The Australian government recently launched a review of pharmaceutical patent protection. Central to the review will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70). The review will consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new entrants to the market. It will assess how patents for new formulations are granted, the treatment of new methods of manufacturing and use of known products, the impact of contributory infringement provisions and the impacts of data exclusivity provisions. As such, the review is extensive and could have far reaching implications for pharmaceutical patents in Australia.
The pharmaceutical patents review panel is tasked with evaluating whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.
The review follows concerns expressed by members of the Australian healthcare sector that provisions in the Australian Patents Act lead to over-priced and restricted consumer access to pharmaceutical and medical technologies. As a result, we expect there will be considerable pressure on the panel to make recommendations which curtail the current patent monopoly available for pharmaceuticals.
The panel invites submissions from all interested parties on its Background and Suggested Issues paper. Contributions can also be made by commenting on the pharmaceutical patents review's blog where the panel is posting topics and papers for discussion during the review.
The panel is required to report its findings to the Government in April 2013, with public submissions due by 21 January 2013. In inviting submissions, the panel has identified 11 questions that they believe should be covered.
The questions are as follows:
- Is the breadth of pharmaceutical patents eligible for an extension of term appropriate?
- Is the length of the extension of term provided for appropriate?
- Are the recent amendments to increased thresholds of the grant in Australia patent appropriate in the context of pharmaceuticals? If not, why not, and what further changes are necessary?
- Do the systems for opposition and re-examination provide appropriate avenues for challenge to the granting and validity of a pharmaceutical patent?
- Do interlocutory injunctions as the laws currently apply provide appropriate relief in cases involving pharmaceuticals?
- Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
- Are the current time frames in which infringement proceedings must commence appropriate for pharmaceutical patents?
- Are follow on patents being used to inappropriately extend protection of pharmaceuticals? If so, how, and, if they are, is this sound policy and what changes, if any, are needed?
- Is the law on data exclusivity appropriate?
- Are the laws on patent certificates appropriate?
- Are the laws on copyright of product information appropriate?
As you will appreciate, the panel’s assessment may have a significant impact on amendments to the Australian Patents Act and could therefore be instrumental in determining the extent and duration of pharmaceutical patent protection in Australia.