# C_2021035EN.01005401.xml

| 1.2.2021 | EN | Official Journal of the European Union | C 35/54 |
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1.2.2021

EN

Official Journal of the European Union

C 35/54

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Action brought on 27 November 2020 — Mylan Ireland v EMA

(Case T-703/20)

(2021/C 35/72)

Language of the case: English

Parties

Applicant: Mylan Ireland Ltd (Dublin, Ireland) (represented by: J. Krens, lawyer)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicant claims that the Court should:

| — | declare that a plea of illegality raised by the applicant against the conclusion of the Committee for Medicinal Products for Human Use that the Biogen Idec Ltd medicinal product Tecfidera® has a different active substance status resulting in a new global marketing authorisation as quoted in the decision of 30 January 2014 granting marketing authorisation for ‘Tecfidera® — Dimethyl Fumarate’ is admissible and well founded; |
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declare that a plea of illegality raised by the applicant against the conclusion of the Committee for Medicinal Products for Human Use that the Biogen Idec Ltd medicinal product Tecfidera® has a different active substance status resulting in a new global marketing authorisation as quoted in the decision of 30 January 2014 granting marketing authorisation for ‘Tecfidera® — Dimethyl Fumarate’ is admissible and well founded;

| — | annul the decision of the EMA of 1 October 2020 not to validate the applicant’s application for a generic version of the medicinal product Tecfidera; |
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annul the decision of the EMA of 1 October 2020 not to validate the applicant’s application for a generic version of the medicinal product Tecfidera;

| — | order the EMA to pay the costs. |
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order the EMA to pay the costs.

Pleas in law and main arguments

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

| 1. | First plea in law, alleging that, the exception of illegality being well-founded, the challenged decision is not legally admissible because the EMA erred in fact and law and failed to fulfil its duty to state reasons and to perform a careful and thorough assessment, as provided under Article 296 TFEU. |
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1.

First plea in law, alleging that, the exception of illegality being well-founded, the challenged decision is not legally admissible because the EMA erred in fact and law and failed to fulfil its duty to state reasons and to perform a careful and thorough assessment, as provided under Article 296 TFEU.

| 2. | Second plea in law, contesting the legality of the challenged decision, given that the ‘different active substance’ status should have been examined again upon the filing of the applicant’s objections, which were submitted during the application phase. Thus, the EMA has failed to perform its duties appropriately, in particular its duty to perform an effective and careful assessment and to state reasons, pursuant to Article 296 TFEU, which in turn renders the challenged decision illegal. |
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2.

Second plea in law, contesting the legality of the challenged decision, given that the ‘different active substance’ status should have been examined again upon the filing of the applicant’s objections, which were submitted during the application phase. Thus, the EMA has failed to perform its duties appropriately, in particular its duty to perform an effective and careful assessment and to state reasons, pursuant to Article 296 TFEU, which in turn renders the challenged decision illegal.

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