Teva UK Ltd & Ors v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 December 2019)

Teva UK Ltd & Ors v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 December 2019)

The combination of tenofovir disoproxil and emtricitabine is not protected by the basic patent within the meaning of Article 3(a) of the SPC Regulation because claim 27 only optionally includes other therapeutic ingredients and does not require the presence of emtricitabine or any specific second ingredient. The claim does not necessarily and specifically relate to the combination, nor is emtricitabine specifically identifiable at the priority date based on the patent and prior art. Therefore, the SPC is invalid.

Citation
[2019] EWCA Civ 2272
Parties
Respondent/claimant: TEVA UK LIMITED; Respondent/claimant: ACCORD HEALTHCARE LIMITED; Respondent/claimant: LUPIN LIMITED; Respondent/claimant: LUPIN (EUROPE) LIMITED; Respondent/claimant: GENERICS (UK) LIMITED (TRADING AS MYLAN); Appellant/defendant: GILEAD SCIENCES, INC.
Jurisdiction
England and Wales
Judgment Date
19 December 2019
Procedural Posture
Patent/intellectual Property Appeal / Court of Appeal (civil Division) on Appeal From High Court (patents Court)
Outcome
Appeal dismissed; SPC declared invalid.
Legal Topics
Supplementary Protection Certificates (spc), Patent Claims Interpretation, Article 3(a) SPC Regulation, Combination Products, Extent of Patent Protection
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificates (spc) Patent Claims Interpretation Article 3(a) SPC Regulation Combination Products Extent of Patent Protection

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Parties

TEVA UK LIMITED

Respondent/claimant

ACCORD HEALTHCARE LIMITED

Respondent/claimant

LUPIN LIMITED

Respondent/claimant

LUPIN (EUROPE) LIMITED

Respondent/claimant

GENERICS (UK) LIMITED (TRADING AS MYLAN)

Respondent/claimant

GILEAD SCIENCES, INC.

Appellant/defendant

Procedural Posture

Patent/intellectual Property Appeal / Court of Appeal (civil Division) on Appeal From High Court (patents Court)

Legal Issues

  1. 1 Whether a combination product (tenofovir disoproxil and emtricitabine) is 'protected by a basic patent in force' under Article 3(a) of the SPC Regulation
  2. 2 Whether claim 27 of Gilead's patent, which refers to 'optionally other therapeutic ingredients', satisfies the requirements for SPC protection for the combination product

Ratio Decidendi

The combination of tenofovir disoproxil and emtricitabine is not protected by the basic patent within the meaning of Article 3(a) of the SPC Regulation because claim 27 only optionally includes other therapeutic ingredients and does not require the presence of emtricitabine or any specific second ingredient. The claim does not necessarily and specifically relate to the combination, nor is emtricitabine specifically identifiable at the priority date based on the patent and prior art. Therefore, the SPC is invalid.

Court Disposition

Appeal dismissed; SPC declared invalid.

Orders

  • The appeal by Gilead Sciences, Inc. is dismissed.
  • The supplementary protection certificate SPC/GB05/041 is declared invalid.