This document is an excerpt from the EUR-Lex website
Document 62014TJ0705
Judgment of the General Court (Ninth Chamber) of 12 December 2018.
Unichem Laboratories Ltd v European Commission.
Competition — Agreements, decisions and concerted practices — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Article 101 TFEU — Patent dispute settlement agreement — Commission’s territorial jurisdiction — Imputation of the unlawful conduct — Administrative procedure — Legal professional privilege protecting communications between lawyers and their clients — Potential competition — Restriction of competition by object — Objective necessity of the restriction — Balance between competition law and patent law — Conditions for exemption under Article 101(3) TFEU — Fines.
Case T-705/14.
Judgment of the General Court (Ninth Chamber) of 12 December 2018.
Unichem Laboratories Ltd v European Commission.
Competition — Agreements, decisions and concerted practices — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Article 101 TFEU — Patent dispute settlement agreement — Commission’s territorial jurisdiction — Imputation of the unlawful conduct — Administrative procedure — Legal professional privilege protecting communications between lawyers and their clients — Potential competition — Restriction of competition by object — Objective necessity of the restriction — Balance between competition law and patent law — Conditions for exemption under Article 101(3) TFEU — Fines.
Case T-705/14.
Judgment of the General Court (Ninth Chamber) of 12 December 2018 –
Unichem Laboratories v Commission
(Case T‑705/14)
(Competition — Agreements, decisions and concerted practices — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Article 101 TFEU — Patent dispute settlement agreement — Commission’s territorial jurisdiction — Imputation of the unlawful conduct — Administrative procedure — Legal professional privilege protecting communications between lawyers and their clients — Potential competition — Restriction of competition by object — Objective necessity of the restriction — Balance between competition law and patent law — Conditions for exemption under Article 101(3) TFEU — Fines)
1. |
Judicial proceedings — Application initiating proceedings — Defence — Formal requirements — Handwritten signature — Lodging and notification of procedural documents by electronic means (Rules of Procedure of the General Court (1991), Art. 43) (see paras 44-46) |
2. |
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 — Circumstances allowing the existence of decisive influence to be established — Actual control of the board of directors of the subsidiary — Veto rights giving rise to control by the parent company over its subsidiary — Information exchanges between the parent company and its subsidiary (Art. 101(1) TFEU) (see paras 62-65, 69-89) |
3. |
Competition — EU rules — Territorial scope — Competence of the Commission — Conformity with public international law — Implementation or qualified effects of abusive practices in the EEA — Alternative methods — Implementation criterion (Art. 101 TFEU) (see paras 100-106) |
4. |
Competition — Administrative procedure — Advisory Committee on agreements, decisions, concerted practices and dominant positions — Obligation to consult — Essential formality — Scope (Arts 101 and 102 TFEU; Council Regulation No 1/2003, Art. 14) (see paras 109-111) |
5. |
Competition — Administrative procedure — Commission’s powers of investigation — Power to demand production of a communication between lawyer and client — Limits — Protection of the confidentiality of such a communication — Waiver of confidentiality (Art. 101 TFEU; Council Regulation No 1/2003, Arts 2, 17 and 19) (see paras 118-127) |
6. |
Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Description of an undertaking as a potential competitor — Real, concrete prospects of market entry — Criteria — Essential evidence — Ability of the undertaking to enter the relevant market — Sufficiently fast entry — Perception of operators present on the market (Art. 101(1) TFEU) (see paras 133-147) |
7. |
Judicial proceedings — Application initiating proceedings — Formal requirements — Brief summary of the pleas in law on which the application is based — Pleas in law not set out in the application — General reference to documents annexed to the application — Inadmissibility (Statute of the Court of Justice, Arts 21, first para. and 53, first para.; Rules of Procedure of the General Court (1991), Art. 44(1)(c) and (d)) (see paras 173-176) |
8. |
Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Description of an undertaking as a potential competitor — Criteria — Essential evidence — Ability of the undertaking to enter the relevant market — Generic medicines undertaking — Obstacles linked to the originator company’s patents and to the technical, regulatory and financial difficulties faced by the generic undertaking — Real concrete possibilities of overcoming those difficulties and entering the market (Art. 101(1) TFEU) (see paras 177-243, 250-258) |
