CELEX: 62013TA0067
Language: en
Date: 2015-09-15 00:00:00
Title: Case T-67/13: Judgment of the General Court of 15 September 2015 — Novartis Europharm v Commission (Medicinal products for human use — Marketing authorisation for the generic medicinal product Zoledronic acid Hospira — zoledronic acid — Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid — Directive 2001/83/EC — Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 — Global marketing authorisation — Regulatory data protection period)

3.11.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 363/29
            
         Judgment of the General Court of 15 September 2015 — Novartis Europharm v Commission
   (Case T-67/13) (1)
   
   ((Medicinal products for human use - Marketing authorisation for the generic medicinal product Zoledronic acid Hospira - zoledronic acid - Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid - Directive 2001/83/EC - Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 - Global marketing authorisation - Regulatory data protection period))
   (2015/C 363/37)
   Language of the case: English
   
      Parties
   
   
      Applicant: Novartis Europharm Ltd (Horsham, United Kingdom) (represented by: C. Schoonderbeek, lawyer)
   
      Defendant: European Commission (represented by: K. Mifsud-Bonnici and M. Šimerdová, acting as Agents)
   
      Intervener in support of the defendant: Hospira UK Ltd (Royal Leamington Spa, United Kingdom) (represented: initially by N. Stoate and H. Austin, Solicitors, and J. Stratford QC, and subsequently by N. Stoate and E. Vickers, Solicitors, and J. Stratford QC)
   
      Re:
   
   Application for annulment of Commission Implementing Decision C (2012) 8605 final of 19 November 2012 granting a marketing authorisation in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council for the medicinal product for human use ‘Zoledronic acid Hospira — zoledronic acid’.
   
      Operative part of the judgment
   
   The Court:
   
               1.
            
            
               Dismisses the action;
            
         
               2.
            
            
               Orders Novartis Europharm Ltd to bear its own costs and to pay the costs incurred by the European Commission and by Hospira UK Ltd.
            
         
      (1)  OJ C 101, 6.4.2013.