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.

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.

Valsartan: French court upholds ex parte preliminary injunction

The SPC Blog has received further information on the French Valsartan litigation from Laëtitia Benard (Allen & Overy, Paris). This relates to the very recent decision of the Paris First Instance Court on 31 October 2011, ruling on an attempt by Sanofi to remove the preliminary injunction which had previously been granted ex parte  Laëtitia (whose firm acted for Novartis in these proceedings) takes up the story from here:

Further to a preliminary injunction rendered on an ex-parte basis against Sanofi on 27 October 2011, which ruled that Sanofi's generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan and ordered the prohibition of the manufacturing, the importation, the offer for sale, the holding, the storing and the marketing of the infringing medicines as well as the recall of these medicines from all the distribution channels, Sanofi sought the withdrawal of this ex-parte order on the ground that the infringement was challengeable.  

Ruling on Sanofi's recourse, the President of the Paris First Instance Court rendered an inter-partes decision on 31 October 2011, confirming the ex-parte preliminary injunction previously issued as well as the measures ordered. This ruling is in accordance with the previous decisions of the Paris First Instance Court and of the Losartan decision from the Paris Court of Appeals.   

The main findings of the President of the Paris First Instance Court are as follows: 

"Article 5 of EC Regulation No. 469/2009 provides that subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. 

Thus, since the basic patent covering the active ingredient at stake, Valsartan, protects the owner of the patent against any non-allowed manufacture or marketing of pharmaceutical products containing this active ingredient, an SPC protects its owner against any non-allowed manufacture or marketing of any further pharmaceutical products containing this active ingredient and whose marketing would have been allowed before the expiry of the certificate.

Infringement is characterised when the claims of the patent are reproduced in the litigious product. 

The protection conferred by SPC No. 97C0050 covers the active ingredient that is the subject-matter of EP No. 0 443 983, i.e. Valsartan, which has been the subject-matter of an MA for the treatment of hypertension, cardiac insufficiency and myocardial post-infarction. 

In the present case, it is not challenged that the Valsartan Hydrochlorothiazide Zentiva product is a generic product of Valsartan and that it reproduces the claims of the patent relating to the Valsartan active ingredient. It does not matter that another active ingredient is present in the pharmaceutical product, because this is a mere addition that does not change the features of the claimed active ingredient. Therefore, since the claims of the patent are reproduced, the infringement is sufficiently likely for the measures of Article L. 615-3 to be implemented.

The preliminary injunction measures as well as the measures of recall of the products already marketed must therefore be maintained". 

You can read the French decision here and the English translation here.
An appeal can still be lodged against this decision. 

Merci beaucoup

Following yesterday's post here on the French Cour d'appel de Paris decision in the Valsartan dispute, a number of correspondents emailed to ask whether, if the order of the court was available in English, it might not be available in the original French too.

Thanks once again to Tougane and Grégoire, you can now read the decision in French here.