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Case C-237/22 P: Judgment of the Court (Eighth Chamber) of 4 October 2024 – Mylan IRE Healthcare Ltd v European Commission, UAB VVB (Appeal – Regulation (EC) No 141/2000 – Orphan medicinal products – Articles 3 and 8 – Concept of significant benefit – Concept of clinical superiority – Regulation (EC) No 847/2000 – Article 3 – Marketing authorisation for the medicinal product for human use Tobramycin VVB – Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Derogation from that market exclusivity)
ECLI:EU:UNKNOWN:62022CA0237
62022CA0237
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Official Journal of the European Union
C series
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C/2025/873
17.2.2025
(Case C-237/22 P)
(Appeal - Regulation (EC) No 141/2000 - Orphan medicinal products - Articles 3 and 8 - Concept of ‘significant benefit’ - Concept of ‘clinical superiority’ - Regulation (EC) No 847/2000 - Article 3 - Marketing authorisation for the medicinal product for human use Tobramycin VVB - Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin - Derogation from that market exclusivity)
(C/2025/873)
Language of the case: English
Parties
Appellant: Mylan IRE Healthcare Ltd (represented initially by: L. Bidaine and I. Vernimme, and subsequently by: L. Bidaine, Q. Declève and I. Vernimme, avocats)
Other parties to the proceedings: European Commission (represented initially by: K. Mifsud-Bonnici and A. Sipos, and subsequently by: E. Mathieu, K. Mifsud-Bonnici, A. Sipos and A. Spina, acting as Agents), UAB VVB (represented by: V. Horcajuelo Rivera, E. Rivas Alba and M.C. Yáñez Cañas, abogados, and by: M. Martens and B. Mourisse, advocaten)
Intervener in support of the European Commission: European Medicines Agency (EMA) (represented initially by: S. Marino, S. Drosos and C. Schultheiss, subsequently by: S. Marino and S. Drosos, and finally by: S. Drosos, acting as Agents)
Operative part of the judgment
The Court:
1.Dismisses the appeal.
2.Orders Mylan IRE Healthcare Ltd to pay the costs.
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Language of the case: English
ELI: http://data.europa.eu/eli/C/2025/873/oj
ISSN 1977-091X (electronic edition)
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