Warner-Lambert Company LLC v Actavis Group PTC EHF, Actavis UK Ltd, Caduceus Pharma Ltd, Patents Court, 21 January 2015, [2015] EWHC 72 (Pat), Arnold J
The English Patents Court has refused an application made by Warner-Lambert for interim relief in respect of Actavis’ generic pregabalin medicine known as Lecaent. Pregabalin is the active ingredient in Warner-Lambert’s Lyrica medicine which is authorised to treat several conditions. Compound patent protection for pregabalin expired in 2013 but Warner-Lambert has a second medical use patent with Swiss-form claims to the treatment of pain. Arnold J refused to order the interim relief requested by Warner-Lambert on the grounds that: (i) Warner-Lambert did not have an arguable case of infringement by Actavis of its pain patent and (ii) even if there was an arguable case of infringement, he would not have granted an interim injunction on the balance of the risk of injustice.
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The relief requested by the patentee was unusual in that it was applying for a mandatory injunction forcing Actavis to take various steps to try and preserve the Lyrica market for pain pending the outcome of the trial scheduled for June 2015. Both sides had already taken (or agreed to take) a number of steps to try and prevent the dispensing of Lecaent for pain. The interim measures requested from the court included a requirement for notices to be placed on Lecaent’s packaging highlighting that it should not be dispensed for pain, and for conditions to be imposed into any agreement for the supply of Lecaent to the effect that reasonable endeavours should be used not to dispense it for treatment of pain. Having heard 3 days of argument on the application of the American Cyanamid test to the unusual facts of the case, Arnold J found in favour of the Defendants.
The decision is of interest for a number of reasons, including the Judge’s comments on the construction of Swiss-form claims. Having considered other UK case law on second medical use patents, Arnold J held that “the word ‘for’ in Swiss form claims imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition”. Arnold J did not consider that intention to sell with knowledge that the product would be used for the patent protected indication was sufficient; the manufacturer must have a subjective intention that its product will be used for the protected indication. Given this construction, the Judge felt that there was no serious issue to be tried as Warner-Lambert had not relied upon any allegation of subjective intention on the part of Actavis. Perhaps less controversially, Arnold J also confirmed that Swiss-form claims are process claims not product claims.
Arnold J nevertheless went on to consider the balance of convenience and noted that, whilst it would be difficult to quantify Warner-Lambert’s loss if no order was granted, the effect of the relief sought would be to deter pharmacists from dispensing Lecaent for any indication and as such Actavis may be excluded from the non-patented market. The Judge felt that granting the relief “would create a greater risk of injustice then refusing it” and that wrongly granting the relief would cause more damage to Actavis than wrongly refusing to grant it would cause Warner-Lambert.
Arnold J did note that the best solution to the problem of cross-label use would be to try and ensure that doctors prescribing pregabalin for the treatment of pain did so by reference to the brand name Lyrica rather than by INN. He felt that there was a reasonable prospect that guidance could be issued by the NHS to encourage prescription by brand for pain and that he “would encourage them to consider doing so”.
This decision, particularly the points on construction, gives some indication of the pitfalls and difficulties in the enforcement of second medical use claims. Arnold J made clear that his judgment does not deal with EPC 2000 claims (i.e. X for use in the treatment of Y) which remain to be considered on another occasion. The case continues with an appeal of this decision of Arnold J and a full trial in June 2015, both of which will no doubt be followed closely by those with an interest in this area.
Read the decision here.
Head note: Katie Rooth
