Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017)

Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017)

The SPC for the combination of tenofovir disoproxil and emtricitabine does not comply with Article 3(a) of Regulation 469/2009/EC because the basic patent does not specifically identify emtricitabine or the combination in the wording of its claims. The reference to 'other therapeutic ingredients' is too general and does not meet the specificity required by CJEU jurisprudence. Therefore, the product is not 'protected by a basic patent in force' within the meaning of Article 3(a), and the SPC is invalid.

Citation
[2017] EWHC 13 (Pat)
Parties
Claimant: TEVA UK LIMITED; Claimant: ACCORD HEALTHCARE LIMITED; Claimant: LUPIN LIMITED and LUPIN EUROPE LIMITED; Claimant: GENERICS (UK) LIMITED trading as MYLAN; Defendant: GILEAD SCIENCES INC
Jurisdiction
England and Wales
Judgment Date
13 January 2017
Procedural Posture
Patent Validity Challenge / High Court (patents Court) Judgment
Outcome
SPC declared invalid for non-compliance with Article 3(a) of Regulation 469/2009/EC.
Legal Topics
Supplementary Protection Certificates (spc), Interpretation of Article 3(a) SPC Regulation, Patent Claim Construction, Combination Pharmaceutical Products, Scope of Patent Protection
Intellectual Property Law Patent Law Pharmaceutical Law Supplementary Protection Certificates (spc) Interpretation of Article 3(a) SPC Regulation Patent Claim Construction Combination Pharmaceutical Products Scope of Patent Protection

Case Brief

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Parties

TEVA UK LIMITED

Claimant

ACCORD HEALTHCARE LIMITED

Claimant

LUPIN LIMITED and LUPIN EUROPE LIMITED

Claimant

GENERICS (UK) LIMITED trading as MYLAN

Claimant

GILEAD SCIENCES INC

Defendant

Procedural Posture

Patent Validity Challenge / High Court (patents Court) Judgment

Legal Issues

  1. 1 Whether Gilead's SPC for Truvada (combination of tenofovir disoproxil and emtricitabine) complies with Article 3(a) of Regulation 469/2009/EC (SPC Regulation)
  2. 2 Whether the product is 'protected by a basic patent in force' within the meaning of Article 3(a)
  3. 3 Interpretation of patent claims for combination products

Ratio Decidendi

The SPC for the combination of tenofovir disoproxil and emtricitabine does not comply with Article 3(a) of Regulation 469/2009/EC because the basic patent does not specifically identify emtricitabine or the combination in the wording of its claims. The reference to 'other therapeutic ingredients' is too general and does not meet the specificity required by CJEU jurisprudence. Therefore, the product is not 'protected by a basic patent in force' within the meaning of Article 3(a), and the SPC is invalid.

Court Disposition

SPC declared invalid for non-compliance with Article 3(a) of Regulation 469/2009/EC.

Orders

  • The supplementary protection certificate SPC/GB05/041 is declared invalid.
  • No reference to the CJEU is necessary as the law is sufficiently clear.