Keywords

Summary



Keywords

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)

Summary

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 greater efficacy of the pharmaceutical product concerned, the different therapeutic use of that product from that of other pharmaceutical products, the trend o f asymmetrical substitution that characterises the growth in sales of that product and the corresponding decrease or the stagnation in sales of the other products, and price indicators, such as they result from the regulatory framework in force.

As regards therapeutic use, for the purposes of defining the relevant market, it is necessary to take account of differences between medicines’ modes of action where they give rise to different therapeutic uses and to disregard them where the medicines in question have a similar therapeutic use.

As regards price indicators, the specific features which characterise competitive mechanisms in the pharmaceutical sector do not negate the relevance of price-related factors in the assessment of competitive constraints, although those factors must be assessed in their specific context. In the pharmaceutical sector, competitive relationships respond to mechanisms which differ from those determining competitive interactions normally present in markets which are not so heavily regulated. In this respect, the Commission cannot maintain that, in principle, the ability of an undertaking to maintain its prices above the reimbursement level, where demand tends to be more elastic, constitutes in itself evidence of an absence of any significant competitive constraint, without examining the extent to which the price of other potentially substitutable products is reimbursed by the national health insurance system. Moreover, the circumstance that prescribing doctors are essentially guided by the therapeutic use of products does not make price-based indicators wholly irrelevant, since the latter may also be evidence of the competitive constraints on the relevant products.

The evidence referred to above constitutes a body of relevant data that is sufficient to establish the conclusion that other pharmaceutical products do not exercise, during the period of time examined, a significant competitive constraint over the product concerned. In those circumstances, the Commission does not commit a manifest error of assessment in finding that the relevant product market is composed solely of that pharmaceutical product.

(see paras 61, 153, 182-183, 203, 219-222)

5. In the context of a procedure in respect of an abuse of a dominant position in the pharmaceutical sector, for the purposes of defining the relevant market, the Commission is entitled to take the view that the differentiated therapeutic use of two pharmaceutical products designed to treat the same conditions is a factor supporting the conclusion that the relevant market does not include one of those products.

The fact that two pharmaceutical products are prescribed to treat the same conditions, or that both constitute first-line treatments, is of limited relevance, since it does not make it possible to determine whether, in the light of the differentiated therapeutic use of the two products, one of which is used to treat the severe forms and the other the less serious forms of the same conditions, one exercises a significant competitive constraint over the other.

(see paras 69, 71-73)

6. In a procedure initiated in respect of infringement of the competition rules, it is important that the Commission bases its assessment on all the relevant data that must be taken into consideration in a specific case. That implies inter alia that the Commission is required to examine with particular attention the relevant arguments and evidence submitted to it by the undertakings involved in the administrative procedure. However, it cannot be inferred from this that the Commission must rely solely on the evidence that it has gathered as a result of its own investigations. It is permissible for the Commission to rely on evidence submitted by the parties to the administrative procedure, provided that that evidence is reliable and relevant, the onus being on the Commission, if necessary, to supplement it with other evidence where the information submitted by the parties to the administrative procedure proves to be insufficient or defective.

(see paras 78-79)

7. In a procedure in respect of infringement of the competition rules, the Commission is obliged to set out the reasons for not using certain data in a study only to the extent that the parties to the administrative procedure have put forward arguments during that procedure that were specifically based on those data and where it is apparent that those data are relevant. The Commission cannot in any event be required to set out systematically the reasons why it does not use or rejects certain data from a study, since it is sufficient that it states the reasons on which its decision is based, mentioning the facts and points of law which provide the legal basis for the measure and the considerations which have led it to adopt its decision. That applies all the more given that the Commission is not required to discuss all the issues of fact and of law which have been raised by a party during the administrative procedure.

(see para. 81)

8. According to paragraphs 15 to 19 of the Commission’s notice on the definition of the relevant market for the purposes of Community competition law, the Commission assesses demand substitutability in the light of a theoretical approach which presupposes a small (in the range 5% to 10%) but permanent relative price increase in the product on the basis of which the relevant market is defined and which evaluates whether that hypothetical increase could be applied profitably by the hypothetical monopolist of the relevant product. According to that economic test, if substitution were enough to make such a price increase unprofitable because of the resulting loss of sales, substitutes must be regarded as exercising a significant competitive constraint over the relevant product. As regards the specific case of the launch of a new product, it is often the case that the sales development of such a product substituting, even partly, for an existing product takes a certain amount of time, and accordingly, that those sales develop gradually.

