VALSARTAN HCT France: Court of Appeals reverses trial court decision granting Novartis ex parte injunction

The SPC Blog would like to thank Floriane Codevelle and Arnaud Casalonga (Casalonga Avocats, Paris) for sharing the following information, which is of particularly interesting with regard to the availability of interim injunctive relief in France:

Alleging infringement of the European patent and the SPC by the product Valsartan hydrochlorothiazide, Zentivalab 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg, the NOVARTIS companies submitted an application for ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS before the President of the Regional Court of Paris which, by order of 27 October 2011, granted the request.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS summoned NOVARTIS for rescission of the order and alternatively for the provision of a guarantee.

By order of 31 October 2011, the judge in chambers maintained the order on application in all of its provisions -- with the exception of those relating to the obligation to communicate information intended to determine the origin and the distribution networks of the pharmaceutical compositions reproducing the claims of the patent EP0443983 and of the SPC No. 97C0050.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS made appeal of this decision and asked the Court of Appeal, inter alia, to state that the conditions of Article L 615-3 of the Intellectual Property Code, authorizing under specific conditions ex partes interim measures, were not met.

In its decision issued on December 11, 2012, the Court annulled the order issued on October 31, 2011 and in a new ruling rescinds the order on application of 27 October 2011.

After finding that:

-          the documents at the Court’s disposal, which would be those submitted as proof of the infringement to the applications judge in support of the injunction request, did not sufficiently prove the imminent marketing of the products in question; 

-          interim measures could have been ordered through inter parte proceedings, since there are urgent short-notice summary proceedings which make it possible to observe the requirements of inter partes proceedings within a shortened period;

-          the “irremediable prejudice” invoked by NOVARTIS was not sufficient to grant ex parte interim measures, in addition to not being irremediable;

 The Court stated that

“ … the grounds invoked in support of the application for authorization of non‑compliance with the principle of inter partes proceedings are insufficient; whereas they could not allow recourse to ex partes proceedings, since inter partes proceedings were essential, the interests at stake being significant and the injunction measures sought themselves having serious consequences for the opposing parties. … it follows that as the grounds presented for justifying the departure from the principle of inter partes proceedings are unreasonable, the referred order which had to examine the ground set out for justifying the departure from this principle could only rescind the application and whereas it must therefore be annulled on this basis”.

The full text of the French decisions can be accessed in the original French (here) and in English translation (here).

Thanks so much, Floriane and Arnaud: we are most grateful to you.