Australian Senate Committee rejects Bill that seeks to prevent the patenting of human genes
The Australian Senate Committee Report on proposals to amend the Patents Act to prohibit patenting of human genes and other biological materials existing in nature has made a single recommendation “that the Senate should not pass the Bill”.
On 26 November 2010, the Senate referred the Patent Amendment (Human Genes and Biological Materials) Bill (Bill) to the Legal and Constitutional Affairs Legislation Committee for inquiry and report.
As part of the inquiry, the Committee held two public hearings and received 122 submissions.
The Committee identified the following key issues to be addressed:
- the distinction between discoveries and inventions;
- the scope of the Bill’s exclusion for biological materials;
- access to treatments, diagnostics and methods for healthcare;
- the freedom to conduct research;
- investment in research and development;
- access to new products and knowledge;
- ethical issues with respect to the patenting of human genes and biological materials;
- the Crown use and compulsory licensing provisions of the Patents Act; and
- international considerations.
The Committee concluded that:
- the amendments proposed in the Bill will not assist to clarify the distinction between discovery and invention in the patent system and may make the distinction more obscure
- the proposed exclusion for biological materials which are identical or substantially identical to such materials “as they exist in nature” is likely to have significant implication on broad range of sectors and industries, including healthcare, pharmaceuticals, agriculture, food manufacturing and biotechnology
- the proposed exclusion for biological materials would also have significant adverse consequences for healthcare in Australia because it could potentially include long delays for patients to access new diagnostic tests, medicines and treatments, reduced access for Australian patients to clinical trials and a reduction in investment for medical research and development in Australia
- the proposed exclusion for biological materials does not provide any certainty for researchers seeking an exemption from infringement for research and experimental activities relating to patented inventions
- the evidence the Committee received indicates that patents over human genes and biological materials have not hindered research, particularly medical research and that the ambiguous nature of the Bill’s provisions could negatively affect investment in research and development in Australia
- there is a 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
- there are ethical dimensions to the issue of patenting human genes and biological materials
- the enactment of the Bill could breach Australia’s international obligations under the TRIPS Agreement and the US Free Trade Agreement to allow for the patenting of inventions in “all fields of technology” without discrimination
- the Crown Use and compulsory licensing provisions in the Patents Act can effectively influence patent-holder behaviour.
In the end, the committee did 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 … Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues.”
See the full report — Australian Senate Committee Report