Patent law has been the subject of a number of reports and proposals for reform, particularly in relation to gene technology, including:
- the Senate Community Affairs References Committee's Gene Patents Report – calling for increased patentability standards, particularly regarding gene patents;
- the 2011 Advisory Council on Intellectual Property's Patentable Subject Matter Report (the ACIP Report) – recommending that, among other things, the Patents Act 1990 (Cth) is amended (i) to include a statement of objectives, (ii) to define the requirements for patentable subject matter; and (iii) to replace the current exclusions to patentability with a morality exclusion;
- the 2004 Australian Law Reform Commission's Report No 99, Genes and Ingenuity: Gene Patenting and Human Health (the ALRC Report) – calling for improved patent law and practice, and greater monitoring and education regarding gene patents and licensing; and
- IP Australia's review of the patent system.
In addition, there is currently before Parliament:
- the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (the IP Bill); and
- the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (the Genes Bill).
On 23 November 2011 the Australian Government issued a consolidated response to these reports, clarifying how it intends to deal with the various proposals.
In the Government's view, most of the recommendations are addressed by the IP Bill, which broadly seeks to:
- extend the information that can invalidate the inventiveness of a patent (eg. common general knowledge outside Australia is relevant if it would be 'understood and appreciated' as relevant (without the current 'ascertained' requirement));
- raise the standard of information a patent specification must include to support the invention;
- raise the burden of proof to a 'balance of probabilities' threshold for all patentability criteria; and
- expand the grounds on which the Commissioner can challenge a patent or patent application.
Significantly, the Government accepts that the Patents Act:
- in principle, should not be amended to exclude genetic material and technologies from patentable subject matter; and
- should not exclude methods of diagnostic, therapeutic or surgical treatment from patentable subject matter (Recommendations 7-1(a) and (b) of the ALRC Report).
The only recommendations that require substantive further drafting are those of the ACIP Report noted above. While the ACIP Report proposed some straightforward drafting solutions, the Government's desire that the proposals receive a 'considered and comprehensive public consultation process' will likely mean that there are no conclusive developments in the near future.
In the meantime, the IP Bill has had its first reading in the Senate; and the Government's view that the IP Bill addresses a number of the calls for reform will likely assist the passage of the IP Bill through Parliament.
Partner: John Fairbairn
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