Order of the Court of Justice of July 16, 2024, Genmab (C-181/24)
Facts
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 marketing authorization (the “subsequent marketing authorization”) for a new drug “B,” intended for a therapeutic indication different from that of drug “A,” but whose active ingredient was also ofatumumab. On the basis of this “subsequent marketing authorization,” Genmab applied to the Hungarian Patent Office for the issuance of a supplementary protection certificate (“SPC”) for drug “B.” The Hungarian Patent Office denied the application, finding that the subsequent marketing authorization was not the first marketing authorization, for the purposes of the requirement under Article 3(d) of Regulation (EC) No. 469/2009 (“SPC Regulation”), for ofatumumab.
Genmab filed an appeal with the Hungarian courts against the Hungarian Office’s previous decision. The company argued that the “first marketing authorization” for the purposes of that provision could only be a marketing authorization in force as of the date of submission of the SPC and that, in that regard, the Hungarian Office had erred in considering that the “first marketing authorization” for ofatumumab was the one granted for drug “A,” since that marketing authorization was no longer in effect at the time of filing the CCP application for drug B.
Under these circumstances, the referring Hungarian court decided to stay the proceedings and refer a question to the CJEU for a preliminary ruling, seeking clarification on the interpretation of the requirement set forth in Article 3(d) of the CCP Regulation.
Statements
The Court of Justice states that, for the purposes of Article 3(d) of the CCP Regulation, the relevant “first marketing authorization” is the one granted first in chronological order for the same active ingredient, even if it is no longer in effect. The withdrawal of the initial marketing authorization does not negate its status as the first authorization.
Therefore, a CCP cannot be granted when there is a “prior marketing authorization” (even if it has been revoked and is not in effect at the time the CCP is applied for) and the application is based on a subsequent marketing authorization for the same active ingredient. The decisive factor is the chronological order of the authorizations, not their validity.
Comment
The Supreme Court clarifies that the mere fact of revoking a “previous marketing authorization” does not allow for a fresh opportunity to obtain a CCP based on a “subsequent marketing authorization” 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 that is consistent with the stance taken in previous CJEU rulings regarding products or active ingredients that have already been authorized and have different therapeutic applications. It also aims to prevent strategies designed to artificially extend exclusivity by revoking a “prior marketing authorization” and applying for a “subsequent marketing authorization” for the same product or active ingredient.
María Cadarso, Senior Associate in the Legal Department.