Düsseldorf valsartan/HTC proceedings referred for preliminary ruling

Düsseldorf District Court

The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court).  This is what they have told us:

"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:

1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). 

2. The Düsseldorf District Court ordered Novartis to file actions on the merits.

On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).

The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.

The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:

"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"

The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".

Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.