High Court grants special leave to appeal extension of time in pharmaceutical patent case

Last Friday the High Court of Australia granted Alphapharm special leave to appeal from a decision of the Full Federal Court in Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129.  The Full Court’s decision affirmed an earlier decision of the Administrative Appeals Tribunal to grant Lundbeck an extension of time in which to make an application to extend the term of its patent for (+)-citalopram.

The High Court granted Alphapharm special leave to appeal on the question of whether the Commissioner of Patents had the power to grant Lundbeck an extension of time to apply for an extension of the term of its patent.  A decision to grant Lundbeck an extension of time was made by a delegate of the Commissioner, pursuant to section 223 of the Patents Act, in June 2011, and affirmed by the Administrative Appeals Tribunal in December 2012.

On appeal, the High Court will be asked to decide whether section 223 of the Patents Act, and the accompanying regulation, can be invoked where the act for which an extension of time is sought is the making of an application for an extension of the term of a patent.

The High Court’s decision to grant special leave is the latest development in a long-running dispute between Lundbeck and other pharmaceutical companies concerning Lundbeck’s entitlement to an extension of the term of its patent for the antidepressant escitalopram.

The decision of the High Court on the appeal will have important ramifications for extensions of time in the context of pharmaceutical patent term extensions in Australia.

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About the Author

James EllsmoreJames is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.View all posts by James Ellsmore