France: Ex Parte injunctions and SPCs

25 February 2013

Anne-Charlotte Le Bihan, Enora Baron

Ex parte injunctions are extremely rare in patent infringement cases in France. The Paris Court of Appeal rendered an interesting ruling in that respect on 11 December 2012.

Background

Novartis AG was the holder of European Patent EP 0 443 983 which expired on 12 February 2011. This patent was used as the basis of SPC No.97C0050 on Valsartan and Novartis AG obtained a pediatric extension which expired on 13 November 2011.

Sanofi obtained a Marketing Authorization in March 2011 for a combination product comprising Valsartan and hydrochlorothiazide (HCTZ).

Considering that Sanofi was about to launch the corresponding drug, Novartis filed an ex parte motion before the Presiding Judge of the Paris Court of First Instance. The Presiding Judge accepted and granted a preliminary injunction against Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S. (hereinafter “Sanofi”) and ordered the communication of information on 27 October 2011.

Two days later, Sanofi asked the Presiding Judge to withdraw his order. On 31 October 2011, the Presiding Judge confirmed the preliminary injunction and the order to communicate information on the scope of the alleged infringement. However, he withdrew his order as regards to the communication of information relating to the origin and the distribution networks of the litigious pharmaceutical compositions.

This order was interesting in two respects: 

  • it dealt with ex parte preliminary injunctions (hereinafter PI) and,

  • it ruled on the issue as to whether a combination product (Valsartan / HCTZ) infringes an SPC covering only one active ingredient (Valsartan).

Sanofi lodged an appeal against this order. 

The Court did not take a position on the SPC related issue but overturned the order on the ground that the conditions of an ex parte PI procedure were not fulfilled.

The debate

Ex parte preliminary injunctions were introduced in France for patent infringement, by a Law dated 29 October 2007, which implemented Directive N°2004/48/CE.

Article L.615-3 IPC now provides that: “The competent civil Court may also order ex parte urgent measures when the circumstances require that these measures should not be ordered in the presence of both parties, in particular when any delay would cause an irreparable harm to the right holder”.

In the case at hand, the Court considered that the circumstances did not require that the procedure be ex parte for the following reasons:

  • Novartis had not provided the Presiding Judge with enough tangible evidence of the imminent marketing of the product at stake.

  • Preliminary injunctions can be obtained through expedited inter partes proceedings in a few days. Despite the very tight schedule (17 days from the expiration of the pediatric extension), the Court considered that there was time for an inter partes procedure.

  • The irreparable harm that Novartis was invoking to justify the use of an ex parte procedure was only one of the circumstances that could justify such a procedure but may not be enough.

  • The marketing of generic drugs 17 days before the expiry of the pediatric extension would not cause an irreparable harm to Novartis. The Court went as far as stating that “the existence of generic drugs is favored by the authorities in the interests of public health;  the damage suffered due to the marketing of such products, which necessarily leads to a loss of markets for Novartis, is the result of the authorization and of the marketing independently of a possible early marketing 17 days in advance; furthermore this harm is not irreparable and can be solved by damages

The Court further reminded that the presence of both parties was essential due to the substantial interests at stake and the important consequences of a PI for the defendant.

Even though the decision had no real impact since the pediatric extension had expired long before it was rendered, this decision is worth mentioning since it is a new illustration of French magistrates’ reluctance to grant ex parte PI in patent cases.

As a matter of fact, this decision is in line with existing French case law and notably an order dated 8 July 2009 (Zhejiang Huakang Pharmaceutical and Zhejiang Huakang Entreprises v. Roquette Freres) where the Judge withdrew an order which had granted ex parte PI due to the lack of loyalty of the claimant.

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