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Europa English Court of Justice of the European Union CJEU
18.07.2023
Application (OJ)
European Court of Justice 

Mylan Ireland v Commission

Action brought on 15 May 2023 – Mylan Ireland v Commission(Case T-256/23)Language of the case: English Parties Applicant: Mylan Ireland Ltd (Dublin, Ireland)(represented by: K. Roox, T. De Meese, J. Stuyck and C. 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;annul Commission Implementing Decision C(2023)3067(final) of 2 May 2023 (published on 4 May 2023) amending the ...
Action brought on 15 May 2023 – Mylan Ireland v Commission(Case T-256/23)Language of the case: English Parties Applicant: Mylan Ireland Ltd (Dublin, Ireland)(represented by: K. Roox, T. De Meese, J. Stuyck and C. 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;annul Commission Implementing Decision C(2023)3067(final) of 2 May 2023 (published on 4 May 2023) amending the marketing authorisation granted by Decision C(2014)601(final) for “Tecfidera - Dimethyl fumarate”, a medicinal product for human use (‘the contested decision’), as well as any later decision, to the extent that 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. Pleas in law and main arguments In support of the action, the applicant relies on nine pleas in law. First plea in law, alleging failure by the European Commission to observe the time limit for obtaining an extension of market protection as required by Article 14(11) Regulation EC No. 726/2004 of the European Parliament and of the Council. 1 Second plea in law, alleging that the European Commission misapplies the law, as the Commission erred with respect to the scope of the 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)...

Errors and omissions excepted. As of: 18.07.2023