Warner-Lambert Company, LLC v Actavis Group PTC EHF & Ors [2015] EWHC 485 (Pat) (02 March 2015)

Warner-Lambert Company, LLC v Actavis Group PTC EHF & Ors [2015] EWHC 485 (Pat) (02 March 2015)

The court has jurisdiction to order NHS England to issue guidance to CCGs regarding the prescribing of pregabalin by brand name for pain, such an order is proportionate, does not create barriers to legitimate trade, and contains appropriate safeguards. The cross-undertaking in damages should extend to the Actavis, Teva, and Dr Reddy's groups of companies as they may suffer loss as a result of the order.

Citation
[2015] EWHC 485 (Pat)
Parties
Claimant: Warner-Lambert Company, LLC; Defendant: Actavis Group PTC EHF; Defendant: Actavis UK Limited; Defendant: Caduceus Pharma Limited; Respondent: National Health Service Commissioning Board (NHS England); Interested Party: Teva UK Limited; Interested Party: Generics (UK) Limited trading as Mylan; Interested Party: Dr Reddy's Laboratories (UK) Limited; Interested Party: Consilient Health Limited; Interested Party: Sandoz Limited; Interested Party: Department of Health
Jurisdiction
England and Wales
Judgment Date
02 March 2015
Procedural Posture
Patent Infringement and Interim Relief Application / Application for Mandatory Injunction and Related Orders
Outcome
Application granted in part; mandatory order made against NHS England to issue guidance; cross-undertaking in damages extended to specified groups; costs awarded as specified.
Legal Topics
Interim Injunctions, Mandatory Orders, Cross Undertaking in Damages, Jurisdiction Under Senior Courts Act 1981 S.37, Norwich Pharmacal Relief, Proportionality Under Enforcement Directive, Guidance to NHS Bodies, Patent Enforcement
Intellectual Property Patent Law Administrative Law Interim Injunctions Mandatory Orders Cross Undertaking in Damages Jurisdiction Under Senior Courts Act 1981 S.37 Norwich Pharmacal Relief +3 more

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Parties

Warner-Lambert Company, LLC

Claimant

Actavis Group PTC EHF

Defendant

Actavis UK Limited

Defendant

Caduceus Pharma Limited

Defendant

National Health Service Commissioning Board (NHS England)

Respondent

Teva UK Limited

Interested Party

Generics (UK) Limited trading as Mylan

Interested Party

Dr Reddy's Laboratories (UK) Limited

Interested Party

Consilient Health Limited

Interested Party

Sandoz Limited

Interested Party

Department of Health

Interested Party

Procedural Posture

Patent Infringement and Interim Relief Application / Application for Mandatory Injunction and Related Orders

Legal Issues

  1. 1 Whether the court has jurisdiction to order NHS England to issue guidance to CCGs regarding prescribing pregabalin by brand name for pain
  2. 2 Whether such an order is proportionate, does not create barriers to legitimate trade, and contains safeguards against abuse under Article 3 of Directive 2004/48/EC
  3. 3 Whether cross-undertakings in damages should extend to groups of companies of interested parties

Ratio Decidendi

The court has jurisdiction to order NHS England to issue guidance to CCGs regarding the prescribing of pregabalin by brand name for pain, such an order is proportionate, does not create barriers to legitimate trade, and contains appropriate safeguards. The cross-undertaking in damages should extend to the Actavis, Teva, and Dr Reddy's groups of companies as they may suffer loss as a result of the order.

Court Disposition

Application granted in part; mandatory order made against NHS England to issue guidance; cross-undertaking in damages extended to specified groups; costs awarded as specified.

Orders

  • NHS England to issue guidance to CCGs and NHS Business Services Authority regarding prescribing pregabalin by brand name for pain by 4pm on 3 March 2015.
  • Liberty to apply for variation or setting aside of guidance.