In Warner-Lambert LLC v Actavis Group Ptc EHF and others v Secretary of State for Health, the Court of Appeal widened the test for Swiss form patent claims, but upheld the High Court’s decision to refuse an interim injunction intended to prevent the supply of a drug for non-patented indications.
The patentee claimant Warner-Lambert Company LLC markets a prescription only drug ‘Lyrica’ (pregabalin) that is used to treat three different indications. Patent protection has expired in respect of the molecule itself but remains for one of the three indicated uses: pain relief. This use is a so called “second medical use” for pregabalin, which was used previously for the treatment of generalised anxiety disorder (“GAD”) and epilepsy.
The patent at issue contains Swiss form claims (“use of [substance] for the preparation of a pharmaceutical composition for treating [condition]”). The EPO no longer grants Swiss form claims but they were granted prior to the introduction of the EPC 2000 as a way to provide novelty to second medical uses and to avoid the prohibition on granting claims to methods of treatment.
The defendants to this action (together “Actavis”) obtained a marketing authorisation for generic pregabalin under the brand name ‘Lecaent’. Lecaent has been authorised in Europe with a limited marketing authorisation – what is known as a “carved out” or “skinny” label. This means that Lecaent is authorised for use only in the two non-patented indications, not for the patented pain indication.
Warner-Lambert issued patent infringement proceedings against Actavis because they believed, notwithstanding the skinny label for Lecaent, the Actavis product would be prescribed in the UK for treatment of pain. Warner-Lambert was concerned that this was particularly likely given the financial incentives in the UK healthcare system for pharmacists to dispense generic versions of drugs where available.
Warner-Lambert sought an interim injunction requiring Actavis to take numerous steps intended to prevent Lecaent being dispensed for patients who had been prescribed pregabalin for pain relief.
There were four interim judgments between January and February 2015. This appeal was by Warner Lambert against two of them: the refusal to grant a positive injunction against Actavis and the decision to strike out Warner-Lambert’s claim of indirect infringement, which would have left only the matter of direct infringement to proceed to trial.
Court of Appeal decision
The Court of Appeal disagreed with the High Court decision to strike out indirect infringement based on Arnold J’s finding that infringement of Swiss form claims required subjective intention on behalf of the infringer. Arnold J found that in the present case, the subjective intention had to be that of the manufacturer, not someone else in the process by which medicines are prescribed. This subjective intention test required that the patentee prove it is the manufacturer’s “wish or desire” to sell some medication for the patented indication. Simple knowledge that infringing use might occur was not sufficient.
The Court of Appeal disagreed holding that knowledge, including constructive knowledge or foreseeability, on the part of the manufacturer that the product might be used for the patented second use was sufficient. Floyd LJ stated that “it is plain that Warner-Lambert have an arguable case of infringement“.
The Court of Appeal did however uphold the High Court decision not to grant interim relief, choosing not to reassess the balance of justice as found at first instance. Warner-Lambert could not object to supplies of Lecaent for the non-patented indications. The interim injunction sought consisted of requirements for Actavis to enter into contractual arrangements with pharmacies and intermediaries in addition to various notification requirements. Arnold J considered that “wrongly” granting such relief was more likely to cause Actavis substantial unquantifiable harm than wrongly refusing it would cause Warner-Lambert. Floyd LJ agreed, concluding that “the judge properly evaluated the material before him on this aspect of the case and came to a conclusion with which this court could not interfere”.
The question of indirect infringement will therefore be considered at the trial of this matter along with direct infringement at the end of June 2015.
Warner-Lambert LLC v Actavis Group Ptc EHF and others v Secretary of State for Health  EWCA Civ 556
Charles Hopper and Natalie Coan