C-418/01

1 — Original language: Italian. 2 — That article provides: 'Any abuse by one or more under- 3. Both parties to the proceedings are takings of a dominant position within the common market or in a substantial part of it shall be prohibited as engaged in the collection, processing and incompatible with the common market in so far as it may interpretation of data concerning regional affect trade between Member States. Such abuse may, in particular, consist in: sales of pharmaceutical products in Ger- (a) directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions; many. For present purposes, it is important (b) limiting production, markets or technical development to to point out that the studies produced by the prejudice of consumers; (c) applying dissimilar conditions to equivalent transactions those companies are structured on the basis with other trading parties, thereby placing them at a of a geographical criterion under which the competitive disadvantage; (d) making the conclusion of contracts subject to acceptance data on the sales of medicines are grouped by the other parties of supplementary obligations which, together in a series of areas into which by their nature or according to commercial usage, have no connection with the subject of such contracts.' Germany is subdivided. I - 5042

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8. PII, founded by a former director of IMS, initially drew up its reports on the 6. In order to involve the pharmaceutical basis of a segmentation of German territory industry in the determination of its own into 2201 areas. It emerged from contacts structures, IMS some years ago established with potential customers that data pro-

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cessed in that form would be difficult to That order was confirmed on 12 July 2001 market because it did not follow the by a judgment of the referring court but, on structures with which the pharmaceutical the date of the order for reference herein, it undertakings had brought themselves into had not acquired the force of res judicata. line. Accordingly, PIIwent over to working with 1860 and 3000 brick structures which were very close to those used by IMS. 3

10. In those proceedings the national court viewed the IMS structures as data banks (or parts thereof) which are protected by the German copyright law. Without expressing a view on the involvement of the RPM working group in the development of such structures, they considered IMS none the less to be a joint owner of copyright and Previous judgments of the national courts entitled as such to prevent unauthorised use of the structures.

15. On that premiss, in order to assess whether the refusal by IMS to grant a 13. The Commission upheld NDC's licence in respect of its structure constituted request and on 3 July 2001 adopted on an an abuse of a dominant position, the interim basis in line with the decision in Commission considered that it had to Camera Care 4Decision 2002/165/EC 'on a 'examine whether the 1860-brick or com- proceeding under Article 82 of the EC patible structure [was] indispensable to Treaty'. 5 By that decision the Commission compete on the relevant market, that is to (i) required IMS 'to grant a licence without say whether there [was] a realistic possibi- delay to all undertakings currently present lity for undertakings wishing to offer on the market for German regional sales regional sales data services in Germany to data services, on request and on a non- employ — instead of the 1860-brick or a discriminatory basis, for the use of the compatible structure — another structure 1860-brick structure, in order to permit the which would not infringe IMS's copy- use of and sales by such undertakings of right'. 7 Moreover, 'the answer to this regional sales data formatted according to question depend[ed] on whether there this structure' (Art. 1); (ii) provided for the [was] a real possibility for customers of manner in which royalties were to be regional sales data of buying data for- determined (Art. 2) and (iii) laid down the matted in another structure.' penalty for non-compliance to be imposed on IMS (Art. 30).

16. On the basis of its investigations and in particular in light of information received 14. In the part of the decision concerning from a number of pharmaceutical compa- the /limits boni juris and thus the prima nies questioned by it the Commission facie infringement of Article 82 EC by IMS reached an affirmative determination on the Commission considered that IMS held a thatquestion.'8

