(Case C-175/18 P)

Language of the case: English

Parties

Appellant: PTC Therapeutics International Ltd (represented by: G. Castle, Solicitor, B. Kelly, Solicitor, K. Ewert, Rechtsanwalt, M. Demetriou QC, C. Thomas, Barrister)

Other parties to the proceedings: European Medicines Agency, European Confederation of Pharmaceutical Entrepreneurs (Eucope)

Form of order sought

The appellant claims that the Court should:

—grant PTC’s appeal and set aside the judgment of the General Court;

—annul the decision communicated by the EMA to PTC on 25 November 2015 to release certain information under the Transparency Regulation (1);

—remit the said decision back to the EMA for further consideration regarding redaction of confidential passages for consultation with PTC; and

—order the EMA to pay PTC’s legal and other costs and expenses in relation to this matter.

Pleas in law and main arguments

The judgment should be annulled for the following reasons:

—the General Court failed to find that the documents in issue were protected by a general presumption of confidentiality;

—the General Court failed to find that the documents in issue in their entirety constitute commercially confidential information that is protected by Article 4(2) of the Transparency Regulation;

—the General Court failed to find that the documents in issue should be protected by Article 4(3) of the Transparency Regulation; and

—the EMA failed to carry out a balancing exercise as required by law.

(1) 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).

* * *