Tuesday, 6th December, 2011

Gene patents recommendations by the Australian senate

A final report from the Australian Senate Legal and Constitutional Affairs Legislation Committee on the Patent Amendment (Human Genes and Biological Materials) Bill 2010 was issued on 21 September 2011.

We've previously reported the results of the 2010 Australian Senate Community Affairs Committee's (CAC) inquiry into gene patents. A final report from the Australian Senate Legal and Constitutional Affairs Legislation Committee on the Patent Amendment (Human Genes and Biological Materials) Bill 2010 was issued on 21 September 2011.

The 2010 report

The 2010 CAC's report concluded that more data was needed on the impacts of gene patents on healthcare, medical training and research and on the general health and wellbeing of Australians.  They felt that the available evidence showed no systematic adverse impacts of gene patents in these areas. The report also recommended that the Australian Government provide a combined response to several recent patent inquiries, and that the Patent Amendment (Human Genes and Biological Materials) Bill 2010 be sent to the relevant committee for review. 

The final report

In its final report, issued in September this year, the majority of the Committee recommended that the Senate not pass the Bill.  A minority of the Committee dissented.

The Committee concluded that the Bill was 'well-intentioned' but did not agree that the Bill represented an effective solution to the potential problems caused by patents over human genes and biological materials. The Committee was particularly concerned that proposed amendments in the Bill, which were focused on addressing a specific issue, could have a large number of unintended consequences across the entire patent system with indeterminate impacts on a range of industries and sectors.

The Committee further concluded that despite the need for more reform to the patent system, removing an area of patentable subject matter, as proposed by the Bill, was not an appropriate solution to this complex set of issues.

Response from the Australian Government

The Australian Government issued a response to the CAC's 2010 report on 23 November 2011.  The Government accepted the recommendation for a combined response and, in addition to the CAC's report, considered the 2011 Advisory Council on Intellectual Property's Patentable Subject Matter Report, the 2004 Australian Law Reform Commission's Report No. 99 Genes and Ingenuity: Gene Patenting and Human Health (the ALRC report), and a review of Australia's patent system by IP Australia.

The response addresses a range of patentability questions, but those in the biotechnology community may be most interested in the Government's response to recommendation 7-1 of the ALRC report.  The Government accepted the recommendation that:
The Patents Act 1990 (Cth) should not be amended:
(a) to exclude genetic materials and technologies from patentable subject matter; and
(b) to exclude methods of diagnostic, therapeutic or surgical treatment from patentable subject matter.

The Government also accepted a recommendation (6-1 ALRC report) that "patent 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", noting Australia had an obligation under TRIPS to maintain technology-neutral patentability criteria.

Although the Government did not expressly address the Patent Amendment (Human Genes and Biological Materials) Bill, in light of the positions adopted in the response, and the findings of the Senate Legal and Constitutional Affairs Legislation Committee, it appears unlikely that the Government will support the Bill. 

We will continue monitoring this unfolding story to keep you informed.