In accordance with that theoretical framework, in order to assess whether an existing product exercises a significant competitive constraint over a new product, it is necessary to consider whether, account being taken at the same time of the gradual growth in sales of the new product, a small increase in the price of the new product would lead to a shift in demand towards the existing product in such a way that that price increase would not be profitable, in view of the income which would have been generated had that increase not taken place. The gradual nature of the growth in sales of the new product would not necessarily disappear if that price increase were profitable and, consequently, if it were concluded that the existing product does not exercise a significant competitive constraint over the new product.

Consequently, the Commission is entitled to take the view that, in principle, the gradual nature of the increase in sales of a new product substituting for an existing product cannot, in itself, suffice to conclude that the existing product exercises a significant competitive constraint over the new one.

(see paras 87-90)

9. In a procedure in respect of abuse of a dominant position, the definition of the relevant market consists in identifying the significant competitive constraints on the product concerned during the relevant period and is therefore not concerned with the competitive constraints that that product might have exercised over other products. The concept of relevant market is different from other definitions of market often used in other contexts, such as the area where the companies sell their products or, more broadly, the industry or sector to which the companies belong. The fact that a product is the primary competitive focus of another product does not therefore mean that the former exercises a significant competitive constraint over the latter.

The fact that the absence or insignificance of those competitive constraints is due to the regulatory framework which determines the conditions of the competitive interactions between products and the extent to which they take place does not affect the relevance that should be ascribed, in the context of market definition, to the finding that those competitive constraints are non-existent or insignificant. Where it is established that a group of products is not subject to a significant extent to competitive constraints from other products, so that that group may be considered to form a relevant product market, the type or nature of the factors that shield that group of products from any significant competitive constraint is of only limited relevance, since the finding of an absence of such competitive constraints leads to the conclusion that an undertaking in a dominant position on the market thus defined would be able to affect the interests of consumers on that market by preventing, through abusive behaviour, the maintenance of effective competition.

(see paras 97, 174-175)

10. The position of an undertaking on the market of a pharmaceutical product can be determined by taking into account a number of factors, such as the importance of intellectual property rights and other rights of a regulatory nature, the advantages associated with its first-mover status, the relevance of price as a parameter of competition, the relevance of the presence of monopsony purchasers and of regulated price systems, and the relevance of research and development investment, promotional activities and financial resources. The Commission may not however disregard the importance that has to be attached to that undertaking’s generally very large market share throughout the entire relevant period in all the countries concerned.

Similarly, the fact that innovation is an essential parameter of competition in the pharmaceutical sector does not call in question the relevance that must be attached to that undertaking’s very high market share, as assessed in its context.

(see paras 244-245, 254)

11. The health systems which characterise markets for pharmaceutical products tend to reinforce the market power of pharmaceutical companies, since costs of medicines are fully or largely covered by social security systems, which to a significant extent makes demand inelastic. That is more particularly the case where a pharmaceutical undertaking, which is the first to offer a new product with an added therapeutic value in relation to existing products, is able to obtain a higher reimbursement level than that which will subsequently be granted to ‘me-too’ products. Vis-à-vis undertakings which enjoy first-mover status, the reimbursements paid by social security systems are set at relatively high levels in comparison with ‘me-too’ products and enable the pharmaceutical company which enjoys such status to set its price at a high level without having to worry about patients and doctors switching to other less costly products.

It matters little that the ability of a pharmaceutical undertaking to maintain a particularly high market share while charging significantly higher prices is made possible or favoured by social security systems, that circumstance having no bearing on the finding that that undertaking is able to maintain higher revenues than those of its competitors without the various players in the pharmaceutical product markets, namely patients, prescribing doctors, national social security systems and its competitors, being able to challenge that privileged position during the periods selected by the Commission for the purposes of determining dominance.

