Gene patents debated in Australia
On 26 November 2010, the Community Affairs Committee of the Australian Senate issued its report on gene patents. The terms of reference for the inquiry directed the Committee to consider the impacts of gene patents on healthcare, medical research and the health and wellbeing of Australians. The catalyst for the inquiry was the attempts in 2002-03 and 2008 by Australian company Genetic Technologies Ltd (GTG) to enforce its patents over the BRCA1 and BRCA2 genes in Australia. Testing for these genes can indicate a predisposition to developing breast and ovarian cancer. In 2003, GTG also attempted to enforce its New Zealand patents over the genes. In both countries the disputes were settled before the commencement of infringement proceedings.
In its report, which is available for download here, the Committee stated it was not persuaded to recommend that the Australian Patents Act 1990 be amended to expressly prohibit the patenting of genes. This was due to uncertainty around the potential effectiveness and effect of such a prohibition, legal challenges to the validity of the BRCA gene patents in Australia and the United States which the Committee considered may bring clarity to the patentability of isolated genetic material, and the current review of Australia’s patent laws by the Australian Council on Intellectual Property (ACIP).
The Committee did, however, make a number of recommendations that are intended to increase the threshold requirements of patentability by strengthening the provisions in the Patents Act relating to obviousness, support within the description of the specification, and utility of a claimed invention, as well as clarify the circumstances in which the Crown use provisions may be employed and create a broad research exemption to infringement.
On 24 November 2010, a private member’s Bill was introduced into the Australian Parliament by four Australian senators to amend the Patents Act with the aim to “prevent the patenting of human genes and biological materials existing in nature”. The Patent Amendment (Human Genes and Biological Materials) Bill 2010 seeks to amend the Patents Act by excluding from patentability “biological materials including their 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 Committee noted the introduction of this Bill in its report and expressed the view that a Senate inquiry into the Bill be undertaken to provide a further opportunity for the arguments and questions around the impacts and effectiveness of an express prohibition on gene patents to be considered.
The Bill has been referred to the Senate Legal and Constitutional Affairs Legislation Committee for public submissions. The closing date for receipt of written submissions is 25 February 2011.
Adrian Evans - November 2010.
