Federal Court brings generic manufacturers a step closer to a large damages payment re Escitalopram

The Federal Court of Australia has dismissed an appeal by Alphapharm and others against the Commissioner of Patents’ decision to allow a patent term extension on Lundbeck’s patent covering the antidepressant drug Escitalopram (LEXAPRO) (the Escitalopram Patent) – Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185. This decision immediately followed the High Court’s decision confirming the Commissioner of Patents’ right to extend the time within which to apply for a pharmaceutical patent term extension under s70(1), in relation to the Escitalopram Patent.

 

In December 2003, Lundbeck made an application for a patent term extension for the Escitalopram Patent based on the inclusion of LEXAPRO in the Australian Register of Therapeutic Goods (ARTG) three months earlier, on 16 September 2003; – this conformed with the relevant time limits set out in s71(2). However, in a decision of the Full Federal Court, in 2009, it was held that the patent term extension request should have been based on the inclusion of CIPRAMIL in the ARTG, which occurred on 9 December 1997. Subsequently, Lundbeck applied and was granted a patent term extension of their Escitalopram Patent based on inclusion of CIPRAMIL in the ARTG.

However, Alphapharm and a number of other generic manufacturers opposed the grant of the patent term extension alleging that there was a failure to comply with the relevant requirements because:

  1. Claim 1 of the Escitalopram Patent is not directed to a pharmaceutical substance per se (Section 70(2)(a));
  2. CIPRAMIL does not contain Escitalopram; (Section 70(3)); and
  3. The term of the patent had previously been extended (Section 70(4)).

The opposition to the grant of the patent term extension was dismissed and an appeal was made to the Federal Court.

The Federal Court’s decision

In relation to points 1 and 2, it was argued that if the pharmaceutical substance per se were the pure, isolated or separated (+)-enantiomer, Escitalopram, then it would not be contained in the racemate in CIPRAMIL. This argument was rejected by the Federal Court on the basis that the racemic mixture in CIPRAMIL contained Escitalopram and that s70(3) did not require that it “be contained in any particular form or state or be identifiable separately or that its individual properties be known when it was so contained.”

The Federal Court also rejected the arguments made in relation to point 3 because it was found that the previous patent term extension granted on the basis of the inclusion of LEXAPRO in the ARTG had not been made under s70(3) and “so was vitiated by the jurisdictional error involved in its making”.

The Federal Court also rejected arguments that the delegate erred in granting the extension after deciding the opposition and that the balance of convenience is overwhelmingly in favour of maintaining the status quo, namely the immediate operation of the grant of the extension of the term of the patent.

Conclusions

This Federal Court decision together with the recent High Court decision has confirmed the validity of Lundbeck’s patent term extension on its Escitalopram Patent. Given that damages will be due to Lundbeck for infringement of the Escitalopram Patent from 13 June 2009 to 9 December 2012, it is highly likely that this Federal Court decision will be appealed. Of course, Shelston IP will keep readers promptly informed of developments.