Patent Attorneys Invoke Constitution in Myriad Gene Case

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) has applied to intervene as amicus curiae (i.e. ‘a friend of the court’) in the High Court appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case.  In doing so, IPTA is seeking to raise a Constitutional matter, namely ‘whether the concept of “patents of inventions” in section 51(xviii) of the Commonwealth of Australia Constitution Act (the Constitution) encompasses isolated genetic material and other materials isolated from nature.’

The publicly-available documents filed in the appeal, including IPTA’s written submissions in support of its application for leave to intervene, can be viewed on the High Court’s page for the case, no. S28/2015.

It probably goes without saying that IPTA’s overriding objective is to ensure that the High Court does not overturn the decision of the five-judge panel of the Federal Court of Australia which found unanimously that Myriad’s claims directed to the isolated BRCA genes were patentable.

Historically, the High Court of Australia has been reluctant to entertain amici curiae in civil disputes between private parties.  The Constitutional matter being raised by IPTA is one which has not arisen in arguments before the lower courts, and appears to be unnecessary in order to decide the specific question of whether or not Myriad’s claims directed to isolated BRCA genes are patentable.  Furthermore, in my opinion IPTA’s argument is misconceived, although I am obviously not an expert on constitutional law, so there could be something I am missing. 

Overall, I think it unlikely that the court will allow IPTA’s application, but it could make things more interesting if I am wrong!

The Constitution and IPTA’s Argument

Section 51 of the Australian Constitution sets out the legislative powers of the Federal Parliament, i.e. those areas in which it is empowered to make laws effective throughout the Commonwealth of Australia.  Prior to Federation in 1901, the various Australian colonies (which became the States) each had their own laws which were, for the most part, inherited, copied or adapted from the UK laws.

While laws of the former colonies falling within the Federal power were not rendered void by Federation (see section 108 of the Constitution), once a Federal law has been enacted, it has priority over any corresponding State laws to the extent that there is any incompatibility (section 109).

Section 51(xviii) of the Constitution provides that the Federal Parliament may make laws relating to ‘copyrights, patents of inventions and designs, and trade marks’.  The first Commonwealth law relating to patents was the Patents Act 1903, which was subsequently replaced by the Patents Act 1952, which in turn gave way to the current Patents Act 1990.

As IPTA sets out in its submissions, the High Court has previously considered the extent of the Commonwealth’s powers under section 51(xviii) in Grain Pool of WA v Commonwealth [2000] HCA 14.  The question in the Grain Pool case was whether the Commonwealth was acting outside its constitutional powers in enacting the Plant Variety Rights Act 1987 and the Plant Breeder's Rights Act 1994.  Astute readers will have noticed that section 51(xviii) says nothing about the protection of any rights in new plant varieties, typically produced through ‘traditional’ cross-breeding techniques.  SO the question was, essentially, whether such rights fell within the scope of ‘patents for inventions’.

The answer – which will not surprise anyone who is familiar with the fact that equivalent rights in the US are known as ‘plant patents’, or with the fact that the Plant Breeder’s Rights Act is still in force – was that granting rights to the breeders of new plant varieties is within the power of the Commonwealth as a form of ‘patent’.

The argument put forward by IPTA is essentially that if living plants fall within the power of the Commonwealth to grant patent rights, then so, too, must other biological materials.  Consequently, it is significant that the Parliament has seen fit to expressly exclude only one type of subject matter from patent-eligibility, namely ‘human beings, and the biological processes for their generation’, in section 18(2) of the Patents Act, and has (as the Full Court pointed out in the decision under appeal, D'Arcy v Myriad Genetics Inc [2014] FCAFC 115) thus far declined to legislate to exclude other biological materials, despite having had ample opportunity to do so.

Does IPTA Have a Point?

I am not sure that IPTA’s submissions directly bear on the issue that is before the High Court, which is whether or not isolated genetic material (or, more precisely, the specific isolated BRCA genes claimed in Myriad’s patent) fall within the concept of a ‘manner of manufacture’.  While the Parliament may not have expressly excluded this subject matter in the 1990 Act, it did make a very deliberate decision to retain the ‘manner of manufacture’ terminology, which dates all the way back to the UK Statute of Monopolies 1623, so that the courts could continue to develop the scope of patent-eligibility with the same prudence and flexibility as was shown by the High Court in National Research Development Corporation v Commissioner of Patents (‘NRDC’) [1959] HCA 67.

