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

Arrow Group and Arrow Generics v Commission

(Case T‑467/13)

‛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 — Fines — Legal certainty — Principle that penalties must have a proper legal basis — Duration of the Commission’s investigation — Rights of the defence — Single and continuous infringement’

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 62-68, 81-83, 106, 107, 111, 162, 263, 264)

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 69-77, 116, 117)

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 109, 110, 226, 230, 240, 243, 244, 265, 298)

4. 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 140, 240, 274)

5. 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 paras 167, 199)

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 214-220, 233-236, 262, 265, 266, 270, 281, 288)

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 283, 369-371)

8. 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 316-319)

9. 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 procedure as a whole (Art. 101 TFEU; Council Regulation No 1/2003, Art. 2) (see paras 334-338, 346)

10. 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. 339)

11. 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 343-345)

12. 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 352-355)

13. Agreements, decisions and concerted practices — Prohibition — Infringements — Agreements and concerted practices constituting a single infringement — Concept (Art. 101(1) TFEU) (see paras 382-384)

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;