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Client Update: Pharma patent extensions under attack

23 November 2012

In brief: IP Australia has released a paper highlighting issues it intends to cover in its review of pharmaceutical patents. Partner Richard Hamer (view CV) and Law Graduate Laura Myer report.

IP Australia has released its Background and Suggested Issues Paper for the Pharmaceutical Patents Review (the Review) in relation to its review of the system for pharmaceutical patents in Australia.

The Federal Government announced the Review in October this year. Its terms of reference state that it will evaluate 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 will particularly focus on the adequacy of the pharmaceutical extension of term provisions provided under section 70 of the Patents Act 1990 (Cth).

The extension of term provisions relate to patents for a pharmaceutical substance, and aim to address the practical reality that a patent owner is unable to commercially exploit a pharmaceutical patent until the pharmaceutical obtains regulatory approval from the Therapeutic Goods Administration.

It is possible that the Review will recommend amendments to the current extension of term provisions. Amendments sought by the originator sector of the industry include broadening the interpretation of 'first regulatory approval date' where the relevant patent is for a new formulation, so that the extension is no longer calculated by reference to, for example, the original approval date for the active ingredient (thus effectively preventing any meaningful extension of term for the follow-on patent). This would increase the length of time before generic products are able to enter the market.

Conversely, the generic manufacturing sector of the industry has sought a restriction on the types of pharmaceutical patents eligible for an extension of term, including a prohibition on the use of the provisions for new formulations for active ingredients (which normally encounter a shorter marketing approval period compared to that of the original active ingredient).

The Issues Paper, released on 21 November, raises issues the Review panel is interested in learning more about. The panel has invited public submissions.

Other questions posed in the Issues Paper cover a broad range of issues relating to pharmaceutical patents, including whether:

  • the types of pharmaceutical patents eligible for an extension of term are appropriate;
  • the duration of extension of term provided for is appropriate;
  • the recent amendments (under the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)) to increase the thresholds for the grant of an Australian patent are appropriate in the context of pharmaceuticals. If not, why not and what further changes are necessary?
  • the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent;
  • interlocutory injunctions provide appropriate relief in cases involving pharmaceuticals;
  • the law on contributory infringement (which provides that where use of a product by a person would infringe a patent, the supply of that product to that person is, in certain circumstances, an infringement of the patent by the supplier) is appropriate in relation to pharmaceuticals;
  • the current timeframes in which infringement proceedings must commence are appropriate for pharmaceutical patents;
  • follow-on patents (the practice of patenting further variations and improvements to a patented invention) are being used to inappropriately extend protection for pharmaceuticals;
  • the law on data exclusivity (which provides for a clinical data exclusivity period of five years from marketing approval for products listed on the Australian Register of Therapeutic Goods (the ARTG)) is appropriate;
  • the laws on patent certificates (used by a generic company to state that it believes that it is not marketing/will not market the generic therapeutic good in a way that would infringe a valid patent, or to state that the generic company has given the patent owner notice of the company's application to have the generic therapeutic good included on the ARTG) are appropriate; and
  • the laws on copyright of product information are appropriate.

Submissions for the Review are due on 21 January 2013 and the Final Report is due in April 2013. If you require assistance with a submission, or have any other queries, please contact any of the people below.

For further information, please contact:

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