EPLAW Patent Blog

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.

UK - Actavis v Eli Lilly

Actavis Group HF v Eli Lilly and Company; Medis EHF v Eli Lilly and Company,Patents Court, London, UK, 27 November 2012, Case Nos. HC12E02962 and HC12A03340

The UK Patents Court has held that the UK court can decide whether a declaration of non-infringement should be granted in respect of French, German, Italian and Spanish designations of a European Patent, where the UK designation is also in issue and the validity of the patents will not be called into question by the potential infringer.

Points of particular interest in this decision include:

- Lilly consented in correspondence to service of proceedings and this consent was held to apply to the proceedings concerning the non-UK patents as well as the UK one.

- Actavis (the potential infringer) had undertaken not to challenge validity, or to contend that the patent is invalid, at any stage of the proceedings if the UK court accepted jurisdiction.  (One of the Actavis group companies was in fact a party to an EPO opposition of the Patent and Arnold J noted that the Actavis group had therefore voluntarily bifurcated the infringement and validity aspects of the case.)

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.

DE - Sanofi v. Actavis

Sanofi SA v. Actavis Deutschland GmbH & Co, Düsseldorf Regional Court, Düsseldorf, Germany, 15 August 2012, Case No. 4a 0 109/12, with thanks to Pierre Véron and Isabelle Romet,  Véron & Associés, for sending in the judgment and the translation in English

A preliminary injuction against Actavis was awarded. Read more here.

Read the decision (in German) here.
Read the decision (in English) here.

UK - Actavis v. Sanofi

Actavis Group PTC EHF and Actavis UK Limited v. Sanofi, High Court of Justice, Chancery Division, Patents Court, London, UK, 20 September 2012, [2012] EWHC 2545 (Pat)

The Patents Court referred two questions of interpretation on the Supplementary Protection Certificate (SPC) Regulation to the CJEU for a preliminary ruling.

Sanofi was the proprietor of European Patent (UK) No. 0454 511 which covered the anti-hypertensive drug, irbesartan (marketed under the name Aprovel). The patent had expired on 20 March 2011 but Sanofi had obtained two SPCs based on the patent. The first, SPC GB98/07 (the Irbesartan SPC), had expired on 14 August 2012 and the second, SPC GB99/008 (the Combination SPC) was due to expire on 14 October 2013. The Combination SPC covered a fixed dose of irbesartan and hydrochlorothiazide and was marked by Sanofi under the trade name, CoAprovel.

Actavis intended to market generic versions of Aprovel and CoAprovel and applied to revoke the Combination SPC.

Mr Justice Arnold decided to refer two questions to the CJEU regarding the SPC Regulation. The first related to the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation. The second related to the meaning of Article 3(c) of the Regulation regarding the number of SPCs which can be granted in respect of a single basic patent. Mr Justice Arnold has requested the parties to provide submissions regarding the precise wording of the questions to be referred to the CJEU.

Read the judgment in English here.

Head note: Rob Fitt

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

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." 

FR - Actavis v. Merck

Tribunal de grande instance de Paris, third chamber, 28 September 2010, N° RG : 07/16296, Actavis Group and Alfred E. Tiefenbacher GmbH v. Merck Sharp & Dohme Corp

The judgment handed down on 28 September 2010 by the Tribunal de grande instance, Paris in Actavis v. Merck decides that a dosage regime is not patentable because it is “plainly not” a second therapeutic application: “A specific dosage for the treatment of an illness constitutes neither a first nor a second therapeutic application but simply an indication of the range within which this substance is efficacious so as to treat such or such an illness in light of the tests and research completed and explained in the patent.”

 

DK - H. Lundbeck A/S v. Pharma Change ApS - Actavis A/S entered as independent party

H. Lundbeck A/S v. Pharma Change ApS, bailiff's court (enforcement court) Elsinore, Denmark, 16 April 2010, Docket no. 9921/2009

A Danish bailiff's court granted Lundbeck's application for an interim injunction against the wholesaler Pharma Change ApS, selling and distributing a generic escitalopram product manufactured by Dr. Reddy's Laboratories in India.

Having obtained in the summer of 2009 an interlocutory injunction against the largest Danish wholesaler, Nomeco A/S, H. Lundbeck A/S filed an application for an interlocutory injunction against the new and independent wholesaler, Pharma Change ApS, which carried as its only prescription pharmaceutical in its portfolio a generic escitalopram pharmaceutical.