After months of deliberation, the Australian Senate Legal and Constitutional Affairs Committee on 21 Septmeber, 2011 handed down its much anticipated report in relation to the Private Member’s Bill sponsored by Senators Heffernan, Xenophon, Siewert and Coonan. This Bill seeks to ban the patenting of all biological materials, such as genes, which are identical or substantially identical to those found in nature. In short, the Committee makes only one unambiguous recommendation; that the Senate should not pass the Bill.
The Senate Committee’s report provides a very clear distillation and analysis of the issues articulated in both the 133 written submissions made to the Committee and the hearings which were subsequently held. The key findings underpinning the Committee’s recommendation are as follows:
- Scope of the Bill
The Bill uses broad and imprecise language which introduces a level of ambiguity that could discourage investment in research and development and encourage litigation by those seeking to clarify patent rights.
- Access to Healthcare
The Committee notes the irony that enactment of the Bill would not resolve the very issue which underpinned the establishment of the two recent Senate enquiries into gene patenting; this being access to breast cancer diagnostic testing. The Bill would only prevent patenting of biological materials but would not impact on the existence of patent rights over diagnostic methods. Still further, the Bill could potentially result in adverse consequences for healthcare in Australia due to reduced access by Australian patients to clinical trials of drugs which are only patentable overseas and significant delays in subsequent access to such medicines by the community as a whole.
- Freedom to research
The Committee correctly notes that the issue of research based access to patented technology is an important issue but is one which is adequately dealt with by the amendment proposed in the Raising the Bar Bill, which seeks to introduce a research use exemption.
- Investment in research and development
Concern is expressed by the Committee that the inability to patent biological materials in Australia may drive investment, and therefore research and development, overseas. The Committee acknowledges that patents allow researchers to attract crucial investment to pursue their research.
- Crown use and compulsory licensing
The Committee disagrees with the characterisation made during the enquiry that the Crown use and compulsory license provisions, provided for by the Patents Act in order to regulate abusive monopolistic behaviour, are not effective because they are rarely utilised. The Committee acknowledges that legislative mechanisms can effectively influence behaviour by virtue of their mere existence. Any complexity in terms of the use of these provisions is an issue which the Committee believes should be separately considered.
- Ethical considerations
The Committee acknowledges that there are clearly ethical dimensions to the issue of patenting human genes and biological materials. However, it suggests that consideration be given to the recommendations appearing in the ACIP report in relation to a general ethical exclusion to inventions “the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public”. The Committee believes that an exclusion along these lines would provide an ongoing level of flexibility in relation to the grant of patents which might be perceived by the community, at any given point in time, as being unethical.
- Discovery and Invention
The Bill will not only fail to assist in clarifying the distinction between discovery and invention but may in fact make the distinction more obscure. The Committee prefers that any attempt to clarify this distinction be pursued in a technology neutral manner with regard to the recommendations recently handed down by ACIP.
- International obligations
In the view of the Committee, the enactment of the Bill would breach Australia’s international obligations under TRIPS and the Australia/US Free Trade Agreement. Although restrictions on the patenting of biological materials do exist in some developing countries, the Committee is of the opinion that the factors which drive these sorts of exclusions in developing countries do not necessarily translate to an advanced research jurisdiction such as Australia.
In its report the Senate Committee has expressed its view that the Bill does not provide an effective solution to the problems articulated by the wider community in terms of access to healthcare. Although of the opinion that the Bill is well intentioned, the risk of significant unintended consequences across a range of industrial sectors is regarded by the Committee as unacceptable. The Committee concludes by recommending that solutions to the community’s concerns be pursued via alternative mechanisms.