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

A Swiss-form claim is a purpose-limited process claim. The word “for” links manufacture to the medicine’s ultimate intentional use for the claimed therapeutic indication. It does not require the manufacturer to desire or target that use. The requirement is satisfied where the manufacturer knows, including through constructive knowledge, or can reasonably foresee that some of the medicine will intentionally be used for that indication.

Indirect infringement may arguably occur where different persons collectively put the invention into effect, even though no single downstream person performs the whole manufacturing process. The scope of the claim remains distinct from the relief available. Where the medicine also has substantial non-patented uses, an unqualified injunction does not follow automatically.

The patentee held Swiss-form claims for using pregabalin to prepare a pharmaceutical composition for treating pain. The generic manufacturer proposed to market bio-equivalent pregabalin under a “skinny label” covering epilepsy and generalised anxiety disorder, but not pain. Because prescriptions were commonly written generically and did not identify the condition treated, some generic pregabalin was foreseeably liable to be dispensed for pain.

Arnold J refused mandatory interim relief in [2015] EWHC 72 (Pat), holding that no serious question arose on direct or indirect infringement and that the balance of justice opposed relief. He subsequently struck out the indirect infringement claim in [2015] EWHC 249 (Pat). The principal questions were what “for” meant in a Swiss-form claim, whether direct and indirect infringement were arguable, and whether the refusal of interim relief should be disturbed.

1. Appeals allowed in part. The appeal against the refusal of interim relief was dismissed. Permission to appeal against the striking out of the indirect infringement claim was granted, and that appeal was allowed. The application to adduce fresh evidence and the Secretary of State’s application to intervene were dismissed.

2. A Swiss-form claim is a process claim whose technical subject matter extends beyond making the known compound but stops short of including its actual administration. It covers manufacture for patients to whom the medicine will intentionally be administered for the claimed therapeutic purpose. Its novelty lies in that new therapeutic use.

3. The word “for” does not require the manufacturer’s subjective desire that the medicine should be used for the patented indication. The skilled reader would understand it to require that the manufacturer knows, including through constructive knowledge, or can reasonably foresee that some of the medicine will intentionally be used for that indication. Manufacture with that knowledge or foresight may therefore amount to use of the claimed process under section 60(1)(b) of the Patents Act 1977. Disposal of a product obtained directly by that process may engage section 60(1)(c). On the facts, direct infringement raised an arguable case.

4. The indirect infringement claim under section 60(2) was also arguable. First, courts in two other EPC states had recognised possible indirect infringement in comparable circumstances. Secondly, downstream dealings in the direct product of an infringing process could themselves engage section 60(1)(c). Thirdly, “putting the invention into effect” might encompass manufacture by one person followed by intentional use for the patented indication by another. It was unnecessary that one downstream person perform the whole invention. The claim should therefore proceed to trial.

5. Claim construction and remedy are distinct. Legitimate non-patented uses may make an unqualified injunction inappropriate, but that does not justify narrowing the claim. Arnold J had permissibly evaluated the balance of justice, including the prospect and likely effect of NHS prescribing guidance. The appellate court could not interfere with that assessment.

1. Court of Appeal (Civil Division): In [2015] EWCA Civ 556, dismissed the appeal from the refusal of interim relief, granted permission and allowed the appeal from the strike-out of indirect infringement, refused fresh evidence, and dismissed the proposed intervention.
2. Patents Court: In [2015] EWHC 72 (Pat), Arnold J refused mandatory interim relief because no serious question to be tried had been shown and the balance of justice opposed relief.
3. Patents Court: In [2015] EWHC 223 (Pat), Arnold J allowed the amended direct infringement case to proceed to trial despite considering that it had no real prospect of success. That order was not appealed.
4. Patents Court: In [2015] EWHC 249 (Pat), Arnold J struck out the indirect infringement claim. The Court of Appeal reversed that order.
5. Patents Court: In [2015] EWHC 485 (Pat), Arnold J directed NHS England to issue prescribing guidance. That decision was contextual to the balance of justice but was not itself under appeal.