Sandoz AG & Ors v Bayer Intellectual Property GmbH [2024] EWHC 796 (Pat) (12 April 2024)

Sandoz AG & Ors v Bayer Intellectual Property GmbH [2024] EWHC 796 (Pat) (12 April 2024)

The patent is invalid for lack of inventive step. The skilled team, having access to the prior art and the chemical structure of rivaroxaban, would have been motivated to conduct a phase II trial with a once-daily rapid-release dosing regimen and would have had a reasonable expectation of success. The patent does not involve an inventive step over the cited prior art. The insufficiency and added matter arguments were not determinative given the finding on obviousness.

Citation
[2024] EWHC 796 (Pat)
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
12 April 2024
Procedural Posture
Patent Revocation and Counterclaim for Infringement / First Instance Judgment
Outcome
Patent revoked for lack of inventive step
Legal Topics
Patent Validity, Inventive Step, Sufficiency, Obviousness, Added Matter, Pharmaceutical Patents
Intellectual Property Patents Patent Validity Inventive Step Sufficiency Obviousness Added Matter Pharmaceutical Patents

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 / First Instance Judgment

Legal Issues

  1. 1 Whether European Patent (UK) No. 1 845 961 is invalid for lack of inventive step
  2. 2 Whether the patent is insufficient for lack of plausibility
  3. 3 Whether the patent as proposed to be amended would be invalid for added matter

Ratio Decidendi

The patent is invalid for lack of inventive step. The skilled team, having access to the prior art and the chemical structure of rivaroxaban, would have been motivated to conduct a phase II trial with a once-daily rapid-release dosing regimen and would have had a reasonable expectation of success. The patent does not involve an inventive step over the cited prior art. The insufficiency and added matter arguments were not determinative given the finding on obviousness.

Court Disposition

Patent revoked for lack of inventive step

Orders

  • European Patent (UK) No. 1 845 961 is revoked
  • Counterclaims for infringement dismissed