Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland Unlimited Company (Re Patent - Plausibility when determining validity) [2023] EWCA Civ 472 (04 May 2023)

Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland Unlimited Company (Re Patent - Plausibility when determining validity) [2023] EWCA Civ 472 (04 May 2023)

The patent was invalid because the specification did not make it plausible at the priority date that apixaban would have useful factor Xa inhibitory activity. The technical effect was not made plausible by the disclosure, so the invention made no technical contribution and was both lacking inventive step and insufficiently disclosed. Post-published evidence could not remedy the lack of plausibility at the filing date.

Citation
[2023] EWCA Civ 472
Parties
Claimant/respondent: Sandoz Limited; Claimant/respondent: Teva Pharmaceutical Industries Limited; Defendant/appellant/part 20 Claimant: Bristol-Myers Squibb Holdings Ireland Unlimited Company; Part 20 Defendant/respondent: Teva UK Limited
Jurisdiction
England and Wales
Judgment Date
04 May 2023
Procedural Posture
Patent Validity Appeal / Court of Appeal Judgment on Appeal From High Court
Outcome
Appeal dismissed; patent held invalid.
Legal Topics
Patent Validity, Plausibility, Inventive Step, Sufficiency of Disclosure, Supplementary Protection Certificate
Intellectual Property Patents Patent Validity Plausibility Inventive Step Sufficiency of Disclosure Supplementary Protection Certificate

Case Brief

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Parties

Sandoz Limited

Claimant/respondent

Teva Pharmaceutical Industries Limited

Claimant/respondent

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Defendant/appellant/part 20 Claimant

Teva UK Limited

Part 20 Defendant/respondent

Procedural Posture

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

Legal Issues

  1. 1 Whether the patent specification made it plausible that apixaban would have useful factor Xa inhibitory activity at the priority date
  2. 2 Whether the patent was invalid for lack of inventive step and/or insufficiency due to lack of plausibility
  3. 3 Whether post-published evidence can be relied upon to establish plausibility

Ratio Decidendi

The patent was invalid because the specification did not make it plausible at the priority date that apixaban would have useful factor Xa inhibitory activity. The technical effect was not made plausible by the disclosure, so the invention made no technical contribution and was both lacking inventive step and insufficiently disclosed. Post-published evidence could not remedy the lack of plausibility at the filing date.

Court Disposition

Appeal dismissed; patent held invalid.

Orders

  • Patent declared invalid for lack of plausibility, inventive step, and sufficiency.
  • Supplementary Protection Certificate based on the patent also invalid.