In the March 2015 edition of our European Newsletter we reported on the High Court’s decision in Warner-Lambert Company, LLC v Actavis Group PTC EHF & Others1, a case concerning alleged infringement of a second medical use patent by the manufacturer of a generic medicine (a so-called "skinny label" product). In those proceedings, the High Court held that, in order to find direct infringement, the manufacturer of the generic drug had to subjectively intend that its medicine would be used for the patented indication. While there has been no interference with the High Court’s decision not to grant interim relief, the Court of Appeal has put forward a wider test for infringement of second medical use patents2.

To restate the facts, Warner-Lambert prescription drug pregabalin (LYRICA) is used to treat epilepsy, generalised anxiety disorder and neuropathic pain. All patents and supplementary protection certificates protecting pregabalin as such have fallen away, except for a Swiss form second medical use patent protecting the use of pregabalin in the preparation of a medicament for the treatment of pain. Actavis seeks to enter the market with a skinny label limiting its generic pregabalin (LECAENT) to the two non-patented indications. Warner-Lambert sought interim relief, narrowed from the original form sought, including the mandatory inclusion of restricted indication notification on bulk packaging for LECAENT and the imposition of contractual conditions on pharmacies supplying LECEANT. 

Warner-Lambert argued that such a launch would infringe its UK Swiss form patent, where prescriptions are usually written generically, without reference to indication and there is a price incentive for pharmacists to dispense generic versions against all INN prescriptions.

The Court of Appeal was directed to a number of decisions in other European Member States that explored similar issues. These included the 2013 Carvedilol II3 and Cistus4 decisions in Germany, as well as the recent Warner Lambert v Aliud decisions to grant preliminary injunctions against generic manufacturers in respect of the German designation of the patent in suit in the UK, and the Schering v Teva5and Novartis v Sun6 cases in the Netherlands. Having reviewed these cases, the Court of Appeal noted that "the law relating to both direct and indirect infringement of Swiss claims is far from settled”.

Departing from the High Court’s decision, the Court of Appeal has held that, in a claim for direct infringement under section 60(1)(c) Patents Act 1977, the generic manufacturer need only know (including constructive knowledge) or reasonably foresee that the generic medicine would ultimately be used for the patented use. Accordingly, Floyd LJ, handing down the leading judgment, remarked that “it is plain that Warner-Lambert have an arguable case of infringement”.

The Court of Appeal did, however, agree with the High Court’s decision not to grant interim relief, noting that the balance of injustice favoured Actavis. At this point it is interesting to note that Warner-Lambert had already successfully persuaded the High Court to order that the English and Welsh health services issue guidance to the effect that, when pregabalin is prescribed for pain relief, the prescription must state LYRICA. Since there was no reason to suspect that this guidance would be ineffective, the Court of Appeal dismissed the appeal despite disagreeing with the High Court’s reasoning.

The issue of direct infringement will now be considered at trial although, in the event that Warner-Lambert is successful, the Court of Appeal cautioned that it does not necessarily mean that unqualified relief will follow as of right.