Jurisdiction - Australia
News
Australia – Lundbeck Overcomes A Delay Of 10 Years To Extend The Patent Term For Lexapro.

22 April, 2014

 


Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129

Background

 
An extension of term for a patent concerning a pharmaceutical substance is available under the Patents Act 1990 (Cth) (Act) if the patentee meets certain requirements, including applying for the extension within a particular time period. A product containing or consisting of the pharmaceutical substance must also be included in the Australian Register of Therapeutic Goods (ARTG). In some cases, a patentee is required to file the application within 6 months of the date that a product was first included in the ARTG.

 
Escitalopram is the (+) enantiomer of the compound, citalopram. Citalopram is a mixture of both (+) and (-) enantiomers. Citalopram was included in the ARTG on 9 December 1997 under the name CIPRAMIL (CIPRAMIL date). Escitalopram was included in the
ARTG on 16 September 2003 under the name LEXAPRO (LEXAPRO date). On 22 December 2003, Lundbeck filed an application to extend the term of the Patent, based on the LEXAPRO date. The Commissioner of Patents granted the application.

 
On 6 July 2005, Alphapharm applied to revoke the Patent and argued that Lundbeck’s extension of term application should have been based on the CIPRAMIL date, on the basis that CIPRAMIL contains escitalopram. Justice Lindgren held that Lundbeck’s extension of term application was invalid because it had been filed out of time. On 12 June 2009, the Full Federal Court made final orders affirming Lindgren J’s decision. On the same day, Lundbeck filed an application for an extension of time (of around 10 years) to file an extension of term application. The original term of the Patent expired on the following day, and a number of generic companies (the Applicants) then launched generic products containing escitalopram.

 
The Applicants unsuccessfully opposed Lundbeck’s extension of time application before both the Commissioner of Patents and the AAT, and subsequently appealed the AAT’s decision. As with all cases of administrative review, the Court’s role in this case was to consider if the AAT had made any errors of law in affirming the Commissioner’s decision to grant an extension of time to Lundbeck, not to determine what the AAT should or should not have decided on the evidence before it.

 
Full Federal Court Decision

 
A key issue that arose in the case related to a form of preliminary advice that Lundbeck had received on 14 July 2005 from its patent attorneys. That advice suggested that “one immediate action” open to Lundbeck at that time was to make an application for an extension of time to file an extension of term application. The Full Federal Court held that the AAT had made no error in finding that Lundbeck had not acted unreasonably in not filing the extension of time application until 12 June 2009. The AAT accepted that Lundbeck had preferred and had followed later legal advice it had received from another law firm, which had been to the effect that Lundbeck should proceed on the basis that the extension of term application had been correctly based on the LEXAPRO date.

 
The Full Court found that the AAT’s decision was not unreasonable in the unusual circumstances of the case, which had included a number of years of complex patent litigation, during which it should have been expected that Lundbeck would take all reasonable steps to legally open to it to protect its interests. The Full Court noted that the AAT had accepted the likelihood that commercial considerations were taken into account by Lundbeck in preferring the advice that it followed, and that the AAT had considered the evidence of the prejudice suffered by the Applicants as a result of Lundbeck’s delay.

 
Application For Special Leave To Appeal To The High Court

 
On 11 April 2014, the High Court of Australia granted Alphapharm special leave to appeal from the Full Court’s decision. The grant of special leave was limited to the ground of whether the power to extend time for Lundbeck to make its application to extend the term of its patent was available to the Commissioner of Patents under s223 of the Act.

 

Ashurst Logo

 

For further information, please contact:

 

Peter Chalk, Partner, Ashurst
[email protected]


Andrew Sutherland, Ashurst
[email protected]

 

Ashurst Intellectual Property Practice Profile in Australia 

 

Homegrown Intellectual Property Law Firms in Australia

 

Comments are closed.