Judgment of the Court (Eighth Chamber) of 4 October 2024.#Mylan IRE Healthcare Ltd v European Commission.#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.#Case C-237/22 P.