— 'Data for different time periods there- fore need to be comparable, and data in any new structure would have to be — the 'working group played an exten- converted to the 1860 structure (or sive role in designing' the 1860 brick vice versa) to ensure such comparabil- structure. 'The pharmaceutical indus- ity, at considerable cost.' 11 try in Germany invested considerable resources in ensuring that the brick structure fully met their requirements'. This in part explains their 'dependence, built up over a long period, on this structure, the extremely high disincen- tives they have to switch to a new one, and so the impossibility for a regional sales data service formatted in another — 'If regional sales data were supplied in structure to be able to compete'. 9 a structure which was not compatible with the 1860 structure, this would necessitate significant changes in the territories allocated to sales represen- tatives by their pharmaceutical compa- nies' with consequential 'loss of relationships between doctors and sales representatives' which would be the 'inevitable result of a change to a brick structure which was incompati- ble with the 1860-brick structure and — 'the 1860-brick structure functions as would act as a important disincentive an industry standard', in part because for certain pharmaceutical companies of the role played by the firms in this to make such a change.' 12 industry in its creation. The 'pharma- ceutical companies have become "locked in'" to 'this standard such that to switch away from it to buy sales 10 — Paragraphs 86 and 92. data formatted in a non-compatible 11 — Paragraph 93. 12 — Paragraph 114. With reference to the relationship between doctors and sales representatives the Commission observed in particular that 'the pharmaceutical companies attach great importance to the relationship between a doctor and a sales representative, which is one of the few means to 9 — Ibid. promote a drug.' (paragraph 113).

18. The Commission went on to highlight 20. On the basis of all the abovementioned the 'technical and legal constraints' which matters the Commission therefore consid- [might] make it unreasonably difficult for ered that the 1860-brick or compatible other undertakings to create another struc- structure was indispensable to compete on ture in which regional data sales services the relevant market. Taking the view that could be formatted and marketed in Ger- there were no objective grounds for refusal many'. 15 In that connection it observed that 'most of the parameters used in building the structure are in the public 16 — Paragraph 131. The Commission went on to state more domain and fixed (postcode areas, location specifically that 'the clear importance of using postcode areas limits the choices available to potential designers of of pharmacies and doctors, sociodemo- new brick structures' (paragraph 132); that 'there are graphic data, topology, territory able to be strong arguments for the necessity for brick structures to respect the boundaries of the 440 German Kreise' (paragraph 137), and that 'there is a probability that German data protection laws do impose certain constraints on the construction of a second structure in Germany' (paragraph 142). 13 — Paragraph 115. 17 — Paragraphs 143 to 145. 14 — Paragraph 122. 18 — Paragraphs 146 to 152. 15 — Paragraph 124. 19 — Paragraphs 153 to 166.

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of a licence 20 the Commission accordingly in question for the technical, legal and held that such refusal constituted a prima economic constraints referred to above is facie abuse of a dominant position. incapable of being replicated by means of a non-infringing parallel creation'. 23 Again with reference to the Community case-law 'there [was] no requirement for a refusal to supply to prevent the emergence of a new product in order to be abusive'. 24

23 — Paragraph 184. 24 — Paragraph 180. 20 — Paragraphs 167 to 174. 25 — Case T-184/01 R IMS Health v Commission [2001] ECR 21 — Paragraph 182. II-3193. 22 — Paragraph 184. 26 — Paragraph 105.

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23. The appeal by NDC against that order grant a licence constitutes an abuse of a was dismissed by the President of the Court dominant position, the Landgericht seeks a by order of 11 April 2002. 27 ruling by the Court on the following questions:

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make use of the data bank protected by which have already involved in various copyright relevant to the question of regards the Commission and the Presidents abusive conduct by an undertaking of the Court of First Instance and of the with a dominant position on the Court of Justice. Thus, in order to seek to market?' give a useful reply to the national court, in the light also of the Commission Decision and the interim orders adopted by the Community Courts, I consider it appro- priate to make some preliminary remarks concerning the scope of the questions and Procedure before the Court and the pro- the problems essentially raised by them. ceedings pending before the Court of First Instance

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for the use of its structure to persons erroneously adjudged that the refusal to seeking to use it in order to operate on the grant a licence constituted an infringement same market (geographical and product- of Article 82 EC even if it did not prevent based) in which the owner occupies the 'the emergence of a new product in a dominant position and asserts its right to market not connected with that in which that structure. the undertaking concerned was domi- nant'. 31

30 — Paragraph 182 of the Commission Decision. 31 — Paragraph 105 of the order of the President.

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and then considering the second and third undesirable consequences for the market together. Once that examination has been economy inasmuch as it would deprive the concluded, it will finally be appropriate to owners of an intellectual property right of make a few brief observations on the the due recompense for their creative problems relating to the simultaneous endeavour and would act as a disincentive application of Article 82 EC by the national to investments in innovation and research. court and the Commission.

