# C_2023261EN.01004101.xml

| 24.7.2023 | EN | Official Journal of the European Union | C 261/41 |
| --- | --- | --- | --- |

24.7.2023

EN

Official Journal of the European Union

C 261/41

---

Action brought on 5 June 2023 — Aliud Pharma v Commission

(Case T-309/23)

(2023/C 261/56)

Language of the case: German

Parties

Applicant: Aliud Pharma GmbH (Laichingen, Germany) (represented by: P. von Czettritz, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | annul the contested decision; and |
| --- | --- |

—

annul the contested decision; and

| — | order the European Commission to pay the costs. |
| --- | --- |

—

order the European Commission to pay the costs.

Pleas in law and main arguments

The action, which is brought against Articles 1, 2 and 3 of the European Commission Implementing Decision of 2 May 2023 [C(2023)3067 (final)] amending the marketing authorisation granted by Decision C(2014)601 (final) for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use, is based on two pleas in law.

| 1. | First plea in law: Manifest error of assessment and misuse of powers in the interpretation of the judgment of the Court of Justice of the European Union in Joined Cases C-438/21 P to C-440/21 P (1)

  In this decision, the Court of Justice dealt only with the assessment of the Committee for Medicinal Products for Human Use (CHMP) from 2013 and the Commission’s decision of 30 January 2014. In the meantime, however, there was a new scientific assessment concerning the two substances contained in the medicinal product by the CHMP dated 11 November 2021, which the Court had in no way taken into account in its review of whether the EMA’s non-validation decision of 30 July 2018 was justified. On the basis of that assessment report, however, it was clear that a substance was not an active substance, but only an excipient, with the consequence that the medicinal product fell under the overall authorisation of the initial authorisation. |
| --- | --- |

1.

First plea in law: Manifest error of assessment and misuse of powers in the interpretation of the judgment of the Court of Justice of the European Union in Joined Cases C-438/21 P to C-440/21 P (1)

In this decision, the Court of Justice dealt only with the assessment of the Committee for Medicinal Products for Human Use (CHMP) from 2013 and the Commission’s decision of 30 January 2014. In the meantime, however, there was a new scientific assessment concerning the two substances contained in the medicinal product by the CHMP dated 11 November 2021, which the Court had in no way taken into account in its review of whether the EMA’s non-validation decision of 30 July 2018 was justified. On the basis of that assessment report, however, it was clear that a substance was not an active substance, but only an excipient, with the consequence that the medicinal product fell under the overall authorisation of the initial authorisation.

| 2. | Second plea in law: Manifest error of assessment in granting an additional year of marketing protection under Article 14(11) of Regulation (EC) No 726/2004 (2)

  Article 14(11) of Regulation (EC) No 726/2004 provides that the authorisation of a new therapeutic indication which brings a significant clinical benefit in comparison with existing therapies must be granted within the first eight years after the grant of the initial authorisation, which is not so in the present case, since the initial authorisation was granted on 30 January 2014 and the authorisation of the new indication was not granted until 13 May 2022. Thus, the condition for the extension of marketing protection by one year pursuant to Article 14(11) of Regulation (EC) No 726/2004 was not met. |
| --- | --- |

2.

Second plea in law: Manifest error of assessment in granting an additional year of marketing protection under Article 14(11) of Regulation (EC) No 726/2004 (2)

Article 14(11) of Regulation (EC) No 726/2004 provides that the authorisation of a new therapeutic indication which brings a significant clinical benefit in comparison with existing therapies must be granted within the first eight years after the grant of the initial authorisation, which is not so in the present case, since the initial authorisation was granted on 30 January 2014 and the authorisation of the new indication was not granted until 13 May 2022. Thus, the condition for the extension of marketing protection by one year pursuant to Article 14(11) of Regulation (EC) No 726/2004 was not met.

---

(1)  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.

(2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).

---