Case C-457/10 P: Appeal brought on 16 September 2010 by AstraZeneca AB, AstraZeneca plc against the judgment of the General Court (Sixth Chamber, Extended Composition) delivered on 1 July 2010 in Case T-321/05: AstraZeneca AB, AstraZeneca plc v European Commission
Date: 2010-09-16
Institutions: Court of Justice
Subjects: European Commission, action for annulment (EU), intellectual property, market approval, patent, pharmaceutical industry, restriction on competition








C_2010301EN.01001802.xml










6.11.2010   


EN


Official Journal of the European Union


C 301/18





Appeal brought on 16 September 2010 by AstraZeneca AB, AstraZeneca plc against the judgment of the General Court (Sixth Chamber, Extended Composition) delivered on 1 July 2010 in Case T-321/05: AstraZeneca AB, AstraZeneca plc v European Commission
(Case C-457/10 P)
()
2010/C 301/27
Language of the case: English

Parties


Appellants: AstraZeneca AB, AstraZeneca plc (represented by: M. Brealey QC, M. Hoskins QC, D. Jowell, Barristers, F. Murphy, Solicitor)

Other parties to the proceedings: European Federation of Pharmaceutical Industries and Associations (EFPIA), European Commission

Form of order sought

The appellant claims that the Court should:






—


set aside the Judgment of the General Court of 1 July 2010 in Case T-321/05;










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annul Commission Decision (2005) 1757 final of 15 June 2005 (Case COMP A.37.507/F3 — AstraZeneca);










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in the alternative, reduce, at the Court’s discretion, the fine imposed on the Appellants in Article 2 of the contested Commission Decision;










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order the Commission to pay the costs.





Pleas in law and main arguments

The Appellants rely upon several errors of law in the Judgment. The errors are summarised under the separate headings that follow:






 



Definition of the relevant product market. The General Court has erred in law by upholding the Commission’s findings in the Decision on the relevant product market, that for the period 1993-2000 proton pump inhibitors (PPIs) were in a market of their own. There are two grounds of appeal.
The first ground of appeal has two principal parts. First, that the General Court has erred by failing to conduct a temporal analysis of the evidence thereby making a finding as to the relevant product market in 1993 on the basis of the state of competition between PPIs and H2 blockers in 2000. Second, that the General Court erred by ignoring the fact that the increase in use of PPIs was gradual on the basis that the practices of prescribing doctors, characterised by ‘inertia’ was irrelevant to the exercise of market definition.
The second ground of appeal is that the question of the overall cost of treatment by H2 blockers as opposed to PPIs is fundamental to any purported reliance on price differentials in the exercise of market definition and the General Court erred by failing to take the overall cost of treatment into account.










 



The first abuse of a dominant position, relating to supplementary protection certificates. The grounds of appeal on the first abuse fall into two principal parts. First, the General Court has erred in law in its assessment of what constitutes competition on the merits. The General Court was wrong in assessing whether the Appellant’s representations to patent offices were objectively misleading to have dismissed as irrelevant the reasonableness and bona fides of the Appellant’s understanding of its legal rights to a SPC. Lack of transparency is insufficient for a finding of regulatory abuse, there should be a requirement for deliberate fraud or deceit. Second, the General Court has erred in law in its assessment of what constitutes conduct tending to restrict competition. The General Court was wrong to find that the mere act of applying for an intellectual property right that may come into force some 5-6 years later was conduct that could be said to tend to restrict competition regardless of whether the right is ultimately granted and/or enforced. This is because the conduct is too disconnected or remote from the market said to be affected.










 



The second abuse of a dominant position: the withdrawal of marketing authorisations. The grounds of appeal on the second abuse fall into two principal parts. First, the General Court has erred in law in its assessment of what constitutes competition on the merits. The General Court was wrong to decide that the exercise of an unfettered right under Community law is a failure to compete on the merits.










 


Second, the General Court has erred in law in its assessment of what constitutes conduct tending to restrict competition. The General Court was wrong to find that the simple exercise of a legal right under Community law tends to restrict competition. Alternatively, if the Court of Justice considers that the exercise of a right afforded by Community law could in principle amount to an abuse, then there must be something more for there to be a finding of abuse than a mere tendency to distort competition. The Appellants submit that the Commission should be required to prove that the exercise of the validly held right tended to eliminate any effective competition. This would be similar to the conditions in cases concerning compulsory licensing, which effectively the second abuse is concerned with.










 



Fines. The General Court wrongly applied Article 15(2) of Regulation 17 (1) when it failed to object to the Commission’s calculation of the fine and failed to take proper account of the novelty of the alleged abuses, of the absence of any material effects on competition, and other mitigating circumstances.






(1)  EEC Council: Regulation No 17: First Regulation implementing Articles 85 and 86 of the Treaty OJ English special edition: Series I Chapter 1959-1962 p. 87