In the long running legal saga surrounding the H Lundbeck A/S blockbuster drug Escitalopram, the Federal Court has dismissed an appeal by Alphapharm and other generic pharmaceutical companies to the grant of the belated extension of term application on the Escitalopram patent.

The decision comes hot on the heels of the High Court’s decision in Alphapharm Pty Ltd v H Lundbeck A-S [2014] HCA 42 (which we reported here), with the Federal Court handing down its decision just one day after the High Court.

While their timing may be remarkable, the sequence of the two decisions is hardly surprising.

By finding that Lundbeck was not time-barred by section 71(2) of the Patents Act 1990 (“the Act”) from filing its application for an extension of term, the High Court has cleared a path for the Federal Court to decide (as it has done) that Lundbeck’s application satisfies the substantive requirements for extensions of term under section 70 of the Act.

In reaching this view, the Federal Court upheld the earlier decision of the Patent Office rejecting the generic companies’ arguments that Lundbeck’s application failed to comply with the requirements under sections 70(2), (3) and (4) of the Act. The arguments were, essentially, that:

  • Having already been granted an extension of term (albeit one that was ultimately overturned), a second application was not possible.
  • The first entry of the racemate on the ARTG was (still) not an appropriate basis for the extension of term.

The generic companies have until 27 November 2014 to appeal the decision to the Full Federal Court.

While it is hard to see a clear basis for challenging the trial judge’s findings, an appeal seems likely given the significant patent infringement risk that the generic companies are facing if the extension of term is allowed to stand.

The infringement risk relates to generic versions of Escitalopram that were launched shortly after the original expiry date of the Escitalopram patent on 13 June 2009 (ie during the extension of term period).

Interestingly, the 6 year statutory limitation period for Lundbeck to sue in relation these generic products is fast approaching, so any appeal to the Full Court in relation to the validity of Lundbeck’s extension of term application could end up being decided after infringement proceedings are commenced.