Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors [2024] EWCA Civ 562 (24 May 2024)

Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors [2024] EWCA Civ 562 (24 May 2024)

The skilled team, reading the prior art (Harder and Kubitza posters) with common general knowledge, would have found it obvious to conduct a Phase II trial including a once-daily 30 mg rivaroxaban regimen, with a reasonable expectation of success regarding safety and efficacy. The patent therefore lacked inventive step and was invalid for obviousness.

Citation
[2024] EWCA Civ 562
Parties
Claimants/respondents: Sandoz AG and others; Claimants/respondents: Teva Pharmaceutical Industries Limited and another; Claimants/respondents: Cipla Limited and another; Claimants/respondents: Amarox Limited and another; Claimants/respondents: Generics (UK) Limited and another; Claimants/respondents: Stada Arzneimittel AG and others; Defendants/appellants: Bayer Intellectual Property GmbH; Defendants/appellants: Bayer AG; Defendants/appellants: Bayer PLC
Jurisdiction
England and Wales
Judgment Date
24 May 2024
Procedural Posture
Patent Revocation and Counterclaim for Infringement / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed; patent remains revoked for lack of inventive step (obviousness).
Legal Topics
Obviousness, Inventive Step, Pharmaceutical Patents, Clinical Trials, Patent Revocation
Intellectual Property Patents Obviousness Inventive Step Pharmaceutical Patents Clinical Trials Patent Revocation

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Downloadable case file Legal principles 2 Authorities cited 6 Party arguments 2 Amounts and remedies 1
Sign in to unlock

Parties

Sandoz AG and others

Claimants/respondents

Teva Pharmaceutical Industries Limited and another

Claimants/respondents

Cipla Limited and another

Claimants/respondents

Amarox Limited and another

Claimants/respondents

Generics (UK) Limited and another

Claimants/respondents

Stada Arzneimittel AG and others

Claimants/respondents

Bayer Intellectual Property GmbH

Defendants/appellants

Bayer AG

Defendants/appellants

Bayer PLC

Defendants/appellants

Procedural Posture

Patent Revocation and Counterclaim for Infringement / Appeal From High Court (patents Court) to Court of Appeal

Legal Issues

  1. 1 Whether the patent for once-daily administration of rivaroxaban for thromboembolic disorders is invalid for obviousness over the prior art

Ratio Decidendi

The skilled team, reading the prior art (Harder and Kubitza posters) with common general knowledge, would have found it obvious to conduct a Phase II trial including a once-daily 30 mg rivaroxaban regimen, with a reasonable expectation of success regarding safety and efficacy. The patent therefore lacked inventive step and was invalid for obviousness.

Court Disposition

Appeal dismissed; patent remains revoked for lack of inventive step (obviousness).

Orders

  • Appeal dismissed
  • Patent revocation order upheld