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Supplementary protection certificate
Patents - Biology Chemistry

Supplementary protection certificate and new therapeutic application: Where do we stand?

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In its judgement of July 9, 2020 in cases C-673/18 SANTEN, the ECJ clarified an uncertainty on the interpretation of article 3(d) of EC Regulation No.469/2009. This uncertainty was due to the ECJ’s judgement in the Neurim case (C-130/11) of July 19, 2012.  In its new judgement, the ECJ clearly decides that …”  a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”