4.6.2018

EN

Official Journal of the European Union

C 190/35

(Case T-211/18)

(2018/C 190/59)

Language of the case: English

Parties

Applicant: Vanda Pharmaceuticals Ltd (London, United Kingdom) (represented by: M. Meulenbelt, B. Natens, A.-S. Melin, and C. Muttin, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul Commission Implementing Decision C(2018) 252 final of 15 January 2018 refusing marketing authorisation under Regulation (EC) No 726/2004 for ‘Fanaptum — iloperidone’, a medicinal product for human use, together with the scientific conclusions and grounds for refusal of 9 November 2017 and the Assessment Report of the Committee for Medicinal Products for Human Use of 9 November 2017;

—in the alternative, annul only the said Commission Implementing Decision C(2018) 252 final;

—order the European Commission to pay the applicant’s costs.

Pleas in law and main arguments

In support of the action, the applicant relies on five pleas in law.

1.First plea in law, alleging that the risk assessment of the arrhythmogenic potential of iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous), and violates the principle of equal treatment.

2.Second plea in law, alleging that the assessment of the risk minimisation measures proposed for iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous), and violates Articles 5(1) and 5(4) of the Treaty on European Union (TEU) and the principle of equal treatment.

3.Third plea in law, alleging that the assessment of the consequences of the delayed onset of iloperidone is based on a failure to state reasons and violates Articles 5(1) and 5(4) TEU.

4.Fourth plea in law, alleging that the requirement to identify a population in which iloperidone would outperform other products violates Article 5(1), 5(2) and 5(3) TEU, Articles 12 and 81(2) of Regulation 726/2004, and the principle of equal treatment.

5.Fifth plea in law, alleging that the overall risk-benefit assessment of iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous).

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).