In the latest development in a long-running saga, the High Court of Australia has agreed to hear an appeal over whether or not it is possible to obtain an extension of time within which to apply for an extension of the term of a patent relating to a pharmaceutical substance.
The substance in question in this case is the antidepressant drug escitalopram, marketed in Australia as LEXAPRO, and covered (at least until 13 June 2009) by Australian patent no. 623,144 owned by H Lundbeck A/S. Lundbeck is looking to extend the term of the patent to 9 December 2012, which it would be entitled to do as compensation for delays in obtaining regulatory approval to market LEXAPRO in Australia. But, in order to do this successfully, it requires an extension of time to allow its application for an extension of term to be considered, because it was filed about ten years too late!
So far, the Australian Patent Office, the Administrative Appeals Tribunal, and a (unanimous) Full Bench of three experienced judges of the Federal Court of Australia have all upheld Lundbeck’s claim to the extension of time.
However, the additional three-and-a-half years of patent term presumably represents a great deal of money in prospective damages to be paid by generic pharmaceutical manufacturers, who have been selling products in competition with LEXAPRO, and so they not given up on appealing! And, it seems, rightly so – because on 11 April 2014 the High Court of Australia granted ‘special leave’ (transcript at Alphapharm Pty Ltd v H Lundbeck A/S & Ors  HCATrans 79), allowing generic manufacturer Alphapharm Pty Ltd to appeal the Federal Court decision.
In fact, Alphapharm was only 50% successful in its bid. The High Court declined to take the question of whether it was ‘reasonable’ for Lundbeck to be granted an extension of an entire decade any further, presumably feeling that the tribunals below had weighed up all of the relevant factors correctly. The High Court appeal will therefore be limited to the single question of whether an extension of time to apply for an extension of term is available at all under the provisions of the Australian Patents Act 1990 and Patents Regulations 1991.