Since prices are influenced by decisions of public authorities as regards reimbursement levels or maximum prices, those prices are not the result of normal market forces. It is not therefore possible to argue that the level of a price set in such a context is competitive, since it has been set in the absence of competitive mechanisms for ascertaining where such a competitive level lies.

(see paras 262-263, 265)

12. A finding of market power, that is to say the ability of an undertaking to behave to an appreciable extent independently of its competitors, its customers and, ultimately, consumers, in the sense that it is in particular able to maintain prices at a higher level while retaining a much higher market share than those of its competitors, is not conditional on the ability of the undertaking to make use of that market power in such as way as to prevent effective competition from being maintained. As far as concerns practices intended to exclude or reduce competition, in order to be classified as an abuse of a dominant position, behaviour does not necessarily have to result from, or be made possible by, the economic strength of the undertaking, since no causal link is required between the dominant position and the abuse of that position.

(see para. 267)

13. It cannot be argued that intellectual property rights do not constitute a relevant factor for the purposes of determining the existence of a dominant position. Although the mere possession of intellectual property rights cannot be considered to confer such a position, their possession is none the less capable, in certain circumstances, of creating a dominant position, in particular by enabling an undertaking to prevent effective competition on the market. The possession and exercise of intellectual property rights may therefore be relevant evidence of the dominant position.

The argument that the taking into account of intellectual property rights and of their exercise, even if not abusive, in order to establish the existence of a dominant position is liable to reduce any incentive to create innovative products cannot be accepted. Innovation is in any event rewarded by the exclusivity that intellectual property rights confer on the author of the innovation.

Moreover, a dominant position is not prohibited per se ; only the abuse of such a position is so proscribed. In this respect, where the holder of the intellectual property right is regarded as enjoying a dominant position, the requirement that use of that right be non-abusive cannot be regarded as insufficient reward in the light of the incentives for innovation.

To be a relevant factor, the existence of solid protection by means of intellectual property rights does not necessarily have to be such as to exclude all competition on the market.

(see paras 270, 273-274)

14. The Commission may base its assessment of a pharmaceutical undertaking’s dominant position on a series of factors, foremost of which is its much higher market share than those of its competitors. Next, in view, first, of the specific features of the markets for pharmaceutical products, which are characterised by ‘inertia’ on the part of prescribing doctors, and, second, of the difficulties encountered by pharmaceutical undertakings to enter a market which increase in line with the number of competitors and products already on that market, the Commission is entitled to take the view that first-mover status is an appreciable competitive advantage. The fact that generic products are in a position to undermine the pharmaceutical undertaking’s dominant position does not call in question the fact that its first-mover status confers on it appreciable competitive advantages.

Furthermore, although the finding of the financial superiority of a pharmaceutical undertaking over that of its competitors, and the finding of the superiority of the financial and human resources devoted to research and development and to its sales force are not sufficient in themselves to warrant the conclusion that that undertaking is in a dominant position on the relevant market during the relevant period, those findings none the less constitute a series of relevant indicia which permit the inference that that undertaking has superior resources to those of its competitors such as to reinforce its market position in relation to them.

(see paras 278, 280, 285-286)

15. The submission to the public authorities of misleading information liable to lead them into error and therefore to make possible the grant of an exclusive right to which an undertaking is not entitled, or to which it is entitled for a shorter period, constitutes a practice falling outside the scope of competition on the merits which may be particularly restrictive of competition. Such conduct is not in keeping with the special responsibility of an undertaking in a dominant position not to impair, by conduct falling outside the scope of competition on the merits, genuine undistorted competition in the common market.

It follows from the objective nature of the concept of abuse that the misleading nature of representations made to public authorities must be assessed on the basis of objective factors and that proof of the deliberate nature of the conduct and of the bad faith of the undertaking in a dominant position is not required for the purposes of identifying an abuse of a dominant position. The question whether representations made to public authorities for the purposes of improperly obtaining exclusive rights are misleading must be assessed in concreto and that assessment may vary according to the specific circumstances of each case. In particular, it is necessary to examine whether, in the light of the context in which the practice in question was implemented, that practice was such as to lead the public authorities wrongly to create regulatory obstacles to competition, for example by the unlawful grant of exclusive rights to the dominant undertaking. In this respect, the limited discretion of public authorities or the absence of any obligation on their part to verify the accuracy or veracity of the information provided may be relevant factors to be taken into consideration for the purposes of determining whether the practice in question is liable to raise regulatory obstacles to competition.

