Warner Lambert v Actavis – UK Court of Appeal

INFRINGEMENT OF SWISS-FORM MEDICAL USE CLAIMS

Following two UK High Court cases relating to infringement of Swiss-form medical use claims, the UK Court of Appeal have given their interpretation of these claims. If this interpretation is followed in the full trial scheduled for later this year, this could see manufacturers of treatments for non-patented indications having to enter into strict agreements with pharmacists regarding the dispensing of their products.

Warner-Lambert is the proprietor of European Patent 0934061 which claims “Use of Pregablin for the preparation of a pharmaceutical composition for treating pain”. Pregablin is also used for the treatment of generalised anxiety disorder and epilepsy, although treatment of these conditions is not protected by patents. Actavis and other pharmaceutical companies intended to supply generic Pregablin for the treatment of these non-patented indications. Warner-Lambert sought interim injunctive relief to prevent Actavis from supplying their Pregablin product as they believed there were insufficient controls to prevent it being used to treat pain.

At first instance, Arnold J refused to grant interim relief to Warner-Lambert as he found there was no serious case to be tried relating to direct infringement of their patent. In addition to this, Warner- Lambert’s claim to indirect infringement was struck out. Warner-Lambert appealed both of these decisions.

When assessing whether there was a serious issue to be tried under section 60(1)(c) (direct infringement), Arnold J held that the word “for” in claim 1 should be interpreted as “suitable and intended for”. With regard to whose intention should be considered, it was held that the intention of the manufacturer must be considered, rather than the intention of the pharmacist dispensing the product. When deciding which acts would demonstrate intention, Arnold J stated that it must be shown that the manufacturer has a specific intention or desire to infringe the patent (subjective intent).

In relation to indirect infringement, the allegation was rejected by the first instance judge on the basis that it required there to be a “downstream” infringement. As the pharmacists did not use Pregablin for the preparation of a pharmaceutical composition (i.e. they did not manufacture the product), their acts did not infringe the patent. Therefore it was held that there could be no indirect infringement.

On appeal, the scope of infringement for Swiss-form claims was broadened. The Court of Appeal rejected Arnold J’s “subjective intent” test and deemed the correct interpretation to be whether the manufacturer knows or can reasonably foresee the product being used in a way that would infringe the patent. Counsel for Warner-Lambert submitted that the skilled person would understand the claim to protect the new therapeutic use of Pregablin and the inventive concept of the invention lies in the use in treatment rather than in the manufacturing process. Based on this construction of the claim, it was held that there was a serious case to be tried in relation to direct infringement.

Warner-Lambert’s second appeal was also allowed, restoring their claim to indirect infringement. As German and Dutch courts have recently made findings of indirect infringement, where there is no downstream infringer, it was held that the matter should be allowed to proceed to trial. In addition to this, it was held that for a two-step process, any person who carries out one of the steps may be liable for “putting the invention into effect” (as required under section 60(2) for indirect infringement). Therefore in this case, both a manufacturer and pharmacist could be considered capable of putting the invention into effect.

Despite this, the Court of Appeal, even after broadening the scope of infringement for Swiss-form claims, decided on the balance that they were not prepared to grant an interim injunction against Actavis. The damage to Actavis caused by the awarding of the injunction would not have outweighed the damage caused to Warner-Lambert by not doing so.

The full trial is now listed for later this year, when we will see how the Court of Appeal’s interpretation will be applied. It is likely that this will set a precedent as to whether the supply of pharmaceuticals for second medical uses infringes Swiss-form claims and if so, what steps must be taken by manufacturers to absolve themselves from liability, e.g. downstream activity by pharmacists.