CELEX: 62016TA0329
Language: en
Date: 2018-12-05 00:00:00
Title: Case T-329/16: Judgment of the General Court of 5 December 2018 — Bristol-Myers Squibb Pharma v Commission and EMA (Medicinal products for human use — Orphan medicinal products — Decision withdrawing the designation of Elotuzumab as an orphan medicinal product — Decision that the designation criteria were no longer met — Marketing authorisation for the medicinal product for human use Empliciti (Elotuzumab) — Article 5(12)(b) of Regulation (EC) No 141/2000 — Article 5(8) of Regulation No 141/2000 — Obligation to state reasons)

4.2.2019   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 44/21
            
         
      Judgment of the General Court of 5 December 2018 — Bristol-Myers Squibb Pharma v Commission and EMA
      (Case T-329/16) (1)
      
      ((Medicinal products for human use - Orphan medicinal products - Decision withdrawing the designation of Elotuzumab as an orphan medicinal product - Decision that the designation criteria were no longer met - Marketing authorisation for the medicinal product for human use Empliciti (Elotuzumab) - Article 5(12)(b) of Regulation (EC) No 141/2000 - Article 5(8) of Regulation No 141/2000 - Obligation to state reasons))
      (2019/C 44/25)
      Language of the case: English
      
         Parties
      
      
         Applicant: Bristol-Myers Squibb Pharma EEIG (Uxbridge, United Kingdom) (represented by: P. Bogaert and B. Van Vooren, lawyers, and B. Kelly, Solicitor)
      
         Defendant: European Commission (represented by: A. Sipos and K. Petersen, acting as Agents) and European Medicines Agency (represented by: N. Rampal Olmedo, M. Tovar Gomis, T. Jabłoński and S. Drosos, acting as Agents)
      
         Re:
      
      Application pursuant to Article 263 TFEU for annulment of an act adopted by the Commission removing Elotuzumab from the Community Register of orphan medicinal products for human use and/or of a possible act adopted by the Commission or the EMA determining that Elotuzumab no longer met the criteria for designation as an orphan medicinal product when the marketing authorisation was granted for the medicinal product Empliciti (Elotuzumab) under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).
      
         Operative part of the judgment
      
      The Court:
      
                  1.
               
               
                  Dismisses the action;
               
            
                  2.
               
               
                  Orders the European Commission to pay all the costs.
               
            
         (1)  OJ C 314, 29.8.2016.