EPLAW Patent Blog

FR - Sanofi v. Novartis / Cour d’appel de Paris

Sanofi v. Novartis, Cour d’appel de Paris, 11 December 2012, Case number  11/20113, with thanks to Pierre Véron, Véron & Associés, for sending in the judgment, a summary and translation in English

The French cour d’appel de Paris holds that a preliminary injunction cannot be ordered ex parte unless specific circumstances justify not to hear the defendant in inter partes proceedings.

This is a further case in the valsartan saga (see www.eplawpatentblog.com/eplaw/valsartan)

Novartis AG, holder of European patent EP 0 443 983 which expired on 12 February 2011, was granted a French supplementary protection certificate (SPC) for valsartan on 17 September 1999; this SPC No. 97C0050 was in turn the subject of a paediatric extension, which expired on 13 November 2011.Novartis Pharma holds a licence for this SPC and its paediatric extension; it holds several marketing authorisations for proprietary drugs containing valsartan marketed under the name Tareg or Cotareg.

On the basis of these rights, Novartis had obtained a preliminary injunction against Actavis on 28 January 2011; this preliminary injunction was lifted by the cour d’appel de Paris on 16 September 2011 (judgments of first instance and appeal available on www.frenchpatentcaselaw.info); the judgment of the cour d’appel was eventually quashed by the French Cour de cassation on 15 January 2013, see our earlier post here.

In October 2011, as the expiry date of the paediatric extension (13 November 2011) approached, Novartis was informed that Sanofi was about to launch a generic.

FR - Novartis v. Actavis - Cour de cassation

Novartis v. Actavis, French Cour de cassation, Paris, France, 15 January 2013, Case number  A 11-26.632, with thanks to Pierre Véron and Nicolas Bouche, Véron & Associés, for providing the judgment, a translation in English and a summary

The French Cour de cassation follows the Court of Justice of the European Union’s ruling of 9 February 2012 in the parallel UK case and decides that the proprietor of an SPC for product A may prevent third parties from marketing a drug combining A + B.

Novartis was the proprietor of a basic patent (expired on 12 February 2011) covering valsartan and of an SPC for the product valsartan, a drug against hypertension.

Actavis marketed in France a drug containing valsartan and another active ingredient, HCTZ, a diuretic.

Novartis sought a preliminary injunction against Actavis, which was granted by the tribunal de grande instance on 28 January 2011, but the cour d’appel de Paris reversed it on 16 September 2011 on the grounds that “although the medicinal product valsartan + HCTZ contains the active ingredient valsartan, it is not the "product" valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients”.

Novartis brought the case before the Cour de cassation, the highest French court for civil matters.

The legal question (the interpretation of Articles 4 and 5 of Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products) was whether the SPC covering the product valsartan was infringed.

In other words, whether the owner of an SPC for product A can prevent the marketing of an A + B product where B is also an active ingredient.

NO - Actavis v. Novartic / Valsartan

Actavis Group PTC hf and Actavis  Norway AS v. Novartis Norge AS and Novartis AG, Borgarting Court of Appeal, Norway, 23 October 2012, Case no. 11-062214ASD-BORG-02, with thanks to Inga Kaasen and Thomas Hagen, Advokatfirmaet Grette, for sending in the judgment and a head note

On 23 October 2012 the Borgarting Court of Appeal rendered its judgment in the case between Actavis Group PTC hf and Actavis Norway AS, hereafter Actavis, and Novartis Norge AS and  Novartis AG, hereafter Novartis, regarding Novartis’ patent NO 304023. The patent protects an analogical process for the production of valsartan. Valsartan is an active ingredient in medicinal products used for the treatment of cardiovascular diseases. Novartis’ patent NO 304023 expired in February 2011, but SPC/NO 1998024 prolonged the protection until 13 May 2011.

The Court of Appeal had to evaluate whether or not QSSA’s “Route C”, used by Actavis, was an obvious modification of Novartis’ patent protected process. All the features of the patent could not be found in Actavis’ process. However, the Borgarting Court of Appeal’s majority found that Actavis’ process constituted a patent infringement based on the doctrine of equivalence, as it considered the process as a nearby modification of the patent protected process. The minority found that Actavis’ QSSA process was a different process than the patented process.

The Court of Appeal concluded that Actavis had committed patent infringement. When considering Novartis’ claim for damages, the court adjusted the claim reasonably from NOK 17,000,000 to NOK 11,400,000 [approximately EUR 1,553,063; editor]. In accordance to this, Actavis had to pay NOK 11,400,000 in damages to Novartis. Legal fees were not awarded.

Read the judgment (in Norwegian) here.

CJEU - Mono-SPC covers any medicinal use of protected product

European Court of Justice, 9 February 2012, Novartis AG v. Actavis UK Ltd., case number C-442/11

Within about 6 months after referral, the CJEU has already answered the questions referred to it by the English High Court concerning the interpretation of Articles 4 and 5 of the SPC-Regulation in the context of a dispute between Novartis and Actavis.  Novartis was the proprietor of an SPC for the product valsartan. This basic patent for this SPC was also, inter alia, directed to valsartan.  Actavis’ generic drug contained not just valsartan, but also another active ingredient, HCTZ. 

The CJEU now confirms that this amounts to an infringing use of valsartan. According to the court, it follows from Article 5 of the SPC-Regulation that an SPC confers the same rights as the basic patent it ensues from.  Since the basic patent gave Novartis the absolute right to stop unauthorised use of any product containing valsartan, the CJEU held that the same necessarily applies to the ensuing SPC, albeit within the limits of Article 4 of the SPC-Regulation: “if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate” (decision, § 20).

Read the decision (in English) here.  

Head note: Philippe de Jong

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.