Teva Pharmaceutical Industries Limited & Anor. v Astellas Pharma Inc

Teva Pharmaceutical Industries Limited & Anor. v Astellas Pharma Inc

The obviousness attack fails because AU288 does not disclose mirabegron as a potent, selective β3-AR agonist for OAB, and the skilled team would not have a clear expectation of success in using mirabegron for OAB based on AU288 and the common general knowledge. The patent provides specific and concrete disclosure for OAB, and the insufficiency squeeze fails. Accordingly, the patent is valid and would be infringed by the Claimants' proposed acts.

Parties
Claimant/part 20 Defendant in HP 2020 000046 and HP 2021 000005: Teva Pharmaceutical Industries Limited; Claimant/part 20 Defendant in HP 2020 000046 and HP 2021 000005: Sandoz AG; Defendant/part 20 Claimant in HP 2020 000046 & HP 2021 000005: Astellas Pharma Inc.; Part 20 Defendant in HP 2020 000046 & HP 2021 000005: Teva UK Limited; Part 20 Defendant in HP 2020 000046 & HP 2021 000005: Sandoz Limited
Jurisdiction
England and Wales
Judgment Date
01 June 2022
Procedural Posture
Patent Revocation and Infringement / Final Judgment After Trial
Outcome
Patent upheld as valid; infringement admitted if valid.
Legal Topics
Obviousness, Insufficiency, Second Medical Use Claims, Pharmaceutical Patents
Intellectual Property Patent Law Obviousness Insufficiency Second Medical Use Claims Pharmaceutical Patents

Case Brief

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Parties

Teva Pharmaceutical Industries Limited

Claimant/part 20 Defendant in HP 2020 000046 and HP 2021 000005

Sandoz AG

Claimant/part 20 Defendant in HP 2020 000046 and HP 2021 000005

Astellas Pharma Inc.

Defendant/part 20 Claimant in HP 2020 000046 & HP 2021 000005

Teva UK Limited

Part 20 Defendant in HP 2020 000046 & HP 2021 000005

Sandoz Limited

Part 20 Defendant in HP 2020 000046 & HP 2021 000005

Procedural Posture

Patent Revocation and Infringement / Final Judgment After Trial

Legal Issues

  1. 1 Whether European Patent (UK) 1 559 427 B1 is invalid for obviousness over AU 199889288 B2
  2. 2 Whether the patent is insufficient
  3. 3 Whether the patent would be infringed by the Claimants' proposed acts

Ratio Decidendi

The obviousness attack fails because AU288 does not disclose mirabegron as a potent, selective β3-AR agonist for OAB, and the skilled team would not have a clear expectation of success in using mirabegron for OAB based on AU288 and the common general knowledge. The patent provides specific and concrete disclosure for OAB, and the insufficiency squeeze fails. Accordingly, the patent is valid and would be infringed by the Claimants' proposed acts.

Court Disposition

Patent upheld as valid; infringement admitted if valid.

Orders

  • Patent is valid.
  • Patent would be infringed by Claimants' proposed acts.