Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138

Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138

The claim, as properly construed, is to the (+)-enantiomer itself and does not import a further limitation by the requirement of isolation or purity; therefore, it is to a pharmaceutical substance per se under s 70(2)(a) of the Patents Act 1990 (Cth), and the extension of term is validly granted.

Parties
Appellant: Alphapharm Pty Ltd; Appellant: Apotex Pty Ltd; Appellant: Aspen Pharma Pty Ltd; Appellant: Sandoz Pty Ltd; Respondent: H Lundbeck A/S
Jurisdiction
Australia
Judgment Date
22 September 2015
Procedural Posture
Appeal / Decision on Application for Leave to Appeal And, If Granted, Substantive Appeal
Outcome
Application for leave to appeal granted; appeal dismissed
Legal Topics
Patent Extension of Term, Pharmaceutical Substance Per Se, Statutory Construction, Estoppel
Intellectual Property Patents Patent Extension of Term Pharmaceutical Substance Per Se Statutory Construction Estoppel

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Downloadable case file Legal principles 4 Authorities cited 22 Party arguments 2
Sign in to unlock

Parties

Alphapharm Pty Ltd

Appellant

Apotex Pty Ltd

Appellant

Aspen Pharma Pty Ltd

Appellant

Sandoz Pty Ltd

Appellant

H Lundbeck A/S

Respondent

Procedural Posture

Appeal / Decision on Application for Leave to Appeal And, If Granted, Substantive Appeal

Legal Issues

  1. 1 Whether the claim to (+)-enantiomer includes a limitation of isolation or purity such that it is no longer to a pharmaceutical substance per se
  2. 2 Whether extension of term of the Patent should be granted under s 70(2)(a) of the Patents Act 1990 (Cth)

Ratio Decidendi

The claim, as properly construed, is to the (+)-enantiomer itself and does not import a further limitation by the requirement of isolation or purity; therefore, it is to a pharmaceutical substance per se under s 70(2)(a) of the Patents Act 1990 (Cth), and the extension of term is validly granted.

Court Disposition

Application for leave to appeal granted; appeal dismissed

Orders

  • The application for leave to appeal be granted.
  • The appeal be dismissed.