CJEU decision in case C-181/24 (“Genmab”) – July 16, 2024

Contribution by Dr. Kathrin Aftahy and Dr. Axel Berger, BARDEHLE PAGENBERG

With reasoned order of July 16, 2024 in case C-181/24 (“Genmab”), the CJEU holds that an SPC cannot be granted based on a second marketing authorization even if the earlier first marketing authorization for said product was actively withdrawn before the filing of the SPC application.

Art. 3 of Regulation (EC) No 469/2009 concerning supplementary protection certificates for medicinal products (“SPC Reg.”) contains the requirements for the grant of an SPC – and has been hotly debated ever since its coming into force. Art. 3(b) SPC Reg. requires that a marketing authorization (“MA”) has been granted for the product for which an SPC is sought. Art. 3(d) SPC Reg. defines that said MA needs to be the first MA to place the product on the market. 

The recent ruling by the CJEU in case C-181/24 (“Genmab”) addresses the question whether an MA can be considered the first MA if an earlier MA had been granted before but had been actively withdrawn before applying for an SPC referring to the newly granted MA.

In the case at hand, the Hungarian Patent Office had rejected an SPC application for the product Ofatumumab filed by Genmab in July 2021. Ofatumumab had already been the subject of an earlier MA for the medicinal product “Azerra”. The MA for this medicinal product had, however, been actively withdrawn by the MA holder in February 2019. Two years later, in March 2021, a further MA for ofatumumab has been granted for Genmab – this time for a different indication and for the medicinal product “Kesimpta”. The Hungarian Patent Office rejected the SPC application arguing that the subsequent MA would not be “the first authorisation”, as required by Article 3(d) of the SPC Reg. On appeal, the Budapest High Court referred the case to the CJEU. 

Some years back, the interpretation of Art. 3(d) SPC Reg. by the CJEU was rather liberal. Specifically, the CJEU had ruled in case C-130/11 (“Neurim”) that an earlier MA for a veterinary product does not preclude the grant of an SPC for a different application (for human use) of the same product. More recently, however, the CJEU held in case C-673/18 (Santen) that an MA for a new therapeutic application of a known product does not allow for the grant of an SPC under Art. 3(d) SPC Reg. Similarly, the CJEU found in case C-443/17 (“Abraxis”) that a new formulation of an otherwise known – and previously authorized – product, cannot be regarded as being the first MA according to Art. 3(d) SPC Reg. In the case at hand, the relevance of the validity respectively active withdrawal of the earlier MA before the date of the SPC application filed based on another, later MA is addressed. 

In Genmab, the CJEU has now ruled that the withdrawal of the earlier MA was irrelevant for the question of whether the later MA for a different application of the same product can be considered the first MA as provided in Art. 3(d) SPC Reg. In the words of the CJEU (headnote), “Article 3(d) [SPC Reg.] must be interpreted as precluding the marketing authorisation submitted in support of an application for a supplementary protection certificate for a product from being regarded as the first marketing authorisation, within the meaning of that provision, if a prior marketing authorisation was granted for that same product but was withdrawn before the application for the supplementary protection certification was submitted”.

The decision adds to the CJEUs rulings in Abraxis and Santen and confirms the Court’s recent strict(er) interpretation of Art. 3(d) SPC Reg. The MA according to Art. 3(b) SPC Reg. needs to be the first MA for said product, irrespective of the faith of any earlier MA or whether an earlier MA related to a different formulation or a different use of the product. It seems that the only exception to this principle is the situation underlying the Neurim case, i.e. where the product was previously authorized as a veterinary product.

CJEU decision in case C-181/24 (“Genmab”) – July 16, 2024

Contribution by Dr. Kathrin Aftahy and Dr. Axel Berger, BARDEHLE PAGENBERG