Development product market and substitution of importance
"38. First, the General Court examined the competitive interaction between PPIs and H2 blockers throughout the period at issue, taking into account the evolution of the sales of those two products and the gradual nature of the increase in the use of PPIs at the expense of H2 blockers during that period."
Price comparison of H2-blockers and PPI’s of identical treatment period irrelevant in case of absence of competitive constraint due to therapeutic superiority PPI’s
"58. Even if, contrary to what was held by the General Court, the Commission had committed a manifest error of assessment by taking into account the price of medicinal products over an identical period of treatment and, moreover, the general cost of PPI-based treatment, as the appellants claim, did not in actual fact exceed that of H2 blocker-based treatment, the fact remains that H2 blockers were not liable to exercise a significant competitive constraint over PPIs having regard, in particular, to the weight given by doctors and patients to the therapeutic superiority of PPIs."
First abuse: knowingly trying to mislead patent offices and judicial authorities while obtaining Supplementary Protection Certificates (“SPC’s”)
"96. Thus, by making misleading representations to those patent offices, by concealing the existence of that French technical authorisation and deliberately leading them to believe that the date of 21 March 1988 corresponded to the Luxembourg technical authorisation and that that latter was the first MA in the Community, AZ knowingly accepted that those offices granted it SPCs which they would not have issued had they known of the existence of the French technical authorisation and which would have been shown to be unlawful in the event that the alternative interpretation proposed by AZ was not followed by the national courts or the Court of Justice."
Specific responsibility undertaking in dominant position: not to use every legally defensible interpretation and not to lead into error by misleading representations
"98. Regarded in the light of the facts found by the General Court, which the appellants have expressly stated that they are not calling into question, the third ground of appeal raised by them is tantamount to an 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. Such an approach 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."
Anti-competitive effect caused by unlawful SPC’s: By significant exclusionary effect on competition and adversely affecting potential competition by altering market structure even before expiry of patents
"108. As regards, in particular, those countries where the misleading representations enabled AZ to obtain unlawful SPCs, the appellants cannot deny the anti-competitive effect of those representations on the ground that the applications for the SPCs were filed between five and six years before the entry into force of those SPCs and that, until that time, AZ’s rights were protected by lawful patents. Not only do such unlawful SPCs lead, as the General Court observed at paragraphs 362, 375 and 380 of the judgment under appeal, to a significant exclusionary effect after the expiry of the basic patents, but they are also liable to alter the structure of the market by adversely affecting potential competition even before that expiry."
Second abuse: deregistration of Marketing Authorisation (“MA”) of original medicinal product to hinder registrations of generic medicinal products and parallel imports
"117. The General Court inferred, at paragraph 670 of the judgment under appeal, that the deregistration of the MA of the original medicinal product had the effect of preventing the applicant for a MA in respect of an essentially similar medicinal product from being exempted, pursuant to point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65, from having to carry out pharmacological and toxicological tests and clinical trials for the purposes of demonstrating the harmlessness and efficacy of the product in question. Thus, in this case, although the legislation no longer conferred on AZ the exclusive right to make use of the results of those tests and trials, the strict public health protection requirements which informed the Court of Justice’s interpretation of Directive 65/65 enabled it to prevent or make more difficult, by the deregistration of its MAs, the acquisition, by way of the abridged procedure, of MAs for essentially similar medicinal products, to which the manufacturers of generic products were none the less entitled."
Deregistration MA after period of exclusivity results pharmacological, toxicological and clinical trials to hinder generic products and parallel imports does not come within scope of competition on the merits to benefit consumers
"131. In this connection, it must in particular be stated that, as the General Court observed at paragraph 675 of that judgment, after the expiry of the period of exclusivity referred to above, conduct designed, inter alia, to prevent manufacturers of generic products from making use of their right to benefit from those results was not based in any way on the legitimate protection of an investment which came within the scope of competition on the merits, precisely because, under Directive 65/65, AZ no longer had the exclusive right to make use of those results."
Possibility of deregistering MA is not property right: restriction does not constitute expropriation or obligation to grant a licence
"149. In fact, the possibility provided for in Directive 65/65 of deregistering a MA is not equivalent to a property right. Consequently, the fact that, in the light of its special responsibility, an undertaking in a dominant position cannot make use of such a possibility in such a way as to prevent or render more difficult the entry of competitors on the market, unless it can, as an undertaking engaged in competition on the merits, rely on grounds relating to the defence of its legitimate interests or on objective justifications, does not constitute either an ‘effective expropriation’ of such a right or an obligation to grant a licence, but a straightforward restriction of the options available under European Union law."
IPPT20121206, CJEU, AstraZeneca v European Commission
C-457/10 P - ECLI:EU:C:2012:770
