Generics (UK) Limited v AstraZeneca AB

Generics (UK) Limited v AstraZeneca AB

The patent does not plausibly disclose that dapagliflozin is an SGLT2 inhibitor with sufficient efficacy to treat diabetes or to serve as an experimental tool. The patent makes only bare assertions without experimental data or scientific reasoning. There is no technical contribution over WO 128, and dapagliflozin is an arbitrary selection from a known class. The patent is invalid for insufficiency and lack of inventive step; the SPCs are also invalid.

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
17 June 2025
Procedural Posture
Patent/intellectual Property / First Instance Trial Judgment
Outcome
Patent and SPCs declared invalid for insufficiency and lack of inventive step.
Legal Topics
Patent Validity, Inventive Step, Sufficiency of Disclosure, Supplementary Protection Certificates (spcs), Pharmaceuticals, Obviousness, Technical Contribution, Arbitrary Selection
Intellectual Property Patents Patent Validity Inventive Step Sufficiency of Disclosure Supplementary Protection Certificates (spcs) Pharmaceuticals Obviousness +2 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/intellectual Property / First Instance Trial Judgment

Legal Issues

  1. 1 Whether the patent for dapagliflozin (and associated SPCs) is invalid for lack of inventive step and/or insufficiency
  2. 2 Whether the patent makes it plausible that dapagliflozin is an SGLT2 inhibitor useful for treating diabetes
  3. 3 Whether the patent constitutes an arbitrary selection from prior art (WO 128) without technical contribution

Ratio Decidendi

The patent does not plausibly disclose that dapagliflozin is an SGLT2 inhibitor with sufficient efficacy to treat diabetes or to serve as an experimental tool. The patent makes only bare assertions without experimental data or scientific reasoning. There is no technical contribution over WO 128, and dapagliflozin is an arbitrary selection from a known class. The patent is invalid for insufficiency and lack of inventive step; the SPCs are also invalid.

Court Disposition

Patent and SPCs declared invalid for insufficiency and lack of inventive step.

Orders

  • Patent revoked.
  • SPC/GB13/021 and SPC/GB14/050 revoked.