Action brought on 30 October 2012 — Novartis Europharm v Commission

(Case T-472/12)

2012/C 389/13

Language of the case: English

Parties

Applicant: Novartis Europharm (Horsham, United Kingdom) (represented by: C. Schoonderbeek, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

Pleas in law and main arguments

In support of the action, the applicant relies on one plea in law, alleging that the contested decision is unlawful in that it constitutes an infringement of the data protection rights of Novartis Europharm Ltd. for its product Aclasta pursuant to Articles 13(4) of Regulation (EC) No 2309/93 (1), read in conjunction with Article 89 of Regulation (EC) No 726/2004. As Aclasta was granted a separate independent marketing authorisation through the centralised procedure, the Aclasta authorisation does not fall under the same global marketing authorisation as Zometa (another product of Novartis Europharm Ltd), as specified in article 6(1) of Directive 2001/83/EC (2) for the purposes of data protection.

In addition, the contested decision is unlawful in that it constitutes an infringement of Article 10(1) of Directive 2001/83/EC as data protection for the reference medicinal product Aclasta has not expired and hence the conditions for granting a marketing authorisation under this article have not been complied with.

(1)  Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1)

(2)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)