Released last week, the Senate Legal and Constitutional Affairs Committee’s report on the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (“Bill”) had just one recommendation: “The committee recommends that the Senate should not pass the Bill.”

The committee’s conclusions can be found in chapter 5 of the report where, after considering nine issues regarding the provisions of the Bill (discussed below) and describing the Bill as “well-intentioned” stated:

… the committee does not agree that the Bill represents an effective solution to the problems which may be caused by patents over human genes and biological materials.  In particular, the committee is concerned that proposed amendments in the Bill, which are 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.

Importantly, the committee voiced its support for the amendments proposed by the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 and that “serious consideration should also be given to the proposals for legislative enactment of the patentable subject matter test and the general ‘ethical’ exclusion made in the ACIP report on patentable subject matter.”

The Committee’s position on each of the nine key issues was as follows:

  1. the distinction between discoveries and inventions: “…the Bill will, at best, not assist to clarify the distinction between discovery and invention in the patent system and, at worst, make the distinction more obscure … a technology neutral approach to this issue is preferable to an approach which will focus on one category of inventions only.”
  2. the scope of the Bill’s exclusion for biological materials: “The evidence received during the inquiry indicates that this exclusion [for biological materials] is likely to have significant implications for a broad range of sectors and industries in Australia, including healthcare, pharmaceuticals, agriculture, food manufacturing and biotechnology.”
  3. access to treatments, diagnostics and methods for healthcare: “…there was no evidence received by the committee that patents on human genes or biological materials are systematically leading to adverse impacts in the provision of healthcare in Australia.”
  4. freedom to conduct research: “It is clear that legal uncertainty in relation to patents can cause anxiety for researchers and delays for research … In the view of the committee, a clear research exemption is the preferable approach to provide certainty for researchers.”
  5. investment in research and development: “The evidence the committee received indicates that patents over human genes and biological materials have not hindered research, particularly medical research, in Australia” and that “the significant amendments proposed in the Bill risk creating uncertainty regarding the stability of Australia's patent system … [that] could negatively affect investment in research and development in Australia."
  6. access to new products and knowledge: “…there is a clear risk that, without certainty in relation patent protection for biological materials, companies will have less incentive to develop and commercialise new products for the Australian market.”
  7. ethical issues with respect to the patenting of human genes and biological materials: “…the ACIP proposal for a general ethical exclusion has merit and is a preferable approach to prevent the grant of patents which would be perceived as unethical by the community.”
  8. the Crown use and compulsory licensing provisions of the Patents Act: “The committee does not agree with the characterisation, made during the inquiry, that the Crown Use and compulsory licensing provisions in the Patents Act are not effective because they are rarely, if ever, utilised."
  9. international considerations: “In the view of the committee, the enactment of the Bill could breach Australia's international obligations under the TRIPS Agreement and the AUSFTA to allow for the patenting of inventions in 'all fields of technology' without discrimination.”  

The report is the culmination of nearly nine months work, 122 submissions and two public hearings.  Over this period Mallesons’ IP Whiteboard has followed the review closely.  We will keep you updated with how the report is recevied by the Senate in the coming weeks.