Order of the Court of Justice of 16 July 2024, Genmab (C-181/24)
Acts
The pharmaceutical company Genmab obtained an initial marketing authorization (“MA”) for a drug “A” containing the active ingredient ofatumumab (the “previous MA”). It subsequently revoked that MA.
Some time later, Genmab obtained a second AC (the “subsequent AC”) for a new drug “B”, intended for a different therapeutic indication than drug “A”, but whose active ingredient was also ofatumumab. Based on this “subsequent AC”, it applied to the Hungarian Patent Office for a supplementary certificate of protection (“SCP”) for drug “B”. The Hungarian Patent Office refused the application, considering that the subsequent AC was not the first AC for the purposes of the requirement of Article 3(d) of the Hungarian Patent Law. Regulation (EC) No. 469 / 2009 (“CCP Regulation”), for ofatumumab.
Genmab filed an appeal with the Hungarian courts against the Hungarian Office's previous decision. The company argued that the "first AC" for the purposes of that provision could only be an AC in force on the date of the SCP submission and that, in that respect, the Hungarian Office had erred in considering that the "first AC" for ofatumumab was the one granted for medicinal product "A", since that AC was no longer in force at the time the SCP was requested for medicinal product B.
In these circumstances, the referring Hungarian court decided to stay the proceedings and refer a question to the CJEU for a preliminary ruling, seeking clarification of the interpretation to be given to the requirement of Article 3(d) of the CCP Regulations.
pronouncements
The CJEU notes that, for the purposes of Article 3(d) of the CCP Regulation, the relevant “first AC” is the one granted first chronologically for the same active ingredient, even if it is no longer in force. The withdrawal of the initial AC does not eliminate its status as the first authorization.
Therefore, a CCP cannot be granted when a prior AC exists (even if it has been revoked and is no longer in force at the time the CCP is requested) and the request is based on a subsequent AC for the same active ingredient. The determining factor is the chronological order of the authorizations, not their validity.
Comment
The Court of Justice clarifies that simply revoking a “previous AC” does not allow for the possibility of obtaining a CCP again based on a “subsequent AC” for the same active ingredient. The logic of the system remains centered on the first time the active ingredient enters the market.
The decision reinforces a restrictive approach consistent with the line established in previous CJEU rulings on products or active ingredients already authorized and with different therapeutic applications. It also aims to prevent strategies of artificially prolonging exclusivity by revoking a prior marketing authorization and applying for a subsequent one for the same product or active ingredient.
Maria Cadarso, Senior Associate in the Legal area.
