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

Where infringement depends on a developing and unsettled question of patent law, the court may refuse strike-out or summary judgment and require the facts to be established at trial before the law is determined definitively. A pleading of subjective intention must identify objective facts capable of supporting an inference that the manufacturer targeted or aimed at the relevant use. Mere foreseeability that third parties will use a product for a patented indication does not establish that intention. Failures to control independent third parties, or speculative assumptions about sales and business plans, do not ordinarily support the inference.

Warner-Lambert sought to amend its infringement particulars concerning a generic pregabalin product marketed with a “skinny label”. Actavis applied under the CPR rule 3.4(2)(a), alternatively for summary judgment under CPR rule 24.2(b). The applications followed the refusal of an interim injunction in [2015] EWHC 72 (Pat).

The proposed pleading alleged that Actavis subjectively intended the product to be dispensed for patented pain indications. The central issues were whether the pleading disclosed reasonable grounds, whether the requirement for subjective intention might be reconsidered on appeal, and whether the developing state of the law and the prospect of appellate review provided a compelling reason for trial.

1. The court accepted, for the purposes of the application, that if the word “for” in a Swiss-form claim required subjective intention, the relevant intention was that of the manufacturer. It was sufficient that the manufacturer targeted or aimed at the relevant consequence. Such intention could be inferred from objective facts.

2. The pleaded facts did not disclose reasonable grounds for inferring that Actavis intended its product to be dispensed for treating pain. The allegations established, at most, that such dispensing was foreseeable. They did not adequately address the measures taken or proposed by Actavis and third parties, and several allegations were speculative, irrelevant or outside Actavis’s control. The court rejected the proposition that intention could be inferred merely from a failure to prevent independent third parties from causing the relevant use.

3. The court recognised that its earlier construction of “for treating” might be wrong and that the law concerning the mental element in Swiss-form claims was developing. The recent Dutch decision in Novartis v Sun materially concerned indirect infringement and knowledge, but did not address the process-claim character of the claim or the mental element required by “for treating”.

4. Although the pleading might fail if the earlier construction were upheld, there was another compelling reason for trial within CPR rule 24.2(b). The proper course was to establish the facts before attempting a definitive determination of the law, particularly since the issue was likely to reach the Court of Appeal and potentially the Supreme Court.

5. The infringement claim was therefore not struck out and summary judgment was refused. Warner-Lambert received permission to amend largely as proposed, but references to the position in France were excluded as wholly irrelevant. The court reserved further argument on whether the Patents Act 1977 section 60(2) claim should proceed to trial and warned that disclosure would require firm case management.

The judgment records the earlier interim-injunction decision in [2015] EWHC 72 (Pat). The present decision was a first-instance determination of Actavis’s strike-out and summary-judgment application and Warner-Lambert’s amendment application.