9. |
Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Distinction between infringements by object and infringements by effect — Infringement by object — Whether sufficiently damaging — Assessment (Art. 101(1) TFEU) (see paras 288, 289, 298-301) |
10. |
Competition — EU rules — Substantive scope — Amicable agreement on patents — Included — Balancing of patent law and the competition rules (Art. 101(1) TFEU; Council Regulation No 1/2003) (see paras 302-320) |
11. |
Agreements, decisions and concerted practices — Adverse effect on competition — Amicable agreement on patents — Agreement concluded between an originator company and a generic medicine undertaking — Agreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of products — Inducive reverse payment received by the generic undertaking — Restriction by object (Art. 101(1) TFEU) (see paras 325-357) |
12. |
Agreements, decisions and concerted practices — Adverse effect on competition — Amicable agreement on patents — Agreement concluded between an originator company and a generic medicine undertaking — Agreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of products — Payment received by the generic undertaking — Classification as an inducive reverse payment — Conditions (Art. 101(1) TFEU) (see paras 361-371) |
13. |
Agreements, decisions and concerted practices — Adverse effect on competition — Ancillary restriction — Meaning — Restriction necessary to the implementation of a main operation which is not anti-competitive — Main operation constituting a restriction of competition by object — Ancillary restraints doctrine inapplicable in the presence of an inducive reverse payment (Art. 101(1) TFEU) (see paras 381-391) |
14. |
Action for annulment — Purpose — Decision based on several pillars of reasoning, each sufficient to justify the operative part — Annulment of such a decision — Conditions (Art. 263 TFEU) (see paras 394-398) |
15. |
Agreements, decisions and concerted practices — Prohibition — Exemption — Conditions — Improvement of the production or distribution of goods or contribution to technical or economic progress — Appreciable objective advantages of such a character as to compensate for the disadvantages for competition resulting from that agreement — Burden of proof — Cumulative nature of the conditions for exemption (Art. 101(1) and (3) TFEU; Council Regulation No 1/2003, Art. 2) (see paras 409-429) |
16. |
Competition — Fines — Amount — Determination — Determination of the basic amount — Methodology established by the Guidelines not applied — Breach of the principle of equal treatment — None (Art. 101(1) TFEU; Council Regulation No 1/2003, Art. 23(2); Commission notice 2006/C 210/02, points 13 and 37) (see paras 451-486) |
17. |
Fundamental rights — Charter of Fundamental Rights of the European Union — Principle that offences and penalties must have a proper legal basis — Scope — Foreseeability of the infringing nature of the penalised conduct — Patent dispute settlement agreement between an originator company and a generic undertaking — Agreement contrary to competition law — Generic undertaking which could not have been unaware of the anti-competitive nature of its conduct (Art. 101(1) TFEU; Charter of Fundamental Rights of the European Union, Art. 49(1)) (see paras 510-537) |
18. |
Competition — Fines — Amount — Determination — Adjustment of the basic amount — Mitigating circumstances — Participation allegedly under pressure — Matter not providing a justification for an undertaking which did not make use of the possibility of lodging a complaint with the competent authorities (Art. 101(1) TFEU; Commission notice 2006/C 210/02, point 29) (see para. 545) |
19. |
Competition — Fines — Amount — Determination — Whether the Commission is obliged to abide by its previous decision-making practice — No obligation (Art. 101 TFEU) (see para. 546) |
20. |
Competition — Fines — Amount — Determination — Adjustment of the basic amount — Mitigating circumstances — Cooperation of the undertaking concerned outside the scope of the Leniency Notice — Criteria for assessment (Art. 101 TFEU; Council Regulation No 1/2003, Art. 23(2); Commission notice 2006/C 210/02, point 29) (see paras 560-569) |
Re:
Application under Article 263 TFEU for annulment of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] in so far as it concerns the applicant and, in the alternative, for annulment or reduction of the fine imposed on the applicant by that decision.
Operative part
The Court:
1. |
Dismisses the action; |
2. |
Orders Unichem Laboratories Ltd to pay the costs. |