Case C-457/10 P

AstraZeneca AB

and

AstraZeneca plc

v

European Commission

‛Appeal — Competition — Abuse of dominant position — Market in anti-ulcer medicines — Abuse of procedures relating to supplementary protection certificates for medicinal products and of marketing authorisation procedures for medicinal products — Misleading representations — Deregistration of marketing authorisations — Obstacles to the marketing of generic medicinal products and to parallel imports’

Summary — Judgment of the Court (First Chamber), 6 December 2012

Competition — Fines — Amount — Determination — Criteria — Seriousness of the infringement — Abuse of a dominant position — Pharmaceutical undertaking — Submission of misleading information to the authorities enabling an exclusive right to be issued — Deregistration of marketing authorisations for pharmaceutical products

Appeals — Jurisdiction of the Court — Challenge on grounds of fairness to the General Court’s assessment concerning the amount of a fine imposed on an undertaking — Not included

Appeals — Grounds — Incorrect assessment of the facts and evidence — Inadmissibility — Review by the Court of the assessment of the facts and evidence — Possible only where the clear sense of the evidence has been distorted

Competition — Dominant position — Relevant market — Delimitation — Criteria — Demand side substitutability of the products — Launch of a new product — Gradual nature of the increase in sales of a new product not necessarily meaning that a competitive constraint is exercised by an existing product

The gradual nature of the increase in sales of a new product being substituted for an existing product does not necessarily mean that that latter product exercised on the former a significant competitive constraint. It is possible that, even in the absence of an earlier product, the sales of the new product would have evolved overall in the same gradual manner. Consequently, it cannot be assumed that there is, in principle, a causal link between the gradual nature of the increase in sales of the new product and a competitive constraint exercised by the existing products over that new product. (see para. 48)

See the text of the decision. (see para. 51)

The concept of ‘abuse’ is an objective concept referring to the conduct of a dominant undertaking which is such as to influence the structure of a market where the degree of competition is already weakened precisely because of the presence of the undertaking concerned, and which, through recourse to methods different from those governing normal competition in products or services on the basis of the transactions of commercial operators, has the effect of hindering the maintenance of the degree of competition still existing in the market or the growth of that competition. It follows that Article 82 EC prohibits a dominant undertaking from eliminating a competitor and thereby strengthening its position by using methods other than those which come within the scope of competition on the merits. The consistent and linear conduct of a pharmaceutical undertaking, characterised by the notification to the patent offices of highly misleading representations and by a manifest lack of transparency, by which that pharmaceutical undertaking deliberately attempted to mislead the patent offices and judicial authorities in order to keep for as long as possible its monopoly on the relevant market, falls outside the scope of competition on the merits. In this connection, the argument that where an undertaking in a dominant position considers that it can, in accordance with a legally defensible interpretation, lay claim to a right, it may use any means to obtain that right, and even have recourse to highly misleading representations with the aim of leading public authorities into error, is manifestly not consistent with competition on the merits and the specific responsibility on such an undertaking not to prejudice, by its conduct, effective and undistorted competition within the European Union. (see paras 74, 75, 93, 98)

Representations designed to obtain exclusive rights unlawfully constitute an abuse only if it is established that, in view of the objective context in which they are made, those representations are actually liable to lead the public authorities to grant the exclusive right applied for. Although the practice of an undertaking in a dominant position cannot be characterised as abusive in the absence of any anti-competitive effect on the market, it is not, however, necessary for such an effect to be concrete, since it is sufficient to demonstrate that there is a potential anti-competitive effect. (see paras 106, 112)

The preparation by a pharmaceutical undertaking, even in a dominant position, of a strategy whose object it is to minimise the erosion of its sales and to enable it to deal with competition from generic products is legitimate and is part of the normal competitive process, provided that the conduct envisaged does not depart from practices coming within the scope of competition on the merits, which is such as to benefit consumers. An undertaking which holds a dominant position has a special responsibility in that latter regard and it cannot therefore use regulatory procedures in such a way as to prevent or make more difficult the entry of competitors on the market, in the absence of grounds relating to the defence of the legitimate interests of an undertaking engaged in competition on the merits or in the absence of objective justification. The deregistration, without objective justification and after the expiry of the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials granted by EU law, of marketing authorisations with the aim of hindering the introduction of generic products and parallel imports does not come within the scope of competition on the merits. (see paras 129, 130, 134)

Provided that an appellant challenges the interpretation or application of EU law by the General Court, the points of law examined at first instance may be discussed again in the course of an appeal. Indeed, if an appellant could not thus base his appeal on arguments already relied on before the General Court, an appeal would be deprived of part of its purpose. (see para. 147)

The fact that the regulatory framework offers alternative means, which are longer and more costly, to obtain a marketing authorisation for pharmaceutical products does not prevent the conduct of an undertaking in a dominant position from being abusive where that conduct, considered objectively, has the sole purpose of rendering the abridged procedure provided for by the legislator in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 relating to proprietary medicinal products unavailable and therefore of excluding the producers of generic products from the market for as long as possible and of increasing the costs incurred by them in overcoming barriers to entry to the market, thereby delaying the significant competitive pressure exerted by those products. (see para. 154)

See the text of the decision. (see para. 162)

An abuse of a dominant position consisting in misleading representations made deliberately by an undertaking in order to obtain exclusive rights to which it is not entitled, or to which it is entitled for a more limited period, with the aim of excluding competitors from the market, and an abuse of a dominant position consisting, for a pharmaceutical undertaking, in deregistering the marketing authorisations for the medicinal products which it produces with the aim of hindering the entry to the market of generic products and parallel imports clearly constitute serious infringements. Having regard to the nature of those practices as manifestly contrary to competition on the merits, the novelty of such abuses cannot change their classification as serious infringements or constitute a mitigating circumstance justifying a reduction in the fine. (see paras 164, 166)

See the text of the decision. (see para. 176)