Paris, 10 July 2020 – The Court of Justice of the European Union issued this Thursday its judgement in Santen (C-673/18, Santen SAS / Directeur général de l’Institut national de la propriété industrielle), a decision with very important implications for all actors in the pharma sector.
In reply to a prejudicial question by the Appeal Court of Paris, the CJEU has decided that a marketing authorisation cannot be considered to be the first authorisation under Article 3(d) of Regulation No 469/2009, if it is directed to a new therapeutic application of an active ingredient (or a combination of active ingredients) which has previously authorised for a different therapeutic application.
In other words, the CJEU clearly and explicitly states in this decision that a novel therapeutic application does not warrant the grant of a new certificate for a product already covered by an SPC. The Court thus breaks away from its Neurim decision (C-130/11) and returns to its former case law (C-31/03, Pharmacia Italia; C-431/04, MIT; C-2002/05, Yissum Order).
The Court notably stresses that the term “product” as used in the Regulation only refers to active substances having a therapeutic effect of their own, whatever their medical application. That it was issued by the Grand Chamber emphasises the solemnity and the weight that the Court intends to put on this decision.
Consequences for previously-filed SPC applications in light of this decision remain to be determined. However, it is already clear that innovators will have to redefine thoroughly their strategies to protect their medicaments.
