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

Generics (UK) v Commission

(Case T‑469/13)

‛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 — Rights of defence — Fines’

1. 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 69-75, 87, 93-97, 102, 105, 106, 110, 113, 116, 117, 120, 220)

2. 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 76-84, 89, 214)

3. 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 132-138, 149-152, 329)

4. 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 144, 213, 243-245, 253, 260-264, 275)

5. 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 209, 210, 266, 275, 280)

6. 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. 218)

7. Act of the institutions — Statement of reasons — Obligation — Scope — Decision to apply competition rules (Arts 101 TFEU, 296(2) TFEU; Council Regulation No 1/2003, Art. 31) (see para. 228)

8. Agreements, decisions and concerted practices — Prohibition — Exemption — Conditions — Burden of proof — Scope (Art. 101(3) TFEU; Council Regulation No 1/2003, Art. 2) (see paras 346-348, 354, 361)

9. Competition — Administrative procedure — Statement of objections — Provisional character — Necessary content — Limits (Art. 101 TFEU; Charter of Fundamental Rights of the European Union, Art. 41(2)(a); Council Regulation No 1/2003, Art. 27(1)) (see paras 369-372)

10. Competition — Fines — Amount — Determination — Discretion of the Commission — Judicial review — Unlimited jurisdiction of the EU judicature — Scope (Arts 101 TFEU, and 261 TFEU; Council Regulation No 1/2003, Arts 23(1), and 31) (see paras 398-400, 415)

11. 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 407, 408, 410, 411)

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;