# C_2021263EN.01000902.xml

| 5.7.2021 | EN | Official Journal of the European Union | C 263/9 |
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5.7.2021

EN

Official Journal of the European Union

C 263/9

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Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 21 April 2021 — F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato

(Case C-261/21)

(2021/C 263/13)

Language of the case: Italian

Referring court

Consiglio di Stato

Parties to the main proceedings

Appellants: F. Hoffmann-La Roche Ltd, Novartis AG, Novartis Farma SpA, Roche SpA

Respondent: Autorità Garante della Concorrenza e del Mercato

Questions referred

| 1. | In a case where a party’s application seeks directly to assert an infringement of the principles expressed by the Court of Justice in that case in order to secure the setting-aside of the judgment under appeal, can the national court, against whose decisions there is no judicial remedy under national law, determine whether the principles expressed by the Court of Justice in the same case have been applied correctly in that specific case, or is that determination a matter for the Court of Justice? |
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1.

In a case where a party’s application seeks directly to assert an infringement of the principles expressed by the Court of Justice in that case in order to secure the setting-aside of the judgment under appeal, can the national court, against whose decisions there is no judicial remedy under national law, determine whether the principles expressed by the Court of Justice in the same case have been applied correctly in that specific case, or is that determination a matter for the Court of Justice?

| 2. | Has judgment No 4990/2019 of the Consiglio di Stato (Council of State) infringed, in the sense asserted by the parties, the principles expressed by the Court of Justice in the judgment of 23 January 2018 [in Case C-179/16] in relation (a) to the inclusion in the same relevant market of the two medicinal products without taking account of the views of authorities which had held that the off-label demand and supply of Avastin was unlawful; and (b) to the failure to verify the allegedly misleading nature of the information disseminated by the undertakings? |
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2.

Has judgment No 4990/2019 of the Consiglio di Stato (Council of State) infringed, in the sense asserted by the parties, the principles expressed by the Court of Justice in the judgment of 23 January 2018 [in Case C-179/16] in relation (a) to the inclusion in the same relevant market of the two medicinal products without taking account of the views of authorities which had held that the off-label demand and supply of Avastin was unlawful; and (b) to the failure to verify the allegedly misleading nature of the information disseminated by the undertakings?

| 3. | Do Articles 4(3) and 19(1) TEU and Articles 2(1) and (2) and 267 TFEU, read also in the light of Article 47 of the Charter of Fundamental Rights of the European Union, preclude a system such as that concerning Article 106 of the codice del processo amministrativo (Code of Administrative Procedure, Italy) and Articles 395 and 396 of the codice di procedura civile (Code of Civil Procedure, Italy), inasmuch as that system does not permit the use of the remedy of an application for revision to challenge judgments of the Council of State that conflict with judgments of the Court of Justice, and in particular with the legal principles asserted by the Court of Justice in a preliminary ruling on questions referred to it? |
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3.

Do Articles 4(3) and 19(1) TEU and Articles 2(1) and (2) and 267 TFEU, read also in the light of Article 47 of the Charter of Fundamental Rights of the European Union, preclude a system such as that concerning Article 106 of the codice del processo amministrativo (Code of Administrative Procedure, Italy) and Articles 395 and 396 of the codice di procedura civile (Code of Civil Procedure, Italy), inasmuch as that system does not permit the use of the remedy of an application for revision to challenge judgments of the Council of State that conflict with judgments of the Court of Justice, and in particular with the legal principles asserted by the Court of Justice in a preliminary ruling on questions referred to it?

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