Дело T-***/**: *****************, Съдебно решение от **.**.2022 г.

Текст

... n VVB and associated names – Derogation from the market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Article 8(3)(c) of Regulation (EC) No 141/2000 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Article 3(2) and (3)(d) of Regulation (EC) No 847/2000 – Duty of care – Manifest error of assessment)

In Case T‑303/16,

Mylan IRE Healthcare Ltd, established in Dublin (Ireland), represented by I. Vernimme, M. Campolini and D. Gillet, lawyers,

applicant,

v

European Commission, represented by K. Mifsud-Bonnici and A. Sipos, acting as Agents,

defendant,

supported by

UAB VVB, established in Kaunas (Lithuania), represented by E. Rivas Alba, V. Horcajuelo Rivera and M. Martens, lawyers,

intervener,

APPLICATION pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2016) 2083 final of 4 April 2016 concerning, in the framework of Article 29 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for ‘Tobramycin VVB and associated names’, medicinal products for human use which contain the active substance ‘tobramycin’,

THE GENERAL COURT (Ninth Chamber),

composed of M.J. Costeira, President, M. Kancheva (Rapporteur) and T. Perišin, Judges,

Registrar: I. Kurme, administrator,

having regard to the written part of the procedure and further to the hearing on 2 July 2021,

gives the following

Judgment

Background to the dispute

TOBI and Tobi Podhaler

1. In 1999, Novartis Pharmaceuticals UK obtained a marketing authorisation (‘MA’) for TOBI, a medicinal product containing the active substance tobramycin for inhalation by nebuliser, indicated for the treatment ...