First question

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allow the latter to compete with it more obligations of the Community under the effectively on the same market on which it WTO agreement on aspects of intellectual is exploiting its right. property rights relating to trade and the Bern Convention on the protection of literary and artistic works.

38. NDC's pleas and submissions are 36. IMS stresses, moreover, that in the plainly to the contrary. present case no reliance may be placed on the Magill judgment in order to maintain that the refusal to grant a licence constitutes an abuse of a dominant position. In that judgment the Court confirmed that a refusal to grant a licence may constitute 39. In particular that company maintains an abuse only in exceptional cases where (i) that the facts of the present case are it prevents the appearance of a new product analogous in a number of respects with not offered by the dominant undertaking the Magill case in which the Court held that which owns the intellectual property right the refusal by the owner of the copyright to and for which there is a potential demand; grant a licence constituted an abuse. As in (ii) it is unjustified; (iii) it has the effect of that case, reserving a derivative market to the domi- nant undertaking. In the present case the first and third conditions are not satisfied inasmuch as NDC is not seeking to introduce a new product on a derivative market but wishes to avail itself of the structure developed by IMS in order to — the intangible asset protected by copy- supply on the same market a product right is not the result of great creative almost identical to that developed by that effort and considerable investment (in company. the present case the structure is based to a large extent on the borders of the German postal codes and was brought into existence thanks to the decisive contribution of the pharmaceutical industry):

— the monopoly situation in regard to the upstream activity (in this case the brick structure) would be extended to down- 42. For its part the Commission maintains stream activity (marketing of studies that for the refusal by a dominant under- on regional sales of medicines). taking to allow its competitors access to an essential facility to be deemed an abuse it is not necessary for that facility to be in a market different from that in which the competitors seek to operate. To that end it is sufficient for the infrastructure to be located in an upstream production stage and for it to constitute a clearly separable input for the production of given upstream 40. The solution proposed by it is also goods or services. supported, in NDC's view, by the fact that it does not intend merely to reproduce the data collected by IMS but wishes autono- mously to collect and process the data on regional sales in order then to transpose them into a product of its own. Moreover, NDC stresses that in the present case the 43. More specifically, according to the intangible asset protected by the copyright Commission, for a given product or service constitutes a sectoral standard which, on to be deemed to be infrastructure or an the basis of the assessments by the Commis- essential input, it must be distinguishable sion in its guidelines on the applicability of from the downstream goods or services and Article 81 of the EC Treaty to horizontal between it and the downstream product or cooperation agreements, 34 should be as accessible as possible.

35 — in that regard NDC emphasises in particular that at paragraph 47 of the Magill judgment the Court did not assess whether in the present case two markets could 34 — OJ 2001 C 3, p. 2. technically be distinguished.

44. The mere fact that input essential for the production of the downstream goods or service is not independently marketed by the dominant undertaking does not operate Appraisal to exclude the unjustified refusal of access to that input from constituting abusive conduct. In that case as well refusal of access imposes a significant restriction of competition in the market for the down- 46. The question under examination, as stream goods or service in breach of has been seen, raises an important and Article 82 EC. The restriction would be delicate problem of interpretation of Arti- still more serious if the essential input were cle 82 EC concerning the obligation on a not in fact marketed given that the under- dominant undertaking to grant (for valu- takings concerned in the production of the able consideration) to its competitors the downstream goods or service could not right to use an intangible asset protected by secure that input indirectly by having copyright where that is essential for operat- recourse to third parties who had acquired ing on the same market in which that it from the dominant undertaking. undertaking is exploiting its right and occupying a dominant position.

