EPLAW Patent Blog

FR - Novartis v. Sanofi / Valsartan (ex parte)

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:

 

NO - Novartis v. Actavis / Valsartan

Novartis v. Actavis, Valsartan, District Court Oslo, Norway, 10 February 2011, Case No. 10-062600TVI-OTIR/04

On 10th of February 2011 the Oslo District Court rendered its decision in a case between Novartis AG/Novartis Norge AS (hereafter Novartis) and Actavis Group PTC hf/Actavis Norway AS (hereafter Actavis) regarding Novartis’ patent NO 304023. Novartis had initiated the proceedings, requiring preliminary measures to stop Actavis’ infringement of patent NO 304 023 by producing and selling products containing the pharmaceutical ingredient valsartan.

The patent in question is a process patent and the question before the court was whether the process used by Actavis to fabricate valsartan – QSSA Route C – constituted an infringement of patent NO 304 023.The District Court assessed the question using the doctrine of equivalence.

 

DE - Novartis v. Actavis / SPC Valsartan

Novartis AG v. Actavis Deutschland GmbH and Actavis Ltd, Malta, Düsseldorf District Court, Germany, 8 March 2011, Case No. 4b O 280/10, with thanks to Frank-Erich Hufnagel and Cordula Tellmann, Freshfields, for sending in the case, including a translation and summary in English

"In preliminary proceedings initiated by Novartis AG against Actavis the Düsseldorf District Court held that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCTZ) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). In view of the pre-trial correspondence between the parties, there was no imminent threat as to an infringement of the underlying basic patent EP 0 443 983 B1. The decisions may be appealed. The key legal question was whether a combination product containing two active ingredients (e.g. valsartan and HCTZ) would fall under the scope of a SPC for one of these active ingredients, namely valsartan.

The Court explains:

"In view of the not very precisely phrased and thus not easy to understand wording of article 4 SPC-Regulation, the legislative purpose of the limitation of the protection only to "the product covered by the marketing authorisation" is of key importance for the interpretation of this article." 

DK - Novartis v. Teva Denmark (Valsartan)

Novartis AG and Novartis Healthcare A/S v. Teva Denmark A/S (Valsartan), Maritime and Commercial Court, Denmark, 29 September 2009, Docket No. T-32-08

Teva Denmark applied for a marketing authorization for a generic product which would (admittedly)  infringe upon the Novartis process patent if marketed. Novartis filed an application for an injunction prohibiting Teva from obtaining the authorization. Teva argued that the only purpose of the Danish application was to use Denmark as a reference country under the decentralized procedure. The main issue in the present case was whether applying for a marketing authorization was sufficient evidence that Teva would undertake the actions that Novartis  sought prohibited cf. § 642, no. 2 in the Danish Administration of Justice Act. The enforcement court refused to grant an injunction as it found that applying for an authorization in itself did not constitute sufficient evidence that Teva would take steps to infringe the Novartis patent rights. The decision was appealed, and on appeal the application was granted.

In the confirmatory action before the Maritime and Commercial Court, the court stated that it should be possible for competitors to prepare marketing of their products before the patent expires and due to slow processing times for granting marketing authorization it was necessary that Teva filed an application at an early state. This, in combination with the fact that Teva had declared it would respect Novartis’ patent, meant that there was no evidence that Teva would infringe Novartis' patent rights. On these grounds, The Maritime and Commercial Court declined to grant an injunction, therefore adopting the decision of the enforcement court.