Judgment of the General Court of 25 September 2018 — Amicus Therapeutics UK and Amicus Therapeutics v EMA

(Case T-33/17) ¹

(Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA and submitted as part of the request for authorisation to place the medicinal product Galafold on the market — Decision to grant a third party access to a document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)

Language of the case: English

Parties

Applicants: Amicus Therapeutics UK Ltd (Gerrards Cross, United Kingdom) and Amicus Therapeutics, Inc. (Cranbury, New Jersey, United States) (represented by: L. Tsang, J. Mulryne, Solicitors, and F. Campbell, Barrister)

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

Re:

Action under Article 263 TFEU for the annulment of EMA Decision ASK‑22072 of 14 December 2016, 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 a request for marketing authorisation for the medicinal product Galafold.

Operative part of the judgment

The Court:

Dismisses the action;

Orders Amicus Therapeutics UK Ltd and Amicus Therapeutics, Inc. to pay the costs.

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¹ OJ C 104, 3.4.2017.