CJEU Swiftly Deals With Genmab SPC Application In Reasoned Order

The Court of Justice of the European Union (CJEU) has handled the Hungarian referral in case C-181/24 with a straightforward confirmation that an application for a supplementary protection certificate (SPC) must be based on the first marketing authorisation for the product.

In May 2024 we reported the referral by the Metropolitan Court of Hungary relating to the refusal of the Hungarian National Office of Intellectual Property to grant an SPC to Genmab on the basis of Novartis' marketing authorisation for the antibody ofatumumab under the brand name KESIMPTA. Ofatumumab had first been authorised in April 2010 under the brand name ARZERRA, indicated for adult patients with previously untreated, relapsed or refractory chronic lymphocytic leukaemia (CLL), but that marketing authorisation was subsequently withdrawn in February 2019. Genmab's July 2021 SPC application was filed based on the March 2021 KESIMPTA authorisation, indicated for the treatment of adult patients