Moreover, in so far as an undertaking in a dominant position is granted an unlawful exclusive right as a result of an error by it in a communication with public authorities, its special responsibility not to impair, by methods falling outside the scope of competition on the merits, genuine undistorted competition in the common market requires it, at the very least, to inform the public authorities of this so as enable them to rectify those irregularities.

Although proof of the deliberate nature of conduct liable to deceive the public authorities is not necessary for the purposes of identifying an abuse of a dominant position, intention none the less also constitutes a relevant factor which may, should the case arise, be taken into consideration by the Commission. The fact that the concept of abuse of a dominant position is an objective concept and implies no intention to cause harm does not lead to the conclusion that the intention to resort to practices falling outside the scope of competition on the merits is in all events irrelevant, since that intention can still be taken into account to support the conclusion that the undertaking concerned abused a dominant position, even if that conclusion should primarily be based on an objective finding that the abusive conduct actually took place.

Lastly, the mere fact that certain public authorities did not let themselves be misled and detected the inaccuracies in the information provided in support of the applications for exclusive rights, or that competitors obtained, subsequent to the unlawful grant of the exclusive rights, the revocation of those rights, is not a sufficient ground to consider that the misleading representations were not in any event capable of succeeding. Where it is established that behaviour is objectively of such a nature as to restrict competition, the question whether it is abusive in nature cannot depend on the contingencies of the reactions of third parties.

Consequently, the Commission applies Article 82 EC correctly in taking the view that the submission to the patent offices of objectively misleading representations by an undertaking in a dominant position which are of such a nature as to lead those offices to grant it supplementary protection certificates to which it is not entitled or to which it is entitled for a shorter period, thus resulting in a restriction or elimination of competition, constitutes an abuse of that position.

(see paras 355-361)

16. When granted by a public authority, an intellectual property right is normally assumed to be valid and an undertaking’s ownership of that right is assumed to be lawful. The mere possession by an undertaking of an exclusive right normally results in keeping competitors away, since public regulations require them to respect that exclusive right. The argument that a finding of an abuse of a dominant position requires that an exclusive right obtained as a result of misleading representations has been enforced cannot therefore be accepted.

Moreover, it is not the case that the unlawful acquisition of an exclusive right constitutes an abuse of a dominant position only where it would have the effect of eliminating all competition. The fact that the behaviour in question concerns the acquisition of an intellectual property right does not justify such a condition.

Furthermore, where behaviour falls within the scope of the competition rules, those rules apply irrespective of whether that behaviour may also be caught by other rules, of national origin or otherwise, which pursue separate objectives. Similarly, the existence of remedies specific to the patent system is not capable of altering the conditions of application of the prohibitions laid down in competition law and, in particular, of requiring proof of the anticompetitive effects produced by such behaviour.

(see paras 362, 364, 366)

17. Instructions sent to patent attorneys to file supplementary protection certificate applications cannot be regarded as equivalent to the filing of supplementary protection certificate applications before patent offices. The Commission therefore errs in law in considering that an abuse of a dominant position committed by an undertaking in a dominant position on a pharmaceutical product market starts when instructions are transmitted to patent attorneys to file supplementary protection certificate applications before the patent offices. The desired outcome of the alleged misleading nature of the representations, namely the grant of the supplementary protection certificate, can arise only from the time that the supplementary protection certificate applications are filed before the patent offices, and not when the patent attorneys, who have only an intermediary role, receive the instructions regarding those applications.

(see paras 370, 372)

18. In order to constitute an abuse of a dominant position, it is not necessary that the behaviour has a direct effect on competition. In a situation where the practices in question – if they are established – cannot, in any way, be regarded as being covered by normal competition between products on the basis of an undertaking’s performance, it is sufficient for it to be established that, in view of the economic or regulatory context of which those practices form part, they are capable of restricting competition. Thus, the ability of the practice in question to restrict competition may be indirect, provided that it is shown to the requisite legal standard that it is actually liable to restrict competition.

