Judgment of the General Court (Ninth Chamber) of 8 September 2016 —

Merck v Commission

(Case T‑470/13)

‛Competition — Agreements, decisions and concerted practices — Market for antidepressant medicinal products containing the active pharmaceutical ingredient citalopram — Concept of restriction of competition ‘by subject-matter’ — Potential competition — Generic medicinal products — Barriers to market entry resulting from the existence of patents — Agreements concluded between a patent holder and a generic undertaking — Error of law — Error of assessment — Imputability of infringements — Liability of a parent company for infringements of the competition rules committed by its subsidiaries — Legal certainty — Reasonable time — Fines’

1. Judicial proceedings — Application initiating proceedings — Formal requirements — Brief summary of the pleas in law on which the application is based — General reference to documents annexed to the application — Inadmissibility (Statute of the Court of Justice, Art. 21, first para.; Rules of Procedure of the General Court, Art. 44(1)(c)) (see paras 56, 57, 441)

2. Agreements, decisions and concerted practices — Adverse effect on competition — Potential competition — Real and concrete possibility of a generic medicines undertaking entering the market at its risk in the presence of medicines protected by patents — Agreement between the holder of the patents and generic medicine undertakings capable of preventing such entry — Restriction on potential competition (Art. 101(1) TFEU) (see paras 81-87, 102, 103, 111, 112, 119, 120, 124, 151, 152, 164, 176, 179, 180, 227, 245, 300, 301)

3. Competition — Administrative procedure — Commission decision finding an infringement — Burden of proving the infringement and its duration on the Commission — Extent of the burden of proof — Degree of precision required of the evidence used by the Commission — Body of evidence — Presumption of innocence — Applicability — Evidential obligations of undertakings disputing the reality of the infringement — Judicial review — Scope (Arts 101(1) TFEU and 263 TFEU; Council Regulation No 1/2003, Art. 2) (see paras 88-96, 98, 99)

4. Actions for annulment — Jurisdiction of the EU judicature — Interpretation of the national law of a Member State — Question of fact — Included (Art. 263 TFEU) (see para. 136)

5. Act of the institutions — Statement of reasons — Obligation — Scope — Decision to apply competition rules — Judicial review — Scope (Arts 101 TFEU, 261 TFEU and 296(2) TFEU; Council Regulation No 1/2003, Art. 31) (see paras 140, 272, 493, 495)

6. Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Content and objective of a cartel and economic and legal context of its development — Distinction between infringements by subject-matter and infringements by effect — Intention of the parties to an agreement to restrict competition — Not a necessary criterion — Infringement by subject-matter — Sufficient degree of harmfulness — Criteria for assessment (Art. 101(1) TFEU) (see paras 185-191, 208-210, 212, 213, 258, 260, 262, 265, 385, 454-460)

7. Agreements, decisions and concerted practices — Prohibition — Infringements — Amicable agreement on patents — Agreement concluded between an originator company and a generic medicine undertaking — Reverse payments disproportionate in character and combined with an exclusion of competitors from the market — Not permissible (Art. 101(1) TFEU) (see paras 198, 224-226, 228, 231, 234, 248, 275, 283-288, 290, 292, 459)

8. Agreements, decisions and concerted practices — Adverse effect on competition — Amicable agreement on patents — Agreement concluded between an originator company and a generic medicine undertaking — Most profitable or least risky solution for the undertakings in question — Objective of mitigating the effects of excessively unfavourable legal rules — Irrelevant to the illegality of those agreements (Art. 101(1) TFEU) (see paras 248, 289, 387, 388)

9. Competition — Fines — Amount — Determination — No obligation on Commission to abide by its previous decision-making practice — Raising of the general level of fines — Lawfulness (Art. 101 TFEU; Council Regulation No 1/2003, Art. 23(2)) (see paras 263, 517-519)

10. Competition — EU rules — Infringements — Committed intentionally or negligently — Concept — Undertaking not capable of being unaware of the anti-competitive nature of its conduct — Agreement concluded between an originator company and a generic medicine undertaking — Reverse payments disproportionate in character and combined with an exclusion of competitors from the market — Inclusion (Art. 101 TFEU; Charter of Fundamental Rights of the European Union, Art. 47; Council Regulation No 1/2003, Arts 5 and 23(2)) (see paras 267, 501, 502, 509-512)

11. Competition — EU rules — Matters covered — Amicable agreement on patents — Inclusion — Agreement concluded between an originator company and a generic medicine undertaking — Application of the criterion of the scope of the patent — Test not relevant — Infringement by subject-matter (Art. 101(1) TFEU) (see para. 273)

12. Agreements, decisions and concerted practices — Adverse effect on competition — Ancillary restriction — Concept — Objective and proportionate nature — Restriction rendering the main operation more difficult or less profitable — Amicable agreement on patents — Agreement concluded between an originator company and a generic medicine undertaking — Clauses restricting competition ancillary to the protection of an intellectual property right — No objectivity necessary restriction (Art. 101(1) TFEU) (see paras 307, 308)

13. Competition — EU rules — Infringements — Attribution — Parent company and subsidiaries — Economic unit — Criteria for assessment — Presumption of decisive influence exercised by a parent company over its wholly-owned subsidiaries — Evidential obligations of the company seeking to rebut that presumption (Art. 101 TFEU) (see paras 427-435, 445)

14. Competition — Administrative procedure — Obligations of the Commission — Duty to act within a reasonable time — Annulment of the decision finding an infringement because of the procedure’s excessive duration — Condition — Harm to the rights of defence of the undertakings concerned — Assessment having regard to the proceedings as a whole (Art. 101 TFEU; Council Regulation No 1/2003, Art. 2) (see paras 470-474, 483)

15. Competition — Administrative procedure — Observance of the rights of the defence — Excessive duration of the administrative procedure — Disappearance of evidence relevant for the exercise of defence rights — Burden of proof — Obligations incumbent on a diligent undertaking (Art. 101 TFEU; Council Regulation No 1/2003, Art. 2) (see para. 475)

16. Competition — Administrative procedure — Limitation period for fines — Point from which time starts to run — Single and continuous infringement (Art. 101 TFEU; Council Regulation No 1/2003, Art. 25) (see para. 482)

17. Competition — Fines — Amount — Determination — Discretion of the Commission — Judicial review — Unlimited jurisdiction of the EU judicature — Scope — Reduction for excessive duration of the procedure — Account taken of the overall circumstances of the case (Arts 101 TFEU and 261 TFEU; Council Regulation No 1/2003, Arts 23(1), and 31) (see paras 493-495, 525, 526)

18. Competition — Fines — Joint and several liability for payment — Determination of the share of the fine to be borne by joint and several co-debtors in their internal relationship — Jurisdiction of the national courts (Art. 101(1) TFEU; Council Regulation No 1/2003, Art. 23(2)) (see paras 530-537)

Re:

APPLICATION for annulment of Commission Decision C(2013) 3803 final of 19 June 2013 relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39226 — Lundbeck), and for reduction of the amount of the fine imposed on the applicant by that decision.

Operative part

The Court:

1. Dismisses the action;

2. Orders Merck KGaA to bear its own costs and those incurred by the European Commission;