Further to our recent News Alert on the “Gene Patent Debate” the final report of a Senate Committee Inquiry into the impact of patenting of human genes and genetic materials was presented to Parliament late last Friday.
The Inquiry arose largely out of concerns relating to the potential enforcement of patent rights over the BRCA1 and BRCA2 genes, which are utilised in testing for predisposition to developing breast and ovarian cancer. The Senate Committee was tasked with enquiring into concerns relating to the impact of patenting human genes and genetic materials on progress in medical research, the provision of healthcare and the overall health and wellbeing of the Australian people.
Findings and Comment
After an extensive review spanning over 2 years with multiple extensions of time, the Committee found that the “evidence did not show that gene patents are systematically leading to adverse impacts” in medical research or the provision of healthcare. As a result, the Committee concluded that “a number of considerations persuaded the Committee that it would not, at this point in time, recommend that the [Patents] Act be amended to expressly prohibit the patenting of genes.”
Interestingly, although stating agreement with all Recommendations of the Report, two members of the Committee (Senators Coonan and Heffernan) were minded to have additional comments under their own names included in the Report. In these comments, Senators Coonan and Heffernan did recommend that the Act be amended to ban the grant of patents over biological materials which are identical or substantially identical to such materials as they exist in nature. Readers will recall that the primary sponsor of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (see previous News Alert), was Senator Heffernan, supported by Senator Coonan and the Committee Chair, Senator Siewert. Hence, although the Committee did not recommend an express exclusion of genes and biological materials from patentability, significant members of the Committee have already commenced that action by way of the Bill.
The Report provided 16 recommendations. Included among the Recommendations are that the Government put in place systems permitting the collection of relevant data concerning genetic testing and treatment in Australia and tracking the use of patents dealing with genes and genetic materials (Rec. 1 and 2), and that the Government provide a combined response to the various relevant inquiries and reviews that have, and are, looking into patentability of such subject matter (Rec. 4). The Committee recommended various changes to the Patents Act which would raise the level of inventiveness (Rec. 6, 7 and 8) and the level of descriptive support in a patent specification (Rec. 9 and 10) required to justify an invention. Echoing the recommendations of previous inquiries, the Committee recommended an amendment of the Act to clarify the Crown use (Rec. 11) and compulsory licensing provisions (Rec. 12) and the introduction of an explicit research exemption (Rec. 13).
As recommended by the Committee, the Patent Amendment (Human Genes and Biological Materials) Bill 2010 was referred to the Legal and Constitutional Affairs Legislation Committee for inquiry and report. Although many of the submissions to the now concluded Inquiry contemplated the potential effects of such an express exclusion of patenting human genes and genetic material, it is hoped that the new Inquiry specifically into the Bill will provide for an informed debate into all potential ramifications of the Bill. The deadline for submission to that Inquiry is 25 February 2011 and the Report of that Committee is due to be presented to Parliament on 16 June 2011.
For more information on the recommendations and the full Committee Report go to http://www.aph.gov.au/senate/committee/clac_ctte/gene_patents_43/report/report.pdf. For information on the Senate Inquiry into the Bill or to provide submissions please go to http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/index.htm.