45. That reasoning, the Commission adds, (a) Relevant case-law holds good also where the essential input is constituted by an intangible asset protected by copyright. If in fact that intangible asset is distinguishable from the downstream goods or service for the production of which it were essential, the refusal to grant 47. For the purposes of examining that a licence by the dominant undertaking question I believe that it is first necessary to owning the copyright would go beyond recall the judgments of the Court concern- the essential function of that right because it ing the possibility that a refusal to enter into

contractual relations may be deemed to was contrary to Article 86 of the EC Treaty constitute an abuse of a dominant position (now Article 82 EC) for a dominant under- in which (or at least in some of which) it is taking on the telediffusion market to refuse possible to discern an application of the without objective justification to allow essential facility doctrine, to which the television space to independent telemarket- parties have on several occasions ing undertakings thereby reserving to an referred. 36 associated company operations in that sphere, with the risk that that entails of eliminating all competition on that market. In regard to those facts the Court specifi- cally affirmed the principle that 'an abuse within the meaning of Article 86 is com- 48. In that connection I shall begin by mitted where, without any objective neces- recalling the Commercial Solvents judg- sity, an undertaking holding a dominant ment in which those problems were dealt position on a particular market reserves to with by reference to an interruption of the itself an ancillary activity which might be supply of raw materials. Upholding the carried out by another undertaking as part Commission Decision impugned in that of its activities on a neighbouring but case, the Court clarified that 'an under- separate market, with the possibility of taking which has a dominant position in the eliminating all competition from such market in raw materials and which, with undertaking.' 39 the object of reserving such raw material for manufacturing its own derivatives, refuses to supply a customer, which is itself a manufacturer of these derivatives, and therefore risks eliminating all competition on the part of this customer, is abusing its dominant position within the meaning of Article 8 6'. 37 50. With specific reference to intellectual property rights, the Volvo case must be considered next. In that case the Court was essentially asked whether that motor man- ufacturer was abusing its dominant position 49. In the Telemarketing judgment the on the (presumptive) market for original Court subsequently had occasion to specify spare parts by not granting to third parties that that reasoning 'also applies to the case a licence for the manufacture of such spare of an undertaking holding a dominant parts. In reply to that question the Court position on the market in a service which stated that 'the right of the proprietor of a is indispensable for the activities of another protected design to prevent third parties undertaking on another market.' 38 In that from manufacturing and selling or import- case the Community judicature held that it ing, without its consent, products incorpor- ating the design constitutes the very subject- matter of his exclusive right. It follows that 36 — With reference to that doctrine and its application in the United States and in Europe see in particular Opinion of Advocate General Jacobs in the Bronner case, cited above, paragraphs 45 to 53. 39 — Ibid. The same principle has been reaffirmed in a partly 37 — Paragraph 25 of the judgment cited. different context in the GB-Inno-BM judgment, para- 38 — Paragraph 26 of the judgment cited. graph 8.

— first, 'the appellants — who were, by force of circumstances, the only 51. Giving judgment on an appeal from sources of the basic information on two judgments of the Court of First programme scheduling which is the Instance in the well-known Magill case the indispensable raw material for compil- Court had the opportunity of returning to ing a weekly television guide — gave the question of a refusal to grant a licence viewers wishing to obtain information for the use of an intellectual property right. on the choice of programmes for the In the judgments appealed against the week ahead no choice but to buy the Court of First Instance had upheld a weekly guides for each station and decision in which the Commission had draw from each of them the informa- adjudged that certain television broad- tion they needed to make comparisons. The refusal to provide basic informa-

40 — Volvo judgment, paragraph 8. 41 — Paragraph 9 The Court ruled essentially to the same effect in the Renault judgment, cited above. 42 — Paragraph 50.

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— Thirdly, 'the appellants, by their con- duct, reserved to themselves the sec- 54. After recalling the Magill judgment, the ondary market of weekly television Court observed that 'even if that case-law guides by excluding all competition in on the exercise of an intellectual property that market... since they denied access right were applicable to the exercise of any to the basic information which is the property right whatever', it would still be raw material indispensable for the necessary in order to plead the existence of compilation of such a guide.' 45 an abuse within the meaning of Article 86 of the Treaty, not only for 'the refusal of the service comprised in home delivery to be likely to eliminate all competition in the daily newspaper market on the part of the person requesting the service and [for] such refusal to be incapable of being objectively 53. Finally, the Court had the opportunity justified, but also for the service in itself to of examining the problem of the refusal to be indispensable to carrying on that per- grant a licence in the well-known Bronner son's business, inasmuch as there [was] no judgment. In that case the Court, positing actual or potential substitute in existence for that home-delivery scheme.' 47

43 — Paragraphs 53 and 54. 44 — Paragraph 53. 46 — Paragraph 37. 45 — Paragraph 56. 47 — Paragraph 41.

