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
 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
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:
Claim 1 of the Escitalopram Patent is not directed to a
pharmaceutical substance per se (Section 70(2)(a));
CIPRAMIL does not contain Escitalopram; (Section 70(3));
The term of the patent had previously been extended (Section
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.
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.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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