Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat) (21 March 2017)

Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat) (21 March 2017)

Article 3(c) of Regulation 469/2009/EC precludes the grant of an SPC for the combination product (Atripla) because efavirenz, which embodies the core inventive advance of the basic patent, has already been the subject of an SPC based on that patent. The combination does not represent a distinct invention protected by the patent; therefore, the SPC for the combination product is invalid.

Citation
[2017] EWHC 539 (Pat)
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 Validity Challenge / High Court Judgment
Outcome
SPC for the combination product declared invalid.
Legal Topics
Supplementary Protection Certificates, Patent Law, Medicinal Products, SPC Regulation, Combination Products
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificates Patent Law Medicinal Products SPC Regulation Combination Products

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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 Validity Challenge / High Court Judgment

Legal Issues

  1. 1 Does the SPC for Atripla comply with Article 3(a) and 3(c) of Regulation 469/2009/EC?
  2. 2 Is the combination product protected by the basic patent?
  3. 3 Has the product already been the subject of a certificate under Article 3(c)?

Ratio Decidendi

Article 3(c) of Regulation 469/2009/EC precludes the grant of an SPC for the combination product (Atripla) because efavirenz, which embodies the core inventive advance of the basic patent, has already been the subject of an SPC based on that patent. The combination does not represent a distinct invention protected by the patent; therefore, the SPC for the combination product is invalid.

Court Disposition

SPC for the combination product declared invalid.

Orders

  • SPC/GB08/022 for Atripla is revoked.
  • Costs to be determined.