Judgment of the General Court of 15 September 2015 — Novartis Europharm v Commission
(Case T-472/12) 1
(Medicinal products for human use — Marketing authorisation for the generic medicinal product Zoledronic acid Teva Pharma — 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)
Language of the case: English
Parties
Applicant: Novartis Europharm Ltd (Horsham, United Kingdom) (represented by: C. Schoonderbeek, lawyer)
Defendant: European Commission (represented: initially by A. Sipos, and, subsequently by M. Wilderspin, P. Mihaylova and M. Šimerdová, acting as Agents)
Intervener in support of the defendant: Teva Pharma BV (Utrecht, Netherlands) (represented by: K. Bacon, Barrister, and C. Firth, Solicitor)
Re:
Application for annulment of Commission Implementing Decision C (2012) 5894 final of 16 August 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 Teva Pharma — zoledronic acid’.
Operative part of the judgment
The Court:
Dismisses the action;
Orders Novartis Europharm Ltd to bear its own costs and to pay the costs incurred by the European Commission and by Teva Pharma BV.
____________1 OJ C 389, 15.12.2012.