Judgment — ECLI:EU:T:2015:636
Date: 2015-09-15
Language of the case: English
Court formation: Second Chamber
Subject matter: Approximation of laws
Procedure: Action for annulment - unfounded
Origin: United Kingdom

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) 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: Dismisses the action; 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.