EN

Official Journal of the European Union

C 101/24

(Case T-67/13)

2013/C 101/53

Language of the case: English

Parties

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

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—Annul the decision of the European Commission C(2012) 8605 final of 19 November 2012 to grant a marketing authorisation to Hospira UK ltd, in accordance with Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1); and

—Order the European Commission to pay its own costs and those of the applicant.

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, 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) specified in article 6(1) of Directive 2001/83 for the purposes of data protection.

In addition, the contested Decision is also 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

(2) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)

(3) 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