Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2019] IESC 65 (31 July 2019)

Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2019] IESC 65 (31 July 2019)

The Supreme Court held that the adequacy of damages is part of the balance of convenience, not an absolute threshold. In pharmaceutical SPC cases, damages may not always be adequate due to the risk of unquantifiable and irreparable harm from generic entry, such as permanent price depression and loss of market share. The Irish approach in Curust should not be applied as a rigid rule. The correct approach is a flexible, fact-sensitive assessment of the balance of convenience, considering the specific risks and market dynamics in pharmaceutical cases. The High Court and Court of Appeal erred in treating adequacy of damages as determinative. The appeal was allowed and the principles clarified...

Citation
[2019] IESC 65
Parties
Plaintiff/appellant: Merck Sharp & Dohme Corporation; Defendant/respondent: Clonmel Healthcare Limited
Jurisdiction
Ireland
Judgment Date
31 July 2019
Procedural Posture
Appeal (interlocutory Injunction Refusal) / Supreme Court Judgment on Appeal
Outcome
Appeal allowed
Legal Topics
Interlocutory Injunctions, Supplementary Protection Certificates (spcs), Patent Infringement, Adequacy of Damages, Balance of Convenience
Intellectual Property Law Pharmaceutical Law Equity Interlocutory Injunctions Supplementary Protection Certificates (spcs) Patent Infringement Adequacy of Damages Balance of Convenience

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 3 Authorities cited 11 Party arguments 2 Amounts and remedies 4
Sign in to unlock

Parties

Merck Sharp & Dohme Corporation

Plaintiff/appellant

Clonmel Healthcare Limited

Defendant/respondent

Procedural Posture

Appeal (interlocutory Injunction Refusal) / Supreme Court Judgment on Appeal

Legal Issues

  1. 1 Whether an interlocutory injunction should be granted to restrain alleged infringement of a Supplementary Protection Certificate (SPC) prior to its expiry
  2. 2 Whether damages are an adequate remedy for the patentee in pharmaceutical SPC cases
  3. 3 Proper approach to the balance of convenience in interlocutory injunction applications involving pharmaceutical patents/SPCs

Ratio Decidendi

The Supreme Court held that the adequacy of damages is part of the balance of convenience, not an absolute threshold. In pharmaceutical SPC cases, damages may not always be adequate due to the risk of unquantifiable and irreparable harm from generic entry, such as permanent price depression and loss of market share. The Irish approach in Curust should not be applied as a rigid rule. The correct approach is a flexible, fact-sensitive assessment of the balance of convenience, considering the specific risks and market dynamics in pharmaceutical cases. The High Court and Court of Appeal erred in treating adequacy of damages as determinative. The appeal was allowed and the principles clarified...

Court Disposition

Appeal allowed

Orders

  • Clarification of the legal test for interlocutory injunctions in pharmaceutical SPC cases
  • No interlocutory injunction granted due to expiry of SPC, but principles set for future cases