Language of document :

Action brought on 9 December 2015 – PTC Therapeutics International v EMA

(Case T-718/15)

Language of the case: English


Applicant: PTC Therapeutics International Ltd (Dublin, Ireland) (represented by: M. Demetriou, QC, C. Thomas, Barrister, G. Castle, B. Kelly and H. Billson, Solicitors)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicant claims that the Court should:

annul the decision of the European Medicines Agency EMA/722323/2015 of 25 November 2015 to grant a third party access to the information about a medicinal product, pursuant to Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), in so far as the decision concerns commercially confidential information the release of which will infringe the applicant’s rights and in so far as the decision is prohibited by EU law ;

remit the contested decision back to the EMA for further consideration regarding redaction of confidential passages in consultation with the applicant ; and,

order the EMA to pay all costs in these proceedings.

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 document at issue is protected by Article 4(2) and/or Article 4(3) of Regulation (EC) No 1049/2001.

Second plea in law, alleging that the document at issue in its entirety constitutes commercially confidential information that is protected by Article 4(2) of the said Regulation.

Third plea in law, alleging that the release of the document would undermine the EMA’s decision making process.

Fourth plea in law, alleging that the EMA failed to carry out a balancing exercise as required by law.

Fifth plea in law, alleging that the outcome of a proper balancing exercise, as required by law, would have been a decision not to release any part of the document.