Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors

Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors

The patent was invalid for obviousness because the prior art (Harder and Kubitza posters) provided sufficient data and explicit suggestion that once-daily dosing of rivaroxaban was suitable, and the skilled team would have included a 30mg once-daily regimen in a Phase II trial with a reasonable expectation of efficacy and safety. The judge's preference for the respondents' expert evidence was justified, and there was no error of law or principle in the assessment of obviousness.

Parties
Claimant/respondent: Sandoz AG and others; Claimant/respondent: Teva Pharmaceutical Industries Limited and another; Claimant/respondent: Cipla Limited and another; Claimant/respondent: Amarox Limited and another; Claimant/respondent: Generics (UK) Limited and another; Claimant/respondent: Stada Arzneimittel AG and others; Defendant/appellant: Bayer Intellectual Property GmbH; Defendant/appellant: Bayer AG; Defendant/appellant: Bayer PLC
Jurisdiction
England and Wales
Judgment Date
11 December 2024
Procedural Posture
Civil Appeal (intellectual Property/patents) / Appeal From High Court (patents Court) to Court of Appeal, Judgment
Outcome
Appeal dismissed; patent remains revoked for obviousness.
Legal Topics
Patent Revocation, Obviousness, Inventive Step, Pharmaceutical Patents, Clinical Trials, Dosing Regimens
Intellectual Property Patents Pharmaceutical Law Patent Revocation Obviousness Inventive Step Pharmaceutical Patents Clinical Trials +1 more

Case Brief

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Parties

Sandoz AG and others

Claimant/respondent

Teva Pharmaceutical Industries Limited and another

Claimant/respondent

Cipla Limited and another

Claimant/respondent

Amarox Limited and another

Claimant/respondent

Generics (UK) Limited and another

Claimant/respondent

Stada Arzneimittel AG and others

Claimant/respondent

Bayer Intellectual Property GmbH

Defendant/appellant

Bayer AG

Defendant/appellant

Bayer PLC

Defendant/appellant

Procedural Posture

Civil Appeal (intellectual Property/patents) / Appeal From High Court (patents Court) to Court of Appeal, Judgment

Legal Issues

  1. 1 Whether the patent for once-daily administration of rivaroxaban for thromboembolic disorders is invalid for obviousness over prior art.
  2. 2 Whether the skilled team would have had a reasonable expectation of success with once-daily dosing based on prior art.

Ratio Decidendi

The patent was invalid for obviousness because the prior art (Harder and Kubitza posters) provided sufficient data and explicit suggestion that once-daily dosing of rivaroxaban was suitable, and the skilled team would have included a 30mg once-daily regimen in a Phase II trial with a reasonable expectation of efficacy and safety. The judge's preference for the respondents' expert evidence was justified, and there was no error of law or principle in the assessment of obviousness.

Court Disposition

Appeal dismissed; patent remains revoked for obviousness.

Orders

  • Appeal dismissed.
  • Patent for once-daily administration of rivaroxaban revoked.