CELEX: 62016TA0303
Language: en
Date: 2022-01-26 00:00:00
Title: Case T-303/16: Judgment of the General Court of 26 January 2022 — Mylan IRE Healthcare v Commission (Medicinal products for human use — Orphan medicinal products — Marketing authorisations for the medicinal products Tobramycin 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)

14.3.2022   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 119/31
            
         
      Judgment of the General Court of 26 January 2022 — Mylan IRE Healthcare v Commission
      (Case T-303/16) (1)
      
      (Medicinal products for human use - Orphan medicinal products - Marketing authorisations for the medicinal products Tobramycin 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)
      (2022/C 119/40)
      Language of the case: English
      
         Parties
      
      
         Applicant: Mylan IRE Healthcare Ltd (Dublin, Ireland) (represented by: I. Vernimme, M. Campolini and D. Gillet, lawyers)
      
         Defendant: European Commission (represented by: K. Mifsud-Bonnici and A. Sipos, acting as Agents)
      
         Intervener in support of the defendant: UAB VVB (Kaunas, Lithuania) (represented by: E. Rivas Alba, V. Horcajuelo Rivera and M. Martens, lawyers)
      
         Re:
      
      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’.
      
         Operative part of the judgment
      
      The Court:
      
                  1.
               
               
                  Dismisses the action;
               
            
                  2.
               
               
                  Orders Mylan IRE Healthcare Ltd to bear its own costs and pay those incurred by the European Commission and by UAB VVB, including those relating to procedure for the replacement of a party.
               
            
         (1)  OJ C 296, 16.8.2016.