|In the era before the IP Enforcement Directive|
getting a preliminary injunction was a real battle
Grégoire has kindly sent the Kats not only a 26 October decision of the Tribunal de Grande Instance de Paris but also (bless him!) a fully-fledged English translation). The subject matter? coincidentally it happens to be an application for an urgent summary injunction made by Warner-Lambert/Pfizer against Sandoz in respect of alleged patent infringement relating to pregalabine [that's the French for pregabalin, explains Merpel] and "skinny labelling". Says Grégoire:
Sandoz held a market authorisation for pregabaline which specified use for epilepsy and anxiety disorder, but carved out use as a pain medication. Pfizer holds a patent for pregabaline for the use in the treatment of pain, and markets the drug under the brand name Lyrica.
Sandoz was alleged to have communicated to dispensers in France that its pregabaline would take over the market for pregabaline (therefore also taking over the use in the treatment for pain). Consequently the claimants carried out a trap purchase at a pharmacist in France from which it was revealed that the pharmacist had dispensed Sandoz pregabaline without enquiring as to the therapeutic indication. The claimants filed an action en reféré (preliminary injunction), requesting an injunction and damages.Thanks so much, Grégoire! The Kats are now wondering whether to expect reports from elsewhere in Europe, and maybe even beyond, in this fascinating and oh, so expensive litigation.
During the proceedings, Sandoz published a communication to clinicians in France which stated that, if they prescribe pregabaline for the treatment of pain, they infringe Pfizer's rights, and the pharmacists must enquire as to the therapeutic use upon dispensing. The judge held that, in light of this notice, there would be no direct or indirect infringement as the acts in question were not those of the manufacturer; and, by issuing the notice, Sandoz had done all that was necessary to alert practitioners not to prescribe/dispense and so had no further liability.