Generics (UK) Ltd & Ors v AstraZenica AB [2025] EWCA Civ 903 (16 July 2025)

Generics (UK) Ltd & Ors v AstraZenica AB [2025] EWCA Civ 903 (16 July 2025)

The patent was invalid because it did not make it plausible at the priority date that dapagliflozin was an SGLT2 inhibitor or useful for treating diabetes. The patent's assertions were unsupported by experimental data or a priori reasoning, and the skilled person would not derive the technical effect from the patent or common general knowledge. The selection of dapagliflozin from the prior art was arbitrary and not justified by any disclosed technical advantage.

Citation
[2025] EWCA Civ 903
Parties
Claimant/respondent: Generics (U.K.) Limited; Claimant/respondent: Teva Pharmaceutical Industries Limited and Teva UK Limited; Claimant/respondent: Glenmark Pharmaceuticals Europe Limited; Defendant/appellant: AstraZeneca AB
Jurisdiction
England and Wales
Judgment Date
16 July 2025
Procedural Posture
Patent Appeal / Court of Appeal Judgment on Appeal From High Court
Outcome
Appeal dismissed; patent held invalid for lack of inventive step and insufficiency.
Legal Topics
Patent Validity, Inventive Step, Sufficiency of Disclosure, Plausibility, Arbitrary Selection, Supplementary Protection Certificates
Intellectual Property Patents Patent Validity Inventive Step Sufficiency of Disclosure Plausibility Arbitrary Selection Supplementary Protection Certificates

Case Brief

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Parties

Generics (U.K.) Limited

Claimant/respondent

Teva Pharmaceutical Industries Limited and Teva UK Limited

Claimant/respondent

Glenmark Pharmaceuticals Europe Limited

Claimant/respondent

AstraZeneca AB

Defendant/appellant

Procedural Posture

Patent Appeal / Court of Appeal Judgment on Appeal From High Court

Legal Issues

  1. 1 Whether the patent for dapagliflozin was invalid for lack of inventive step and/or insufficiency due to lack of plausibility and arbitrary selection from prior art.

Ratio Decidendi

The patent was invalid because it did not make it plausible at the priority date that dapagliflozin was an SGLT2 inhibitor or useful for treating diabetes. The patent's assertions were unsupported by experimental data or a priori reasoning, and the skilled person would not derive the technical effect from the patent or common general knowledge. The selection of dapagliflozin from the prior art was arbitrary and not justified by any disclosed technical advantage.

Court Disposition

Appeal dismissed; patent held invalid for lack of inventive step and insufficiency.

Orders

  • Patent and Supplementary Protection Certificates declared invalid.
  • Interim injunctions and undertakings restraining launch of generic dapagliflozin products to be lifted.