CELEX: 62015TN0269
Language: en
Date: 2015-05-28 00:00:00
Title: Case T-269/15: Action brought on 28 May 2015 — Novartis Europharm v Commission

24.8.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 279/36
            
         Action brought on 28 May 2015 — Novartis Europharm v Commission
   (Case T-269/15)
   (2015/C 279/45)
   Language of the case: English
   
      Parties
   
   
      Applicant: Novartis Europharm Ltd (Camberley, United Kingdom) (represented by: C. Schoonderbeek, lawyer)
   
      Defendant: European Commission
   
      Form of order sought
   
   The applicant claims that the Court should:
   
               —
            
            
               annul the contested decision; and
            
         
               —
            
            
               order the European Commission to pay its own costs and those of Novartis.
            
         
      Pleas in law and main arguments
   
   By its present action, the applicant seeks the annulment of Commission Decision C(2015) 1977 final of 18 March 2015 granting a marketing authorisation to Pari Pharma for the medicinal product for human use ‘Vantobra — tobramycine’.
   In support of the action, the applicant relies on two pleas in law.
   
               1.
            
            
               First plea in law, alleging that the decision of the European Commission is unlawful in that it constitutes an infringement of the orphan market exclusivity rights of Novartis Europharm Ltd. for its product TOBI Podhaler pursuant to Article 8(1) of Regulation (EC) No. 141/2000 (1) because the period of orphan market exclusivity has not yet expired while the conditions for granting a derogation of market exclusivity pursuant to Article 8(3) of the same Regulation are not fulfilled.
            
         
               2.
            
            
               Second plea in law, alleging that the decision of the European Commission is also unlawful because it does not contain a statement of reasons as required by Article 296 of the Treaty on the Functioning of the European Union and Article 81(1) of Regulation (EC) No. 726/2004 (2).
            
         
      (1)  Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
   
      (2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).