AstraZeneca AB and AstraZeneca plc v European Commission.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2010:266
• Court: General Court (European Union)
• Date: 01 July 2010
• Docket Number: T-321/05
• Celex Number: 62005TJ0321
• Procedure Type: Recours en annulation - fondé

Case T-321/05

AstraZeneca AB and AstraZeneca plc

v

European Commission

(Competition – Abuse of dominant position – Market in anti-ulcer medicines – Decision finding an infringement of Article 82 EC – Market definition – Significant competitive constraints – 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 – Fines)

Summary of the Judgment

1. Procedure – Request for confidential treatment – Criteria

2. Competition – Dominant position – Relevant market – Definition – Purpose

(Art. 82 EC; Commission Notice 97/C 372/03, points 2 and 7)

3. Competition – Administrative procedure – Commission decision finding an infringement – Decision requiring a complex economic or technical assessment – Judicial review – Limits

(Arts 81 EC and 82 EC)

4. Competition – Dominant position – Relevant market – Definition – Criteria – Pharmaceutical products

(Art. 82 EC)

5. Competition – Dominant position – Relevant market – Definition – Criteria – Pharmaceutical products

6. Competition – Administrative procedure – Commission decision finding an infringement – Evidence which has to be gathered

(Arts 81 EC and 82 EC)

7. Competition – Administrative procedure – Commission decision – Duty to state reasons – Scope

(Arts 81 EC, 82 EC and 253 EC)

8. Competition – Dominant position – Relevant market – Definition – Criteria – Demand substitutability of the products – Launch of a new product

(Art. 82 EC; Commission Notice 97/C 372/03, paras 15 to 19)

9. Competition – Dominant position – Relevant market – Definition – Criteria – Identification of the competitive constraints exercised over a product

(Art. 82 EC; Commission Notice 97/C 372/03, para. 3)

10. Competition – Dominant position – Holding of a very large market share an indicator – Pharmaceutical undertaking

(Art. 82 EC)

11. Competition – Dominant position – Existence – Evidence – Level of prices charged – Pharmaceutical undertaking – Effect of coverage by social security on prices of medicinal products

(Art. 82 EC)

12. Competition – Dominant position – Abuse – Concept – Need for a causal link between a dominant position and the abuse of that position – No such link necessary

(Art. 82 EC)

13. Competition – Dominant position – Existence – Evidence – Existence and use of intellectual property rights

(Art. 82 EC)

14. Competition – Dominant position – Existence – Evidence – Pharmaceutical undertaking – First‑mover status on a market – Financial strength of the undertaking

(Art. 82 EC)

15. Competition – Dominant position – Abuse – Submission of misleading information to the authorities – Information which makes the grant of an exclusive right possible – Whether abusive – Criteria for assessment

(Art. 82 EC)

16. Competition – Dominant position – Abuse – Submission of misleading information to the authorities – Information which makes the grant of an exclusive right possible – Whether abusive – Criteria for assessment

(Art. 82 EC)

17. Competition – Dominant position – Abuse – Concept – Start of the implementation of an abusive practice – Pharmaceutical undertaking – Submission of misleading information to the authorities

(Art. 82 EC)

18. Competition – Dominant position – Abuse – Submission of misleading information to the authorities – Information which makes the grant of an exclusive right possible – Whether abusive – Criteria for assessment

(Art. 82 EC)

19. Competition – Dominant position – Abuse – Anticompetitive effects of behaviour produced in the absence of a dominant position – Not relevant

(Art. 82 EC)

20. Competition – Dominant position – Abuse – Proof – Burden of proof – Presumption of innocence

(Art. 6(2) EU; Art. 82 EC)

21. Competition – Dominant position – Abuse – Obligations on the dominant undertaking – Pharmaceutical undertaking – Submission of misleading information to the authorities – Information which makes the grant of an exclusive right possible

(Art. 82 EC)

22. Competition – Dominant position – Abuse – Submission of misleading information to the authorities – Information which makes the grant of an exclusive right possible – Whether abusive – Pharmaceutical undertaking

(Art. 82 EC)

23. Competition – Dominant position – Abuse – Deregistration of marketing authorisations for pharmaceutical products – Deregistration preventing manufacturers of generic medicinal products from benefiting from the abridged procedure

