Teva UK Ltd & Ors v Gilead Sciences, Inc

Teva UK Ltd & Ors v Gilead Sciences, Inc

A claim which makes the presence of other therapeutic ingredients optional does not necessarily relate to a combination product for the purposes of Article 3(a) of the SPC Regulation. The patent claim must require the presence of both compounds, not merely permit it. Claim 27's optional language is insufficient to protect the combination of TD and emtricitabine under the SPC Regulation. The appeal is dismissed as the first limb of the CJEU test is not satisfied.

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
Civil Appeal / Court of Appeal Judgment
Outcome
Appeal dismissed
Legal Topics
Supplementary Protection Certificates, Patent Interpretation, SPC Regulation Article 3(a), Combination Products
Intellectual Property Pharmaceutical Law Supplementary Protection Certificates Patent Interpretation SPC Regulation Article 3(a) Combination Products

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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

Civil Appeal / Court of Appeal Judgment

Legal Issues

  1. 1 Whether a combination product (TD and emtricitabine) is 'protected by a basic patent in force' under Article 3(a) of the SPC Regulation
  2. 2 Interpretation of patent claims for SPC eligibility
  3. 3 Application of CJEU two-limb test for SPC protection

Ratio Decidendi

A claim which makes the presence of other therapeutic ingredients optional does not necessarily relate to a combination product for the purposes of Article 3(a) of the SPC Regulation. The patent claim must require the presence of both compounds, not merely permit it. Claim 27's optional language is insufficient to protect the combination of TD and emtricitabine under the SPC Regulation. The appeal is dismissed as the first limb of the CJEU test is not satisfied.

Court Disposition

Appeal dismissed

Orders

  • SPC declared invalid
  • No need to consider admission of further expert evidence