Merck Sharp & Dohme v Clonmel Healthcare Ltd. (Unapproved) [2022] IESC 11 (21 February 2022)

Merck Sharp & Dohme v Clonmel Healthcare Ltd. (Unapproved) [2022] IESC 11 (21 February 2022)

The Supreme Court determined that the interpretation of Articles 3(a) and 3(c) of Regulation (EC) 469/2009 regarding the eligibility of a combination product for an SPC, where an SPC has already been granted for the monotherapy, is not acte clair and has not been conclusively resolved by existing CJEU case law. Therefore, a preliminary reference to the CJEU is necessary to resolve the legal uncertainty and ensure uniform application of EU law.

Citation
[2022] IESC 11
Parties
Plaintiff/appellant: Merck Sharp & Dohme Limited; Defendant/respondent: Clonmel Healthcare Limited
Jurisdiction
Ireland
Judgment Date
21 February 2022
Procedural Posture
Supreme Court Appeal / Application for Preliminary Reference to the CJEU
Outcome
Preliminary reference to the Court of Justice of the European Union ordered.
Legal Topics
Supplementary Protection Certificates, Pharmaceutical Patents, Patent Law, EU Regulation 469/2009, Preliminary Reference Procedure
Intellectual Property Law European Union Law Supplementary Protection Certificates Pharmaceutical Patents Patent Law EU Regulation 469/2009 Preliminary Reference Procedure

Case Brief

Summary, issues, holding and outcome

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Parties

Merck Sharp & Dohme Limited

Plaintiff/appellant

Clonmel Healthcare Limited

Defendant/respondent

Procedural Posture

Supreme Court Appeal / Application for Preliminary Reference to the CJEU

Legal Issues

  1. 1 Whether a combination product (ezetimibe + simvastatin) is 'protected by the basic patent in force' under Article 3(a) of Regulation (EC) 469/2009 for the purposes of granting a supplementary protection certificate (SPC)
  2. 2 Whether the grant of a second SPC for a combination product is precluded by Article 3(c) of Regulation (EC) 469/2009 if an SPC has already been granted for the monotherapy

Ratio Decidendi

The Supreme Court determined that the interpretation of Articles 3(a) and 3(c) of Regulation (EC) 469/2009 regarding the eligibility of a combination product for an SPC, where an SPC has already been granted for the monotherapy, is not acte clair and has not been conclusively resolved by existing CJEU case law. Therefore, a preliminary reference to the CJEU is necessary to resolve the legal uncertainty and ensure uniform application of EU law.

Court Disposition

Preliminary reference to the Court of Justice of the European Union ordered.

Orders

  • Draft reference to the CJEU to be circulated to the parties and finalised upon approval of this judgment.