Moreover, in order to achieve its aim, conduct aimed at excluding competitors frequently requires cooperation from third parties, whether from public authorities or market players, since, in practice, such conduct is rarely capable of having a direct effect on the competitive position of competitors. Thus, the success of a practice of excluding competitors by setting up barriers to entry of a regulatory nature through unlawfully obtaining exclusive rights necessarily depends on the reaction of public authorities, or even that of national courts if proceedings have been brought by competitors in order to have those rights invalidated. None the less, 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.

Lastly, the fact that the effect on competition of the abusive behaviour would be felt only several years later does not cause the behaviour in question – if it is established – to lose its abusive character.

(see paras 376-377, 380)

19. The fact that an undertaking is no longer in a dominant position at the time when its abusive behaviour produces its effects does not alter the legal classification to be attached to its acts, since those acts were committed at a time when that undertaking was in a dominant position and it was therefore under a special responsibility not to allow its behaviour to impair genuine undistorted competition in the common market.

(see para. 379)

20. The burden of proof of the existence of the circumstances that constitute an infringement of Article 82 EC is borne by the Commission. It is therefore incumbent on the Commission to adduce evidence capable of demonstrating the existence of the circumstances constituting an infringement.

In this respect, any doubt of the Court must benefit the undertaking to which the decision finding an infringement was addressed. The Court cannot therefore conclude that the Commission has established the infringement at issue to the requisite legal standard if it still entertains any doubts on that point, in particular in proceedings for annulment of a decision imposing a fine.

In the latter situation, it is necessary to take account of the principle of the presumption of innocence resulting in particular from Article 6(2) of the European Convention on Human Rights, which is one of the fundamental rights which, acco rding to the case-law of the Court of Justice, reaffirmed in Article 6(2) EU, are general principles of Community law. Given the nature of the infringements in question and the nature and degree of gravity of the ensuing penalties, the principle of the presumption of innocence applies in particular to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments.

Thus, the Commission must show precise and consistent evidence in order to establish the existence of the infringement. However, it is not necessary for the Commission to adduce such evidence in relation to every aspect of the infringement. It is sufficient if the body of evidence relied on by the institution, viewed as a whole, and whose various elements are able to reinforce each other, meets that requirement.

(see paras 474-477, 839)

21. By replacing, in representations made to patent offices for the purposes of applying for supplementary protection certificates, the issue dates of technical marketing authorisations for medicinal products in several Member States by those corresponding to the publications of the price of the medicinal product in those countries, a dominant undertaking cannot reasonably be unaware that, in the absence of an express disclosure of the interpretation that it intends to adopt of the relevant legislation and which underlies the choice of the dates provided, those representations are liable to mislead the patent offices. Thus, there is no need for the Commission to demonstrate that undertaking’s bad faith or positively fraudulent intent on its part, it being sufficient to note that such conduct, characterised by a manifest lack of transparency, is contrary to the special responsibility of an undertaking in a dominant position not to impair by its conduct genuine undistorted competition in the common market.

(see paras 491, 493)

22. A pharmaceutical undertaking which adopts, over a period of several years, a consistent and linear course of conduct, characterised by the communication to the patent offices of several Member States of misleading representations for the purposes of obtaining the issue of supplementary protection certificates to which it is not entitled, or to which it is entitled for a shorter period, abuses its dominant position. Such misleading representations constitute a practice based exclusively on methods falling outside the scope of competition on the merits. Such conduct solely serves to keep manufacturers of generic products, wrongfully, away from the market by means of the acquisition of supplementary protection certificates in a manner contrary to the regulatory framework establishing those certificates.

(see paras 598, 608-609)

23. In order for an application for marketing authorisation of a generic medicinal product to be dealt with by way of the abridged procedure provided for in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 relating to proprietary medicinal products, the marketing authorisation of the reference medicinal product must still be in force in the Member State concerned on the date that that application is lodged. The abridged procedure is no longer available after withdrawal of the marketing authorisation of the reference medicinal product.

