Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44

Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44

The asserted pharmaceutical substances per se do not fall within the scope of any of the relevant claims as required by s 70(2)(a) of the Patents Act, and the claims themselves are invalid for lack of clarity and definition under ss 40(2)(b) and 40(3); therefore, the patent term extension is invalid and must be removed; the cross-claim for threatened infringement and contravention of s 18(1) ACL fails.

Parties
Applicant/cross Respondent: Sun Pharma ANZ Pty Ltd; First Respondent/first Cross Claimant: Otsuka Pharmaceutical Co., Ltd; Second Respondent/second Cross Claimant: H. Lundbeck A/S; Third Respondent/third Cross Claimant: Lundbeck Australia Pty Ltd (ACN 070 094 290); Fourth Respondent/fourth Cross Claimant: Otsuka Australia Pharmaceutical Pty Ltd (ACN 601 768 754)
Jurisdiction
Australia
Judgment Date
05 February 2025
Procedural Posture
Application and Cross Claim / Final Judgment
Outcome
Patent term extension invalid; cross-claims dismissed.
Legal Topics
Patents, Patent Term Extension, Pharmaceutical Patents, Statutory Construction, Patent Clarity and Definition
Intellectual Property Patents Patent Term Extension Pharmaceutical Patents Statutory Construction Patent Clarity and Definition

Case Brief

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Parties

Sun Pharma ANZ Pty Ltd

Applicant/cross Respondent

Otsuka Pharmaceutical Co., Ltd

First Respondent/first Cross Claimant

H. Lundbeck A/S

Second Respondent/second Cross Claimant

Lundbeck Australia Pty Ltd (ACN 070 094 290)

Third Respondent/third Cross Claimant

Otsuka Australia Pharmaceutical Pty Ltd (ACN 601 768 754)

Fourth Respondent/fourth Cross Claimant

Procedural Posture

Application and Cross Claim / Final Judgment

Legal Issues

  1. 1 Whether patent term extension under s 70 of Patents Act valid for controlled release aripiprazole formulations
  2. 2 Whether the asserted pharmaceutical substances per se fall within the scope of relevant claims as required under s 70(2)(a)
  3. 3 Whether claims are invalid for lack of clarity and definition under ss 40(2)(b) and 40(3) Patents Act

Ratio Decidendi

The asserted pharmaceutical substances per se do not fall within the scope of any of the relevant claims as required by s 70(2)(a) of the Patents Act, and the claims themselves are invalid for lack of clarity and definition under ss 40(2)(b) and 40(3); therefore, the patent term extension is invalid and must be removed; the cross-claim for threatened infringement and contravention of s 18(1) ACL fails.

Court Disposition

Patent term extension invalid; cross-claims dismissed.

Orders

  • Access to unredacted text of reasons restricted to legal representatives until further order.
  • Parties to confer and determine necessary redactions by 7 February 2025.