(Art. 82 EC; Council Directive 65/65, Art. 4, third para., point 8, second para., (a)(iii))

24. Competition – Dominant position – Abuse – Concept – Use of regulatory procedures in such a way as to delay the entry of competitors on the market – Whether abusive – Criteria for assessment

(Art. 82 EC)

25. Competition – Dominant position – Abuse – Concept – Compliance of abusive conduct with other legal rules – Not relevant

(Art. 82 EC)

26. Competition – Dominant position – Abuse – Deregistration of marketing authorisations for pharmaceutical products – Deregistration preventing manufacturers of generic medicinal products from benefiting from the abridged procedure – Inapplicability of the case-law on essential facilities

(Art. 82 EC)

27. Competition – Dominant position – Abuse – Objective justification – Burden of proof

(Art. 82 CE)

28. Competition – Dominant position – Abuse – Obligations on the dominant undertaking – Pharmaceutical undertaking – Competition on the basis of merit – Scope

29. Competition – Dominant position – Abuse – Imputability – Parent company and subsidiaries – Economic unit

(Art. 82 EC)

30. Procedure – Application initiating proceedings – Formal requirements

(Rules of Procedure of the General Court, Art. 44(1))

31. Competition – Dominant position – Abuse – Single and continuous infringement – Classification – Criteria

(Art. 82 EC)

32. Competition – Fines – Amount – Determination – Criteria – Gravity of the infringement – Abuse of dominant position – Pharmaceutical undertaking – Submission of misleading information to the authorities which makes the grant of an exclusive right possible – Deregistration of marketing authorisations for pharmaceutical products

(Art. 82 EC)

33. Competition – Fines – Amount – Determination – Criteria – Object and effects of the infringement

(Arts 81 EC and 82 EC)

1. In an action for annulment brought against a Commission competition decision, the Court may grant an application by the applicant for confidential treatment of information that does not appear in the non-confidential version of the contested decision, published on the internet site of the Directorate-General for Competition of the Commission and which is therefore accessible to the public. However, an application for confidential treatment concerning information which appears in the non-confidential version of the contested decision must be dismissed. That information has in any event lost any confidential character it may have had, because it has been accessible to the public.

(see para. 25)

2. In the context of the application of Article 82 EC, the definition of the relevant market is carried out in order to define the boundaries within which it must be assessed whether a given undertaking is able to behave, to an appreciable extent, independently of its competitors, its customers and, ultimately, consumers.

For the purposes of investigating the possibly dominant position of an undertaking, the possibilities of competition must be judged in the context of the market comprising the totality of the products which, with respect to their characteristics, are particularly suitable for satisfying constant needs and are only to a limited extent interchangeable with other products; those possibilities of competition must also be assessed in the light of the competitive conditions and of the structure of supply and demand. The relevant product market therefore comprises all those products or services which are regarded as substitutable by consumers, by reason of the products’ characteristics, their prices and their intended use.

(see paras 30-31)

3. Although as a general rule the Community judicature undertakes a comprehensive review of the question as to whether or not the conditions for the application of the competition rules are met, the review of complex economic appraisals made by the Commission is necessarily limited to checking whether the relevant rules on procedure and on stating reasons have been complied with, whether the facts have been accurately stated and whether there has been any manifest error of assessment or a misuse of powers.

Likewise, in so far as the Commission’s decision is the result of complex technical appraisals, those appraisals are in principle subject to only limited review by the Court, which means that the Court cannot substitute its own assessment of matters of fact for the Commission’s.

However, while the Community judicature recognises that the Commission has a margin of assessment in economic or technical matters, that does not mean that it must decline to review the Commission’s interpretation of economic or technical data. In order to take due account of the parties’ arguments, the Community judicature must not only establish whether the evidence put forward is factually accurate, reliable and consistent but must also determine whether that evidence contains all the relevant data that must be taken into consideration in appraising a complex situation and whether it is capable of substantiating the conclusions drawn from it.

(see paras 32-33)

4. In the context of a procedure in respect of an abuse of a dominant position in the pharmaceutical field, for the purposes of defining the relevant market, the Commission may base its assessment inter alia on the...