Warner-Lambert Company, LLC v Actavis Group PTC EHF & Ors

The court may grant an injunction under section 37(1) of the Senior Courts Act 1981 to require a third party to take proportionate protective measures where there is an arguable case of wrongdoing and the order is otherwise justified. An order affecting persons not represented at the hearing requires independent scrutiny. Under Article 3 of the Enforcement Directive, the court must ensure that the order is proportionate, does not create barriers to legitimate trade and includes safeguards against abuse. A cross-undertaking in damages may extend to identifiable classes of non-parties whose loss is foreseeable, provided the scope of the protection is sufficiently certain.

Warner-Lambert sought an order requiring NHS England to issue guidance about prescribing and dispensing pregabalin. The application followed earlier proceedings concerning alleged infringement of a patent covering pregabalin for the treatment of pain, including refusal of an interim injunction and summary judgment on part of the claim. NHS England accepted, for this application, that the court had jurisdiction under section 37(1) of the Senior Courts Act 1981 and that it had power to issue the guidance. The principal issues were whether the proposed order was proportionate and whether the cross-undertaking in damages should protect NHS England, the Department of Health and generic suppliers affected by the guidance.

1. Jurisdiction. The court made the order requiring NHS England to publish the agreed pregabalin guidance. It was prepared to assume that an equitable protective duty, and analogous duties, could be enforced by injunction under section 37(1) of the Senior Courts Act 1981. The available evidence and the permission to appeal were sufficient, for present purposes, to support the necessary arguable case of wrongdoing.
2. Proportionality. Article 3 of the Enforcement Directive required the order to be proportionate, not to create barriers to legitimate trade and to contain safeguards against abuse. The court could not simply approve an order negotiated by represented parties where it affected unrepresented persons. It had to conduct its own assessment. The order was the most efficacious, dissuasive and least onerous available solution and satisfied Article 3.
3. Safeguards. The order ceased to operate if the patent was revoked or expired. It also included a cross-undertaking in damages and liberty to apply.
4. Cross-undertaking. Applying the principles discussed in Actavis Group PTC EHF v Boehringer Ingelheim Pharma GmBH & Co KG, the court held that an undertaking could extend to identifiable classes where the likely loss and relevant class could be described with reasonable certainty. Protection was extended to the Actavis and Teva groups and to Dr Reddy’s Laboratories (UK) Limited.
5. Order. NHS England was required to publish the guidance by 4 pm on 3 March 2015. The order included provisions for variation, withdrawal and replacement, together with costs orders and liberty to apply.

The judgment records earlier first-instance orders in the same litigation, including dismissal of an interim injunction application on 21 January 2015 and orders dated 6 February 2015 concerning amendment, strike-out, summary dismissal and summary judgment. Permission to appeal against the interim injunction decision was granted by the Court of Appeal on 10 February 2015. This judgment granted the application requiring NHS England to issue guidance.