CELEX: 62012TA0140
Language: en
Date: 2015-01-22 00:00:00
Title: Case T-140/12: Judgment of the General Court of 22 January 2015  — Teva Pharma and Teva Pharmaceuticals Europe v EMA (Medicinal products for human use — Orphan medicinal products — Application for marketing authorisation for the generic version of the orphan medicinal product imatinib — EMA decision refusing to validate the application for marketing authorisation — Market exclusivity)

9.3.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 81/13
            
         Judgment of the General Court of 22 January 2015 — Teva Pharma and Teva Pharmaceuticals Europe v EMA
   (Case T-140/12) (1)
   
   ((Medicinal products for human use - Orphan medicinal products - Application for marketing authorisation for the generic version of the orphan medicinal product imatinib - EMA decision refusing to validate the application for marketing authorisation - Market exclusivity))
   (2015/C 081/16)
   Language of the case: English
   
      Parties
   
   
      Applicants: Teva Pharma BV (Utrecht, Netherlands); and Teva Pharmaceuticals Europe BV (Utrecht) (represented by: D. Anderson, QC, K. Bacon, Barrister, G. Morgan and C. Drew, Solicitors)
   
      Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, M. Tovar Gomis and N. Rampal Olmedo, acting as Agents)
   
      Intervener in support of the defendant: European Commission (represented by: E. White, P. Mihaylova and M. Šimerdová, acting as Agents)
   
      Re:
   
   Application for annulment of the EMA’s decision of 24 January 2012 refusing to validate the applicants’ application for authorisation to place imatinib Ratiopharm, a generic version of the orphan medicinal product imatinib, on the market, in so far as concerns therapeutic indications for the treatment of chronic myeloid leukaemia.
   
      Operative part of the judgment
   
   The Court:
   
               1)
            
            
               Dismisses the action.
            
         
               2)
            
            
               Orders TEVA Pharma BV and Teva Pharmaceuticals Europe BV to bear their own costs and to pay the costs incurred by the European Medicines Agency (EMA).
            
         
               3)
            
            
               Orders the European Commission to bear its own costs.
            
         
      (1)  OJ C 165, 9.6.2012.