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Novartis AG v. Alvogen IPCO SARL and Focus Farma B.V., District Court The Hague, 23 December 2013, Case No. C/09/452370 / KG ZA 13-1160

The provisional relief judge of the Court of The Hague refused to grant a preliminary injunction against Alvogen and Focus Farma. According to the judge, there was a serious, not to be neglected chance that Novartis’ patent would be held to be invalid in proceedings on the merits, due to added matter.

The patent related to rivastigmine for use in a method of preventing, treating or delaying progression of dementia or Alzheimer’s disease. The claim inter alia required the rivastigmine to be administered in a transdermal therapeutic system (TTS), wherein “the starting dose is that of a bilayer TTS of 5 cm2 with a loaded dose of 9 mg rivastigmine…”. The claim also specified in detail the characteristics of one of the layers of the TTS. In spite of this, Novartis argued that the claim was directed towards a dosage regime, and was not limited to the use of the specific TTS described therein.

The provisional relief judge held that in this reading, the claim was invalid due to added matter. According to the judge, the inventive “starting dose” of the claim had only been explicitly disclosed in combination with a TTS having the specific characteristics of claim 1. He furthermore held that the inventive “starting dose” had not been implicitly disclosed for TTS’s in general, as there were no indications that the skilled person reading the patent would appreciate that the advantages of the invention would only depend on the starting dose, irrespective of the characteristics of the TTS to be used in the treatment.

Read the judgment (in Dutch) here.

Head note: Geert Theuws