So, while it might generally be true that the court should be reluctant to impose limits on the scope of legislation falling within the Commonwealth powers under the Constitution, this appears to be one example of the Parliament expressly delegating a power to the courts.  Had the legislature wished to define the scope of patentable subject matter, and/or to exhaustively enumerate exclusions, it could have done so.  Legislation in many other countries does just that.

I do not see a significant Constitutional question here.  The Constitution grants the Federal Parliament the power to legislate in relation to patents for inventions.  It has done so, and deliberately entrusted the continuing development of the scope of the concept of ‘manner of manufacture’ to the courts.  The question in the Myriad case falls squarely within this remit.

The other obstacle to IPTA’s application is that there is not much of a tradition of courts permitting interventions by amici curiae in Australia, particularly in civil disputes.  The leading authority on the role of amici curiae appears to be the observations of Brennan CJ in Levy v Victoria [1997] HCA 31 (a.k.a. the ‘Duck shooting case’):

The hearing of an amicus curiae is entirely in the Court's discretion. …. The footing on which an amicus curiae is heard is that that person is willing to offer the Court a submission on law or relevant fact which will assist the Court in a way in which the Court would not otherwise have been assisted. In Kruger v The Commonwealth, speaking for the Court, I said in refusing counsel's application to appear for a person as amicus curiae:

“As to his application to be heard as amicus curiae, he fails to show that the parties whose cause he would support are unable or unwilling adequately to protect their own interests or to assist the Court in arriving at the correct determination of the case. The Court must be cautious in considering applications to be heard by persons who would be amicus curiae lest the efficient operation of the Court be prejudiced. Where the Court has parties before it who are willing and able to provide adequate assistance to the Court it is inappropriate to grant the application.”

It is not possible to identify in advance the situations in which the Court will be assisted by submissions that will not or may not be presented by one of the parties nor to identify the requisite capacities of an amicus who is willing to offer assistance. All that can be said is that an amicus will be heard when the Court is of the opinion that it will be significantly assisted thereby, provided that any cost to the parties or any delay consequent on agreeing to hear the amicus is not disproportionate to the assistance that is expected.

Recently, in Roadshow Films Pty Ltd v iiNet Limited [2011] HCA 54, the High Court referred to the above observations in Levy to dismiss four applications by non-parties to intervene as amicus curiae, while two other applications were allowed in part, but ‘only to the extent that its submissions do not duplicate the submissions of a party’.

Conclusion – IPTA Opposed, Prospects Not Good?

It seems to me that IPTA is seeking to raise, for the first time, a Constitutional matter that is not already before the court, and that is unnecessary to decide the case.  I cannot see how the court will be ‘significantly assisted’ by the submissions that IPTA is proposing to make.  Furthermore, it is not apparent that the parties to the dispute (i.e. Ms D’Arcy and Myriad Genetics) are not ‘willing and able to provide adequate assistance to the Court’.

On 7 April 2015, Ms D’Arcy’s submissions in reply were filed, in which she has opposed IPTA’s application to intervene.  I find it difficult to imagine that Myriad would see any benefit in IPTA’s intervention, either.  It has already been successful before six Federal Court judges (one at first instance, and five more on appeal), and therefore clearly has a strong case on the question of ‘manner of manufacture’.  Raising a Constitutional question at this late stage would seem only to complicate, rather than bolster, that case.

I should point out that while the majority of registered Australian patent attorneys are IPTA members, I am not among them.  While I agree with IPTA that isolated genes and other biological materials should be patentable, I am not a big fan of the Institute’s approach to the issue.  I previously expressed my reservations regarding its dismissal of community concerns in submissions to the 2011 Australian Senate Legal and Constitutional Committee inquiry in relation to the Patent Amendment (Human Genes and Biological Materials) Bill 2010.

IPTA is not a disinterested party.  This is not necessarily, in itself, a reason why it should not be permitted to intervene in the Myriad case.  However, while the Institute exists to represent the interests of its member patent attorneys in Australia, the intervention it seeks to make is primarily for the benefit of a subset of those patent attorneys’ clients involved in research and/or commercialisation of genetic technologies.  Some of those clients are quite large and well-heeled, which makes me wonder why they would not intervene on their own behalf.  But perhaps they are footing the bill for IPTA’s attempted intervention.

All in all, I find it difficult to imagine the High Court permitting IPTA to intervene as amicus curiae.  But we shall see…

Tags: Amicus curiae, Australia, Constitution, Genetic technology, Patentable subject matter