15.1.2018 |
EN |
Official Journal of the European Union |
C 13/26 |
Action brought on 2 November 2017 — GMPO v Commission
(Case T-733/17)
(2018/C 013/40)
Language of the case: English
Parties
Applicant: GMP-Orphan (Paris, France) (represented by: M. Demetriou, QC, E. Mackenzie, barrister, L. Tsang and J. Mulryne, solicitors)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
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annul Article 5 of Commission Implementing Decision of 5 September 2017 granting marketing authorisation under Regulation (EC) No 726/2004 (1) for ‘Cuprior-trientine’, a medicinal product for human use; |
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order the defendant to provide that Cuprior be classified as an orphan medicinal product and the Community Register of Orphan Medicinal Products updated accordingly; and |
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order the defendant to pay the applicant’s costs. |
Pleas in law and main arguments
In support of the action, the applicant relies on four pleas in law.
1. |
First plea in law, alleging that Article 5 of the contested decision was based upon an erroneous interpretation of the term ‘significant benefit’ in Article 3(1)(b) of Regulation (EC) 141/2000 (‘the Orphan Regulation’).
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2. |
Second plea in law, alleging that the COMP/Commission misdirected itself in law and/or committed a manifest error of assessment in applying Article 3(1)(b) of the Orphan Regulation.
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3. |
Third plea in law, alleging an error in law and/or a breach of the principles of legitimate expectations and/or procedural fairness in applying later guidance to the designation and review of Cuprior.
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4. |
Fourth plea in law, alleging that the COMP/Commission committed a manifest error of assessment in evaluating and rejecting the evidence put forward by the applicant as to the lack of availability of trientine. |
(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 (Text with EEA relevance) (OJ 2004 L 136, p. 1).