Why the Gene Patents Bill Will Not Work

We have written on a number of previous occasions about the ongoing Senate Committee inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (see Senate Submissions Overwhelmingly Oppose ‘Gene Patent’ Ban, ‘Late’ Submissions to Senate Inquiry on ‘Gene Patent’ Ban, Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously and Update on the Australian Senate Gene Patent Inquiry).

It is no secret that we are opposed to the Bill, or that in this regard we are amongst the majority of those who have made submissions to the inquiry.

However, it seems to us that even if the proponents of this Bill are successful in getting it passed into law, it will not – and, indeed, cannot – achieve its stated objectives.

The problem, as we see it, is that the Bill includes no commencement or transitional provisions.  In other words, it does not state how, or if, it is to apply to existing granted patents, and pending applications, at the time upon it becomes effective.

WOULD THE BILL ‘CLARIFY’ OR ‘CHANGE’ THE LAW?

There is a fundamental disagreement between supporters and opponents of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 as to whether it will actually bring about any change to the law.

It is clear that the Bill’s proponents, including its primary author Dr Luigi Palombi, believe that it serves to clarify, rather than to change, the existing law.  Dr Palombi, in particular, in his written and oral submissions to the Committee, has been highly critical of the practice adopted by IP Australia since 1988 in relation to the granting of patent claims directed to isolated genetic materials.  Dr Palombi contends that this practice is contrary to the existing law, but that legislative clarification is necessary because it is neither practical nor desirable to await an opportunity for the High Court to rule on the issue.

Various opponents of the Bill – including IP Australia – contend that it will bring about a change in the law, such that certain claims which have been patentable in the past will henceforth be excluded from patentability.

Only one thing can be stated for certain: if the Bill is passed, it will necessarily change the practice of IP Australia.  For some of the Bill’s proponents, this may be enough.  However, it will do nothing to address the uncertainty regarding the validity of claims that have already been granted.

IS IT NECESSARY TO RESOLVE THE EXISTING DISAGREEMENT?

The Committee may be of the opinion that it is not necessary to resolve this fundamental difference of views.  However, it is our opinion that if the inquiry is to serve any meaningful purpose, then nothing could be further from the truth.

Those who believe that the Bill serves to clarify existing law would no doubt argue that it does not require any specific commencement date or transitional provisions, because nothing will be changed by its passage.  However, it is clear that there are many who disagree with this view, and who may therefore believe that, in the absence of express commencement and transitional provisions, the Bill may retroactively invalidate many granted patents. 

Clearly, Parliament should not enact a law having potential retroactive effect without ensuring firstly that it is constitutional to do so and, if so, that the impact of the effect upon those who have acted in good faith on the basis of the pre-existing law is justified by the benefits to society.

Accordingly, unless the Committee is able to reach a conclusion on the question of whether the Bill would merely clarify, or actually change the law, the effect of its passage would be necessarily uncertain, and would still ultimately require a ruling from the High Court.

WILL TRANSITIONAL PROVISIONS FIX THE PROBLEM?

Obviously, the Bill could be amended to include commencement and transitional provisions.  However, we suspect that such amendments would be unpalatable to the Bill’s existing supporters.  To make provisions for the effect of the Bill on existing patents and applications might implicitly, or explicitly, confirm the validity of claims granted prior to commencement.  Alternatively, the provisions might expressly declare all such claims invalid.

We do not imagine that the Parliament will lightly pass legislation with explicit retroactive effect.  And even if it did so, the validity of such legislation would no doubt be subject to challenge on constitutional grounds.

Either way, the status of patents already granted which include claims to isolated genetic materials – many of which may remain in force until well beyond 2020 – will be no more resolved by passage of the Bill than is presently the case.  Ultimately, unless and until the High Court rules on the validity of such claims (or possibly on the legality and constitutionality of any alleged retroactive effect that the legislation may have), we will be no better off than we are at present.

As the Commissioner of Patents, Mrs Fatima Beattie, made clear in her testimony before the Committee, a greater part of the problem perceived by the Bill’s proponents lies in the past than in the future.  The state of the art has moved on and broad patents claiming genetic materials per se are more difficult to obtain, being more likely now to be found lacking in novelty or inventive step.

CONCLUSION

It is not at all clear that the Bill does – or can do – anything to alter the past, nor that the technology-specific amendments it proposes will serve any substantial useful purpose in the future.

Our initial opinion on Recommendations 8, 9 and 10 of the Advisory Council on Intellectual Property (ACIP) Review of Patentable Subject Matter (see ACIP Reports on ‘Patentable Subject Matter’), which propose an exclusion from patentability on ‘ethical’ grounds, was somewhat negative.   However, we have more recently been persuaded of the potential value of ACIP’s approach not only in addressing current community concerns in relation to gene patents, but also as a framework for addressing similar concerns that may arise in relation to other technologies in the future (see Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously).

According to ACIP’s recommendations, a general approach would involve:

1. provision of an exclusion, as permitted by the TRIPS Agreement, to protect ‘ordre public or morality’;
2. this should ‘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’; and
3. the Commissioner of Patents should be provided with ‘an explicit power to seek advice, from any person the Commissioner considers appropriate, to assist the Commissioner in applying this exclusion.’

This would not fix the past, or resolve the transitional issues, and in this sense the gene genie is well and truly out of the bottle.  But at least it would provide a clear mechanism for addressing community concerns in the future.  And the longer the Patents Act lacks such a mechanism, the more likely it becomes that we will find ourselves in the same situation once again.

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