Lundbeck v Commission (CJEU, C-591/16 P, 2021)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Court dismissed Lundbeck’s appeal against the General Court judgment upholding the Commission’s decision penalising six agreements concluded in 2002 with manufacturers of generic citalopram. Applying the criteria laid down a year earlier in Generics (UK), it held that process patents do not preclude potential competition and that agreements delaying generic entry in return for reverse payments are restrictions by object, even where they do not go beyond the scope of the patents. The judgment also confirms that such an agreement may be fined without any prior decisional precedent, and that the later outcome of the patent dispute cannot be used to rebut, after the event, the existence of potential competition.

Facts and procedure

Lundbeck’s original patents on the citalopram active ingredient and two production processes had expired in the EEA between 1994 and 2003, in January 2002 for the United Kingdom; Lundbeck held new process patents, including a crystallisation patent granted by the EPO on 4 September 2002 (para 6). In 2002 it concluded six agreements with Merck (GUK), Alpharma, Arrow and Ranbaxy, which kept those generic manufacturers out of the markets concerned in return for transfers of value (paras 6 and 116). By decision of 19 June 2013, the Commission fined Lundbeck a total of EUR 93 766 000 (paras 1 and 6). The General Court dismissed its action on 8 September 2016 (T-472/13) (para 1).

The applicable law

The case concerns Article 101(1) TFEU and Article 53 of the EEA Agreement, together with Regulation 1/2003 and the 2006 Fining Guidelines (paras 2 and 3). The Court applied the criteria set out in Generics (UK) of 30 January 2020 (C-307/18) on potential competition and restriction by object (paras 52 to 60 and 112 to 115).

Question

Did the General Court err in law in holding that Lundbeck and the generic manufacturers were potential competitors despite the process patents, and that the agreements were restrictions by object liable to fines?

Decision

On potential competition, a process patent is not in itself an insurmountable barrier, since its presumption of validity sheds no light on the outcome of a dispute (para 58). The Commission did not have to prove that the generic citalopram did not infringe the new patents (para 61). The lack of an MA when the agreements were concluded does not exclude potential competition where sufficient preparatory steps had been taken (paras 83 and 84). Evidence postdating the agreements is admissible if it shows the parties’ positions at the time, but not the later outcome of the dispute: the confirmation in 2009 of the validity of the crystallisation patent by the EPO Board of Appeal and the Netherlands Patent Office, or the grant of interim relief in more than half of the proceedings, could not be taken into account (paras 67 to 72). Subjective factors may confirm potential competition, provided they are not decisive (paras 74 and 75).

On restriction by object, the characterisation applies where the net gain from the transfers of value can be explained only by the common interest in not competing on the merits (paras 114 and 115), and Lundbeck had put forward no legitimate consideration (para 118). Staying within the scope of the patents is irrelevant, since a patent does not entitle its holder to enter into contracts contrary to Article 101 TFEU (paras 120 to 122). The asymmetry of risk between originators and generics does not justify the agreements (paras 126 and 127). No prior condemnation of the same type of agreement is required (paras 130 and 131), the absence of a no-challenge clause is immaterial (paras 133 to 135), and no counterfactual analysis is needed for a restriction by object (paras 139 to 141). As to the fine, it is enough that the undertaking could not have been unaware of the anti-competitive nature of its conduct (paras 156 to 161); a national authority cannot create a legitimate expectation (para 170), and sales across the whole EEA could be taken into account (paras 189 to 193).

Key points for practice

• A process patent and its presumption of validity do not rule out potential competition from a generic company that has taken concrete steps to enter (paras 58 and 61).
• The later outcome of the patent dispute, even one favourable to the patentee before the EPO, cannot retrospectively neutralise a finding of potential competition (paras 68 and 71).
• A settlement that stays within the bounds of the patent may still be a restriction by object if the payments have no explanation other than the absence of competition (paras 114 and 122).
• Practical point: patent validity is to be defended before the patent court; paying a generic company to stay out exposes the patentee to a fine, which the later outcome of the dispute does not cure.

Provisions applied

Treaty on the Functioning of the European Union

Art. 101

Other provisions

EEA Agreement, Art. 53; Regulation (EC) No 1/2003, Art. 23(2); 2006 Fining Guidelines, points 6, 13 and 22; 2014 Technology Transfer Guidelines, point 29; Charter of Fundamental Rights of the European Union, Art. 49

Case law cited

Generics (UK) and Others (C-307/18); Schenker & Co. and Others (C-681/11); Pilkington Group and Others v Commission (C-101/15 P); Rosneft (C-72/15); Knauf Gips v Commission (C-407/08 P); E.ON Ruhrgas and E.ON v Commission (T-360/09)

Related decisions

• Generics (UK) v Competition and Markets Authority, 30 January 2020, the judgment whose criteria on potential competition and restriction by object the Court applies.

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.