do-me/EUR-LEX huggingface dataset:
Case T-718/15: Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA (Access to documents — Regulation (EC) No 1049/2001 — Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna — Decision to grant a third party access to the document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)
Date: 2018-02-05
Institutions: General Court
Subjects: access to EU information, confidentiality, disclosure of information, market approval, medicinal product, trade information








C_2018104EN.01003001.xml










19.3.2018   


EN


Official Journal of the European Union


C 104/30





Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA
(Case T-718/15) (1)

((Access to documents - Regulation (EC) No 1049/2001 - Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna - Decision to grant a third party access to the document - Exception relating to the protection of commercial interests - No general presumption of confidentiality))
(2018/C 104/38)
Language of the case: English

Parties


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

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

Intervener in support of the applicant: European Confederation of Pharmaceutical Entrepreneurs (Eucope) (represented by: D. Scannell, Barrister, and S. Cowlishaw, Solicitor)

Re:

Action under Article 263 TFEU for the annulment of Decision EMA/722323/2015 of the EMA of 25 November 2015, granting to a third party, 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), access to a document containing information submitted in the context of an application for marketing authorisation for the medicinal product Translarna.

Operative part of the judgment

The Court:






1.


Dismisses the action;










2.


Orders PTC Therapeutics International Ltd to bear its own costs and to pay those incurred by the European Medicines Agency (EMA), including those relating to the application for interim measures;










3.


Orders the European Confederation of Pharmaceutical Entrepreneurs (Eucope) to bear its own costs.






(1)  OJ C 59, 15.2.2016.