Appeal brought on 16 May 2013 by Acino AG against the judgment of the General Court (Seventh Chamber) delivered on 7 March 2013 in Case T-539/10 Acino AG (formerly Acino Pharma GmbH) v European Commission

(Case C-269/13 P)

Language of the case: German

Parties

Appellant: Acino AG (represented by: R. Buchner and E. Burk, Rechtsanwälte)

Other party to the proceedings: European Commission

Form of order sought

The appellant claims that the Court of Justice should:

set aside the judgment of the General Court of 7 March 2013 in Case T-539/10 for infringement of European Union law and annul Commission Decisions C(2010) 2203, C(2010) 2205, C(2010) 2210 and C(2010) 2218 of 29 March 2010 and Decisions C(2010) 6430, C(2010) 6432, C(2010) 6434 and C(2010) 6435 of 16 September 2010 concerning the medicinal products Clopidogrel Acino – Clopidogrel, Clopidogrel ratiopharm – Clopidogrel Hexal – Clopidogrel and Clopidogrel ratiopharm GmbH – Clopidogrel;

order the respondent to pay the costs of the proceedings.

Grounds of appeal and main arguments

The appellant raises five grounds in support of its appeal.

By its first ground of appeal the appellant alleges an infringement and wrongful application of Article 20 of Regulation (EC) No 726/2004 ¹ in conjunction with Articles 116 and 117 of Directive (EC) No 2001/83 ² and the precautionary principle. It claims that the General Court wrongly considered that the infringements of the principles and guidelines relating to good manufacturing practice for medicinal products (GMP) relied on in the contested decisions essentially amounted to an unrebuttable presumption of the potential existence of insufficiencies in the qualitative and quantitative composition of the medicinal products.

The second ground of appeal relates to an erroneous legal assessment of the facts established by the General Court. The General Court failed to recognise that, in relying exclusively on the ‘lack of confidence’ resulting from the infringements of the GMP, the Commission infringed its duty of due diligence and its duty to state reasons since it failed to furnish either serious or conclusive evidence of quantitative or qualitative deficiencies in the medicinal products.

The third ground of appeal alleges an erroneous application of the principle of proportionality. The appellant claims that it furnished evidence that any endangerment to health from the medicinal products could be ruled out, with the result, in particular, that the amendment to the product authorisation, with retroactive effect, and the product recall ordered by the Commission were neither necessary nor proportionate.

The fourth ground of appeal alleges an erroneous review of the Commission’s margin of discretion. The appellant alleges that, as a result of the erroneous finding that the GMP rules are ‘absolute’ in nature, the General Court wrongly concluded that the Commission did not clearly exceed the limits of its powers by basing its decisions solely on the irrevocable ‘lack of confidence’.

By its final ground of appeal the appellant alleges an infringement of the duty to state reasons laid down in Article 81(1) of Regulation No 726/2004/EC. In the grounds for its decision the Commission did not address at all the evidence furnished by the appellant, with the result that the decisions are formerly incomplete and unlawful.

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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).