Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414

Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414

The definition of 'pharmaceutical substance' in Schedule 1 to the Patents Act 1990 (Cth) encompasses formulations consisting of mixtures of active ingredients and excipients for therapeutic use, provided that the use meets the statutory criteria. The extension of term granted for the 862 Patent, which claims such formulations, was therefore valid. Cipla's rectification suit fails, and Novo Nordisk is entitled to injunctive relief.

Parties
Applicant/cross Respondent: Cipla Australia Pty Ltd; Respondent/cross Claimant: Novo Nordisk A/S
Jurisdiction
Australia
Judgment Date
12 December 2024
Procedural Posture
Rectification of Patent Register and Cross Claim for Injunction / Judgment at Trial
Outcome
Cipla's application for rectification dismissed; Novo Nordisk's cross-claim upheld.
Legal Topics
Patents, Patent Extension of Term, Pharmaceutical Substances, Statutory Construction
Intellectual Property Law Patents Patent Extension of Term Pharmaceutical Substances Statutory Construction

Case Brief

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Parties

Cipla Australia Pty Ltd

Applicant/cross Respondent

Novo Nordisk A/S

Respondent/cross Claimant

Procedural Posture

Rectification of Patent Register and Cross Claim for Injunction / Judgment at Trial

Legal Issues

  1. 1 Whether the definition of 'pharmaceutical substance' in Schedule 1 to the Patents Act 1990 (Cth) includes formulations comprising active ingredients and excipients
  2. 2 Whether the extension of term for Australian Patent No. 2004290862 was validly granted under Part 3 of Chapter 6, Patents Act 1990 (Cth)
  3. 3 Whether the excipients in the patented formulations are required to have a distinct therapeutic use for the formulation to constitute a pharmaceutical substance

Ratio Decidendi

The definition of 'pharmaceutical substance' in Schedule 1 to the Patents Act 1990 (Cth) encompasses formulations consisting of mixtures of active ingredients and excipients for therapeutic use, provided that the use meets the statutory criteria. The extension of term granted for the 862 Patent, which claims such formulations, was therefore valid. Cipla's rectification suit fails, and Novo Nordisk is entitled to injunctive relief.

Court Disposition

Cipla's application for rectification dismissed; Novo Nordisk's cross-claim upheld.

Orders

  • Cipla's rectification application is dismissed with costs.
  • Novo Nordisk's cross-claim is upheld with costs.