Judgment of the General Court (Fifth Chamber) of 4 July 2012 —
Laboratoires CTRS v Commission

(Case T-12/12)

Medicinal products for human use — Marketing authorisation for the medicinal product Orphacol — Letter informing the applicant of the Commission’s intention to refuse authorisation — Application for a declaration of failure to act — Definition of position by the Commission — Inadmissibility — Application for annulment — Adoption of a new decision — No need to adjudicate

1.                     Actions for failure to act — Institution called upon to act — Conditions — Clear and express request — No precise formal rules — Letter allowing the institution concerned to make a concrete examination of the content of the requested decision (Art. 265, second para., TFEU) (see paras 38, 40)

2.                     Actions for failure to act — Definition of position within the meaning of Article 265, second paragraph, TFEU before commencement of proceedings — Inadmissibility (Art. 265, second para., TFEU) (see paras 41-44)

3.                     Actions for annulment — Interest in bringing proceedings — Need for such an interest to exist at the stage of the bringing of the action and until the delivery of the court decision — Decision replacing the contested decision during the proceedings — Application devoid of purpose — No need to adjudicate where applicant has no interest in an annulment (Art. 263 TFEU) (see paras 52-55)

Re:

APPLICATION for a declaration that the Commission failed to act in unlawfully failing to adopt a final decision in relation to the applicant’s application for a marketing authorisation for the medicinal product Orphacol, and, in the alternative, for annulment of the decision, allegedly contained in the Commission’s letter of 5 December 2011, not to grant that authorisation to the applicant.

Operative part

The Court:

1. Dismisses the application for a declaration of failure to act as inadmissible;

2. Rules that there is no longer any need to adjudicate on the application for annulment submitted in the alternative;

3. Orders the European Commission to bear its own costs and to pay those incurred by Laboratoires CTRS;

4. Orders the Czech Republic, the French Republic and the United Kingdom of Great Britain and Northern Ireland to bear their own respective costs.