EN

Official Journal of the European Union

C 311/13

(Case T-377/18)

(2018/C 311/14)

Language of the case: English

Parties

Applicants: Intercept Pharma Ltd (Bristol, United Kingdom) and Intercept Pharmaceuticals, Inc. (New York, New York, Unites States) (represented by: L. Tsang, J. Mulryne, E. Amos and H. Kerr-Peterson, Solicitors and F. Campbell, Barrister)

Defendants: European Medicines Agency

Form of order sought

—annul the decision ASK-40399 communicated by the defendant to the applicants on 15 May 2018, to release some documentation under Regulation 1049/2001/EC; and

—order the defendant to pay the applicants legal and other costs and expenses in relation to this matter.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

1.First plea in law, alleging that the defendant erred in law by concluding that the ‘court proceedings’ indent of Article 4.2 of Regulation 1049/2001/EC was not engaged in the present case, on the basis that the documentation was not a document ‘prepared for the purpose of court proceedings’. As a matter of law, the defendant should have concluded that the exemption was engaged.

2.Second plea in law, alleging further or in the alternative that the only legally permissible outcome of a proper balancing exercise, under the ‘commercial interests’ indent of Article 4.2 of Regulation 1049/2001/EC, would have been a decision not to release the documentation, in light of: (i) the compelling weight of the applicants’ private interest in avoiding disclosure; and (ii) the merely vague and generic public interest in disclosure.