On 9 July 2020 the Court of Justice of the European Union (CJEU) handed down its decision in Case C-673/18, a referral from the Paris Court of Appeal concerning the interpretation of Article 3(d) of the SPC Regulation. Article 3(d) requires that the marketing authorisation (MA) upon which an SPC is based be "the first authorisation to place the product on the market as a medicinal product". However, in 2012, the CJEU issued a decision in Case C-130-11 (the "Neurim" judgment), which gave rise to the possibility of "second medical use SPCs" i.e. SPCs granted on the basis of a second MA for a product but directed to a new use of the product. In the current case, the CJEU was essentially asked by the French court to clarify the scope of the Neurim judgment so as to improve the understanding of when (if ever) a second MA for a product might be considered "the first authorisation" under Article 3(d) of the SPC Regulation. The CJEU has ruled against SPCs based upon MAs for new therapeutic applications concluding that:
"Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning 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."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
