# C_2023235EN.01005101.xml

| 3.7.2023 | EN | Official Journal of the European Union | C 235/51 |
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3.7.2023

EN

Official Journal of the European Union

C 235/51

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Action brought on 2 May 2023 — Zaklady Farmaceutyczne Polpharma v Commission

(Case T-228/23)

(2023/C 235/65)

Language of the case: English

Parties

Applicant: Zaklady Farmaceutyczne Polpharma S.A. (Starogard Gdański, Poland) (represented by: K. Roox, T. De Meese, J. Stuyck, M. Van Nieuwenborgh and N. Dumont lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | declare its request for annulment admissible and well-founded; |
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declare its request for annulment admissible and well-founded;

| — | annul the Commission Decision embedded in its letter of 17 March 2023 [ref. SANTE.DDG1.B.5/AL/mmc (2023) 2915860], as well as any later decisions to the extent they perpetuate and/or replace that decision, including any follow-up regulatory actions, in so far as they relate to the applicant; |
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annul the Commission Decision embedded in its letter of 17 March 2023 [ref. SANTE.DDG1.B.5/AL/mmc (2023) 2915860], as well as any later decisions to the extent they perpetuate and/or replace that decision, including any follow-up regulatory actions, in so far as they relate to the applicant;

| — | order the Commission to pay the costs of the proceedings. |
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order the Commission to pay the costs of the proceedings.

Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.

| 1. | First plea in law, alleging lack of competence and misuse of power by the above-mentioned Commission Decision of 17 March 2023 (‘the contested decision’) to amend and/or to withdraw the applicant’s granted marketing authorization. |
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1.

First plea in law, alleging lack of competence and misuse of power by the above-mentioned Commission Decision of 17 March 2023 (‘the contested decision’) to amend and/or to withdraw the applicant’s granted marketing authorization.

| 2. | Second plea in law, alleging infringement of essential procedural requirement, as the contested decision lacks a legal basis and infringed the applicant’s right to be heard pursuant to Article 41 of the Charter of Fundamental Rights of the European Union. |
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2.

Second plea in law, alleging infringement of essential procedural requirement, as the contested decision lacks a legal basis and infringed the applicant’s right to be heard pursuant to Article 41 of the Charter of Fundamental Rights of the European Union.

| 3. | Third plea in law, alleging infringement of the Treaties or of any rule of law relating to their application:






  — | the contested decision misapplies the law, as the Commission erred with respect to the scope of the Court of Justice’s inter partes judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C-438/21 P to C-440/21 P, EU:C:2023:213), and disregards the review of the Committee for Medicinal Products for Human Use; |
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3.

Third plea in law, alleging infringement of the Treaties or of any rule of law relating to their application:

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the contested decision misapplies the law, as the Commission erred with respect to the scope of the Court of Justice’s inter partes judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C-438/21 P to C-440/21 P, EU:C:2023:213), and disregards the review of the Committee for Medicinal Products for Human Use;

| — | the contested decision infringes the rights of defence and to a fair trial pursuant to Article 47 of the Charter of Fundamental Rights of the European Union; |
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the contested decision infringes the rights of defence and to a fair trial pursuant to Article 47 of the Charter of Fundamental Rights of the European Union;

| — | the contested decision infringes legal certainty; |
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the contested decision infringes legal certainty;

| — | the contested decision violates the applicant’s legitimate expectations, including the numerous obligations with its clients, public authorities, wholesalers, transport companies, and hospitals, for the sale and distribution of generic dimethyl fumarate products, and patients; |
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the contested decision violates the applicant’s legitimate expectations, including the numerous obligations with its clients, public authorities, wholesalers, transport companies, and hospitals, for the sale and distribution of generic dimethyl fumarate products, and patients;

| — | the contested decision violates the right to property laid down in Article 17 of the Charter of Fundamental Rights of the European Union. |
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the contested decision violates the right to property laid down in Article 17 of the Charter of Fundamental Rights of the European Union.

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