Journal

C-181/24: The CJEU has given its view on the interpretation of article 3(d)

The CJEU has issued a reasoned order in relation to a recent referral from the Metropolitan Court of Budapest (Genmab C-181/24) concerning the interpretation of articles 3(b) and 3(d) of the SPC Regulation. By Natalia Wegner (Fellow).

The Metropolitan Court of Budapest asked for guidance on the following question:

‘Must Article 3(b) and (d) of [the SPC Regulation] be interpreted as meaning that a marketing authorisation predating the marketing authorisation appearing in the application for a supplementary protection certificate and referring to the same product must be regarded as the first marketing authorisation for the purposes of that regulation, even where that prior marketing authorisation was withdrawn prior to the submission of the application for the certificate?’

In brief, the question concerns whether the ‘first’ marketing authorisation within the meaning of article 3(d) refers to the earliest authorisation for placing the product on the market per se or whether the ‘first’ marketing authorisation refers to the earliest ‘valid’ authorisation at the date of the SPC application.

The CJEU acknowledged that the referring court endorsed Genmab’s arguments (paragraph 18 of the reasoned order), but nonetheless ruled that:

‘Article 3(d) of [the SPC Regulation] 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within the meaning of that provision, if a prior marketing authorisation was granted for that same product but was withdrawn before the application for the supplementary protection certification was submitted.’

Natalia Wegner is a Partner at Carpmaels & Ransford LLP. More information is available on the CJEU’s website: tinyurl.com/2znn93xc

Danubia and Carpmaels & Ransford represent the SPC applicant Genmab