Information;Order — ECLI:EU:C:2024:115
Date: 2024-02-02
Language of the case: English
Court formation: Vice-President
Subject matter: Public health
Procedure: Action for annulment;Application for interim measures - unfounded;Appeal - successful;Appeal - decision unnecessary
Origin: Poland

Order of the Vice-President of the Court of 2 February 2024 – Zakłady Farmaceutyczne Polpharma v Commission (Case C‑608/23 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, Zaklady Farmaceutyczne Polpharma v Commission (T‑258/23 R, EU:T:2023:418), 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. Zaklady Farmaceutyczne Polpharma S.A. and the European Commission shall each bear their own costs relating to the appeal. 5. Zaklady Farmaceutyczne Polpharma S.A., 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 Zaklady Farmaceutyczne Polpharma S.A. and the Commission relating to the interlocutory proceedings at first instance are reserved.