Merck Sharp & Dohme LLC v Mylan IRE Healthcare Ltd & Ors (Approved) [2023] IECA 111 (14 March 2023)

Merck Sharp & Dohme LLC v Mylan IRE Healthcare Ltd & Ors (Approved) [2023] IECA 111 (14 March 2023)

The Court of Appeal held that, given the unsettled legal principles regarding Article 3 of Regulation EC 469/2009 and the pending CJEU references, it was appropriate for the trial judge to rely on the presumption of validity of SPC 024 and not to attempt a preliminary assessment of the strength of Mylan's invalidity case. The balance of justice therefore favoured maintaining the injunction until trial or expiry of the SPC.

Citation
[2023] IECA 111
Parties
Respondent/plaintiff: Merck Sharp & Dohme LLC; Appellant/defendant: Mylan IRE Healthcare Limited; Appellant/defendant: Mylan Ireland Limited; Appellant/defendant: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin
Jurisdiction
Ireland
Judgment Date
14 March 2023
Procedural Posture
Appeal / Interlocutory Injunction Appeal
Outcome
Appeal dismissed
Legal Topics
Supplementary Protection Certificate (spc), Patent Validity, Interlocutory Injunctions, Balance of Justice, Article 3 Regulation EC 469/2009, Combination Pharmaceutical Products
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificate (spc) Patent Validity Interlocutory Injunctions Balance of Justice Article 3 Regulation EC 469/2009 +1 more

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Parties

Merck Sharp & Dohme LLC

Respondent/plaintiff

Mylan IRE Healthcare Limited

Appellant/defendant

Mylan Ireland Limited

Appellant/defendant

McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin

Appellant/defendant

Procedural Posture

Appeal / Interlocutory Injunction Appeal

Legal Issues

  1. 1 Whether the trial judge erred in granting an interlocutory injunction restraining Mylan from launching a generic version of Janumet pending trial or expiry of SPC 024
  2. 2 Whether the presumption of validity of SPC 024 should outweigh Mylan's arguments for invalidity at the interlocutory stage
  3. 3 Whether the court should assess the strength of the parties' cases in light of pending CJEU references on Article 3 of Regulation EC 469/2009

Ratio Decidendi

The Court of Appeal held that, given the unsettled legal principles regarding Article 3 of Regulation EC 469/2009 and the pending CJEU references, it was appropriate for the trial judge to rely on the presumption of validity of SPC 024 and not to attempt a preliminary assessment of the strength of Mylan's invalidity case. The balance of justice therefore favoured maintaining the injunction until trial or expiry of the SPC.

Court Disposition

Appeal dismissed

Orders

  • Interlocutory injunction restraining Mylan from offering, putting on the market, or using products containing sitagliptin and metformin (Janumet) until judgment in the substantive action or expiry of SPC 024 on 7 April 2023 is affirmed.