Warner-Lambert Company LLC v Sandoz GmbH & Ors [2015] EWHC 3153 (Pat) (04 November 2015)

Warner-Lambert Company LLC v Sandoz GmbH & Ors [2015] EWHC 3153 (Pat) (04 November 2015)

There is a serious issue to be tried regarding infringement of the patent by Sandoz's full label product. The NHS Guidance is not fully effective in preventing off-label dispensing or infringement. Warner-Lambert would suffer unquantifiable and irreparable harm if interim relief is not granted, and the balance of convenience favours maintaining the status quo by granting interim injunctions against Sandoz and Lloyds until trial.

Citation
[2015] EWHC 3153 (Pat)
Parties
Claimant: Warner-Lambert Company LLC; First Defendant: Sandoz GmbH; Second Defendant: Sandoz Limited; Third Defendant: Lloyds Pharmacy Limited
Jurisdiction
England and Wales
Judgment Date
04 November 2015
Procedural Posture
Patent Interim Injunction Application / Interim Relief Pending Trial
Outcome
Interim injunctions granted against Sandoz and Lloyds until trial or further order.
Legal Topics
Patent Infringement, Interim Injunctions, Swiss Form Claims, Pharmaceutical Regulation, Market Authorisation, Cross Undertakings, Balance of Convenience

Case Brief

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Parties

Warner-Lambert Company LLC

Claimant

Sandoz GmbH

First Defendant

Sandoz Limited

Second Defendant

Lloyds Pharmacy Limited

Third Defendant

Procedural Posture

Patent Interim Injunction Application / Interim Relief Pending Trial

  1. 1 Whether Warner-Lambert is entitled to an interim injunction restraining Sandoz from infringing European Patent (UK) No. 0 934 061 by dealings in a full label generic pregabalin product
  2. 2 Whether Lloyds should be restrained from dispensing quantities of that product in its possession
  3. 3 Whether the balance of convenience favours the grant or refusal of interim relief

Ratio Decidendi

There is a serious issue to be tried regarding infringement of the patent by Sandoz's full label product. The NHS Guidance is not fully effective in preventing off-label dispensing or infringement. Warner-Lambert would suffer unquantifiable and irreparable harm if interim relief is not granted, and the balance of convenience favours maintaining the status quo by granting interim injunctions against Sandoz and Lloyds until trial.

Court Disposition

Interim injunctions granted against Sandoz and Lloyds until trial or further order.

Orders

  • Sandoz restrained from supplying or offering to supply the Sandoz Full Label Product pending trial or further order.
  • Lloyds required to refrain from dispensing quantities of the Sandoz Full Label Product in its possession pending trial or further order.