Action brought on 29 January 2013 - AbbVie v EMA
(Case T-44/13)
Language of the case: English
Parties
Applicants: AbbVie, Inc. (Wilmington, United States); and AbbVie Ltd (Maidenhead, United Kingdom) (represented by: P. Bogaert, G. Berrisch, lawyers, and B. Kelly, Solicitor)
Defendant: European Medicines Agency
Form of order sought
The applicant claims that the Court should:
Annul the Decision of the European Medicines Agency EMA/748792/2012 of 14 January 2013 granting access to documents from the marketing authorisation dossier of a medicinal product ; and
Order the European Medicines Agency to pay the applicants' costs.
Pleas in law and main arguments
In support of the action, the applicant relies on five pleas in law.
First plea in law, alleging that the Decision violates Article 4(2) of the Transparency Regulation
2 and the applicants' fundamental rights to the protection of confidential commercial information.
Second plea in law, alleging that the Decision violates Article 4(4) of the Transparency Regulation and the principle of good administration.
Third plea in law, alleging that the Decision violates the obligation to state reasons as regards the application of Article 4(2) of the Transparency Regulation.
Fourth plea in law, alleging that the Decision violates the principle of legitimate expectations
Fifth plea in law, alleging that the Decision violates Directive 2001/29/EC, the fundamental rights protecting property rights, including copyright and the principle of proportionality and good administration, insofar as the access is granted by providing a copy of the documents.
____________1 - Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43)2 - Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ 2001 L 167, p. 10)