Novartis v Actavis in Norway

"Novartis v Actavis: ruling on the merits confirms scope of SPC" is the title of this blog's first note from Norway -- and also one of the first full hearings on the merits of any litigation relating to Novartis’ compound valsartan. In this ruling the Oslo District Court held that Actavis’ valsartan/HCTZ product infringes Novartis’ Norwegian process patent NO 304 023 which protects a route of synthesis for valsartan. The judgment, handed down on 10 February 2011, deals inter alia with the question of the scope of Novartis’ Norwegian SPC in relation to valsartan (SPC/NO 1998 024).

The SPC Blog is grateful to Gunnar Sørlie (Partner, Bugge, Arentz-Hansen & Rasmussen, Oslo) for kindly providing this information. As Gunnar explains:

"On the question of whether the scope of the valsartan SPC covers Actavis’ valsartan-plus-HCTZ combination products, the court found as follows:

“The wording of SPC/NO 1998 024 is not restricted to mono products. The target molecule is drawn under the product designation “Valsartan”. This is an argument in favour of concluding that SPC/NO 1998 024 protects against infringement through the marketing of any form of valsartan.

The Court is of the view that valsartan is a “product” for the purposes of Article 1(b). Reference is also made to Stenvik (2006), p. 359, where it is assumed that a certificate will also protect against use of the active ingredient in combination products.

The Court therefore concludes that SPC/NO 1998 024 also protects against valsartan in combination products.”

The effect of the decision is that following the expiry of patent NO 304 023 on 18 February 2011, SPC/NO 1998 024 will continue to provide protection until 13 May 2011 for any valsartan-containing medicine in Norway if the route of valsartan synthesis infringes Novartis’ synthetic process claims. As a result of the decision, Actavis had to withdraw both its monotherapy and combination therapy valsartan-containing medicines from the Norwegian market with immediate effect".