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:
2. | | Orders Unichem Laboratories Ltd to pay the costs. |