Myriad Revisited – Morality and the Patent Law

Last 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.

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Tags: Australia, Genetic technology, Law reform, Patent law, Patentable subject matter