Order of the President of the General Court of 29 April 2013 - AbbVie v EMA

(Case T-44/13 R)

(Application for interim measures - Access to documents - Regulation (EC) No 1049/2001 - Documents held by the EMA containing information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market - Decision to grant a third party access to the documents - Application for suspension of operation of a measure - Urgency - Prima facie case - Weighing up of interests)

Language of the case: English

Parties

Applicants: AbbVie, Inc. (Wilmington, Delaware, United States); and AbbVie Ltd (Maidenhead, United Kingdom) (represented by: P. Bogaert and G. Berrisch, lawyers, B. Kelly, G. Castle, Solicitors, D. Anderson QC and D. Scannell, Barrister)

Defendant(s): European Medicines Agency (EMA) (represented by: T. Jablonski, N. Rampal Olmedo and A. Spina, Agents)

Re:

Application, in essence, for suspension of operation of EMA Decision EMA/748792/2012 of 14 January 2013, granting a third party access to certain documents containing information submitted as part of an application for authorisation to place the medicinal product Humira, used to treat Crohn's Disease, on the market, pursuant to 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).

Operative part of the order

1.    The operation of EMA Decision EMA/748792/2012 of 14 January 2013 of the European Medicines Agency (EMA), granting a third party access to Clinical Study Reports M02-404, M04-691 and M05-769, submitted as part of an application for authorisation to place the medicinal product Humira, used to treat Crohn's Disease, on the market, pursuant to 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, is suspended.

2.    The EMA is ordered not to disclose the documents referred to in point 1 of the operative part of this order.

3.    Costs are reserved.

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