Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185

Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185

The pharmaceutical substance per se, being the isolated (+)-enantiomer, was contained in the racemate in Cipramil; therefore, inclusion of Cipramil on the ARTG satisfied s 70(3) and fixed the permissible extension date. The earlier, invalid extension was not a 'previous extension' under s 70(4) since the decision involved a jurisdictional error and was no decision at law. The Commissioner did not err in immediately granting the extension after deciding the opposition, as the Court had plenary powers to correct the Register and there was no statutory stay pending appeal. The grounds of opposition all failed and the appeal was dismissed.

Parties
First Appellant: Alphapharm Pty Limited; Second Appellant: Apotex Pty Ltd; Third Appellant: Aspen Pharma Pty Ltd; Fourth Appellant: Sandoz Pty Ltd; Respondent: H Lundbeck A/S
Jurisdiction
Australia
Judgment Date
06 November 2014
Procedural Posture
Appeal / Judgment After Appeal Hearing
Outcome
Appeal dismissed
Legal Topics
Patents, Statutory Interpretation, Pharmaceutical Patents, Extension of Patent Term
Intellectual Property Law Patents Statutory Interpretation Pharmaceutical Patents Extension of Patent Term

Case Brief

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Parties

Alphapharm Pty Limited

First Appellant

Apotex Pty Ltd

Second Appellant

Aspen Pharma Pty Ltd

Third Appellant

Sandoz Pty Ltd

Fourth Appellant

H Lundbeck A/S

Respondent

Procedural Posture

Appeal / Judgment After Appeal Hearing

Legal Issues

  1. 1 Whether the pharmaceutical substance per se for purposes of s 70(2)(a) of the Patents Act 1990 (Cth) was the isolated molecule as claimed in the patent or part of goods containing that molecule
  2. 2 Whether earlier inclusion on ARTG of a pharmaceutical good before the molecule was isolated could form the basis for an extension of term of the patent under s 70
  3. 3 Whether an earlier, invalid extension constituted a previous extension for purposes of s 70(4) of the Patents Act 1990 (Cth)

Ratio Decidendi

The pharmaceutical substance per se, being the isolated (+)-enantiomer, was contained in the racemate in Cipramil; therefore, inclusion of Cipramil on the ARTG satisfied s 70(3) and fixed the permissible extension date. The earlier, invalid extension was not a 'previous extension' under s 70(4) since the decision involved a jurisdictional error and was no decision at law. The Commissioner did not err in immediately granting the extension after deciding the opposition, as the Court had plenary powers to correct the Register and there was no statutory stay pending appeal. The grounds of opposition all failed and the appeal was dismissed.

Court Disposition

Appeal dismissed

Orders

  • The appeal be dismissed.
  • The appellants pay the respondent's costs.