15 May 2012

Gene Patent Opponents Take the Fight Back to Australian Parliament

Lateline DNAIt was less than eight months ago that the most recent attempt to legislate against so-called ‘gene patents’, the Patent Amendment (Human Genes and Biological Materials) Bill 2010, was effectively killed by a Senate Committee report containing just one recommendation: ‘the Committee recommends that the Senate should not pass the Bill.’  (See Divided Senate Committee Urges Rejection of Gene Patents Bill).

Since then, the Intellectual Property Amendment (Raising the Bar) Act 2012 has been passed into law, providing (amongst much else) a new defence to infringement for research uses of a patented invention, and elevated standards for utility and inventive step which should go some way towards preventing the grant of patents covering isolated genes obtained by non-inventive techniques, or which are not limited by some specific practical application.

Yet opponents of gene patents remain unsatisfied.  On Monday 14 May 2012, the ABC television program Lateline ran a report on a new push to ban the patenting of genes, this time via a private members bill to be introduced by Labor government backbench MP Melissa Parke (the member for Fremantle, in Western Australia).  The report was followed by an interview with Ms Parke, and Liberal Party Senator Bill Heffernan (who was the driving force behind the previous gene patents bill).

The Lateline report was disturbingly one-sided, with much inaccurate – or at least incomplete – information being provided, with no balancing input from any of the organisations (including many research institutions, such as the Walter and Eliza Hall Institute) which opposed the previous attempt to bar patents on genes.  It appears that the opposition camp has once again caught patent supporters off-guard, with Lateline reporting that it had contacted AusBiotech, but that the organisation was unable to comment in time to contribute to the report.

SCOPE OF THE PROPOSED EXCLUSION?

As yet, the proposed legislation has not been introduced into parliament, however Ms Parke says that she will be seeking the support of the Labor Party caucus in the near future.

In the meantime, we note that the following text – which may or may not be the actual final text of the proposed bill – was clearly visible in a few frames of the Lateline report.  It appears to be a proposed replacement for the existing subsection 18(2) of the Patents Act 1990, which currently contains the single express exclusion that ‘Human beings, and the biological processes for their generation, are not patentable inventions.

18 (2) The following are not patentable inventions:

(a) human beings, and the biological processes for their generation;

(b) genetic materials that exist in nature, or are the same as or not markedly different from those existing in nature, whether such materials are in situ, isolated or purified;

(c) any method that involves the mere comparison of genetic materials or genetic sequences in the provision of a diagnosis for a human being.
(2A) A reference in subsection (2) to genetic materials includes, but is not limited to, DNA or RNA whether in whole or in part or in fragments, however made.

If this is indeed the amendment which will be proposed to the parliament, it is significantly more focussed than the Patent Amendment (Human Genes and Biological Materials) Bill 2010.  The previous bill failed in part because of concerns that it was overly broad in its language, and would therefore have unintended effects of excluding a wide range of inventions in the biological, medical and agricultural fields from patentability.

The above language is directed specifically to genetic materials (and not other ‘biological materials’ as covered in the earlier bill).  However, it goes further than simply barring patents on genes themselves (which seems to be the way in which Ms Parke and Senator Heffernan are currently promoting it) to also encompass genetic tests that are based on a ‘mere comparison’ of genetic materials.  This is a surprising development, considering that one of the arguments that has been consistently presented by supporters of a ban is that there is no intention to bar patents on specific applications of genetic technologies – including diagnostic methods.

No doubt the situation will become clearer in due course, and this blog will, as always, be keeping a close eye on developements.

3 comments:

Donut said...

Much sharper this time though can't see "but is not limited to" in 2A getting through considering the Senate Committee's findings. However, re 2(c) if I was GTG or a similar company providing diagnostic tests I would maintain my genetic tests as trade secrets (for far longer than 20y) since the US patentscape is going the same way. No one could copy them or use them to develop better tests. You can just supply doctors with a yes/no answer for patients so it can't be reverse engineered. This is one of the main reasons the patent system was introduced: disclsoure for temporary monopoly.

Patentology (Mark Summerfield) said...

Thanks for raising a good point.  Perhaps 'mere comparison' would be obvious, and thus unpatentable anyway, but why would any provider of diagnostic testing take the risk of disclosure only to fall foul of a provision like this?  And if a test is not obvious, then it may well be suitable for protection as a trade secret.

The problem with private member's bills is that they are often not very well drafted.  Contrary to some opinion, drafting unambiguous legislation is not a trivial task.

If you look over this proposed provision there is much to criticise.  Repetition does not create emphasis, but confusion.  We have, for example, 'genetic materials that exist in nature', as well as those that 'are the same as' those existing in nature and, just to be sure, the 'genetic materials' include DNA and RNA, in whole, part or fragments, and 'however made', but also whether the materials are 'in situ, isolated or purified'.  Oh yes, and other unspecified stuff as well ('...not limited to...').

So how much of this overlaps, and how much is meant to define distinct things?  How is anybody to know the scope of all this?

On top of this, we have to worry about what is meant by a 'mere' comparison.  (As opposed to what?  A 'substantive' comparison?  A comparison plus something more?)  And what, exactly, is the extent of a 'marked' difference?  Is there to be a 10% rule?!

I am sure we will be provided with an Explanatory Memorandum which purports to explain the intent behind all this.  And we will be told that the various terms have been successfully interpreted in the context of other legislation, and so it is all going to be OK.

The provisions of ss 15AA and 15AB of the Acts Interpretation Act 1901 (which provide for an interpretation 'best achieving the act's purpose' and for the use of extrinsic materials, such as explanatory memoranda, in interpretation) are not intended as a substitute for clarity in drafting of legislation. 

All we ask is that those who would legislate over us say clearly and concisely just what it is that they mean!

Donut said...

Some good points. We had a little chuckle over the use of "mere". Someone obviously hasn't spent much time in the lab. 

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