AstraZeneca v Commission (CJEU, C-457/10 P, 2012)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Court dismissed AstraZeneca’s appeal and the cross-appeals of the EFPIA and the Commission, upholding the General Court’s judgment which had largely confirmed the Commission’s decision finding two abuses of a dominant position on the market for proton pump inhibitors. The first abuse consisted of misleading representations to patent offices and national courts in order to obtain or keep supplementary protection certificates (SPCs) for omeprazole; the second, of requests to deregister the marketing authorisations (MAs) for Losec capsules so as to obstruct generics and parallel imports. The judgment sets a competition law limit on a dominant undertaking’s use of SPC and MA procedures.

Facts and procedure

Following a complaint by two generic companies of 12 May 1999 (para 16), the Commission found two abuses by decision of 15 June 2005 and imposed fines of EUR 46 million jointly and severally and EUR 14 million on AstraZeneca AB (paras 17 to 20). The General Court annulled the decision insofar as it found a restriction of parallel imports in Denmark and Norway, reduced the fines to EUR 40 250 000 and EUR 12 250 000 and otherwise dismissed the action (para 22). The AstraZeneca companies appealed, supported by the EFPIA; the Commission cross-appealed (paras 1 to 3).

The applicable law

The case turned on Article 82 EC (now Article 102 TFEU) and Article 54 of the EEA Agreement. Under the transitional rule in Article 19(1) of Regulation 1768/92, an SPC was available in Denmark and Germany only where the first MA in the Community had been obtained after 1 January 1988 (para 13). Directive 65/65 offered generics an abridged MA procedure relying on the reference product’s file (para 5). The Court recalled that abuse is an objective concept and that Article 82 EC prohibits a dominant undertaking from eliminating a competitor by methods outside competition on the merits (paras 74 and 75).

Question

Do misleading representations to patent offices to obtain SPCs, and the deregistration of MAs without objective justification, by a dominant undertaking fall within competition on the merits, and on what conditions do they amount to an abuse?

Decision

On the first abuse, AstraZeneca had given the offices « March 1988 » as the date of the first MA without disclosing the French technical authorisation of 15 April 1987, which would have barred an SPC in Denmark and Germany (paras 77 and 78). That consistent conduct, marked by highly misleading representations and a manifest lack of transparency, fell outside competition on the merits (para 93). However defensible its interpretation, AstraZeneca was bound to disclose all relevant information to the offices (paras 95 and 98). An objectively wrong representation is not abusive in itself, the assessment being made in concreto (para 99), and such representations are abusive only if they are actually liable to lead the authorities to grant the exclusive right sought (para 106). A potential anti-competitive effect suffices (paras 111 and 112).

On the second abuse, deregistering the Losec capsule MAs in Denmark, Sweden and Norway, without objective justification and after expiry of data exclusivity, was not competition on the merits (para 130). Its lawfulness under other rules was immaterial (para 132), and a dominant undertaking may not use regulatory procedures to prevent or hinder the entry of competitors (para 134). Pharmacovigilance obligations could justify deregistration, but the argument lacked a factual basis (paras 135 to 138). The situation was not comparable to a compulsory licence or to IMS Health (paras 148 and 149). The Court declined to reduce the fine on account of the novelty of the abuses (paras 164 to 166) and rejected the Commission’s cross-appeal for want of tangible evidence of an effect on parallel imports in Denmark and Norway (paras 196 and 202).

Key points for practice

• Misleading representations to patent offices in order to obtain SPCs may amount to an abuse of dominance, without any need for the right obtained to have produced concrete effects (paras 93 and 112).
• An undertaking relying on a contestable reading of the regulation must disclose it and provide all relevant information to the offices (para 95).
• Deregistering an MA, though lawful under pharmaceutical law, may be abusive where it aims to deprive generics of the abridged procedure (paras 132 and 154).
• Practical point: for a dominant undertaking, SPC filings and the management of its MA portfolio are also a matter of competition law, which calls for full transparency towards the authorities and a documented objective justification for any deregistration.

Provisions applied

Treaty on the Functioning of the European Union

Art. 102 (formerly Art. 82 EC)

Regulation (EEC) No 1768/92

Arts 3, 7, 8, 13 and 19

Other provisions

Directive 65/65/EEC, Arts 3, 4 and 10; EEA Agreement, Art. 54

Case law cited

Hoffmann-La Roche v Commission (85/76); United Brands v Commission (27/76); AKZO v Commission (C-62/86); France Télécom v Commission (C-202/07 P); TeliaSonera Sverige (C-52/09); AstraZeneca (C-223/01); IMS Health; Magill; Paranova Läkemedel and Others

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.