Sandoz AG & Ors v Bayer Intellectual Property GmbH

Sandoz AG & Ors v Bayer Intellectual Property GmbH

The patent is invalid for lack of inventive step because, based on the phase I data in Harder and the Kubitza posters, the skilled team would have found it obvious to conduct a phase II trial including a once daily 30 mg regimen of rivaroxaban, with a reasonable expectation of success. The evidence showed that the skilled team would have believed such a regimen would not pose unacceptable risk and would have been worth trying. The patent is not insufficient for lack of plausibility as to dose or scope of thromboembolic disorders, as the skilled person would understand the claims to be limited to safe and effective doses and to exclude non-thromboembolic disorders.

Parties
Claimant/part 20 Defendant: Sandoz AG; Claimant/part 20 Defendant: Sandoz Limited; Claimant/part 20 Defendant: Accord Healthcare Limited; Claimant/part 20 Defendant: Teva Pharmaceutical Industries Limited; Claimant/part 20 Defendant: Cipla Limited; Claimant/part 20 Defendant: Amarox Limited; Claimant/part 20 Defendant: Hetero Labs Limited; Claimant/part 20 Defendant: Generics (UK) Limited; Claimant/part 20 Defendant: Viatris (UK) Healthcare Limited; Claimant/part 20 Defendant: Stada Arzneimittel AG; Defendant/part 20 Claimant: Bayer Intellectual Property GmbH; Third Party: Teva (UK) Limited; Third Party: Cipla (EU) Limited; Third Party: Thornton & Ross Limited; Third Party: Genus Pharmaceuticals Limited
Jurisdiction
England and Wales
Judgment Date
11 December 2024
Procedural Posture
Patent Revocation and Counterclaim for Infringement / High Court Trial Judgment
Outcome
Patent revoked for lack of inventive step
Legal Topics
Inventive Step (obviousness), Sufficiency, Added Matter, Pharmaceutical Patents, Clinical Trials, Patent Construction
Intellectual Property Patents Inventive Step (obviousness) Sufficiency Added Matter Pharmaceutical Patents Clinical Trials Patent Construction

Case Brief

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Parties

Sandoz AG

Claimant/part 20 Defendant

Sandoz Limited

Claimant/part 20 Defendant

Accord Healthcare Limited

Claimant/part 20 Defendant

Teva Pharmaceutical Industries Limited

Claimant/part 20 Defendant

Cipla Limited

Claimant/part 20 Defendant

Amarox Limited

Claimant/part 20 Defendant

Hetero Labs Limited

Claimant/part 20 Defendant

Generics (UK) Limited

Claimant/part 20 Defendant

Viatris (UK) Healthcare Limited

Claimant/part 20 Defendant

Stada Arzneimittel AG

Claimant/part 20 Defendant

Bayer Intellectual Property GmbH

Defendant/part 20 Claimant

Teva (UK) Limited

Third Party

Cipla (EU) Limited

Third Party

Thornton & Ross Limited

Third Party

Genus Pharmaceuticals Limited

Third Party

Procedural Posture

Patent Revocation and Counterclaim for Infringement / High Court Trial Judgment

Legal Issues

  1. 1 Whether European Patent (UK) No. 1 845 961 is invalid for lack of inventive step (obviousness) over the prior art (Harder and Kubitza posters)
  2. 2 Whether the patent is insufficient for lack of plausibility as to dose and scope of thromboembolic disorders
  3. 3 Whether proposed amendments would add matter

Ratio Decidendi

The patent is invalid for lack of inventive step because, based on the phase I data in Harder and the Kubitza posters, the skilled team would have found it obvious to conduct a phase II trial including a once daily 30 mg regimen of rivaroxaban, with a reasonable expectation of success. The evidence showed that the skilled team would have believed such a regimen would not pose unacceptable risk and would have been worth trying. The patent is not insufficient for lack of plausibility as to dose or scope of thromboembolic disorders, as the skilled person would understand the claims to be limited to safe and effective doses and to exclude non-thromboembolic disorders.

Court Disposition

Patent revoked for lack of inventive step

Orders

  • European Patent (UK) No. 1 845 961 is revoked for lack of inventive step over Harder and the Kubitza posters.
  • Bayer's application to amend the claims falls away.