RULING: SPCs are not available for new uses of already authorised medicines

Today, in an landmark judgment from the CJEU (Court of Justice of the European Union) on Supplementary Protection Certificates for medicinal products in Europe, the Court has reached a decision in Santen C-673/18, relating to whether an SPC may be granted for a new use of an already authorised medicinal product.

Article 3(d) of the SPC regulation (EC) No 469/2009 precludes the grant of an SPC for a product already subject to a previous Marketing Authorisation, and the question referred in Santen was whether this included the situation where a new medical use had been authorised in the current Marketing Authorisation as compared to the previous one, or, in other words, whether the term “product” in Article 1(b) of the SPC regulation should be interpreted strictly as the active ingredient, or if that definition could include the particular medical use of the active ingredient.

A previous CJEU judgement (Neurim C-130/11) had opened a possibility that at least previously authorised veterinary medicines could be eligible for an SPC, provided the new marketing authorisation was for human use.

The judgment in C-673/18 is however quite clear, and states:

Article 3(d) of [the regulation] 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.

Therefore, this judgment is likely to severely restrict the access to SPCs for already authorised active ingredients, for which a new medical indication has been developed and brought to market.

Do not hesitate to contact SPC specialist Jan Mondrup Pedersen, if you have questions regarding the judgment.


SPC – Supplementary Protection Certificate