This document is an excerpt from the EUR-Lex website
Document 62023CO0604
Order of the Vice-President of the Court of 2 February 2024.
Mylan Ireland Ltd v European Commission.
Appeal – Interim relief – Medicinal product for human use – Marketing authorisation – Extension of the marketing protection period – No urgency.
Case C-604/23 P(R).
Order of the Vice-President of the Court of 2 February 2024.
Mylan Ireland Ltd v European Commission.
Appeal – Interim relief – Medicinal product for human use – Marketing authorisation – Extension of the marketing protection period – No urgency.
Case C-604/23 P(R).
Court reports – general
ECLI identifier: ECLI:EU:C:2024:117
Order of the Vice-President of the Court of 2 February 2024 –
Mylan Ireland v Commission
(Case C‑604/23 P(R))
(Appeal – Interim relief – Medicinal product for human use – Marketing authorisation – Extension of the marketing protection period – No urgency)
|
1. |
Appeal – Grounds – Inadequate statement of reasons – Reliance by the General Court on implied reasoning – Whether permissible – Conditions (Art. 256 TFEU; Statute of the Court of Justice, Arts 36 and 53, first para.; Rules of Procedure of the General Court, Art. 117) (see paragraphs 28, 29) |
|
2. |
Appeal – Grounds – Lack of or inadequate statement of reasons – Order of the General Court dismissing an application for interim measures – No reasons given for rejecting the applicant’s argument in respect of whether the condition of urgency was satisfied – Setting aside of the order under appeal (Art. 256 TFEU; Statute of the Court of Justice, Arts 36 and 53, first para.; Rules of Procedure of the General Court, Art. 117) (see paragraphs 30-37) |
|
3. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Prima facie case – Urgency – Serious and irreparable damage – Cumulative nature – Balancing of all the interests involved – Order of examination and method of verification – Discretion of the judge hearing the application for interim relief (Arts 256(1), 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraphs 40, 41) |
|
4. |
Interim relief – Jurisdiction of the judge hearing the application for interim relief – Limits – Application seeking an order that an EU institution suspend a procedure that does not depend on a contested act – Not included (Art. 279 TFEU; Rules of Procedure of the General Court, Art. 156(1) and (2)) (see paragraph 54) |
|
5. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Prima facie case – Urgency – Cumulative nature – Particularly strong prima facie case – No impact on the obligation to examine urgency separately (Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraphs 56, 57) |
|
6. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Serious and irreparable damage – Burden of proof borne by the party seeking the interim measure – Need to plead the risk of suffering that damage personally (Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraphs 64, 65, 89) |
|
7. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Serious and irreparable damage – Burden of proof – Financial loss – Obligation to show that there are structural or legal obstacles preventing the applicant company from regaining a significant proportion of the market share (Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraphs 84, 85) |
|
8. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Serious and irreparable damage – Risk of fundamental rights being undermined – Risk not in itself constituting serious damage (Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraph 90) |
|
9. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Serious and irreparable damage – Burden of proof – Financial loss which can be the subject of subsequent financial compensation – No urgency (Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paragraphs 91-93, 99-104) |
|
10. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Serious and irreparable damage – Financial loss – Serious nature of the damage – Situation liable to endanger the existence of the applicant company – Assessment in the light of its size and turnover and the situation of the group to which it belongs (Arts 278 and 279 TFEU) (see paragraph 94) |
|
11. |
Interim relief – Suspension of operation of a measure – Interim measures – Conditions for granting – Serious and irreparable damage – Irreparable nature of the damage – Definition – Financial loss not capable of being entirely compensated for at a later stage – Included – Conditions (Arts 278 and 279 TFEU) (see paragraphs 96-98) |
Operative part
|
1. |
The order of the President of the General Court of the European Union of 24 July 2023, Mylan Ireland v Commission (T‑256/23 R, EU:T:2023:421), is set aside. |
|
2. |
There is no longer any need to adjudicate on the application for leave to intervene in the appeal submitted by Biogen Netherlands BV. |
|
3. |
The application for interim measures is dismissed. |
|
4. |
Mylan Ireland Ltd and the European Commission shall each bear their own costs relating to the appeal. |
|
5. |
Mylan Ireland, the Commission and Biogen Netherlands shall each bear their own costs relating to the application for leave to intervene in the appeal submitted by Biogen Netherlands. |
|
6. |
The costs of Mylan Ireland and the Commission relating to the interlocutory proceedings at first instance are reserved. |