Joined Cases C-438/21 P to C-440/21 P: Judgment of the Court (Fourth Chamber) of 16 March 2023 — European Commission v Pharmaceutical Works Polpharma S.A., European Medicines Agency, Biogen Netherlands BV (C-438/21 P), Biogen Netherlands BV v Pharmaceutical Works Polpharma S.A., European Medicines Agency, European Commission (C-439/21 P), European Medicines Agency v Pharmaceutical Works Polpharma S.A, European Commission, Biogen Netherlands BV (C-440/21 P) (Appeal — Public health — Medicinal products for human use — Directive 2001/83/EC — Regulation (EC) No 726/2004 — Application for marketing authorisation for a generic version of the medicinal product Tecfidera — Decision of the European Medicines Agency (EMA) not to validate the application for marketing authorisation — Earlier European Commission decision taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm — Previously authorised combination medicinal product — Subsequent marketing authorisation for a component of the combination medicinal product — Assessment of the existence of a global marketing authorisation)
Date: 2023-03-16
Institutions: Court of Justice
Subjects: drug surveillance, generic drug, market approval








C_2023164EN.01000701.xml










8.5.2023   


EN


Official Journal of the European Union


C 164/7






Judgment of the Court (Fourth Chamber) of 16 March 2023 — European Commission v Pharmaceutical Works Polpharma S.A., European Medicines Agency, Biogen Netherlands BV (C-438/21 P), Biogen Netherlands BV v Pharmaceutical Works Polpharma S.A., European Medicines Agency, European Commission (C-439/21 P), European Medicines Agency v Pharmaceutical Works Polpharma S.A, European Commission, Biogen Netherlands BV (C-440/21 P)
(Joined Cases C-438/21 P to C-440/21 P) (1)

(Appeal - Public health - Medicinal products for human use - Directive 2001/83/EC - Regulation (EC) No 726/2004 - Application for marketing authorisation for a generic version of the medicinal product Tecfidera - Decision of the European Medicines Agency (EMA) not to validate the application for marketing authorisation - Earlier European Commission decision taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm - Previously authorised combination medicinal product - Subsequent marketing authorisation for a component of the combination medicinal product - Assessment of the existence of a global marketing authorisation)
(2023/C 164/09)
Language of the case: English

Parties


(Case C-438/21 P)


Appellant: European Commission (represented by: initially, S. Bourgois, L. Haasbeek and A. Sipos, and subsequently, L. Haasbeek and A. Sipos, acting as Agents)

Other parties to the proceedings: Pharmaceutical Works Polpharma S.A. (represented by: N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat), European Medicines Agency (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents), Biogen Netherlands BV (represented by: C. Schoonderbeek, advocaat)

(Case C-439/21 P)


Appellant: Biogen Netherlands BV (represented by: C. Schoonderbeek, advocaat)

Other parties to the proceedings: Pharmaceutical Works Polpharma S.A. (represented by: N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat), European Medicines Agency (EMA) (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents), European Commission (represented by: initially, S. Bourgois, L. Haasbeek and A. Sipos, and subsequently, L. Haasbeek and A. Sipos, acting as Agents)

(Case C-440/21 P)


Appellant: European Medicines Agency (EMA) (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents)

Other parties to the proceedings: Pharmaceutical Works Polpharma S.A. (represented by: N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat), European Commission (represented by: initially, S. Bourgois, L. Haasbeek and A. Sipos, and subsequently, L. Haasbeek and A. Sipos, acting as Agents), Biogen Netherlands BV (represented by: C. Schoonderbeek, advocaat)

Operative part of the judgment

The Court:






1.


Sets aside the judgment of the General Court of the European Union of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T-611/18, EU:T:2021:241);










2.


Dismisses the action brought by Pharmaceutical Works Polpharma S.A. in Case T-611/18;










3.


Orders Pharmaceutical Works Polpharma S.A. to bear its own costs and to pay those incurred by the European Commission, Biogen Netherlands BV and the European Medicines Agency (EMA).






(1)  OJ C 391, 27.9.2021.