1. 

Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Description of an undertaking as a potential competitor – Real or concrete possibilities of entering the market – Criteria – Firm intention and inherent ability of the undertaking to enter the relevant market – Sufficient preparatory steps to enter the relevant market – No insurmountable barrier – Assessment – Existence of a process patent

(Art. 101(1) TFEU)

(see paras 35-45)

2. 

Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Distinction between restrictions by object and by effect – Restriction by object – Sufficient degree of harmfulness – Assessment

(Art. 101(1) TFEU)

(see para. 84)

3. 

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 to delay the entry of the manufacturer of generic medicines into the relevant market – Consideration consisting in transfers of value – Characterisation of a restriction by object – Criteria – Assessment of whether transfers of value act as an incentive to refraining from entering the market

(Art. 101(1) TFEU)

(see paras 85-95)

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 108, 109)

5. 

Competition – EU rules – Infringements – Committed intentionally or negligently – Meaning – 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 – Included

(Art. 101 TFEU; Charter of Fundamental Rights of the European Union, Art. 47; Council Regulation No 1/2003, Arts 5, 23(2))

(see paras 122-126)

1. 

Dismisses the appeal.

2. 

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

3. 

Orders the United Kingdom of Great Britain and Northern Ireland to bear its own costs.