Novartis AG and Novartis Pharma v. Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S., the President of the Court of First Instance (ex parte preliminary injunction), Paris, France, 27 October 2011, Case No. 11/15302, with thanks to Pauline Debre, Bird & Bird, for providing a summary and comments in English
On 27 October 2011, the President of the Court of First Instance in Paris ordered ex parte preliminary injunctions against Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S. (hereinafter "Sanofi"), prohibiting the Valsartan generic Zentiva from being sold on the French market.
This ruling is important in two respects:
1. It is one of the first decisions in which an ex-parte preliminary injunction has been ordered in a patent case in France; and
2. It seems to conflict with a recent decision of the Court of Appeal in Paris on the extent of protection given by supplementary protection certificates.
Read the entire summary below the break:
Novartis is the owner of the patent EP 0 443 983 and of the SPC n°97C0050 covering Valsartan, with a pediatric extension up until 13 November 2011. Sanofi obtained Marketing Authorisation for a combination product of Valsartan and hydrochlorothiazide in March 2011 and launched its generic product on the French market in October 2011. Novartis filed an ex-parte request before the President of Court of First Instance in Paris and obtained a preliminary injunction against Sanofi on 27 October 2011.
On 29 October 2011, Sanofi asked the President of the Court of First Instance in Paris to revoke his first order, but this request was refused in a decision dated 31 October 2011. In refusing the request, the President confirmed the grant of an injunction which prohibited the manufacture, the importation, the offer for sale, the holding, the storing and the marketing of the generics as well as ordering the recall of the products from every distribution channel.
This ruling is important in two respects:
1. It is one of the first decisions in which an ex-parte preliminary injunction has been ordered in a patent case in France; and
2. It seems to conflict with a recent decision of the Court of Appeal in Paris on the extent of protection given by supplementary protection certificates.
1. Ex-parte preliminary injunction
It is one of the first decisions in which an ex-parte preliminary injunction has been ordered in a patent case, in accordance with Article L.615-3 of French IP Code introduced by the Law of 29 October 2007.
Article L.615-3 provides for ex parte requests in patent matters "when the circumstances require that these measures should not be ordered inter partes, in particular where any delay would cause irreparable harm to the rightholder."
Before this judgment, such ex-parte injunctions seemed to be mostly limited to soft IP cases, for which the potential infringement is more easily established. Indeed, French judges have indicated in several conferences that they would not use this provision in patent matters, or only in very exceptional cases.
To our knowledge (bearing in mind that ex parte orders are not published) the Court of First Instance in Paris has granted preliminary injunctions on the basis of an ex-parte request only three times since 2007. One of those orders was immediately revoked, another one was handed down in a case where the validity of the patent had already been discussed and confirmed in other proceedings, and the third one was never executed by the claimant.
In the present case, in holding that these were not inter partes proceedings, the President took into account the fact that there was great urgency as the pediatric extension was set to expire on 13 November.
However, this is surprising because it is possible to obtain a preliminary injunction in inter partes proceedings in a few days or even hours ("référé d'heure à heure") if necessary. This can be seen in the judgment of a similar case dated 15 March 2011 relating to Myland and Du Pont De Nemours (Here there was an SPC covering Losartan which was about to expire, and a new product which was a combination of Losartan and HCTZ). In this case the Court of First Instance in Paris made an order for a preliminary injunction after hearing both parties' arguments in a shortened period of time (a few days). Following this case, urgency is not, per se, an "exceptional circumstance" in the sense of the law or the directive. Moreover, there was no irreparable harm which could justify the absence of inter partes proceedings.
Turning to the case at hand, it is all the more surprising as the adverse party was Sanofi which is one of the main pharmaceutical companies established in France against which urgent proceedings could easily be launched and an order or judgment easily executed. Taking this into account, we would expect exceptional circumstances which justify an ex-parte order to be, for instance, a foreign company's temporary presence at a pharmaceutical exhibition. In such a case, it would be difficult to notify the writ of summons and to quickly prevent the patent infringement so an ex-parte preliminary injunction could be justified.
2. Conflict with the recent debate on SPC
The ruling is also surprising because the questions of validity and infringement of the SPC are not easily answered, which is illustrated by the recent Medeva and Georgetown CJEU decisions. As in many EU countries, there has been debate as to whether a combination product (A + B) infringes an SPC covering only the active ingredient A. The decision of 27 October is in line with the decisions rendered in the Losartan case but it is more strict because, in the Losartan case, the President of the Court of First Instance in Paris and the Court of Appeal had only prohibited the sale of generics until the expiration of the SPC, but had refused to prohibit the importation, detention or manufacture of the generics.
The decision is nevertheless in direct contradiction with the most recent judgment handed down in the Valsartan case. On 16 September 2011, the Court of Appeal in Paris ruled that a combination product Valsartan and HCTZ did not infringe the SPC covering only Valsartan. They overturned the order of the President of the Court of First Instance in Paris (Actavis/Novartis). This decision has been appealed to the Supreme Court. It appears that Sanofi decided to launch its Valsartan generic after receiving this favorable decision.
It seems that the President of the Court of First Instance in Paris ignored these previous rulings as, in holding that infringement was likely, he has found that an SPC confers the same rights as a patent and therefore covers all products containing Valsartan.
In light of this decision there is now an increased likelihood that litigants will be faced with ex-parte preliminary injunctions in patent cases in France. This increases the benefits of filing protective letters, which is now possible before the Court of First Instance in Paris.
Read the judgment (in French) here.
Comments