Warner -Lambert Company, LLC v Actavis Group Ptc EHF & Ors (Rev 1)

A Swiss-form second medical use claim requires subjective intention by the manufacturer that the medicament will be used for the specified therapeutic indication. Foreseeability, or knowledge that downstream dispensing may occur for that indication, is insufficient.

Interim mandatory relief should be assessed by its practical consequences, particularly where it is directed principally at influencing third parties outside the defendant’s control. The court must select the course likely to cause the least irremediable prejudice. On the facts, neither packaging notices nor contractual supply terms justified interim relief.

Warner-Lambert sought an interim injunction against Actavis before the trial of infringement and revocation claims concerning a Swiss-form patent for pregabalin in the treatment of pain. Actavis intended to launch a generic product with a “skinny label” limited to epilepsy and generalised anxiety disorder.

The proposed orders required Actavis to impose contractual terms on pharmacies, place notices on product packaging and notify healthcare bodies. Warner-Lambert alleged that generic prescribing and dispensing would result in infringement. Actavis disputed infringement and opposed relief on the balance of the risk of injustice.

1. Infringement issue. Swiss-form claims are process claims. Under section 60(1)(c) of the Patents Act 1977, the relevant intention is that of the manufacturer carrying out the claimed process, not the person later disposing of the product. The word “for” requires that the pharmaceutical composition be suitable and subjectively intended by the manufacturer for treating the specified condition. Knowledge or foreseeability that pharmacists may dispense the product for pain is insufficient. Warner-Lambert’s pleaded section 60(1)(c) case therefore raised no serious issue to be tried on the case advanced.
2. The claim under section 60(2) failed to raise a serious issue because neither wholesalers nor pharmacists would use Lecaent to prepare a pharmaceutical composition. The section 60(1)(a) case could not succeed because the claims were not product claims.
3. Interim relief. The court applied the approach in National Commercial Bank Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16: the question is which course is likely to cause the least irremediable prejudice. The fact that relief is mandatory creates no separate legal hurdle, but its practical consequences may be more serious. Particular care was required because the proposed orders were aimed largely at the conduct of pharmacists, prescribers and other third parties who were not before the court.
4. Even assuming a serious issue to be tried, the balance favoured refusal. Warner-Lambert’s likely loss before trial was difficult to quantify but unlikely to be substantial. Actavis faced substantial unquantifiable loss through launch delay and the risk that pharmacies would not stock its product. The proposed packaging notice was of doubtful efficacy and might create regulatory difficulties. Contractual terms might not be transmitted through the supply chain and would not solve the difficulty of identifying the indication on a generic prescription.
5. The court accepted that Actavis had failed to clear the path by bringing appropriate declaratory proceedings sufficiently early, which favoured relief. That factor was outweighed by Warner-Lambert’s own delay and the other considerations. The application for interim relief was refused. Competition-law arguments were not determined, although they would not have justified refusal if the injunction were otherwise warranted.