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Dokumentas 62019CJ0166
Judgment of the Court (First Chamber) of 27 June 2024.
Unichem Laboratories Ltd v European Commission.
Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement.
Case C-166/19 P.
Judgment of the Court (First Chamber) of 27 June 2024.
Unichem Laboratories Ltd v European Commission.
Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement.
Case C-166/19 P.
Teismo praktikos rinkinys. Bendrasis rinkinys. Skyrius „Informacija apie nepaskelbtus sprendimus“
Europos teismų praktikos identifikatorius (ECLI): ECLI:EU:C:2024:548
Judgment of the Court (First Chamber) of 27 June 2024 –
Unichem Laboratories v Commission
(Case C‑166/19 P) ( 1 )
(Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement)
1. |
Competition – EU rules – Infringements – Attribution – Parent company and subsidiaries – Economic unit – Criteria for assessment – Exercise of decisive influence over the conduct of the subsidiary which may be inferred from a set of indicia relating to the economic, organisational and legal links with its parent company (Art. 101(1) TFEU) (see paragraphs 51-59) |
2. |
Appeal – Grounds – Error of law relied on not identified – Ground lacking precision – Inadmissibility (Art. 256 TFEU; Statute of the Court of Justice, Art. 58, first para.) (see paragraphs 60, 61) |
3. |
Competition – EU rules – Infringements – Attribution – Parent company and subsidiaries – Subsidiary which participated in an agreement, decision or concerted practice – Parent company which participated directly in that agreement, decision or concerted practice – Personal responsibility of the parent company for that infringement (Art. 101(1) TFEU) (see paragraphs 62-64) |
4. |
Competition – EU rules – Territorial scope – Competence of the Commission – Agreement, decision or concerted practice implemented in the European Union – Undertaking participating in the agreement, decision or concerted practice situated in a third country – Jurisdiction of the Commission to apply Article 101 TFEU to that undertaking (Art. 101 TFEU) (see paragraphs 66-69) |
5. |
Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Characterisation of an undertaking as a potential competitor – Real and concrete possibilities of entering the market – Criteria – Firm intention and inherent ability of the undertaking to enter the relevant market – No insurmountable barriers – Assessment – Burden of proof – Existence of patents protecting an originator medicine or one of its manufacturing processes – Characterisation of a manufacturer of generic medicines as a potential competitor of the originator manufacturer holding the patents (Art. 101 TFEU) (see paragraphs 80-93, 98-107) |
6. |
Appeal – Grounds – Plea raised for the first time in the context of the appeal – Inadmissibility – Plea seeking solely to contest the merits of the judgment under appeal – Plea arising from the judgment under appeal – Admissibility (Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58; Rules of Procedure of the Court of Justice, Art. 170) (see paragraphs 94-97) |
7. |
Appeal – Grounds – Incorrect assessment of the facts and evidence – Inadmissibility – Review by the Court of Justice of the assessment of the facts and evidence – Possible only where the facts or evidence have been distorted – Requirement that the distortion be obvious from the documents in the file (Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58, first para.) (see paragraphs 108-117, 186-198) |
8. |
Agreements, decisions and concerted practices – Adverse effect on competition – Patent dispute settlement agreements – Agreement concluded between a manufacturer of originator medicines and a manufacturer of generic medicines – Agreement containing clauses under which the manufacturer of generic medicines undertakes not to challenge patents and not to market products – Consideration consisting in transfers of value – Characterisation as a restriction by object – Criteria – Degree of harm of the agreements to competition in the market concerned – Assessment of the inducive effect of the transfers of value on the decision of the generic manufacturer not to enter the market (Art. 101(1) TFEU) (see paragraphs 131-156) |
9. |
Agreements, decisions and concerted practices – Adverse effect on competition – Ancillary restriction – Concept – Restriction necessary to the implementation of a main operation which is not anticompetitive – Main operation constituting a restriction of competition by object – Ancillary restraints doctrine inapplicable (Art. 101(1) TFEU) (see paragraphs 179-184) |
10. |
Competition – Administrative procedure – Observance of the rights of the defence – Privileged nature of correspondence between lawyers and their clients – Waiver of such protection – Whether permissible – Conditions – Waiver established in an unequivocal manner – Waiver attended by minimum safeguards commensurate to its importance (Art. 101 TFEU; Charter of Fundamental Rights of the European Union, Art. 48(2)) (see paragraphs 227-234) |
Operative part
The Court:
1. |
Dismisses the appeal; |
2. |
Orders Unichem Laboratories Ltd to bear its own costs and to pay the costs incurred by the European Commission; |
3. |
Orders the United Kingdom of Great Britain and Northern Ireland to bear its own costs. |
( 1 ) OJ C 148, 29.4.2019.