# C_2020433EN.01006502.xml

| 14.12.2020 | EN | Official Journal of the European Union | C 433/65 |
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14.12.2020

EN

Official Journal of the European Union

C 433/65

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Action brought on 28 October 2020 — Mylan Ireland v EMA

(Case T-653/20)

(2020/C 433/81)

Language of the case: English

Parties

Applicant: Mylan Ireland Ltd (Dublin, Ireland) (represented by: O. Swens, lawyer)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

| — | declare that the plea of illegality raised by the applicant against the conclusion of the CHMP that Sanofi has a new active substance status, as quoted in the decision of 26 August 2013 granting marketing authorisation for ‘AubagioTM — Teriflunomide’ is admissible and well founded; |
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declare that the plea of illegality raised by the applicant against the conclusion of the CHMP that Sanofi has a new active substance status, as quoted in the decision of 26 August 2013 granting marketing authorisation for ‘AubagioTM — Teriflunomide’ is admissible and well founded;

| — | annul the decision of EMA of 18 August 2020 not to validate Mylan’s application for a generic version of the medicinal product AubagioTM.; and, |
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annul the decision of EMA of 18 August 2020 not to validate Mylan’s application for a generic version of the medicinal product AubagioTM.; and,

| — | 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, alleging that the legality of the challenged decision is also contested, given that the ‘new active substance’ status should have been examined again upon the filing of Mylan’s objections which were submitted during the application phase. Thus, the EMA has allegedly 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, alleging that the legality of the challenged decision is also contested, given that the ‘new active substance’ status should have been examined again upon the filing of Mylan’s objections which were submitted during the application phase. Thus, the EMA has allegedly 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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