Novartis's VALSARTAN appeal: French Cour de Cassation says "non!"

From our friends Arnaud Casalonga and Floriane Codevelle of Casalonga et Avocats and Gérard Dossmann, Patent attorney of Casalonga & Associés, whose firms acted as counsel to Sanofi, comes the following information for which The SPC Blog offers its sincere thanks:

Valsartan HCT France: the end of ex parte preliminary injunctions in France? 

The Supreme Court confirms the Paris Court of Appeal, rescinding the ex parte Order of the First Instance Court

This post relates to the Appeal before the French Supreme Court concerning the ruling of the Paris Court of Appeal of December 11, 2012 (see our previous post of January 11, 2013) reversing the Ruling of the judges in Chamber of the First Instance Court maintaining the ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS ("SANOFI") (post of November 4, 2011)

NOVARTIS filed an appeal before the French Supreme Court against this judgment, raising three grounds. In its decision issued on September 16, 2014, the French Supreme Court dismissed NOVARTIS's appeal in whole.

NOVARTIS's first ground of appeal 

NOVARTIS argued that judges must apply the principle that both sides must be heard. Therefore, according to NOVARTIS, the Court of appeal couldn’t raise ex officio the question of whether the circumstances justified ex parte interim measures without inviting the opposing parties to submit their comments. 

However, in its ruling, the French Supreme Court considered that since the Court of Appeal was asked to rescind an ex parte order, it could verify whether the circumstances justified asking for ex parte interim measures, without having to invite the parties to present their observations, such a verification being not a point of law raised ex officio. 

NOVARTIS's second ground of appeal 

To question the decision issued by the Court of Appeal, NOVARTIS argued that: 

* The mere fact that the delay to take interim measures could cause an irremediable harm justified the granting of ex parte interim measures,  

* The Court of appeal, to say that the prejudice was not irreparable, ignored the ratio legis of the SPC by ruling that investments to discover the originator product had been compensated by both the patent and the SPC,  

* The loss of French market share, an accelerated decrease of the price of the products incorporating Valsartan in France and subsequently in Europe, the launch of other generic medicinal products, the development of parallel imports and the disturbance of the treatments for patients, constitute a very hardly quantifiable prejudice and therefore an irreparable prejudice,  

* The loss of market share, a price war, parallel imports and the disincentive to innovation simply cannot be reparable by the payment of damages. 

However the French Supreme Court considered that since the Court of Appeal found that: 

* The SPC of Novartis expired 17 days after the submission of the application, it was still time to obtain a decision from the judge by complying with the principle of contradiction, by ordering through inter parte proceedings, since there are urgent short-notice summary proceedings; 

* There was an uncertainty regarding the imminent marketing of the products on the day of the submission of the application, the prejudice resulting from the marketing of the products 17 days before the supplementary protection certificate expiration was likely to be compensated by the payment of damages it could have obtained inter partes interim measures through urgent short-notice summary proceedings, 

the Court could rightly, and in the exercise of its sole discretion, determine that the conditions to order ex parte interim measures were not met.

“But whereas after having acknowledged that the CCP expired 17 days after the presentation of the petition, the judgment noted that it was still possible on October 27, 2011 to obtain, before Nov. 13, 2011, a decision from the judge respecting the principle of contradiction, through urgent short notice summary proceedings or at a very early date by invoking the emergency; after having also noted that there was a doubt about the imminent commercialization of the products concerned on the date of presentation of the petition, it holds that the harm that would result from the marketing of generic 17 days before the expiration of the CCP was capable of being remedied by the award of damages; that these sovereign findings and assessments, apart from the superfluous reasoning criticized by the first part, the Court of Appeal, which was not bound to follow the parties in the details of their argument, could conclude that the circumstances requiring urgent measures under Article L 615-3 of the Code of intellectual property are taken ex parte were not met; that the plea is unfounded”

NOVARTIS's third ground of appeal

NOVARTIS argued that since SANOFI detained the generic medicinal products and that it has declared that the product was already marketed, the proof of imminent harm was sufficiently established to order interim measures.

However, the French Supreme Court ruled that this ground was irrelevant since the Court of appeal had ruled that conditions to grant ex parte interim measures weren’t met.

“But whereas the Court of Appeal had held that the requirements to proceed ex parte were not met, the appeal is irrelevant”

This decision (in the original French) can be downloaded here or accessed online here.