1. 

Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Description of an undertaking as a potential competitor — Real, concrete prospects of market entry — Criteria — Essential evidence — Ability of the undertaking to enter the relevant market — Sufficiently fast entry — Perception of operators present on the market

(Art. 101(1) TFEU)

(see paras 46-65)

2. 

Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Description of an undertaking as a potential competitor — Criteria — Essential evidence — Ability of the undertaking to enter the relevant market — Generic medicines undertaking — Obstacles linked to the originator company’s patents and to the technical, regulatory and financial difficulties faced by the generic undertaking — Real concrete possibilities of overcoming those difficulties and entering the market

(Art. 101(1) TFEU)

(see paras 87-133)

3. 

Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Distinction between infringements by object and infringements by effect — Infringement by subject-matter — Whether sufficiently damaging — Assessment

(Art. 101(1) TFEU)

(see paras 150-161)

4. 

Competition — EU rules — Substantive scope — Amicable agreement on patents — Included — Balancing of patent law and the competition rules

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

(see paras 163-181)

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 — Agreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of products — Inducive reverse payment received by the generic undertaking — Restriction by object

(Art. 101(1) TFEU)

(see paras 183-209)

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 — Agreement containing clauses prohibiting patent challenges and clauses prohibiting the marketing of products — Payment received by the generic undertaking — Classification as an inducive reverse payment — Conditions

(Art. 101(1) TFEU)

(see paras 201-221)

7. 

Action for annulment — Purpose — Decision based on several pillars of reasoning, each sufficient to justify the operative part — Annulment of such a decision — Conditions

(Art. 263 TFEU)

(see paras 236-240)

8. 

Fundamental rights — Charter of Fundamental Rights of the European Union — Principle that offences and penalties must have a proper legal basis — Scope — Foreseeability of the infringing nature of the penalised conduct — Patent dispute settlement agreement between an originator company and a generic undertaking — Agreement contrary to competition law — Generic undertaking 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 243-255)

9. 

Competition — EU rules — Infringements — Committed intentionally or negligently — Meaning — Undertaking not capable of being unaware of the anti-competitive nature of its conduct

(Art. 101(1) TFEU; Council Regulation No 1/2003, Art. 23(1))

(see paras 259-268)

10. 

Competition — Fines — Amount — Determination — Methodology established by the Guidelines not applied — Calculation method — Deterrent effect of the fine — Need to set an amount higher than the benefit derived from the infringement

(Art. 101(1) TFEU; Council Regulation No 1/2003, Art. 23; Commission notice 2006/C 210/02, point 37)

(see paras 274-306)

11. 

Competition — Administrative procedure — Observance of the rights of the defence — Statement of objections — Production of additional evidence after sending the statement of objections — Lawfulness — Conditions

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

(see paras 310-317)

12. 

Competition — EU rules — Infringements — Attribution — Parent company and subsidiaries — Economic unit — Criteria for assessment — Exercise of decisive influence over the conduct of the subsidiary which may be inferred from a set of indicia relating to the economic, organisational and legal links with its parent company — Circumstances allowing the existence of decisive influence to be established — Influence of the parent company on the subsidiary’s decision-making processes — Actual control of the board of directors of the subsidiary — Obligation to consolidate the subsidiary’s annual financial statements with those of the parent company

(Art. 101(1) TFEU)

(see paras 331-369)

1. 

Dismisses the action;

2. 

Orders Mylan Laboratories Ltd and Mylan, Inc. to pay the costs.