Article 3(d) of the Regulation concerning the supplementary protection certificate for medicinal products (No 469/2009) provides a condition for obtaining a supplementary protection certificate (hereafter certificate). The authorisation has to be the first authorisation to place the product on the market as a medicinal product.
According to the Danish Patent and Trademark Office’s earlier practice, it has been possible to obtain a certificate based on a second marketing authorisation for a product, if the second authorisation was given for another therapeutic use.
The Danish Patent and Trademark Office interprets ruling by the ECJ in case C-673/18 (Santen) of 9 July 2020, that according to Article 3(d) a marketing authorisation cannot be considered to be the first marketing authorisation irrespective of that it relates to another use of a product which has previously obtained a marketing authorisation.
The condition of Article 3(d) of the Regulation is therefore not fulfilled when the application for a certificate is based on a marketing authorisation for a second use; and thus a certificate cannot be issued on the basis of the marketing authorisation for the second use.
The Danish Patent and Trademark Office therefore changes its practice so that the conditions for issuing a certificate are not met when the application is based on a subsequent marketing authorisation for a second therapeutic use of a product which has previously obtained a marketing authorisation.
What does this mean in practice?
If you have a pending application (including those which have been suspended) or submit a new application, the application will be examined in accordance with the new practice.
The Danish Patent and Trademark Office has decided not to resume proceedings of already issued certificates ex officio. Please note that any person has the possibility to request for an administrative re-examination of an issued certificate.