Sandoz Limited v Bristol-Myers Squibb Holdings Ireland Unlimited Company

Sandoz Limited v Bristol-Myers Squibb Holdings Ireland Unlimited Company

The Application did not make it plausible that apixaban had useful factor Xa inhibitory activity. There was no data or reasoning in the Application linking apixaban to the asserted technical effect, and the skilled person would not infer from the Application that apixaban had been tested and found to have the required potency. The assertion of utility was speculative. Therefore, the patent was invalid for lack of inventive step and insufficiency.

Parties
Claimant/respondent: Sandoz Limited; Claimant/respondent: Teva Pharmaceutical Industries Limited; Part 20 Claimant/appellant: Teva UK Limited; Defendant/appellant: Bristol-Myers Squibb Holdings Ireland Unlimited Company
Jurisdiction
England and Wales
Judgment Date
11 September 2024
Procedural Posture
Civil Appeal (patents) / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed; patent held invalid for lack of plausibility (inventive step and sufficiency).
Legal Topics
Patent Validity, Inventive Step, Sufficiency of Disclosure, Plausibility, Second Medical Use Claims
Intellectual Property Patents Patent Validity Inventive Step Sufficiency of Disclosure Plausibility Second Medical Use Claims

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Parties

Sandoz Limited

Claimant/respondent

Teva Pharmaceutical Industries Limited

Claimant/respondent

Teva UK Limited

Part 20 Claimant/appellant

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Defendant/appellant

Procedural Posture

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

Legal Issues

  1. 1 Whether the patent specification made it plausible that apixaban would have useful factor Xa inhibitory activity
  2. 2 Whether the patent was invalid for lack of inventive step and/or insufficiency due to lack of plausibility
  3. 3 Whether the standard of plausibility as articulated in Warner-Lambert applies to claims to a single chemical compound

Ratio Decidendi

The Application did not make it plausible that apixaban had useful factor Xa inhibitory activity. There was no data or reasoning in the Application linking apixaban to the asserted technical effect, and the skilled person would not infer from the Application that apixaban had been tested and found to have the required potency. The assertion of utility was speculative. Therefore, the patent was invalid for lack of inventive step and insufficiency.

Court Disposition

Appeal dismissed; patent held invalid for lack of plausibility (inventive step and sufficiency).

Orders

  • Appeal dismissed
  • Patent declared invalid for lack of inventive step and insufficiency due to lack of plausibility