62023TJ0299_INF
Judgment of the General Court (Fourth Chamber) of 24 September 2025 –Hexal v Commission
(Case T‑299/23)
(Medicinal products for human use – Variation of the marketing authorisation for the medicinal product for human use Tecfidera – dimethyl fumarate – Directive 2001/83/EC – Article 14(11) of Regulation (EC) No 726/2004 – Article 266 TFEU)
1.
Approximation of laws – Medicinal products for human use – Marketing authorisation – Period of protection for a medicinal product – Extension of that period from 10 to 11 years – Conditions – Obtention of authorisation for a new therapeutic indication during the first eight years of that period
(European Parliament and Council Regulation No 726/2004, Art. 14(11))
(see paragraphs 34-36, 47)
2.
Action for annulment – Judgment annulling a measure – Effects – Implementing measures to be taken by the defendant institution – Purpose – Removal of the effects of the illegalities found in order to resolve them in accordance with EU law
(Art. 266 TFEU)
(see paragraphs 43, 44)
Operative part
The Court:
1.
Annuls Commission Implementing Decision C(2023) 3067 final of 2 May 2023 amending the marketing authorisation granted by Implementing Decision C(2014) 601 final for the medicinal product for human use Tecfidera – dimethyl fumarate;
2.
Orders the European Commission to bear its own costs and to pay those incurred by Hexal AG;
3.
Orders Biogen Netherlands BV to bear its own costs.