The data relating to the results of the pharmacological and toxicological tests and of the clinical trials which an undertaking carries out for the purposes of obtaining an original marketing authorisation are the fruit of an investment that it makes for the purposes of being able to market a medicinal product. Such an investment is characteristic of practices which come within the scope of competition on the merits and which are liable to benefit consumers.

Directive 65/65 has recognised the interest in protecting such investment by providing for a period of exclusivity during which only the owner of those data can use them. However, after the expiry of that period of exclusivity, point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 no longer confers on the owner of an original proprietary medicinal product the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials placed in the file and enables manufacturers of essentially similar medicinal products to benefit from the existence of those data in order to be granted a marketing authorisation under an abridged procedure.

In those circumstances, after expiry of the period of exclusivity, conduct designed to prevent manufacturers of generic products from making use of their right to benefit from the results of the pharmacological and toxicological tests and clinical trials produced for the purposes of marketing the original product is not based in any way on the legitimate protection of an investment which comes within the scope of competition on the merits, because, under Directive 65/65, the undertaking no longer has the exclusive right to make use of the results of those pharmacological and toxicological tests and clinical trials.

The deregistration by an undertaking of the marketing authorisations is only such as to prevent applicants for marketing authorisations in respect of essentially similar medicinal products from being able to make use of the abridged procedure and, therefore, to obstruct or delay the market entry of generic products. Similarly, depending on the attitude adopted by the national authorities towards deregistration of the marketing authorisation for a product for reasons unrelated to public health, such deregistration may be such as to prevent parallel imports.

The fact that an undertaking is entitled to request the deregistration of its marketing authorisations for medicinal products that it produces in no way causes that conduct to escape the prohibition laid down in Article 82 EC.

The fact that the regulatory framework offers an alternative route to obtaining a marketing authorisation does not remove the abusive nature of the conduct of an undertaking in a dominant position where that conduct, considered objectively, has the sole object of making the abridged procedure provided for by the legislature in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 unavailable and, accordingly, of keeping producers of generic products away from the market for as long as possible and increasing their costs in overcoming barriers to market entry.

Lastly, the fact that the delay caused to competitors in gaining access to the market is not evaluated precisely does not affect the finding that the conduct at issue is such as to restrict competition, where it is established that that deregistration results in the unavailability of the abridged procedure.

(see paras 669-670, 674-677, 812, 829, 831)

24. Whilst the fact that an undertaking is in a dominant position cannot deprive it of its entitlement to protect its own commercial interests when they are attacked, it cannot 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.

As regards conduct in which regulatory procedures are used without any basis in competition on the merits, evidence that, in view of its economic or regulatory context, that conduct is capable of restricting competition is sufficient to classify it as an abuse of a dominant position.

(see paras 672, 817, 824, 845)

25. The illegality of abusive conduct under Article 82 EC is unrelated to its compliance or non-compliance with other legal rules. In the majority of cases, abuses of dominant positions consist of behaviour which is otherwise lawful under branches of law other than competition law.

(see para. 677)

26. The case-law on ‘essential facilities’ relates, in essence, to circumstances in which a refusal to supply by an undertaking in a dominant position, by virtue, in particular, of the exercise of a property right, may constitute an abuse of a dominant position. That case-law therefore relates in particular to situations in which the free exercise of an exclusive right, being a right which rewards investment or innovation, may be limited in the interest of undistorted competition in the common market.

In the case of a pharmaceutical undertaking in a dominant position which deregisters the marketing authorisations for the medicinal products that it manufacturers, so as to render inapplicable the abridged procedure provided for in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 relating to proprietary medicinal products, thus restricting the use of the information derived from pharmacological and toxicological tests and clinical trials, the case-law on ‘essential facilities’ is not applicable. Thus, such conduct is not a refusal to give access to the results of the pharmacological and toxicological tests and clinical trials contained in the file, since the undertaking cannot, in any event, use its alleged property right to prevent the national authorities from relying on the data in question in the abridged procedure. Moreover, the fact that the abridged procedure is no longer available after withdrawal of the marketing authorisation of the reference medicinal product is not the concern to ensure that the manufacturer of the reference medicinal product has exclusivity with regard to the data that he has supplied, but the concern to ensure that public health is safeguarded, which constitutes a primary purpose of Directive 65/65.

