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

CompetitionAdministrative procedurePrinciple of sound administrationRequirement of impartialityScopePublic statements made by Members of the Commission during the administrative procedureBreach of the principle of good administration and of the presumption of innocenceNone

(Art. 101(1) TFEU; Charter of Fundamental Rights of the European Union, Arts 41 and 48(1))

(see paras 54-62)

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 65-80)

Agreements, decisions and concerted practicesAdverse effect on competitionCriteria for assessmentDescription of an undertaking as a potential competitorReal and concrete possibilities of entering the marketCriteriaEssential evidenceAbility of the undertaking to enter the relevant marketPerceptions of the incumbent operators

(Art. 101(1) TFEU)

(see paras 86-95)

Agreements, decisions and concerted practicesAdverse effect on competitionCriteria for assessmentDescription of an undertaking as a potential competitorReal and concrete possibilities of entering the marketCriteriaEssential evidenceAbility of the undertaking to enter the relevant marketPatent-related obstacles

(Art. 101(1) TFEU)

(see paras 124-132)

Agreements, decisions and concerted practicesAdverse effect on competitionCriteria for assessmentDistinction between infringements by object and infringements by effectInfringement by subject-matterWhether sufficiently damagingSufficientConsideration of the potential effects of the agreementLimits

(Art. 101(1) TFEU)

(see paras 181-194, 270, 315-317)

CompetitionEU rulesSubstantive scopeAmicable agreement on patentsIncludedBalancing of patent law and the competition rules

(Art. 101(1) TFEU; Council Regulation No 1/2003)

(see paras 196-214)

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 218-241)

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 286-304)

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 314-318)

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 proof

Cumulative nature of the conditions for exemption (Art. 101(1) and (3) TFEU; Council Regulation No 1/2003, Art. 2)

(see paras 327-345)

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 lawOriginator company 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 349-381)

CompetitionFinesDecision imposing finesObligation to state reasonsScopePossibility of the Commission departing from the Guidelines for the calculation of finesObligation to state reasons all the stricter

(Arts 101(1) and 296 TFEU; Council Regulation No 1/2003, Art. 23(2); Commission notice 2006/C 210/02, points 13 and 37)

(see paras 389-399)

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 401-434, 439-458)

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. 462)

CompetitionFinesAmountDeterminationWhether the Commission is obliged to abide by its previous decision-making practiceNone

(Art. 101 TFEU; Commission notice 2006/C 210/02)

(see para. 485)

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 applicants and, in the alternative, for reduction of the fine imposed on the applicants by that decision.

Operative part

The Court:

Dismisses the action;

Orders Teva UK Ltd, Teva Pharmaceuticals Europe BV and Teva Pharmaceutical Industries Ltd to pay, in addition to their own costs, the costs incurred by the European Commission;

Orders the European Generic medicines Association AISBL (EGA) to bear its own costs.