Sandoz Ltd v Teva Pharmaceutical Industries Ltd [2022] EWHC 822 (Pat) (07 April 2022)

Sandoz Ltd v Teva Pharmaceutical Industries Ltd [2022] EWHC 822 (Pat) (07 April 2022)

The patent is invalid because the specification did not make it plausible that apixaban would have factor Xa inhibitory activity or therapeutic utility at the priority date. The disclosure was insufficient to justify the monopoly claimed, as required by law. Later evidence of efficacy or commercial success is irrelevant. The proposed amendments do not cure the lack of plausibility or sufficiency.

Citation
[2022] EWHC 822 (Pat)
Parties
Claimant/part 20 Defendant in HP 2020 000042: Sandoz Limited; Claimant in HP 2021 000003: Teva Pharmaceutical Industries Limited; Defendant/part 20 Claimant in HP 2020 000042 & HP 2021 000003: Bristol-Myers Squibb Holdings Ireland Unlimited Company; Part 20 Defendant in HP 2021 000003: Teva UK Limited
Jurisdiction
England and Wales
Judgment Date
07 April 2022
Procedural Posture
Patent Revocation and Counterclaim for Infringement / High Court Trial Judgment
Outcome
Patent revoked; counterclaim for infringement dismissed; proposed amendments refused.
Legal Topics
Patent Validity, Plausibility, Obviousness, Sufficiency, Patent Amendments, Pharmaceutical Patents
Intellectual Property Patents Patent Validity Plausibility Obviousness Sufficiency Patent Amendments Pharmaceutical Patents

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Parties

Sandoz Limited

Claimant/part 20 Defendant in HP 2020 000042

Teva Pharmaceutical Industries Limited

Claimant in HP 2021 000003

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Defendant/part 20 Claimant in HP 2020 000042 & HP 2021 000003

Teva UK Limited

Part 20 Defendant in HP 2021 000003

Procedural Posture

Patent Revocation and Counterclaim for Infringement / High Court Trial Judgment

Legal Issues

  1. 1 Whether European Patent (UK) 1 427 415 B1 (apixaban) is invalid for lack of plausibility, insufficiency, or obviousness; whether proposed amendments cure any invalidity; whether the patent is infringed if valid

Ratio Decidendi

The patent is invalid because the specification did not make it plausible that apixaban would have factor Xa inhibitory activity or therapeutic utility at the priority date. The disclosure was insufficient to justify the monopoly claimed, as required by law. Later evidence of efficacy or commercial success is irrelevant. The proposed amendments do not cure the lack of plausibility or sufficiency.

Court Disposition

Patent revoked; counterclaim for infringement dismissed; proposed amendments refused.

Orders

  • European Patent (UK) 1 427 415 B1 is revoked for lack of plausibility and insufficiency.
  • Counterclaim for infringement by BMS is dismissed.