27.4.2020

Official Journal of the European Union

C 137/41

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(Case C-115/20 P)

(2020/C 137/57)

Language of the case: English

Parties

Appellant: Vanda Pharmaceuticals Ltd (represented by: M. Meulenbelt, S. De Knop, B. Natens, advocaten, C. Muttin, avocate)

Other party to the proceedings: European Commission

Form of order sought

The appellant claims that the Court should:

—quash the judgment of the General Court in case T-211/18;

—uphold the application at first instance and annul the European Commission Implementing Decision ‘C(2018) 252 final’ refusing a marketing authorisation under Regulation (EC) No 726/2004 (1) for the medicinal product for human use Fanaptum — iloperidone;

—order the respondent to pay the appellant’s costs, and its own costs, both at first instance and on appeal;

In the alternative, the appellant requests that the Court:

—quashes the judgment of the General Court in case T-211/18;

—refers the case back to the General Court for judgment;

—reserves the costs at first instance and on appeal for final judgment by the General Court;

Pleas in law and main arguments

First ground of appeal: The General Court misinterpreted and misapplied the applicable standard of judicial review, and distorted the evidence.

Second ground of appeal: The General Court misinterpreted and misapplied the Note for Guidance CHMP/ICH/2/04 on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs (‘QT Guidance’).

Third ground of appeal: The General Court did not assess the appellant’s second plea in law in its entirety.

Fourth ground of appeal: The General Court distorted the evidence and misapplied the principle of equal treatment.

Fifth ground of appeal: The General Court misinterpreted Articles 5(1), 5(2) and 5(3) of the Treaty on European Union and Articles 12 and 81(2) of Regulation No 726/2004.

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(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004, L 136, p. 1).