Action brought on 17 January 2013 - AbbVie e.a. v EMA
(Case T-29/13)
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 applicants claim that the Court should:
Annul the Decision of the European Medicines Agency EMA/685471/2012, of 5 November 2012, granting access to documents from the marketing authorisation dossier of a medical product ; and
Order the European Medicines Agency to pay all costs in these proceedings, including the applicants' costs.
Pleas in law and main arguments
The present action concerns a request for annulment under Article 263(4) TFEU of the Decision of the European Medicines Agency EMA/685471/2012, of 5 November 2012, granting access to documents from the marketing authorisation dossier of a medicinal product, pursuant to Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.
In support of the action, the applicants rely on four pleas in law.
First, the Decision violates Article 4(2) of the Transparency Regulation and the Applicants' fundamental right to the protection of confidential commercial information.
Second, the Decision violates the obligation to state reasons as regards the application of Article 4(2) of the Transparency Regulation.
Third, the Decision violates the principle of legitimate expectations.
Fourth, the Decision violates Directive No 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society, of fundamental rights protecting property rights, including copyright and of the principles of proportionality and of good administration, insofar as access is granted by providing a copy of the documents.
____________1 - 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