This document is an excerpt from the EUR-Lex website
Document 62012TA0472
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)
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)
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)
IO C 363, 3.11.2015, p. 26–27
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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3.11.2015 |
EN |
Official Journal of the European Union |
C 363/26 |
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))
(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:
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1. |
Dismisses the action; |
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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. |