Bristol-Myers Squibb Holdings Ireland Company v Norton (Waterford) Ltd Trading as TEVA (Approved) [2024] IECA 143 (13 June 2024)

Bristol-Myers Squibb Holdings Ireland Company v Norton (Waterford) Ltd Trading as TEVA (Approved) [2024] IECA 143 (13 June 2024)

The High Court erred by placing undue weight on its invalidity finding and failing to properly weigh BMS's right to exclusivity, the risk of irreparable harm, and the possibility of restoration of rights if appeal succeeds. The correct approach is to assess the balance of justice, considering the inadequacy of damages, the status quo ante, and the potential for irreparable harm, without discounting the appellant's rights pending appeal. Damages are not necessarily commensurate with loss of exclusivity and market position. The refusal of the injunction was based on misapplication of legal principles and incorrect assessment of evidence.

Citation
[2024] IECA 143
Parties
Plaintiff/appellant: Bristol-Myers Squibb Holdings Ireland Unlimited Company; Defendant/respondent: Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland
Jurisdiction
Ireland
Judgment Date
13 June 2024
Procedural Posture
Civil Appeal / Appeal Against Refusal of Interlocutory Injunction Pending Appeal
Outcome
Appeal allowed; interlocutory injunction granted pending determination of appeal.
Legal Topics
Patent Validity, Supplementary Protection Certificate, Interlocutory Injunction, Balance of Convenience, Adequacy of Damages

Case Brief

Summary, issues, holding and outcome

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Parties

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Plaintiff/appellant

Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland

Defendant/respondent

Procedural Posture

Civil Appeal / Appeal Against Refusal of Interlocutory Injunction Pending Appeal

  1. 1 Whether an interlocutory injunction restraining generic launch should be granted pending appeal after patent found invalid
  2. 2 Whether damages are an adequate remedy for loss of exclusivity
  3. 3 Proper weight to be given to trial court's invalidity finding in balance of justice

Ratio Decidendi

The High Court erred by placing undue weight on its invalidity finding and failing to properly weigh BMS's right to exclusivity, the risk of irreparable harm, and the possibility of restoration of rights if appeal succeeds. The correct approach is to assess the balance of justice, considering the inadequacy of damages, the status quo ante, and the potential for irreparable harm, without discounting the appellant's rights pending appeal. Damages are not necessarily commensurate with loss of exclusivity and market position. The refusal of the injunction was based on misapplication of legal principles and incorrect assessment of evidence.

Court Disposition

Appeal allowed; interlocutory injunction granted pending determination of appeal.

Orders

  • Teva restrained from launching, offering, or putting on the Irish market a generic version of Eliquis pending appeal.
  • Stay on revocation of patent to continue until appeal determined.