Generics (UK) Limited & Ors v AstraZeneca AB

Generics (UK) Limited & Ors v AstraZeneca AB

The patent did not disclose enough to make it plausible that dapagliflozin is an SGLT2 inhibitor useful for treating diabetes. The patent made only bare assertions without supporting data or reasoning, and the skilled person would have legitimate reason to doubt the claimed technical effect, especially in light of referenced prior art. Therefore, the patent was invalid for lack of inventive step and insufficiency. The patent was also an arbitrary selection from prior art, making no technical contribution over WO 128.

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
Civil Appeal / Appeal From High Court (patents Court) to Court of Appeal
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, Pharmaceutical Patents
Intellectual Property Patent Law Patent Validity Inventive Step Sufficiency of Disclosure Plausibility Arbitrary Selection Pharmaceutical Patents

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

Civil Appeal / Appeal From High Court (patents Court) to Court of Appeal

Legal Issues

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

Ratio Decidendi

The patent did not disclose enough to make it plausible that dapagliflozin is an SGLT2 inhibitor useful for treating diabetes. The patent made only bare assertions without supporting data or reasoning, and the skilled person would have legitimate reason to doubt the claimed technical effect, especially in light of referenced prior art. Therefore, the patent was invalid for lack of inventive step and insufficiency. The patent was also an arbitrary selection from prior art, making no technical contribution over WO 128.

Court Disposition

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

Orders

  • Appeal dismissed
  • Patent claims 2 and 15 declared invalid for lack of inventive step and insufficiency