EPLAW Patent Blog

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.

UK - Actavis UK Limited v Novartis AG

Actavis UK Limited v Novartis AG, High court of Justice, Court of Appeal (Civil Division), London, UK, 17 February 2010, [2010] EWCA Civ 82

The Court of Appeal has dismissed Novartis's appeal against the High Court's decision that its European Patent EP0948320, claiming a sustained release formulation of fluvastatin, a drug used to treat high cholesterol, was invalid for obviousness. In its appeal, Novartis submitted that a reformulation of the problem identified in their patent, would have resulted in the skilled person viewing the basis of the invention as a problem. The evidence however, showed that fluvastatin was itself widely known before the patent application, and that a number of standard production methods for a sustained release formulation would work.

Favouring the multifactorial approach for assessing Art 56 EPC obviousness laid down in Pozzoli, Jacob LJ dismissed the appeal, finding the patent invalid for lack of inventive step. He disagreed with Warren J that the case was finely balanced, stating that, "once the basis of the patent was proved illusory there was nothing left to save it." Jacob LJ favoured English jurisprudence over the "two-bite" approach allowing for consideration of obviousness under the EPO problem/solution approach. In Jacob LJ's opinion, the problem/solution approach does not adequately deal with cases where the invention involves perceiving that there is a problem.

Read the judgment (in English) here.

DK - Lundbeck v. Pharma Change & Actavis

Lundbeck a/S vs. Pharma Change Aps & Actavis A/S., Danish Enforcement Court of Helsingor, 26 November 2009, Docket No. FS FO-9921/2009, with thanks to Anders Valentin, Horten

After having initially filed an application for an inter partes injunction prohibiting the wholesaler Pharma Change Aps to sell or use a pharmaceutical containing a specific API (Active Pharmaceutical Ingredient), if manufactured pursuant to a certain Lundbeck process patent, Lundbeck subsequently filed an application for an ex parte injunction. Actavis A/S intervened, claiming that an injunction would also prevent its distribution of its generic version of that same pharmaceutical.

The enforcement court first turned down the application for a temporary (i.e. until such time as an inter partes application could be heard) ex parte injunction, stating that such  a remedy lacks legal basis in the Danish Administration of Justice Act. Secondly, even though another enforcement court had ruled in favor of Lundbeck in a similar case, the court decided that that ruling did not have legal force in the present case. And thirdly, the court ruled that in order for the court to grant an ex parte injunction, a clear infringement of Lundbeck’s patent rights must have been shown. The court did not find that Lundbeck had lifted the burden of evidence sufficiently and so the application for an ex parte injunction was turned down. The decision is under appeal and dates have been set for an inter partes hearing of the application for an injunction.

 

UK - Actavis v. Merck / Dosage Regimes

Actavis UK Limited v. Merck & Co Inc, Court of Appeal (Civil Division) London, UK, 21 May 2008, Case No. [2008] EWCA Civ 444, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

"The Court of Appeal's decision in Actavis v Merck (England & Wales Court of Appeal, 21 May 2008) is a landmark in pharmaceutical patent law and its finding on the patentability of (non-obvious and new) dosage regimes will be welcomed by pharmaceutical companies. However, it is also of relevance to patent litigators in all industries since it emphasises the importance of settled case law of the European Patent Office Boards of Appeal and creates a new exception, where such settled EPO jurisprudence exists, to the rule that the Court of Appeal is bound by its previous decisions."

Read the first instance decision (in English) here.

Read the Court of Appeal decision (in English) here.

Read the extended summary (provided by Rowan Freeland) here.