Order of the President of the General Court of 25 April 2013 - InterMune UK and Others v EMA

(Case T-73/13 R 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: UK Ltd (London (United Kingdom)); InterMune, Inc. (Brisbane, California, United States); and InterMune International AG (Muttenz, Switzerland) (represented by: I. Dodds-Smith, A. Williams, Solicitors, T. de la Mare, QC and F. Campbell, Barrister)

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

Re:

Application, in essence, for suspension of operation of EMA Decision EMA/24685/2013 of 15 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 Esbriet 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), inasmuch as that information is not yet within the public domain

Operative part of the order

The operation of EMA Decision EMA/24685/2013 of 15 January 2013, granting a third party access, under 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, to the documents '2.4 Non-clinical Overview; 2.5 Clinical Overview; 2.6 Non-clinical Summary; and 2.7 Clinical Summary', submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, is suspended inasmuch as those documents contain information which is not yet publicly available.

The EMA is ordered not to disclose the documents referred to in point 1 of the operative part of this order in a version which is more detailed than the edited version of those documents as provided by InterMune UK Ltd, InterMune, Inc., and InterMune International AG to the EMA on 8 October 2012.

Costs are reserved.

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