Action brought on 18 July 2007 — CSL Behring v Commission and EMEA

(Case T-264/07)

(2007/C 235/22)

Language of the case: German

Parties

Applicant: CSL Behring GmbH (Marburg, Federal Republic of Germany) (represented by: Professor C. König and F. Leinen, Rechtsanwalt)

Defendants: Commission of the European Communities and European Medicines Agency (EMEA)

Form of order sought

Pleas in law and main arguments

The applicant contests EMEA's letter of 24 May 2007. The applicant takes the view that, by that letter, the EMEA refuses in a legally binding manner to continue the procedure for the designation of the applicant's medicinal product as an orphan medicinal product pursuant to Article 5(1) of Regulation (EC) No 141/2000 (1).

The applicant relies on two pleas in law in support of its action.

The applicant submits, first, that an interpretation of Article 5(1) of Regulation No 141/2000 to the effect that the application for designation of a medicinal product as an orphan medicinal product must be submitted before the application for marketing authorisation for that medicinal product is incorrect. That provision was therefore applied incorrectly.

Second, the applicant asserts that Article 5(1) of Regulation No 141/2000 is contrary to primary law and should be declared inapplicable pursuant to Article 241 EC in the event that it is to be interpreted as meaning that the application for designation of a medicinal product as an orphan medicinal product must be submitted before the application for marketing authorisation for that medicinal product. In that connection, it is submitted that that interpretation infringes the fundamental Community law principles of freedom to enjoy property rights and pursue a trade or profession, the principle of equal treatment and the principle of good faith.

(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).