By Martin O'Brien --
The patentability of genetic materials has been the subject of considerable community debate in Australia and elsewhere in recent years. Several inquiries have been held in Australia, including the Senate Gene Patents Report (24 November 2010), the 2011 ACIP Report on Patentable Subject Matter, and the 2004 Australian Law Reform Commission's Report on Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99 Report). One of the recommendations of the Senate Gene Patents Report was that the Government provide a combined response to these Reports.
The Government accepted that recommendation and, on 23 November 2011, the Government's combined response to those Reports was released. A copy of the full response can be accessed here.
In the Media Release accompanying the Government response, the Minister for Innovation stated that "the response is designed to give confidence to the significant investments in biotechnology innovation and research and development. It will also ensure that patients will not be denied reasonable access to affordable treatments and essential diagnostic tests through inappropriate use of the Patents Act."
The Government response addresses many aspects of the debate. This article focuses on what, for some biotechnology companies, might be described as the ultimate question, namely whether genetic materials may properly be considered appropriate subject matter for patentability. Recommendation 7-1 of the ALRC 99 Report was that "[t]he Patents Act 1990 (Cth) should not be amended: (a) to exclude genetic materials and technologies from patentable subject matter; (b) to exclude methods of diagnostic, therapeutic or surgical treatment from patentable subject matter." In the Government response, Recommendation 7-1 (a) is accepted in principle and Recommendation 7-1 (b) is accepted in full.
During the course of the inquiries and public debates the desirability of a technology-neutral approach to patentability arose. For example, the ALRC 99 Report recommended (6-1) that "[p]atent applications relating to genetic materials and technologies should be assessed according to the same legislative criteria for patentability that apply to patent applications relating to any other type of technology." In accepting this recommendation the Government drew attention to Australia's obligations under TRIPS to maintain technology-neutral patentability criteria.
The Patent Amendment (Human Genes and Biological Materials) Bill 2010 seeks to exclude biological materials, including genetic materials, from patentability ("The Gene Patent Debate -- Bill Seeks to Exclude Biological Materials from Patentability"). That Bill remains pending. Other than noting that the Senate Gene Patents Inquiry recommended that Bill be sent to the relevant Senate Committee for review and report, the Government's response to the three inquiries does not directly express an opinion on that Bill. As we have previously reported, however, that Bill has now been the subject of a Senate Inquiry, the majority finding of which was that the Bill should not be passed.
With the Government response to the three inquiries now having stated agreement in principle with the ALRC 99 Report that the Patents Act should not be amended to explicitly exclude genetic materials from patentability, it is difficult to see how the Government could now support that Bill.
Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia, specializing in molecular biology and biotechnology.
For additional information regarding this topic, please see:
• "Australian Senate Committee Issues Recommendation on Gene Patenting Bill," October 6, 2011
• "Australian Senate to Release Gene Patenting Findings Next Week," June 8, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009