Action brought on 6 February 2008 - Now Pharma v Commission

(Case T-74/08)

Language of the case: German

Parties

Applicant: Now Pharma AG (Luxembourg, Luxembourg) (represented by: C. Kaletta and I.J. Tegebauer, Rechtsanwälte)

Defendant: Commission of the European Communities

Form of order sought

The Court is asked to:

annul Commission Decision C (2007) 6132 of 4 December 2007;

hold that the Commission should take a new decision in relation to the applicant's application of 6 February 2007, taking into consideration the Court's view of the law;

order the defendant to pay the costs of the proceedings.

Pleas in law and main arguments

The applicant challenges the Commission's Decision of 4 December 2007 refusing the applicant's request for designation of the medicinal product 'Extrait liquide spécial de Chelidonii radix' ('Chelidonii radix special liquid extract') as an orphan medicinal product within the meaning of Regulation (EC) No 141/2000¹.

In support of its application, the applicant submits that the contested decision infringes Article 3 of Regulation No 141/2000. In this respect, the applicant submits, in particular, that the final negative opinion of the European Medicines Agency was based on a wrong standard, namely the requirements for marketing authorisation in respect of a medicinal product pursuant to Article 8(3)(c) of Regulation No 141/2000. However, according to the applicant, whether a medicinal product is to be designated as an orphan medicinal product depends on whether the medicinal product will be of significant benefit to those affected by the particular condition, within the meaning of Article 3(2) of Regulation (EC) No 847/2000.² According to the applicant, the requirements of Article 3(1)(b) of Regulation No 141/2000 are fulfilled, because the medicinal product constitutes an orphan medicinal product and will be of significant benefit.

In addition, the applicant takes issue with the lack of qualifications and the bias of the expert.

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¹ - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1)

² - Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts similar medicinal product and clinical superiority (OJ 2000 L 103, p. 5)