Inevitable change to the Australian patent system progresses

On 23 November 2011, the Federal Government tabled its combined response addressing the recommendations of the Senate Gene Patents Report (November 2010) and a number of previous reports into gene patenting and patentable subject matter in Australia. In their response, the Government endorsed a number of recommendations which aim at increasing the quality of granted patents in Australia. Significantly, the Government also supported recommendations not to exclude the patenting of genes and biological material.

 

In November 2010, the Community Affairs References Committee Gene Patents Report was tabled. This Report made a number of recommendations in relation to improving patent quality and the operation of the patent system. Most significantly, the Report made no recommendation that the Patents Act 1990 be amended to expressly prohibit the patenting of genes/biological materials.

Recommendation 4 of the Report proposed that the Government provide a combined response addressing the Senate Community Affairs References Committee Gene Patents Report as well as a number of previous reports into gene patenting and patentable subject matter, namely:

  • The 2004 Report on Genes and Ingenuity: Gene Patenting and Human Health by the Australian Law Reform Commission
  • The review of patentable subject matter by the Australian Council on Intellectual property (ACIP) and
  • The review of Australia’s Patent System by IP Australia.

Issues

Specifically in their response, the Government accepted a number of recommendations which aim at increasing the quality of patents in line with major jurisdictions, Europe and the United States. These accepted recommendations include:

  • Broadening the prior art base for inventive step as well increasing the inventive step threshold;
  • Increasing support and utility requirements; and
  • Introducing a broad research exemption.

Most significantly, the Government appears to have acknowledged community concerns about the patenting of genes and biological material. However, rather than supporting a ban on these types of patents, the Government has taken a technology neutral approach to patent reform and supported clarification of existing safeguards in the legislation such as Crown use and compulsory licensing provisions.

A number of the accepted recommendations are included in the Intellectual Property Raising the Bar Bill which was introduced into the Senate on 22 June 2011.

Minister for Innovation Senator Kim Carr said, “the response is designed to give confidence to the significant investments in biotechnology innovation and research and development. It will also ensure that patients are not denied reasonable access to affordable treatments and essential diagnostic tests through inappropriate use of the Patents Act”.

The Government’s response suggests that the Private Members Bills proposing patent reform to exclude the patenting of genes and biological materials are redundant and unlikely to be supported.

Future Directions

The Government’s response almost certainly puts an end to the calls for legislative reform to exclude the patenting of genes and biological material. However, Federal Court proceedings are currently in progress to consider whether isolated genes can be considered legitimate patentable subject matter. A decision on these proceedings is expected in 2012.