Teva UK Ltd & Ors v Gilead Sciences Inc

Teva UK Ltd & Ors v Gilead Sciences Inc

Neither of the tests laid down by the CJEU for Article 3(a) are satisfied: the patent does not specifically and necessarily relate to the combination of tenofovir disoproxil and emtricitabine, nor is emtricitabine specifically identifiable in the patent. Therefore, the SPC is invalid and must be revoked.

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/intellectual Property / Post Trial Judgment After CJEU Reference
Outcome
SPC declared invalid and revoked; Gilead's application to adduce further evidence refused.
Legal Topics
Supplementary Protection Certificate (spc), Article 3(a) SPC Regulation, Extent of Patent Protection, Combination Products, Interpretation of Patent Claims
Intellectual Property Patent Law European Union Law Supplementary Protection Certificate (spc) Article 3(a) SPC Regulation Extent of Patent Protection Combination Products Interpretation of Patent Claims

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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/intellectual Property / Post Trial Judgment After CJEU Reference

Legal Issues

  1. 1 Whether Gilead's SPC for Truvada complies with Article 3(a) of the SPC Regulation
  2. 2 Whether the combination of tenofovir disoproxil and emtricitabine is protected by the basic patent

Ratio Decidendi

Neither of the tests laid down by the CJEU for Article 3(a) are satisfied: the patent does not specifically and necessarily relate to the combination of tenofovir disoproxil and emtricitabine, nor is emtricitabine specifically identifiable in the patent. Therefore, the SPC is invalid and must be revoked.

Court Disposition

SPC declared invalid and revoked; Gilead's application to adduce further evidence refused.

Orders

  • Gilead's application to adduce further expert evidence refused.
  • Supplementary Protection Certificate SPC/GB05/041 revoked.