# C_2019337EN.01001501.xml

| 7.10.2019 | EN | Official Journal of the European Union | C 337/15 |
| --- | --- | --- | --- |

7.10.2019

EN

Official Journal of the European Union

C 337/15

---

Action brought on 8 August 2019 — Medac Gesellschaft für klinische Spezialpräparate v Commission

(Case T-549/19)

(2019/C 337/15)

Language of the case: German

Parties

Applicant: Medac Gesellschaft für klinische Spezialpräparate mbH (Wedel, 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; |
| --- | --- |

—

annul the contested decision;

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

—

order the European Commission to pay the costs.

Pleas in law and main arguments

The action is brought against Article 5 of Commission Implementing Decision of 20 June 2019 C92019) 4858 (final) granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) for ‘Trecondi — Treosulfan’, a medicinal product for human use.

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

| 1. | First plea in law, alleging that the contested decision is vitiated by a manifest error in law in so far as, in the interpretation of the concept of ‘satisfactory method’ for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000, (2) data about Trecondi compared with unauthorised uses of Melphalan und Cyclophosphamid was requested in breach of that provision. |
| --- | --- |

1.

First plea in law, alleging that the contested decision is vitiated by a manifest error in law in so far as, in the interpretation of the concept of ‘satisfactory method’ for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000, (2) data about Trecondi compared with unauthorised uses of Melphalan und Cyclophosphamid was requested in breach of that provision.

| 2. | Second plea in law, alleging a resulting misuse of powers in so far as the consideration of unauthorised uses infringes the relevant ‘Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (2016/C 424/03) (3). |
| --- | --- |

2.

Second plea in law, alleging a resulting misuse of powers in so far as the consideration of unauthorised uses infringes the relevant ‘Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (2016/C 424/03) (3).

| 3. | Third plea in law, alleging that the contested decision also breaches the principle of equal treatment and the principle of the protection of legitimate expectations as categories of the misuse of powers, in so far as the Commission, in the assessment of satisfactory methods for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000 in the present case, no longer relied on conditioning therapy in the context of stem-cell transplantation, but rather on stem-cell transplantation treatment as a benchmark. |
| --- | --- |

3.

Third plea in law, alleging that the contested decision also breaches the principle of equal treatment and the principle of the protection of legitimate expectations as categories of the misuse of powers, in so far as the Commission, in the assessment of satisfactory methods for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000 in the present case, no longer relied on conditioning therapy in the context of stem-cell transplantation, but rather on stem-cell transplantation treatment as a benchmark.

| 4. | Fourth plea in law, alleging in addition a manifest misuse of powers in so far as, in the assessment whether there existed a ‘significant benefit’ of Trecondi for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000, not all of the data was taken into account, but rather clinical data, which were obtained on the basis of indirect comparisons, and which as methodologically invalid were excluded from the evaluation. |
| --- | --- |

4.

Fourth plea in law, alleging in addition a manifest misuse of powers in so far as, in the assessment whether there existed a ‘significant benefit’ of Trecondi for the purposes of Article 3(1)(b) of Regulation (EC) No 141/2000, not all of the data was taken into account, but rather clinical data, which were obtained on the basis of indirect comparisons, and which as methodologically invalid were excluded from the evaluation.

| 5. | Fifth plea in law, alleging finally that the contested decision breached the principle of equal treatment as a specific category of the misuse of powers, in so far as indirect comparison data were not accepted from a methodological point of view, although in the past indirect comparison data based on comparable methodology had been accepted in similar cases. |
| --- | --- |

5.

Fifth plea in law, alleging finally that the contested decision breached the principle of equal treatment as a specific category of the misuse of powers, in so far as indirect comparison data were not accepted from a methodological point of view, although in the past indirect comparison data based on comparable methodology had been accepted in similar cases.

---

(1)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community 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).

(2)  Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).

(3)  Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (2016/C 424/03) (OJ 2016 C 424, p. 3).

---