Official Journal of the European Union

JUDGMENT OF 6. 3. 2025 – CASE C-41/24 WALTHAM ABBEY RESIDENTS ASSOCIATION

12.9.2009

(Case T-275/09)

2009/C 220/81

Language of the case: English

Parties

Applicant: Sepracor Pharmaceuticals (Ireland) Ltd (Dublin, Ireland) (represented by: I. Dodds-Smith, Solicitor, D. Anderson, QC and J. Stratford, Barrister)

Defendant: Commission of the European Communities

Form of order sought

—annul the contested decision;

—order that the applicant’s costs of these proceedings are paid by the Commission.

Pleas in law and main arguments

By means of this application, the applicant seeks the annulment, pursuant to Article 230 EC, of the Commission decision by which the Commission, confirming the opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA), granted the marketing authorisation for the applicant’s product ‘Lunivia’ but considered that the ‘eszopiclone’ contained in it was not a new active substance under Article 3(2) (a) of Regulation No 726/2004 (1).

The applicant puts forward two pleas in law in support of its claims.

First, the applicant claims that the defendant failed to apply the correct legal criteria for a new active substance in violation of the legislation, in particular of Article 10(2)(b) of Directive 2001/83 (2) and annex I, part II, section III of the same directive, as well as the applicable guidance such as Notice to Applicants, in particular its volume 2A and volume 3. The applicant further submits that the approach adopted by the defendant in the contested decision regarding the condition for qualifying as new active substance infringes the object and purpose of the legislative scheme which is predicted not upon concepts of ‘added value’ or comparative efficacy, but upon absolute standards of quality, safety and efficacy.

Second, the applicant claims that the defendant infringed its essential procedural rights since the EMEA received and took account of representations made by a third party without informing the applicant of their existence or giving it an opportunity to comment.

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(1) 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)

(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)