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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)
ECLI:EU:UNKNOWN:62021CA0438
62021CA0438
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Official Journal of the European Union
C 164/7
(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.