# C_2023164EN.01000701.xml

| 8.5.2023 | EN | Official Journal of the European Union | C 164/7 |
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8.5.2023

EN

Official Journal of the European Union

C 164/7

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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); |
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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; |
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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). |
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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).

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(1)  OJ C 391, 27.9.2021.

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