Novartis AG v. Alvogen IPCO S.a.r.l. and Focus Farma B.V., Court of Appeal The Hague, Appeal in preliminary relief proceedings, 18 November 2014, case number 200.141.272-01.

The Court of Appeal confirms the earlier judgment of the preliminary relief judge, who denied Novartis an injunction on the ground that there was a serious, not to be neglected chance that the patent of Novartis would be held to contain added subject matter in proceedings on the merits.

Novartis argued that the claim related to, summarized, the medicinal product rivastigmine, which is used in a method for treatment of Alzheimer or dementia, in which method rivastigmine is applied in transdermal therapeutic system (TTS, a plaster), with a specific starting dose. According to the court, that specific starting dose was only disclosed in the original application in combination with a certain adhesive layer comprising a silicone polymer and a tackifier (something which improves adhesive power). According to the court of appeal, a TTS with the specific starting dose, without the adhesive layer was not disclosed directly and unambiguously to the skilled person.

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The court of appeal explicitly considers the fact that its judgment deviates from certain other European judges. According to the court of appeal, the Italian, Romanian, Danish, Belgian and Spanish judges did not consider the same issue of added matter for various reasons, whereas the court of appeal finds support for its judgment in the decision of the German Landesgericht Dusseldorf.

Read the decision (in Dutch) here.