In a recent ruling (February 2 2016) the Court of Appeal The Hague assessed the validity of a patent and SPC of Janssen Pharmaceuticals, Inc. The Court further decided on awarding costs based on European directive 2004/48/EC.
Validity of SPC
In first instance Mylan BV requested invalidation of the Dutch part of European patent EP 0 566 709 of Janssen. The District Court rejected invalidation of the patent because it had expired. However, the SPC was invalidated for lack of inventive step of the patent claims.
The Court of Appeal confirmed this decision. It considered that the combination of two active ingredients into a single preparation was obvious over a disclosure relating to administration of the two compounds in two separate preparations. Synergy of the combination could not be relied on in assessing inventive step because this effect was considered to be inherently present in the prior disclosure as well.
The decision and reasoning are in line with a decision of the German Bundesgerichtshof, but deviate from the decision of the Spanish Sección de la Audiencia Provincial de Navarra, which considered the Spanish part of the patent inventive. The same case is also pending before the courts in Hungary and Italy, but these have not yet issued a decision.
In first instance Mylan was not awarded full litigation costs, which decision Mylan appealed against. The Court of Appeal confirmed the decision because it considered that Articles 1019 and 1019h of the Dutch Code of Civil Procedure (implementation of directive 2004/48/EC) only relate to costs of enforcement of IP rights. Invalidity proceedings, as in the present case, in which a threat of infringement was insufficiently substantiated, are outside the scope of the directive. This is in agreement with the CJEU decision of November 15 2012 (C-180/11 Bericap-ruling), and with an earlier ruling of the current Court of Appeal where costs were awarded in invalidity proceedings (Danisco-ruling, February 26 2013). Contrary to the present case, the invalidity proceedings were started by Danisco with the intention to defend against an impending infringement claim, and litigation costs could therefore be awarded.
Next year the Unified Patent Court will be operational. Then (if the patent owner has not filed an opt-out) such invalidity proceedings will have to be held before the UPC and parallel proceedings in different countries (except for Spain) will no longer be necessary. It will be interesting to learn how the UPC will rule on awarding recoverable costs.
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