Teva UK Ltd & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (18 September 2018)

Teva UK Ltd & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (18 September 2018)

The SPC is invalid because the combination of tenofovir disoproxil and emtricitabine is not necessarily and specifically disclosed in the basic patent; emtricitabine is neither mentioned nor specifically identifiable in the patent, and the combination does not embody the technical contribution of the patent as understood by a skilled person at the priority date.

Citation
[2018] EWHC 2416 (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
18 September 2018
Procedural Posture
Patent Revocation/validity Challenge / Post Trial Judgment Following CJEU Preliminary Reference
Outcome
SPC revoked; judgment for Claimants; Defendant's application for further evidence refused
Legal Topics
Supplementary Protection Certificates (spc), Patent Validity, Interpretation of Article 3(a) SPC Regulation, Combination Products, Scope of Patent Protection
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificates (spc) Patent Validity Interpretation of Article 3(a) SPC Regulation Combination Products Scope of Patent Protection

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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 Revocation/validity Challenge / Post Trial Judgment Following CJEU Preliminary Reference

Legal Issues

  1. 1 Whether Gilead's SPC for the combination of tenofovir disoproxil and emtricitabine is valid under Article 3(a) of Regulation 469/2009/EC (SPC Regulation)
  2. 2 Whether the combination product is 'protected by a basic patent in force' within the meaning of Article 3(a)
  3. 3 Whether the claims of the basic patent necessarily and specifically relate to the combination product

Ratio Decidendi

The SPC is invalid because the combination of tenofovir disoproxil and emtricitabine is not necessarily and specifically disclosed in the basic patent; emtricitabine is neither mentioned nor specifically identifiable in the patent, and the combination does not embody the technical contribution of the patent as understood by a skilled person at the priority date.

Court Disposition

SPC revoked; judgment for Claimants; Defendant's application for further evidence refused

Orders

  • Gilead's application to adduce further evidence and for a second trial is refused.
  • The SPC (SPC/GB05/041) is revoked for non-compliance with Article 3(a) of Regulation 469/2009/EC.