Court of Rome applies Medeva, suspends provisional relief

From Evelina Marchesoni (Bird & Bird) comes an update to The SPC Blog's recent post on the Italian proceedings on valsartan and hydrochlorotiazide.She writes:

"On 11 November 2011 the Court of Rome granted a preliminary injunction requested by Novartis enforcing its SPC no. C-UB1999P000648, expiring on September 25, 2012 and covering the medicinal product “Cotareg” (valsartan + HCTZ).

In his decision the dudge ordered Mylan to stop manufacturing, commercializing, advertising, distributing, importing, exporting, storing and/or offering in any form (including the request of insertion in the so called “transparency list”) the generic products of Cotareg. 

Mylan appealed against this interim order and, after the issue of the decision of the Court of Justice in Case C-322/10 Medeva and Case C-422/10 Georgetown, sought an application to stay the preliminary injunction pending appeal. 

Mylan pointed out that, also in light of the Court of Justice's ruling, Novartis’s certificate claiming the combination of valsartan and HCTZ was invalid according to Article 3(a) of the Regulation, as it referred to a basic patent, EP 0 443 983, which did not provide such a combination.

By his decision, issued on 25 November 2011, the President of the IP Division of the Court of Rome, considering that on 24 November 2011 the decisions from the ECJ were published and they affirmed that Art.3(a) of the Regulation should be interpreted “as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”, ordered the provisional suspension of the preliminary injunction decision. 

This short decision of the Court of Rome, which you can access in full here (in Italian) probably constituted the first application in Europe of the interpretation of the Court of Justice decisions in the Medeva and Georgetown cases.

Discussion of the appeal is scheduled for 16 December 2011".

Thank you, Evelina, for this information, which is much appreciated.