(see paras 679, 682-683)

27. Although the Commission is required to take into account a possible objective justification for conduct which may constitute an abuse of a dominant position, it is still necessary for the undertaking concerned to raise that objective ground of justification during the administrative procedure and put forward arguments and evidence in support thereof. That is more specifically the case where the undertaking concerned is alone aware of that objective justification or is naturally better placed than the Commission to disclose its existence and demonstrate its relevance.

Since the lawfulness of a Community act is to be assessed in the light of the information available to the Commission when it was adopted, in proceedings before the Community judicature, no one can rely on matters of fact which were not put forward in the course of the administrative procedure.

(see paras 686-687)

28. The preparation by a pharmaceutical undertaking, even in a dominant position, of a strategy whose object it is to minimise 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.

However, the fact that an undertaking in a dominant position is under no obligation to protect the interests of competitors does not make practices implemented solely to exclude competitors compatible with Article 82 EC. The mere desire of an undertaking in a dominant position to protect its own commercial interests and to guard against competition from generic products and parallel imports does not justify recourse to practices falling outside the scope of competition on the merits.

(see paras 804, 816)

29. Under Community competition law different companies belonging to the same group form an economic unit and therefore an undertaking, if those companies do not independently determine their own conduct on the market.

In order for conduct to be capable of being classified as an abuse within the meaning of Article 82 EC, it is not necessary that it be implemented as a result of a strategy prepared at the management level of a group of companies.

Conduct implemented by one of the companies in the economic unit constituted by that group is also capable of infringing Article 82 EC.

Furthermore, where a subsidiary is wholly owned by a parent company, it is not necessary to examine whether the parent company is able to exert decisive influence over the policy of its subsidiary, since that subsidiary necessarily follows a policy laid down by the same executive bodies as those which determine that parent company’s policy.

(see paras 818-820)

30. Where an applicant requests the Court, in the body of the arguments set out in the application and in the reply, to reduce the amount of the fines that the Commission imposed on it for infringement of the competition rules, but omits, in the form of order sought, to formally seek an order that their amount should be reduced, such an omission does not preclude the Court’s exercising its unlimited jurisdiction in relation to fines. Even in the absence of any formal submission, the Court is authorised to reduce the amount of an excessive fine since such a result would not be ultra petita , but would on the contrary amount to a partial upholding of the application.

(see para. 884)

31. The concept of a single and continuous infringement relates to a series of actions which form part of an ‘overall plan’ because their identical object distorts competition within the common market. For the purposes of characterising various instances of conduct as a single and continuous infringement, it is necessary to establish whether they complement each other inasmuch as each of them is intended to deal with one or more consequences of the normal pattern of competition and, by interacting, contribute to the realisation of the objectives intended within the framework of that overall plan. In that regard, it is necessary to take into account any circumstance capable of establishing or casting doubt on that complementary link, such as the period of application, the content (including the methods used) and, correlatively, the objective of the various actions in question.

A single and continuous infringement encompasses conduct by a pharmaceutical undertaking which is consistent over time, stems from a strategy prepared by its central bodies and is characterised by the communication to the patent offices of misleading representations for the purposes of obtaining the issue of supplementary protection certificates to which it is not entitled or to which it is entitled for a shorter period.

(see paras 892-893)

32. 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 shorter period, the purpose of which is to keep competitors away from the market, quite clearly constitutes a serious infringement. The fact that such abuse is novel cannot call that finding into question, given that such practices are manifestly contrary to competition on the merits. Moreover, the fact that conduct with the same features has not been examined in past Commission decisions does not exonerate an undertaking.

33. An abuse of a dominant position consisting in the deregistration by a pharmaceutical undertaking of marketing authorisations for medicinal products that it manufactures, the purpose of which is to create obstacles to the market entry of generic products in several countries and to parallel imports in other countries, thus resulting in partitioning of the common market, also constitutes a serious infringement.

(see para. 901)

When determining the amount of the fine for infringement of the Community competition rules, factors relating to the object of a course of conduct may be more significant for the purposes of setting the amount of the fine than those relating to its effects.

(see paras 902, 911)