Generics (UK) Ltd Ltd v Astrazeneca AB [2025] EWHC 1012 (Pat) (28 April 2025)

Generics (UK) Ltd Ltd v Astrazeneca AB [2025] EWHC 1012 (Pat) (28 April 2025)

The Patent and associated SPCs are invalid because the specification did not make it plausible, at the priority date, that dapagliflozin was an SGLT2 inhibitor or useful for the treatment of diabetes. The disclosure amounted to a bare assertion without sufficient supporting information or data, failing the plausibility threshold required by Warner-Lambert and related authorities. The selection of dapagliflozin from the prior art was arbitrary and not justified by a technical contribution. Therefore, the Patent and SPCs are invalid for lack of inventive step and insufficiency.

Citation
[2025] EWHC 1012 (Pat)
Parties
Claimant: Generics (U.K.) Limited; Claimant: Teva Pharmaceutical Industries Limited; Claimant: Teva UK Limited; Claimant: Glenmark Pharmaceuticals Europe Limited; Defendant: AstraZeneca AB
Jurisdiction
England and Wales
Judgment Date
28 April 2025
Procedural Posture
Patent Revocation and Invalidity Proceedings / First Instance Judgment in the High Court (patents Court)
Outcome
Patent and SPCs declared invalid and revoked.
Legal Topics
Patent Validity, Inventive Step, Sufficiency of Disclosure, Supplementary Protection Certificates (spcs), Pharmaceutical Patents, Plausibility, Arbitrary Selection
Intellectual Property Patents Patent Validity Inventive Step Sufficiency of Disclosure Supplementary Protection Certificates (spcs) Pharmaceutical Patents Plausibility +1 more

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Parties

Generics (U.K.) Limited

Claimant

Teva Pharmaceutical Industries Limited

Claimant

Teva UK Limited

Claimant

Glenmark Pharmaceuticals Europe Limited

Claimant

AstraZeneca AB

Defendant

Procedural Posture

Patent Revocation and Invalidity Proceedings / First Instance Judgment in the High Court (patents Court)

Legal Issues

  1. 1 Whether European Patent (UK) No. 1506211 and associated SPCs SPC/GB13/021 and SPC/GB14/050 are invalid for lack of inventive step and/or insufficiency; specifically, whether the patent made it plausible that dapagliflozin is an SGLT2 inhibitor useful for treating diabetes, and whether the selection of dapagliflozin from the prior art was arbitrary.

Ratio Decidendi

The Patent and associated SPCs are invalid because the specification did not make it plausible, at the priority date, that dapagliflozin was an SGLT2 inhibitor or useful for the treatment of diabetes. The disclosure amounted to a bare assertion without sufficient supporting information or data, failing the plausibility threshold required by Warner-Lambert and related authorities. The selection of dapagliflozin from the prior art was arbitrary and not justified by a technical contribution. Therefore, the Patent and SPCs are invalid for lack of inventive step and insufficiency.

Court Disposition

Patent and SPCs declared invalid and revoked.

Orders

  • Declarations that SPC/GB13/021 and SPC/GB14/050 are invalid.
  • Orders for revocation of SPC/GB13/021 and SPC/GB14/050.