Case T-611/18: Judgment of the General Court of 5 May 2021 — Pharmaceutical Works Polpharma v EMA (Medicinal products for human use — Application for marketing authorisation for a generic version of the medicinal product Tecfidera — Decision of the EMA not to validate the application for marketing authorisation — Previous decision of the Commission taking the view that Tecfidera — Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm — Plea of illegality — Admissibility — Previously authorised combination medicinal product — Subsequent marketing authorisation for a component of the combination medicinal product — Assessment of the existence of two different global marketing authorisations — Manifest error of assessment)
Date: 2021-05-05
Institutions: General Court
Subjects: admissibility, drug surveillance, generic drug, market approval








C_2021242EN.01002001.xml










21.6.2021   


EN


Official Journal of the European Union


C 242/20






Judgment of the General Court of 5 May 2021 — Pharmaceutical Works Polpharma v EMA
(Case T-611/18) (1)

(Medicinal products for human use - Application for marketing authorisation for a generic version of the medicinal product Tecfidera - Decision of the EMA not to validate the application for marketing authorisation - Previous decision of the Commission taking the view that Tecfidera - Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm - Plea of illegality - Admissibility - Previously authorised combination medicinal product - Subsequent marketing authorisation for a component of the combination medicinal product - Assessment of the existence of two different global marketing authorisations - Manifest error of assessment)
(2021/C 242/26)
Language of the case: English

Parties


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

Defendant: European Medicines Agency (represented by: T. Jabłoński, S. Drosos and R. Pita, acting as Agents)

Interveners in support of the defendant: European Commission (represented by: A. Sipos and L. Haasbeek, acting as Agents), Biogen Netherlands BV (Badhoevedorp, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Re:

Application, first, for a declaration that the plea of illegality raised in respect of Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation for Tecfidera — Dimethyl fumarate, a medicinal product for human use, is admissible and well founded in so far as, in that implementing decision, the Commission considers that Tecfidera — Dimethyl fumarate is not covered by the same global marketing authorisation as Fumaderm, and, second, based on Article 263 TFEU seeking annulment of the decision of the EMA of 30 July 2018 not to validate the application submitted by the applicant with a view to obtaining a marketing authorisation for a generic version of the medicinal product Tecfidera.

Operative part of the judgment

The Court:






1.


Annuls the decision of the European Medicines Agency (EMA) of 30 July 2018 not to validate the application submitted by Pharmaceutical Works Polpharma S.A. with a view to obtaining a marketing authorisation for a generic version of the medicinal product Tecfidera;










2.


Dismisses the action as to the remainder;










3.


Orders the EMA to bear its own costs and to pay those incurred by Pharmaceutical Works Polpharma;










4.


Orders Biogen Netherlands BV and the European Commission to bear their own costs.






(1)  OJ C 455, 17.12.2018.