On June 23 2015 Barcelona Commercial Court No 4 dismissed a preliminary injunction motion by Warner-Lambert and Pfizer against generics in a patent case regarding pregabalin (Lyrica).

Facts

Warner-Lambert Company LLC and Pfizer, SLU applied for a preliminary injunction against a group of companies for alleged patent infringement, unfair competition and extra contractual liability, and asked the court to require the companies to take a number of steps to prevent their pregabalin generic drugs from being dispensed to treat pain.

Warner-Lambert holds European Patent 0934 061, which claims the use of pregabalin for the preparation of a pharmaceutical composition for treating pain. The relevant claim is a second medical use 'Swiss-type' claim.

Pregabalin is marketed in Spain by Pfizer under the trademark LYRICA not only for neuropathic pain, but also for epilepsy and generalised anxiety disorder. Patent protection for the drug as such expired.

In 2015 a group of generics companies entered the market in Spain for the two non-patented indications (epilepsy and generalised anxiety disorder). To that end, the generics companies obtained marketing authorisations limited to those two indications, which were the only ones included in their respective summaries of product characteristics and labels. Generic pregabalin drugs have the same price as Lyrica, as Pfizer voluntarily reduced the price of its product in December 2014.

Warner-Lambert and Pfizer argued that the generics companies were infringing the patent because it was foreseeable that doctors would prescribe and pharmacists would dispense their pregabalin generics for treating pain regardless of the fact that they had not been approved for such indication.

In turn, the defendants alleged that they were not infringing the patent because their products were not indicated for the treatment of pain, and further that the Spanish regulatory framework prevented pregabalin generics from being prescribed or dispensed for treating pain.

Warner-Lambert had also applied for preliminary injunctions based on the same patent in Germany and the United Kingdom, with the German court issuing a limited injunction and the UK court rejecting the injunction application, but accepting the case for trial.

Decision

In a unanimous ruling Barcelona Commercial Court No 4 dismissed the preliminary injunction application. The court comprised three patent judges.

The decision first analysed the scope of Warner-Lambert's patent claim by reference to case law from the European Patent Office Boards of Appeal, which is usually followed by the Spanish courts, regarding Swiss-type use claims for second medical indications.

The court found no evidence of alleged patent infringement because, in light of the applicable prescription and dispensation rules and the evidence on file, pregabalin generics cannot be prescribed or dispensed off-label, whereas Lyrica is the only pregabalin drug which can be prescribed and dispensed to treat pain. In this regard, the court acknowledged that some competent authorities had already taken measures, at Pfizer's request, to avoid generics being prescribed or dispensed for the treatment of pain.

Regarding the alleged contributory infringement of the patent, the decision reviewed the previous German and UK decisions, acknowledging that the facts of the Spanish case differed in some key respects such as the prescription and dispensation framework, the price of Lyrica and the generics being the same, and the specific acts of the defendants.

Finally, the court dismissed Warner-Lambert and Pfizer's additional claims regarding unfair competition and extra-contractual liability.

The plaintiffs may appeal to the Barcelona Court of Appeal. Further, it remains to be seen whether Warner-Lambert and Pfizer will initiate main infringement proceedings on the merits against the defendants.

For further information on this topic please contact Ignacio Pontijas at Grau & Angulo by telephone (+34 91 353 36 77) or email (i.pontijas@gba-ip.com). The Grau & Angulo website can be accessed at www.gba-ip.com.

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