Newsalert - The CJEU rejects the possibility to be granted SPCs for new therapeutic applications of an existing active ingredient already covered by an MA


On 9 July 2020 in case C‑673/18, the Court of Justice of the European Union (“CJEU”) issued a decision on the interpretation of the term “product” within Article 3(d) of the Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (“SPC”) for medicinal products (“SPC Regulation”).
Said Article 3(d) provides that an SPC can only be granted if the product for which it is requested has previously obtained an MA, provided that it is the first MA granted for such product.

See the Alert by our IP, TMT and Data Protection Department