Action brought on 24 November 2010 - Acino Pharma GmbH v Commission

(Case T-539/10)

Language of the case: German

Parties

Applicant: Acino Pharma GmbH (Miesbach, Germany) (represented by: R. Buchner, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

annul Commission decisions C(2010)2203, C(2010)2204, C(2010)2205, C(2010)2206, C(2010)2207, C(2010)2208, C(2010)2210, C(2010)2218 of 29 March 2010 and C(2010)6428, C(2010)6429, C(2010)6430, C(2010)6432, C(2010)6433, C(2010)6434, C(2010)6435, C(2010)6436 of 16 September 2010;

order the defendant to pay the costs.

Pleas in law and main arguments

First, the applicant challenges the Commission's decisions of 29 March 2010 by which it suspended the placing on the market of batches of the medicinal products 'Clopidogrel Acino - Clopidogrel', 'Clopidogrel Acino Pharma GmbH - Clopidogrel', 'Clopidogrel ratiopharm - Clopidogrel', 'Clopidogrel Sandoz - Clopidogrel', 'Clopidogrel 1A Pharma - Clopidogrel', 'Clopidogrel Acino Pharma - Clopidogrel', 'Clopidogrel Hexal - Clopidogrel', and 'Clopidogrel ratiopharm GmbH - Clopidogrel', and withdrew batches which were already on the European Union market. Second, the applicant seeks the annulment of those decisions of the Commission of 16 September 2010 by which it amended the authorisation of medicinal products which have already been authorised and ordered the prohibition of the placing on the market of certain batches of those medicinal products.

In support of its action the application raises five pleas in law.

By its first plea the applicant claims that the requirements under Article 20 of Regulation (EC) No 726/2004, ¹ in conjunction with Articles 116 and 117 of Directive 2001/83/EC, ² for a suspension, withdrawal or recall of, or amendment to, Community authorisations for the placing on the market of the medicinal products concerned were not satisfied. The applicant claims that it provided evidence during the procedure that the infringements found to exist did not compromise the quality of the medicinal products.

By its second plea the applicant claims that the Commission failed to satisfy the requirement of proof in finding that the requirements under Article 116 and 117 of Directive 2001/83/EC were satisfied.

By its third plea the applicant claims that the Commission infringed the general principle of proportionality in determining the level of protection to be applied.

By its fourth plea the applicant claims that essential procedural requirements were infringed since the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency was unlawful. In the applicant's view, as a result of the decisive importance of that opinion, its unlawfulness calls into question that of the Commission's decisions. In addition, it is not apparent from the reasons given in the contested decision that the Commission made use of the discretion which it is granted.

Finally, the applicant submits, as its fifth plea, that the Commission failed to provide sufficient reasoning in the contested decision, since it failed to provide its own reasons, but rather relied wholesale on the scientific assessment of the Committee for Medicinal Products for Human Use of the European Medicines Agency.

____________

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).