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Document 62016CJ0588
Judgment of the Court (Fourth Chamber) of 25 March 2021.
Generics (UK) Ltd v European Commission.
Appeal – Competition – Agreements, decisions and concerted practices – Pharmaceutical products – Market for antidepressants (citalopram) – Settlement agreements relating to disputes concerning process patents concluded by a manufacturer of originator medicines who is the holder of those patents and manufacturers of generic medicines – Article 101 TFEU – Potential competition – Restriction by object – Characterisation – Calculation of the amount of the fine.
Case C-588/16 P.
Judgment of the Court (Fourth Chamber) of 25 March 2021.
Generics (UK) Ltd v European Commission.
Appeal – Competition – Agreements, decisions and concerted practices – Pharmaceutical products – Market for antidepressants (citalopram) – Settlement agreements relating to disputes concerning process patents concluded by a manufacturer of originator medicines who is the holder of those patents and manufacturers of generic medicines – Article 101 TFEU – Potential competition – Restriction by object – Characterisation – Calculation of the amount of the fine.
Case C-588/16 P.
Court reports – general – 'Information on unpublished decisions' section
ECLI identifier: ECLI:EU:C:2021:242
Judgment of the Court (Fourth Chamber) of 25 March 2021 – Generics (UK) v Commission
(Case C‑588/16 P) ( 1 )
(Appeal – Competition – Agreements, decisions and concerted practices – Pharmaceutical products – Market for antidepressants (citalopram) – Settlement agreements relating to disputes concerning process patents concluded by a manufacturer of originator medicines who is the holder of those patents and manufacturers of generic medicines – Article 101 TFEU – Potential competition – Restriction by object – Characterisation – Calculation of the amount of the fine)
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 31-40) |
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. 66) |
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 67-73, 80) |
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 76, 77) |
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 – Reverse payments disproportionate in character and combined with an exclusion of competitors from the market – Included (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 91, 135-140) |
Operative part
The Court:
1. |
Dismisses the appeal. |
2. |
Orders Generics (UK) Ltd to bear its own costs and to pay the costs incurred by the European Commission. |
3. |
Orders the United Kingdom of Great Britain and Northern Ireland to bear its own costs. |
( 1 ) OJ C 30, 30.1.2017.