23 December 2010

Australian Senate Inquiry Seeks Submissions on 'Gene Patent' Amendments

On 25 November 2010 we reported on the introduction of a Private Senator's Bill, the Patent Amendment (Human Genes and Biological Materials) Bill 2010, to outlaw the patenting of human genes, and other biological materials that are 'substantially identical to such materials as they exist in nature'.

It has now come to our attention (thanks to AusBiotech) that the Bill was almost immediately referred to the Senate Legal and Constitutional Committee for inquiry.  The Commitee is due to report on 16 June 2011, and is currently seeking written submissions from interested individuals and organisations.

The deadline for submissions is 25 February 2011, and the preferred method of submission is online, although submissions may also be made via email to legcon.sen@aph.gov.au or post.

IMPACT OF THE BILL

AusBiotech contends (and we are inclined to agree) that:

If the legislative amendment is progressed in its current form, it would have far-reaching and unintended consequences across the industry, impacting almost every member; including those developing novel therapies, tests, vaccines, and even medical device companies with drug delivery platforms.
It is therefore important that stakeholders, whether in favour of or opposed to 'gene patents', provide constructive input to the Senate Committee.

We expressed the view previously that the current Bill was unlikely to make significant progress, in part because it undermines a number of other ongoing activities, including the ACIP Review of Patentable Subject Matter, and IP Australia's ongoing program of patent law reform.  Indeed, we anticipate that IP Australia may prepare its own submission to the Committee, and we would not be surprised if these were quite critical of the proposed amendments to the Patents Act 1990.

Nonetheless, a Senate Committee inquiry is a reasonably significant step, considering the time and resources involved, which can only serve to increase the seriousness with which the Bill is viewed.

REASONS FOR REFERENCE

The terms of reference for the inquiry are broad.  In fact, there are no specific objectives stated beyond 'inquiry and report'.  Given the brevity of the Bill, this might seem adequate.  However, considering the controversial nature of the subject matter the Committee may well find itself inundated with extensive submissions of similar scope to those already considered by the Senate Community Affairs Committee.

The probability of this becoming a de facto further inquiry into gene patents generally is exacerbated by the reasons for reference.  According to the official Senate Hansard of 26 November 2010 (page 2379), the Bill was referred to allow for possible submissions and evidence from:
  1. Cancer Council Australia
  2. Dr Luigi Palombi (ANU)
  3. Breast Cancer Action Group
  4. National Breast Cancer Foundation
  5. Breast Cancer Network of Australia
  6. Australian Gene Ethics Network
  7. Dr Leslie Cannold ACCC
  8. Peter MacCallum Cancer Institute
  9. Walter and Eliza Hall Institute
  10. Cancer Voices
  11. Maurice Blackburn
  12. Professor Ian Frazer
  13. Australian Law Reform Commission
  14. Genetic Technologies Ltd
  15. Intellectual property lawyers
  16. Civil liberties groups 
This list includes a veritable 'who's who' of the most strident voices for and (mostly) against gene patents, and far too many of them are the parties specifically involved in the Myriad BRCA patent invalidity litigation (on which we have previously reported here, here, here and here) which frankly reflects only a very narrow perspective on the broad range of issues raised by the Bill. 

If the full spectrum of interested individuals and representative organisations makes submissions, the Committee will certainly have its work cut out!

CONCLUSION

Details of the inquiry, including further information on preparing suitable submissions, are available on the Australian Parliament web site.

AusBiotech's call for submissions can be found on their web site.

We will keep an eye on the inquiry, and report any further developments.

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