On 15 October 2012, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, announced a review into pharmaceutical patents. The review will focus on the term extensions available for pharmaceutical patents but may also lead to more broad-ranging reforms. IP Australia’s report on the announcement can be found here.
Since 1999 it has been possible for patentees to obtain extensions of term of up to five years for pharmaceutical patents where the patentee has experienced delay in obtaining regulatory approval from the Therapeutic Goods Administration.
The overarching purpose of the review is to reconsider whether the period of monopoly available for pharmaceutical patents (including extensions) is appropriate. However, it is clear from the terms of reference that the review may consider broader issues. Under the Terms of Reference, the panel will consider:
- the availability of competitively priced pharmaceuticals in the Australian market;
- the role of Australia's patent system in fostering innovation and hence to bringing new pharmaceuticals and medical technologies to the market;
- the role of the patent system in providing employment and investment in research and industry;
- the range of international approaches to extensions of term and arrangements for pharmaceutical inventions;
- Australia's obligations under international agreements (including free trade agreements and the World Trade Organisation agreements); and
- Australia's position as a net importer of patents and medicines.
Medicines Australia CEO Dr Brendan Shaw, has indicated that the term in Australia for pharmaceutical patents (currently 20 years plus any extension) is too short. Medicines Australia represents “innovative pharmaceutical companies”. Mr Shaw’s comments can be found here. It is likely that manufacturers of generic pharmaceuticals will advocate for a reduction in the extension of term available for pharmaceutical patents (or the abolition of extensions).
We hope the review will consider ways in which the language of the extension of term provisions (s70 of the Patents Act) can be amended. These provisions have been judicially interpreted in ways that were contrary to the expectations of the industry and inconsistent with the equivalent US and UK provisions. In particular, Australian courts have held that the right to obtain an extension of term for a patent may be:
- affected by TGA approval in relation to a product not claimed in the patent; and
- triggered when a product containing the pharmaceutical substance is approved by the TGA even where it is only present as an impurity.
Over the coming months the panel will call for submissions. The panel will furnish its final report in early 2013.