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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 41 AusBioFEATURE By Michael Caine and Sam Mickan, Davies Collison Cave IP Australia proposes far-reaching changes IP Australia—the Australian Government agency responsible for the administration of patents and trade marks—is proposing changes to Australian intellectual property (IP) law and practice. Some of these proposals relate to patent and trade mark office procedures, while other proposals relate to the substantive law of Australia. Seven papers have been released since March 2009 proposing changes that could profoundly affect Australia's IP landscape. In general, IP Australia alleges that Australia has lower patentability standards than other jurisdictions such as Europe, Japan and the US. The 'balance' paper proposes amendments to our legislation to bring these standards into 'alignment'. The 'streamlining' paper proposes changes intended to remove perceived differences between Aus- tralian law and the laws of Europe, Japan and/or the USA. It is not clear, however, that foreign law has been correctly analysed in developing these proposals. Of particular interest to the AusBiotech community are proposals to remove uncertainty surrounding the potential for patent infringement through the use of patented inventions for experimentation purposes. The 'exemp- tions' paper proposes legislative amendments to codify which experimental acts are exempt, by their very nature, from potential infringement. In this paper, IP Australia also contends that a patentee has a de facto extension of term if their invention requires regulatory approval, including for non-pharmaceutical inventions: competitors cannot apply for regulatory approval---which takes some time---until the patent expires. This paper proposes an expansion of the current pharmaceutical patent exemptions but does not propose a corresponding extension of term. These proposals follow some recommendations, but not all, from reviews of the patent system, eg by the ALRC and ACIP, discussed below. The papers, and their release dates, are: (i) 'Exemptions to Patent Infringement', 27 March 2009, proposes legislative clarification for experimental use and for seeking regulatory approval; (ii) 'Getting the Balance Right', 27 March 2009, proposes substantive changes to Australia's patentability standards; (iii) 'Resolving Divisional Applications Faster', 18 June 2009, proposes limitations to the use of divisional applications; (iv) 'Resolving Patent Opposition Proceedings