On the 5th of July of this year, the Court of Appeals of Barcelona rendered its decision on the request for interim remedies brought by Warner-Lambert and Pfizer against several Spanish generic companies for violation of the second medical use patent owned by WL (EP 934061) on the active principle Pregabalin, commercialized under the trademark Lyrica.
Those proceedings represent the Spanish side of the Pregabalin litigation, which has taken place also in countries such as the UK, Germany or Denmark, and which has resulted on decisions supporting different views on the scope of second medical use patents containing Swiss-type of claims when confronted with off-label or cross-label prescriptions of generics for the patented indication (infringement vs. non-infringement, or direct vs. indirect infringement).
In the Spanish case, the claimants argued that the regime on prescription of medicines resulted in the prescription being made by the doctors of the active principle Pregabalin for the patented indication and in the subsequent dispensation for that indication of the generic products. The plaintiffs claimed against the manufacturers of those generics (whose prospect and technical documentation did not include the patented indication) and asked the court to take some measures to prevent prescription and dispensation of the generics for the patented indication (such as to impose on the defendants the obligation to inform their clients that the generics could not be prescribed or dispensed for the patented indication).
While in the first instance the commercial court no. 4 of Barcelona rejected the existence of either a direct or an indirect infringement of the patent (there was, in view of the court, no evidence that the generics were manufactured for the intended use, nor of the alleged prescription or dispensation of generics for the patented indication), the Court of Appeals has now revoked that decision. Unlike the lower court, the Court of Appeals considers that under the legal system for prescription and dispensation of medicines is probable that generics end up being used for the patented indication, and that if knowing this the defendants did not take certain steps to prevent it, this would amount to an indirect infringement of the patent. The court orders the defendants to inform their clients about the restriction on the prescription and dispensation of their products resulting from the patent, and not to supply said products if they have reasonable grounds to believe that will be used for the patented indication.
With this decision, the Court of Appeals of Barcelona adheres to the position of those courts (e.g. the LG Hamburg in the case Warner-Lambert v. Aliud or the Gerechtshof Den Haag in the case Novartis AG v. Sun Pharmaceutical Industries (Europe) B.V., [a decision la later reversed]) which accept the possibility of an indirect infringement of those type of patents, and separates itself from those which have rejected said possibility (as exemplified by the decisions of Justice Arnold in the Warner-Lambert vs. Actavis case).