arise.

In the past I was opposed to this kind of general 'moral' exclusion. But I have come to believe that it is essential to the integrity of the patent system, and to maintaining public confidence, that we at least give serious consideration to it. As you are aware, the patent system is under increasing public scrutiny, because of issues such as gene patents, business method patents, and the practices of certain litigants. The system must not only strike the right balance between public and private interests, it must be seen to strike the right balance. Laws apply to the entire community, and so if there are members of the community who believe that there is a place for ethical considerations in the grant and defence of patents, then we need to look at that.

'Technical' subject matter exclusions, such as have been proposed in the Australian parliament, are not the answer, for at least two reasons. Firstly, they are likely to have unintended consequences, either of excluding unobjectionable subject matter, or failing to exclude the target subject matter. Secondly, they only address a single issue, e.g. patenting of human genes. They do not provide a framework for dealing with the next moral challenge that the system might face!

Finally, as for why 'general inconvenience' was not argued, I think there were probably a couple of reasons. Firstly, in Australia more so than in New Zealand, it is not at all clear that the 'generally inconvenient' proviso has any residual exclusionary power that has not already been extracted into one or more explicit provisions of the 1990 Act (this is discussed on pages 51-53 of the ACIP report). Secondly, I do not think that the forces behind the challenge in this case wanted the case to be decided on the shaky ground of 'general inconvenience'. I believe that their ideological goal was to have the court decide that isolated genes are just fundamentally unpatentable because they are nothing more than a part of nature. A decision that they could have been patented, but for the 'general inconvenience' of it all, would not have satisfied their objective!


Cheers,

Mark

Mark Summerfield said...

Wow - another great comment! Thanks for contributing.

It is an interesting thought that some of those behind the challenge might have been hoping to lose. I have some private correspondence which would suggest otherwise, in at least one case. Unfortunately, despite repeated requests on my part the individual in question declined to give permission for me to publish the views expressed via email, and did not respond to invitations to provide a guest article for this blog.

Even so, I think you are right that the loss is more likely to instigate another legislative push, rather than an appeal. A proposed Bill is already floating around (see http://blog.patentology.com.au/2012/05/gene-patent-opponents-take-fight-back.html), although I think its prospects would be pretty poor in an election year.

You are absolutely right, of course, about the unintended consequences of express exclusions. In your example, an obvious concern is that antipsychotics are clearly mind-altering substances, though (hopefully) in a good way!

Section 50 of the Patents Act 1990 already permits the Commissioner to refuse to accept an application for an invention 'the use of which would be contrary to law'. I cannot recall an instance of this having been the subject of any published decision, although it has been held that a corresponding provision in the Trade Marks Act 1995 is of very narrow scope: 'would' (as opposed to 'could') effectively means 'must', so it is likely that a patent for an invention which has plausible legal uses, as well as illegal ones, could not be refused on the basis of this provision.

From a purely rational perspective, I agree with you that there is not really a moral dimension to the mere act of entering a patent onto the Register. However, human beings are not purely rational, and by and large our laws need to have moral, as well as legal, authority. We know, for example, that drivers are more likely to ignore speed limits if they are perceived as unreasonably low (e.g. a 50 km/h limit on a six-lane arterial road), and that people are more likely to support the use of speed cameras if they are perceived to be targeting black spots, rather than revenue-raising. Yet there is a rational basis for the setting of speed limits, and the rational response is to obey them, and not get fined!



There are no doubt many things that most people would not wish to see patents granted on, whether or not their use would necessarily be illegal in all circumstances. These could include methods and apparatus primarily intended for abhorrent purposes such as, for example, killing or torturing human beings, or enhancing the addictive effect of nicotine. A morality exclusion might not be invoked very often, though it would give the public some comfort to know that it was there. I am not sure that I would want it to be available as a ground of opposition, though!


Mark

Susie Ruthenbeck said...

Hi Mark,

Thank-you for this clear discussion which isolates the key issues.
I have been following the gene patent cases in the last few years as I wrote my law honours paper in this area. So refreshing to see clear expression, when so much of the reporting has conflated the different aspects.

A court would be reluctant to examine the moral/philosphical questions - this comes under the aegis of "policy" and is for the legislature to examine in the interest of all stakeholders. A balance between the public interest and the desire to stimulate investment in R&D for human genes as part of the innovation system is important.
It will be interesting to see what the next round of Myriad litigation in the United States brings. This decision:
Mayo Collaborative Services, Mayo Medical Laboratories et al v. Prometheus Laboratories Inc. No. 10-1150 Argued December 7, 2011 – Decided March 20, 2012
found that some diagnostic tests are not patentable in a situation where the invention does not contain a transformative step; involving merely a correlation between the tissue sample and a data set. It is not a 'gene patents' case so no regard is given to how innovative the process of isolating a specific gene might be in any given circumstance. But you are right in saying that the Myriad patents may have involved ingenuity in 1994 over techniques which would now be considered somewhat routine.

The Mayo v Prometheus case examines the US "laws of nature" doctrine and points to the idea of specific subject matter based exclusions to the patent scheme. So the question arises whether genes should have their own scheme, or be excluded altogether? To date, the Australian parliament has said no to a ban on gene patents and the Australian Law Reform Commission has affirmed that Australia is to continue with a generalised subject matter patent system. So no specific guidelines for genes like the European Patent Office provides.

Thanks for the opportunity to be part of an informed and sensible discussion on these issues!

Mark Summerfield said...

Thanks for your comment, Susie, and welcome to the discussion!

I think you are right that the Federal Court is currently inclined to steer away from policy issues, however 'manner of manufacture' is perhaps a special case, because the parliament deliberately retained the centuries-old wording in order to leave the management of evolving subject matter in the hands of the courts. In effect, the 'policy' is to let the court set policy.

Even so, the Federal Court (especially at first instance) does seem to have been less activist in this area in recent times. Whereas courts had been quite happy to make policy decisions in the past, for example by declaring methods of medical treatment to be unpatentable, there has been a much greater tendency to defer to the apparent 'intention of parliament' since the 1990 Act came into effect.

The High Court seems generally less reticent to set policy in this area. It is interesting to compare the majority and minority opinions in Philips v Mirabella [1995] HCA 15 (a case which has proved to be something of a disaster, in my opinion). Here it was the minority who closely followed the wording of the Act, while the majority tied themselves in knots to find a way to enforce what they saw as a policy decision, i.e. that the parliament could not possibly have intended to change the law such that something which (in their view) would not have been patentable under previous patents statutes would become patentable under the 1990 Act. In fact, there is a perfectly good argument to be made that the parliament fully intended to introduce greater objectivity into the assessment of inventive step, and that the High Court in Philips rode roughshod over this intention!

In Grant v Commissioner of Patents [2006] FCAFC 120 the Full Court was perfectly happy to express opinions (albeit obiter dicta) that legal strategies, no matter how ingenious and imaginative, cannot be 'manners of manufacture' (at [34]), but that the presence of 'science and technology' is not a necessary prerequisite for 'invention' (at [38]).

Of course, the courts would have no choice in the matter if the legislation expressly directed them to have regard to the sensibilities of reasonable and informed members of the public. The question naturally arises, however, whether the most vocal opponents of allowing patents on subject matter such as genetic materials can generally be described as 'reasonable' and/or 'fully informed'. In most cases, the court would find itself presented with reasonable and well-informed people on both sides of the debate. This is not, however, what wins the argument in the court of public opinion!

Cheers,

Mark

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