Proposed ban on the patenting of "biological materials"

Proposed ban on the patenting of "biological materials" - Griffith Hack

6 December 2010

Patents for biological materials, including genes, may face a significant change if a proposed amendment to section 18 of the Australian Patents Act proceeds.

Proposed amendments



The Patent Amendment (Human Genes and Biological Materials) Bill 2010, a private members bill introduced to the Australian Senate by Senator Bill Heffernan on 24 November 2010, proposes to ban the ability to patent certain biological material. The Patents Act currently bans the patenting of human beings and the biological process for their generation. However, the bill proposes an expansion of this ban to exclude the patenting of ‘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.’ "Biological material" is defined to include DNA, RNA, proteins, cells and fluids.

If passed in this current form, this is likely to have a significant effect on the biotechnology industry, and possibly other industries in any way involved with biological materials. The proposed amendment is also significantly broader than originally anticipated or foreshadowed by many stakeholders who have been involved in the debate on gene patents that has been underway in recent years – the definition of biological material is not limited and captures more than just a ban on the patenting of DNA or RNA. Claims directed to isolated proteins such as antibodies would be captured, as would pure cultures of cells such as stem cells. There is no restriction in the proposed amendments (as opposed to the title of the bill) to biological materials of human origin. Further, since the definition is inclusive, the ban potentially extends to organic chemicals of biological origin such as secondary metabolites (including antibiotics) and carbohydrates, even if chemically synthesized. Derivatives of biological molecules are also encompassed if they are “substantially identical” to a material which exists in nature, and this appears to extend the exclusion beyond natural molecules, although just how far this extension would operate is unclear. Importantly, methods of use of such materials as diagnostics and in medical treatments will continue to be afforded patent protection, provided they otherwise qualify for patentability.

There is no clarification on whether or not the bill will operate retrospectively; the Explanatory Memorandum for the bill suggests that the amendment merely ”seeks to clarify and apply existing patent law”. In this instance however, retrospectivity is likely to meet challenges under constitutional law, as an acquisition of property. We believe it will be unlikely for the amendment to operate retrospectively.

Current status of bill



In line with the recommendation of the Senate Community Affairs Committee (see below), the Senate has now referred the bill to its Legal and Constitutional Affairs Committee for inquiry and report. That committee has asked for written submissions on the proposed bill, to be provided by 25 February 2011. The committee is due to report back to the Senate by 16 June 2011.

Senate inquiry into gene patents



In further developments in this area, the long-awaited Senate Community Affairs Committee's report on its inquiry into gene patents was finally released on 26 November 2010. To some extent, the Committee is recommending a "wait and see" approach, citing a lack of data and information about the impact of gene patents as one justification of continued monitoring of this area. The Committee noted current and future national and international legal developments (essentially the outcomes of the appeal in the US Myriad decision and the similar proceeding in Australia) which may require the Committee to revisit this area. Finally, the Committee noted that the Australian Council on Intellectual Property (ACIP) is currently considering reforms to the manner of manufacture test, and ACIP's recommendations in this area may also have an impact on the issue of gene patenting. At this point in time, the Committee would not recommend that the Patents Act be amended to expressly prohibit the patenting of genes. However, the Committee makes several key recommendations, including:

  • increasing the threshold requirements for patentability to ensure that patents (including patents over genes and genetic materials) are granted only where an invention is sufficiently novel, inventive and useful;
  • the development of clear policies for the Crown use provisions in the Act, together with clarification of the compulsory licence provisions, observing that these recommendations were recommended by the Australian Law Reform Commission's review of gene patents in 2004;
  • the amendment of the Act to include a broad research exemption;
  • the establishment of an external patent audit committee to guide and inform the Government's engagement with the patent system; and
  • referral of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (discussed above) to the relevant Senate committee for inquiry and report.

Other developments



There is continued interest in the outcome of the appeal in the Myriad Genetics case (where the US District Court for the Southern District of New York found that isolated genetic materials are not patentable subject matter), along with the continuing Myriad/GTG litigation in the Australian Federal Court. In October, the US government indicated that it had changed its policy to reflect the District Court's findings on isolated genetic materials however it is not clear whether the USPTO would implement this revised policy. The ramifications of this litigation may still be felt through both the USPTO and IP Australia.

Next steps



The next six months will involve much further debate on this issue. Anyone with an interest in this area should stay tuned to the debate and, if necessary, get involved in the public inquiry process for the proposed amendment to the Patent Act, including by making submissions to the Senate committee. We will continue to monitor the debate and provide regular updates as issues arise.

For further information contact:
Geraldine Farrell, Special Counsel
Email Geraldine