The current provisions in the Australian Patents Act providing for extensions of term for pharmaceutical patents were introduced in 1998. They provide for an effective 15 year patent life for patents which protect pharmaceutical substances where the substance has been subject to the rigorous regulatory approval process prior to entry on the Australian market.
Australia has a very strong Generic Medicines Industry Association which has in the past argued for a change in these provisions.
Yesterday, the Australian Government announced a review of pharmaceutical patent issues and has commissioned an expert panel to review the appropriateness of the current PTE provisions.
Parliamentary Secretary for Industry and Innovation, Mr Mark Dreyfus said concerns had been raised about a number of aspects of pharmaceutical patents, including bringing generic pharmaceuticals to market and the effect of patent terms on innovation.
The review will consider:
- issues that impact on competition in the pharmaceutical industry, for example, the ability of generic medicines to enter the market
- issues around fostering innovation and bringing new pharmaceuticals to market
- the importance of the patent system in providing employment and investment in research and industry
- the impact of pharmaceutical patent provisions on Government health expenditure
- the impact on the Pharmaceutical Benefits Scheme
- international approaches to extensions of term for pharmaceutical patents
- Australia’s obligations under international agreements (including free trade agreements and World Trade Organisation agreements)
- Australia’s position as a net importer of patents and medicines
The review panel will be chaired by Mr Tony Harris with members, Dr Nicholas Gruen and Professor Dianne Nicol. A public consultation process will form part of the review. The panel’s final report is due to be provided to the Government in April 2013.
As the review was only announced yesterday, there is little information available at present. However, we will inform you once we receive more details.
The Australian Patents Act currently does not provide any further patent term extension for paediatrics or for new indications.
Pharmaceutical patentees can use this review as an opportunity to highlight the inadequacies of the present PTE provisions and to seek additional patent term extension as exists in some other countries.
Perhaps Pharmaceutical patentees can also take this opportunity to raise the issue of the current data exclusivity provisions which exist in Australia which are a minimum under TRIPS.
Spruson & Ferguson will work with Medicines Australia, AusBiotech and other Industry Groups to ensure that all our clients have input into this review.