Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation

Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation

Claim 16 of the patent does not protect the combination of efavirenz, emtricitabine, and tenofovir as a triple combination; the SPC is invalid under Article 3(a) because the product is not protected by the patent, and under Article 3(c) because efavirenz has already been the subject of an SPC and the combination does not represent a distinct invention.

Parties
Claimant: Teva UK Limited; Claimant: Accord Healthcare Limited; Claimant: Generics (UK) Limited trading as Mylan; Defendant: Merck Sharp & Dohme Corporation
Jurisdiction
England and Wales
Judgment Date
21 March 2017
Procedural Posture
Patent Invalidity Challenge / Judgment
Outcome
SPC declared invalid
Legal Topics
Supplementary Protection Certificate (spc), Patent Claim Construction, Combination Therapy Patents, SPC Regulation Article 3(a) and 3(c) Interpretation
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificate (spc) Patent Claim Construction Combination Therapy Patents SPC Regulation Article 3(a) and 3(c) Interpretation

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Parties

Teva UK Limited

Claimant

Accord Healthcare Limited

Claimant

Generics (UK) Limited trading as Mylan

Claimant

Merck Sharp & Dohme Corporation

Defendant

Procedural Posture

Patent Invalidity Challenge / Judgment

Legal Issues

  1. 1 Whether the SPC for the combination product Atripla complies with Article 3(a) and 3(c) of the SPC Regulation
  2. 2 Whether the combination of efavirenz, emtricitabine, and tenofovir is protected by the basic patent
  3. 3 Whether Article 3(c) precludes the grant of an SPC for the combination product when an SPC for efavirenz has already been granted

Ratio Decidendi

Claim 16 of the patent does not protect the combination of efavirenz, emtricitabine, and tenofovir as a triple combination; the SPC is invalid under Article 3(a) because the product is not protected by the patent, and under Article 3(c) because efavirenz has already been the subject of an SPC and the combination does not represent a distinct invention.

Court Disposition

SPC declared invalid

Orders

  • The supplementary protection certificate SPC/GB08/022 is invalid for non-compliance with Article 3(a) and 3(c) of Regulation 469/2009/EC.