The Patent Review 2013 - 2014: Remedies - A novel approach

By Neil Jenkins, Audrey Horton


Warner-Lambert v Actavis Respondent NHS Commissioning Board Interested parties: Teva, Generics UK, Dr Reddy's Laboratories, Consilient Health, Sandoz, Department of Health, [2015] EWHC 485 (Pat), Arnold J. 

Following the approach taken by the Judge at the hearing of Warner-Lambert's previous application for a mandatory interim injunction against Actavis, on 16 February 2015, Warner-Lambert’s solicitors wrote to NHS England stating that Warner-Lambert intended to make an application to the Court for an Order requiring NHS England to issue guidance to Clinical Commissioning Groups (CCGs) on the basis that other steps agreed by Warner-Lambert and Actavis in respect of the CCGs and pharmacists might not be sufficiently effective to achieve the desired objective, namely to prevent generic pregabalin from being prescribed for the patented indication of treating pain. In response, NHS England noted that whilst NHS England was an innocent bystander in the present dispute and was therefore unwilling for various reasons to issue guidance of its own motion, it would not oppose an application by Warner-Lambert for an Order requiring it to issue guidance provided certain conditions were met. Warner-Lambert duly made the application.

At the hearing, the Judge ordered NHS England to issue guidance along the lines requested by Warner-Lambert.  The Judge considered that the Order was proportionate, did not create barriers to trade and also contained appropriate safeguards in compliance with Article 3 of the Enforcement Directive.

One issue before the court was the ambit of the cross-undertaking in damages. Warner-Lambert argued that it was sufficient for the cross-undertaking to be given in favour of NHS England and the Department of Health. Actavis, Teva and Dr Reddy’s as interested parties requested that the benefit of the cross-undertaking should be extended to each of their respective group companies to compensate them for the lost profits on their lost sales of generic product should the patent be held invalid.

Paragraph 5.1A of the Practice Direction 25A states that:"When the court makes an order for an injunction, it should consider whether to require an undertaking by the applicant to damages sustained by a person other than the respondent, including another party to the proceedings or any other person who may suffer loss as a consequence of the order."

The principles to be applied when addressing this question were considered by Birss J. in Actavis Group PTC EHF v Boehringer Ingelheim Pharma GmBH & Co KG. Applying those principles to the case before him, the Judge ordered that the cross-undertakings be extended to the group companies of the three interested parties.