17.12.2018

EN

Official Journal of the European Union

C 455/29

(Case T-611/18)

(2018/C 455/38)

Language of the case: English

Parties

Applicant: Pharmaceutical Works Polpharma S.A. (Starogard Gdański, Poland) (represented by: M. Martens, N. Carbonnelle, lawyers and S. Faircliffe, Solicitor)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicant claims that the Court should:

—annul the EMA’s decision of 30 July 2018 not to validate the applicant’s marketing authorisation application for Dimethyl Fumarate Polpharma, a generic version of Tecfidera;

—order the EMA to pay the costs.

Pleas in law and main arguments

In support of the action, the applicant relies on a single plea in law.

The contested decision refuses to validate the applicant’s marketing authorisation application for Dimethyl Fumarate Polpharma in consideration of the fact that the reference product allegedly benefits from regulatory data protection.

An exception of illegality based on Article 277 TFEU is directed against the decision granting marketing authorisation to the reference medicinal product insofar as it expresses a manifestly erroneous conclusion regarding that product’s difference from Fumaderm for ‘global marketing authorisation’ purposes. Under a single plea in law, the applicant submits that, the exception of illegality being admissible and well-founded, the statement of reasons of the contested decision not to validate the applicant’s application for marketing authorisation is not legally admissible under Article 296 TFEU.