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Document 62024CN0814

Case C-814/24, Alexion Pharma Germany: Request for a preliminary ruling from the Landgericht München I (Germany) lodged on 27 November 2024 – Alexion Pharma Germany GmbH v Amgen Technology (Ireland) Unlimited Company and AMGEN GmbH

OJ C, C/2025/1081, 24.2.2025, ELI: http://data.europa.eu/eli/C/2025/1081/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

ELI: http://data.europa.eu/eli/C/2025/1081/oj

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Official Journal
of the European Union

EN

C series

C/2025/1081

24.2.2025

Request for a preliminary ruling from the Landgericht München I (Germany) lodged on 27 November 2024 – Alexion Pharma Germany GmbH v Amgen Technology (Ireland) Unlimited Company and AMGEN GmbH

(Case C-814/24, Alexion Pharma Germany)

(C/2025/1081)

Language of the case: German

Referring court

Landgericht München I

Parties to the main proceedings

Applicant: Alexion Pharma Germany GmbH

Defendants: Amgen Technology (Ireland) Unlimited Company, AMGEN GmbH

Questions referred

1.

Does Article 8 of Regulation (EC) No 141/2000 (1) grant the holder of one or more indication-specific marketing authorisations for an orphan medicinal product a subjective legal position under civil law in the form of a right to market exclusivity, which the holder of market exclusivity may assert in civil proceedings against third parties if they interfere with the legal position?

2.

If Question 1 is answered in the negative: Does Regulation (EC) No 141/2000, according to its overall objective, as reflected in particular in recital 8 of the regulation, grant the holder of one or more indication-specific marketing authorisations for an orphan medicinal product, over and above the prohibition on processing and authorisation by an authority laid down in Article 8 of that regulation, a subjective legal position under civil law in the form of a right to market exclusivity, which the holder of market exclusivity may assert in civil proceedings against third parties if they interfere with the legal position?

3.

If Question 1 or 2 is answered in the affirmative: Do the claims of the holder of such a subjective civil-law right of market exclusivity in the event of interference with that legal position by third parties arise directly from EU law or are their scope and form governed by national law?

(1)  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).

ELI: http://data.europa.eu/eli/C/2025/1081/oj

ISSN 1977-091X (electronic edition)

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