The High Court of Australia has granted Alphapharm special leave ¹ to appeal a decision made last year by the Full Federal Court ², concerning Lundbeck’s right to extend the term of its Escitalopram (Lexapro™) patent.
The Full Federal Court had dismissed an appeal regarding the grant of an extension of time to Lundbeck, whose application to extend the term of its patent for the antidepressant drug, LexaproTM, had been found to have been filed out of time. The decision to grant Lundbeck an extension of almost 10 years in which to file its extension of term application, was originally made by a delegate of the Commissioner of Patents and affirmed by the Administrative Appeals Tribunal. The Full Federal Court dismissed the appeal on the basis that the Tribunal’s decision was not unreasonable in light of the subject matter, scope and purpose of the Patents Act (Cth) 1990 (the Act), such as to require that decision to be set aside.
In its application for special leave, Alphapharm argued that the extension of time provisions of the Act did not apply in relation to certain prescribed actions, one of which was the filing of an extension of term application. It also argued that it was not ‘reasonable’ for Lundbeck to be granted such a lengthy extension of time in which to file its application to extend the term of the patent.
The High Court appeal will be limited solely to the question of whether an extension of time is available under the provisions of the Act and associated regulations for the purpose of filing an extension of term application. The court declined to hear the question as to whether it was ‘reasonable’ for Lundbeck to be granted such a lengthy extension of time, presumably because it was felt that the Administrative Appeals Tribunal had correctly weighed up all of the relevant factors in granting the extension.
The High Court of Australia rarely grants special leave to appeal patent cases from the Full Federal Court. Usually, special leave is only granted where there is a matter raised in the case which has constitutional implications or is otherwise considered a major issue of law. Thus, this High Court decision will be awaited with keen interest and is likely to have important implications for the grant of extensions of time in Australia, particularly in circumstances where the extension of time is to apply for an extension of the term of a patent.
If you have any specific enquiries about the Escitalopram case in Australia, please contact Paul Jones or Debra Tulloch.
This article was written by Dr Rosemary Manhire-Heath.
¹ Alphapharm Pty Ltd v H Lundbeck A/S & Ors  HCATrans 79
² Aspen Pharma Pty Ltd v H Lundbeck A/S  FCAFC 129