26 November 2010

Gene Patents Survive Australian Senate Enquiry – For Now

Australia's Parliament House,
where Committees roam free
in their natural habitat!
The report of the Australian Senate Community Affairs Committee Inquiry into Gene Patents was released today.  (Download a copy of the report.)

The Committee has not recommended any drastic amendments to the law, and in particular has stopped short of recommending that patents for genetic or other biological materials be expressly prohibited.

We reported yesterday on the Patent Amendment (Human Genes and Biological Materials) Bill 2010 that was introduced by Senator Bill Heffernan, who was a participating member of the inquiry Committee.  It appears that the committee as a whole may not have been persuaded to his relatively extreme position, and that the proposed legislation is a largely independent effort by Senator Heffernan and its co-sponsors (including the committee's chair, Senator Rachel Siewert).

Recommendation 3 of the report is 'that the Senate refer the Patent Amendment (Human Genes and Biological Materials) Bill 2010 to the relevant Senate committee for inquiry and report.'  The Bill is mentioned in a number of places in the context of its potential to supersede other national and international legal developments and issues.  Presumably these references, and the associated recommendation, were late additions to the report, since plans to introduce the Bill into the Senate were only announced on 17 November 2010 (according to the report, paragraph [4.26]).

The question of whether there should be an express prohibition on gene patents (or patents directed to naturally-occurring biological materials more broadly) was the subject of numerous submissions, and occupied a great deal of the Committee's attention.  Ultimately, it seems that the Committee was undecided (or perhaps divided) on this issue and therefore, on balance, determined that it might be best to maintain the status quo pending further developments and inquiries.  The Committee's position is summarised in the report as follows:

4.127 ... [T]he Committee concluded that there would need to be a very clear case and significant social and political consensus on the need for such a change [amendment of the Patents Act to expressly exclude gene patents]. The totality of the submissions and evidence to the inquiry shows that there are legitimate and sometimes finely balanced arguments on both sides of the debate. Given this, the Committee believes it is critical to improve the extent and quality of interaction with the patent system by Government, as well as its understanding of the principles underpinning the operation of the patent system. ...
4.128 ... [T]he Committee notes a strong consensus among opponents of an express prohibition on gene patents that the concerns which formed the basis of the Committee's inquiry can be more effectively addressed through a range of responses directed not at gene patents per se but at improving the operation of the patent system more generally. The Committee was encouraged to consider the conclusions and recommendations of a number of previous inquiries into gene patents or the patent system as the basis for its own conclusions and recommendations in this report.
4.129 In light of the factors and analysis outlined above, and despite its concern with the current practices of IP Australia around application of the invention-discovery distinction to isolated genetic materials, the Committee determined that it would not recommend at this stage that the Patents Act 1990 be amended to include an express prohibition on human genes and genetic products.
We have not yet read the entire 190 pages of the report.  It is clear that the Committee's recommendations recognise the ongoing ACIP inquiry into patentable subject matter, and IP Australia's review of the patent system.  A number of recommendations are directed to strengthening the patent laws around obviousness, written description, enablement, utility, prior art, common general knowledge, and so forth, as well as changes to compulsory licensing provisions and creating a research exemption to infringement.  Many of these proposals are substantially similar to those currently being developed by IP Australia.

Overall, the report and its recommendations appear reasonable, especially considering the emotional public and political environment in which it was conducted.  Certainly, the Committee's approach will not result in any hasty changes or harm to the Australian patent system


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