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;(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.
(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.
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.