Gene Patents
In November 2010 a Private Members’ Bill was introduced in Parliament containing a proposal to ban patents on “biological materials including components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature”. The bill was immediately referred to the Senate Legal & Constitutional Affairs Committee for review; submissions were due on 25 February 2011 and public hearings, at which Medicines Australia testified, were held at Parliament House on 28 and 29 April. The Committee was initially expected to issue its final report on 16 June, but the reporting date later shifted to 25 August.
The “problem” of gene patents” has been on the minds of policy makers for many years: in 2004, for example, the Government asked the Australian Law Reform Commission to investigate whether, as some critics claim, patents restrict patient access to new treatments and diagnostic tests and/or make it difficult for scientists to conduct medical research. The Commission did not discover a widespread problem. It recommended a number of changes to the Australian patent system, but not to laws governing patentable subject matter. Then in November 2010, the Senate Community Affairs Committee (to which Medicines Australia made multiple submission) released its final report after a two-year inquiry into gene patents. The Committee also recommended changes to the Patents Act, but stopped well short of recommending a ban on patents on genetic and biological materials.
However, recent developments, especially an unexpected decision in 2010 by a U.S. district court in the matter of Myriad v. ACLU (currently under appeal), in which Myriad’s patents on isolated BRCA1 and BRCA2 gene sequences were declared invalid by virtue of being a priori ineligible, has given extra cause to critics to seek an urgent amendment to Australia’s patent law.
Medicines Australia has urged the Senate Legal & Constitutional Affairs Committee, both in submissions as well as in public testimony and media statements, to recommend that the Private Members’ Bill be rejected and that Parliament investigate other, more meaningful ways to achieve the Bill’s goals, which we support. These are:
- to improve Australian patients’ access to new health technologies; and
- to ensure that Australian scientists are free to conduct research on patented inventions (so long as it is for the purpose of investigating a patented invention, and not their intention to infringe valid patents by selling these inventions without the inventors’ permission).
Medicines Australia submitted that excluding all biological materials from patentable subject matter would, contrary to the Bill’s intention, harm Australian patients, destroy jobs and stall medical research in Australia. It would also be in breach of Australia’s international obligations under Article 27(1) of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights.
The Senate Legal & Constitutional Affairs Committee has received, to date, over 110 submissions, more than two thirds of which contain statements strongly opposing the implementation of the Bill.
Medicines Australia has worked closely with AusBiotech on an advocacy campaign against the Bill. Since December 2010 representatives from both organisations have met with nearly two dozen Senators and MPs.
To view Medicines Australia’s submission on the Private Members’ Bill, please visit the submissions page on our website.
Page updated: August 2011