Judgment of the General Court (Second Chamber) of 15 September 2015 — Novartis Europharm v Commission

(Case T‑67/13)

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

1.                     Approximation of laws — Medicinal products for human use — Authorisation to market — Abridged procedure — Global marketing authorisation — Scope — Developments of a medicinal product authorised to be marketed and of a name distinct — Included — No regulatory protection period granted (European Parliament and Council Regulation No 726/200; Council Regulation No 2309/93; Commission Regulations No 1085/2003 and No 1234/2008; European Parliament and Council Directive 2001/83, Arts 6(1), and 10(1)) (see paras 45, 46, 52, 54, 56, 59)

2.                     Approximation of laws — Medicinal products for human use — Authorisation to market — Abridged procedure — Generic medicinal product of a reference medicinal product — Exemption from the obligation to supply the results of pharmaceutical, pre-clinical and clinical trials — Objectives (European Parliament and Council Directive 2001/83, Arts 6(1), 8(3)(i), and 10(1)) (see paras 62, 63)

3.                     Approximation of laws — Medicinal products for human use — Authorisation to market — Protection differing by reference to use of a national or centralised authorisation procedure — Not permissible (European Parliament and Council Regulation No 726/2004; Council Regulation No 2309/93; European Parliament and Council Directive 2001/83; European Parliament and Council Directive 65/65) (see paras 73, 74, 77, 80)

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

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 Hospira UK Ltd.