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Case T-472/12: 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 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)
ECLI:EU:UNKNOWN:62012TA0472
62012TA0472
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Official Journal of the European Union
C 363/26
(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)
(2015/C 363/34)
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:
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 Teva Pharma BV.
(1) OJ C 389, 15.12.2012.