Appeal brought on 29 July 2019 by Intercept Pharma Ltd, Intercept Pharmaceuticals, Inc. against the judgment of the General Court (Second Chamber) delivered on 28 June 2019 in Case T-377/18: Intercept Pharma and Intercept Pharmaceuticals v EMA

(Case C-576/19 P)

Language of the case: English

Parties

Appellants: Intercept Pharma Ltd, Intercept Pharmaceuticals, Inc. (represented by: L. Tsang, J. Mulryne, E. Amos, Solicitors, F. Campbell, Barrister)

Other party to the proceedings: European Medicines Agency

Form of order sought

The appellants claim that the Court should:

set aside the decision of the General Court delivered on 28 June 2019;

annul the decision communicated by the respondent to the appellants on 15 May 2018 to release the Periodic Benefit Risk Evaluation Report, and

order the respondent to pay the appellants’ legal and other costs and expenses in relation to this matter, both at first instance and on appeal.

Pleas in law and main arguments

In support of the appeal, the appellants rely on two pleas in law.

1. First plea in law, that the General Court erred in concluding that the ‘protection of court proceedings’ indent of Article 4(2) of Regulation 1049/20011 is only relevant where documents were drawn up in the context of specific court proceedings or where they contain legal positions that are the subject of such proceedings. This put an impermissible restriction and limitation onto the wording of Article 4(2) that is not contained in the Regulation.

2. Second plea in law, that the General Court erred in concluding that the ‘commercial interests’ indent of Article 4(2) of Regulation 1049/2001 can only apply where specific elements of the document are identified as undermining the commercial interests of the relevant party, and cannot apply simply on the basis that the disclosure of a document as a whole would harm the commercial interests of its creator. This view prevented the General Court from recognising the error in law and assessment made by the respondent by refusing to consider the context of the request for disclosure in this case.

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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).