Judgment of the General Court (Ninth Chamber) of 12 December 2018

1. Judicial proceedingsApplication initiating proceedingsDefenceFormal requirementsHandwritten signatureLodging and notification of procedural documents by electronic means

(Rules of Procedure of the General Court (1991), Art. 43)

(see paras 44-46)

2. CompetitionEU rulesInfringementsAttributionParent company and subsidiariesEconomic unitCriteria for assessmentExercise 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 companyCircumstances allowing the existence of decisive influence to be establishedActual control of the board of directors of the subsidiaryVeto rights giving rise to control by the parent company over its subsidiaryInformation exchanges between the parent company and its subsidiary

(Art. 101(1) TFEU)

(see paras 62-65, 69-89)

3. CompetitionEU rulesTerritorial scopeCompetence of the CommissionConformity with public international lawImplementation or qualified effects of abusive practices in the EEAAlternative methodsImplementation criterion

(Art. 101 TFEU)

(see paras 100-106)

4. CompetitionAdministrative procedureAdvisory Committee on agreements, decisions, concerted practices and dominant positionsObligation to consultEssential formalityScope

(Arts 101 and 102 TFEU; Council Regulation No 1/2003, Art. 14)

(see paras 109-111)

5. CompetitionAdministrative procedureCommission’s powers of investigationPower to demand production of a communication between lawyer and clientLimitsProtection of the confidentiality of such a communicationWaiver of confidentiality

(Art. 101 TFEU; Council Regulation No 1/2003, Arts 2, 17 and 19)

(see paras 118-127)

6. Agreements, decisions and concerted practicesAdverse effect on competitionCriteria for assessmentDescription of an undertaking as a potential competitorReal, concrete prospects of market entryCriteriaEssential evidenceAbility of the undertaking to enter the relevant marketSufficiently fast entryPerception of operators present on the market

(Art. 101(1) TFEU)

(see paras 133-147)

7. Judicial proceedingsApplication initiating proceedingsFormal requirementsBrief summary of the pleas in law on which the application is basedPleas in law not set out in the applicationGeneral reference to documents annexed to the applicationInadmissibility

(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 practicesAdverse effect on competitionCriteria for assessmentDescription of an undertaking as a potential competitorCriteriaEssential evidenceAbility of the undertaking to enter the relevant marketGeneric medicines undertakingObstacles linked to the originator company’s patents and to the technical, regulatory and financial difficulties faced by the generic undertakingReal 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 practicesAdverse effect on competitionCriteria for assessmentDistinction between infringements by object and infringements by effectInfringement by objectWhether sufficiently damagingAssessment

(Art. 101(1) TFEU)

(see paras 288, 289, 298-301)

10. CompetitionEU rulesSubstantive scopeAmicable agreement on patentsIncludedBalancing 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 practicesAdverse effect on competitionAmicable agreement on patentsAgreement concluded between an originator company and a generic medicine undertakingAgreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of productsInducive reverse payment received by the generic undertakingRestriction by object

(Art. 101(1) TFEU)

(see paras 325-357)

12. Agreements, decisions and concerted practicesAdverse effect on competitionAmicable agreement on patentsAgreement concluded between an originator company and a generic medicine undertakingAgreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of productsPayment received by the generic undertakingClassification as an inducive reverse paymentConditions

(Art. 101(1) TFEU)

(see paras 361-371)

13. Agreements, decisions and concerted practicesAdverse effect on competitionAncillary restrictionMeaningRestriction necessary to the implementation of a main operation which is not anti-competitiveMain operation constituting a restriction of competition by objectAncillary restraints doctrine inapplicable in the presence of an inducive reverse payment

(Art. 101(1) TFEU)

(see paras 381-391)

14. Action for annulmentPurposeDecision based on several pillars of reasoning, each sufficient to justify the operative partAnnulment of such a decisionConditions

(Art. 263 TFEU)

(see paras 394-398)

15. Agreements, decisions and concerted practicesProhibitionExemptionConditionsImprovement of the production or distribution of goods or contribution to technical or economic progressAppreciable objective advantages of such a character as to compensate for the disadvantages for competition resulting from that agreementBurden of proofCumulative nature of the conditions for exemption

(Art. 101(1) and (3) TFEU; Council Regulation No 1/2003, Art. 2)

(see paras 409-429)

16. CompetitionFinesAmountDeterminationDetermination of the basic amountMethodology established by the Guidelines not appliedBreach of the principle of equal treatmentNone

(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 rightsCharter of Fundamental Rights of the European UnionPrinciple that offences and penalties must have a proper legal basisScopeForeseeability of the infringing nature of the penalised conductPatent dispute settlement agreement between an originator company and a generic undertakingAgreement contrary to competition lawGeneric 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. CompetitionFinesAmountDeterminationAdjustment of the basic amountMitigating circumstancesParticipation allegedly under pressureMatter 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. CompetitionFinesAmountDeterminationWhether the Commission is obliged to abide by its previous decision-making practiceNo obligation

(Art. 101 TFEU)

(see para. 546)

20. CompetitionFinesAmountDeterminationAdjustment of the basic amountMitigating circumstancesCooperation of the undertaking concerned outside the scope of the Leniency NoticeCriteria 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.