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

Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission

(Case T‑460/13)

‛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 — Agreement concluded between a patent holder and a generic undertaking — Fines — Legal certainty — Principle that penalties must have a proper legal basis — 2006 Guidelines on the method of setting fines — Duration of the Commission’s investigation’

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 58-64, 77-79, 119, 120, 142, 258)

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 65-73, 94, 95, 100)

3. 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 140, 141, 218, 222, 232, 242, 243, 259)

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. 172)

5. 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 206-212, 224-227, 259, 260, 265, 272, 279, 283)

6. 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 232, 289)

7. 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 274, 304-306)

8. 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 299-307, 376)

9. Competition — Fines — Amount — Determination — Commission not obliged to abide by its previous decision-making practice (Art. 101 TFEU; Council Regulation No 1/2003, Art. 23(2)) (see para. 312)

10. 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 357-361, 369)

11. 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. 362)

12. 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 paras 366-368)

Re:

APPLICATION for annulment in part 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 applicants by that decision

Operative part

The Court:

1. Dismisses the action;