Order of the vice-President of the Court of 28 November 2013 — EMA v AbbVie

(Case C‑389/13 P(R))

‛Appeal — Order for interim measures — Regulation (EC) No 1049/2001 — Access to documents of the institutions — Documents held by the European Medicines Agency in the context of an application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Serious and irreparable damage — Evidence’

1. Application for interim measures — 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 (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see para. 34)

2. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Burden of proof on the party requesting the interim measure (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 35, 36)

3. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Burden of proof on the party requesting the interim measure — Risk of infringement of fundamental rights — Insufficient for a finding of serious damage — Assessment in accordance with the facts of the case — Harm linked to the disclosure of information covered by professional secrecy — Criteria for assessment — Importance of the information for the undertaking concerned and the usefulness thereof for other undertakings (Arts 278 TFEU and 279 TFEU; Charter of Fundamental Rights of the European Union, Arts 4, 7 and 47; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 38, 40-43)

4. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Irreparable nature of the damage — Meaning — Financial damage not capable of being compensated in full at a later date — Included — Conditions (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 46-49)

5. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Irreparable nature of the damage — Scope of the review carried out by the court hearing the application for interim measures (Arts 278 TFEU and 279 TFEU) (see paras 53, 55)

Re:

Appeal brought against the order of the President of the General Court of 25 April 2013 in Case T‑44/13 AbbVie v EMA, by which the General Court ordered the suspension of the enforcement of Decision EMA/748792/2012 of the European Medicines Agency (EMA) of 14 January 2013 which granted a third party access to certain documents containing information submitted by the applications in the context of the application to place on the market a medicinal product used to treat Crohn’s disease.

Operative part

1. The order of the President of the General Court of the European Union of 25 April 2013 in Case T‑44/13 R AbbVie v EMA is set aside.

2. The case is referred back to the General Court of the European Union.

3. The costs are reserved.

Order of the vice-President of the Court of 28 November 2013 — EMA v AbbVie

(Case C‑389/13 P(R))

‛Appeal — Order for interim measures — Regulation (EC) No 1049/2001 — Access to documents of the institutions — Documents held by the European Medicines Agency in the context of an application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Serious and irreparable damage — Evidence’

1. Application for interim measures — 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 (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see para. 34)

2. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Burden of proof on the party requesting the interim measure (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 35, 36)

3. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Burden of proof on the party requesting the interim measure — Risk of infringement of fundamental rights — Insufficient for a finding of serious damage — Assessment in accordance with the facts of the case — Harm linked to the disclosure of information covered by professional secrecy — Criteria for assessment — Importance of the information for the undertaking concerned and the usefulness thereof for other undertakings (Arts 278 TFEU and 279 TFEU; Charter of Fundamental Rights of the European Union, Arts 4, 7 and 47; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 38, 40-43)

4. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Irreparable nature of the damage — Meaning — Financial damage not capable of being compensated in full at a later date — Included — Conditions (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the Court of Justice, Art. 160(3); Rules of Procedure of the General Court, Art. 104(2)) (see paras 46-49)

5. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Irreparable nature of the damage — Scope of the review carried out by the court hearing the application for interim measures (Arts 278 TFEU and 279 TFEU) (see paras 53, 55)

Re:

Appeal brought against the order of the President of the General Court of 25 April 2013 in Case T‑44/13 AbbVie v EMA, by which the General Court ordered the suspension of the enforcement of Decision EMA/748792/2012 of the European Medicines Agency (EMA) of 14 January 2013 which granted a third party access to certain documents containing information submitted by the applications in the context of the application to place on the market a medicinal product used to treat Crohn’s disease.

Operative part

1. The order of the President of the General Court of the European Union of 25 April 2013 in Case T‑44/13 R AbbVie v EMA is set aside.

2. The case is referred back to the General Court of the European Union.