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(b) Inferences the existence of a market in the nationwide home-delivery scheme for daily newspapers even where the undertaking holding a monopoly in such a (hypothetical) market did not independently sell the home-deliv- ery scheme.

58. To take a classic example of the essential facility doctrine it is instructive to consider the case where access to a port is indispensable in order to be able to provide maritime transport services in a given geographical market. For the purposes of such a case it may be assumed that the 56. As has been rightly pointed out by owner of the port uses that infrastructure NDC and the Commission, however, in on an exclusive basis in order to secure a order to identify an (upstream) market for monopoly over the market for maritime inputs the Court has not deemed it neces- transport services refusing without any sary that the latter be autonomously marketed by the dominant undertaking. In Magill the Court in fact identified a market for television listings even where they were 48 — In identifying the relevant market the Court does not seem to have taken into consideration the fact that the owner of not marketed independently by the televi- the delivery scheme provided a series of services to an independent publisher including home delivery of one of its sion broadcasters but merely offered free of daily newspapers. In that case the home-delivery scheme charge to certain newspapers. Then, in the was not sold independently hut formed part of a 'package' including the printing and sale i n kiosks of the daily Bronner judgment the Court acknowledged newspaper i nquestion.

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61. That said, I must none the less add that the judgments of the Court on the refusal to 59. Since it has therefore been established grant a licence over an intellectual property that in order to be able to identify a market right lead me to believe that, in order for an for upstream inputs it is not necessary for unjustified refusal to be deemed abusive, it them to be marketed independently by the is not sufficient that the intangible asset undertaking controlling them, it seems forming the subject-matter of the intellec- plain to me that such a market may by tual property right be essential for operat- definition be always identified where: (a) ing on a market and that therefore, by the inputs in question are essential (since virtue of that refusal, the owner of the they cannot be substituted or duplicated) to copyright may eliminate all competition on operating on a given market; (b) there is an the secondary market.

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65. Yet it is perhaps possible also to construe the Volvo judgment in this way. In that case the Court stated that 'a refusal to grant ... a licence cannot in itself constitute an abuse of a dominant posi- tion'. 50 Even though in that case a regis- tered design in respect of car body panels 63. That was in my view clearly held in the could be regarded as an essential input for Magill judgment in which, as has been seen, operating on the (presumptive) market for the Court held an unjustified refusal to original spare parts, it may be considered grant a licence to be abusive, inasmuch as that the Court did not deem the refusal to (a) 'it prevented the appearance of a new product, a comprehensive weekly guide to television programmes, which the appel- 49 — Paragraph 56. lants did not offer and for which there was 50 — Paragraph 8.

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carried out on the basis of another struc- structure constitutes an essential facility, ture. In that connection the decisive factor given that in certain circumstances they can is whether it is objectively possible for a mean that access to an infrastructure is competitor of comparable dimensions to essential where it normally would not be. develop an alternative structure.

72. NDC goes on to emphasise that, in line 69. In regard to the role played by the with the Bronner judgment, access to a pharmaceutical companies in the develop- predetermined infrastructure may be ment of the brick structure, IMS observes deemed essential where the creation of an that a contribution by customers to the alternative infrastructure would not be creation of products or services more and economically viable. In the present case more in keeping with their requirements is the costs of adjustment which would have entirely normal. In that context the imposi- to be borne by the pharmaceutical compa- tion of a requirement to grant a licence has nies in order go over to another brick negative consequences inasmuch as it structure would be so great that the would incite the undertakings to forgo any introduction of a competing structure not contact with customers in regard to the only would not be profitable but would development of their products. indeed be economically unviable.

73. For its part the Commission points out 70. As to the costs of adjustment to be that its decision indicates numerous matters borne by customers in order to be able to in support of the contention that the IMS use studies carried out on the basis of other 1860 brick structure is indispensable for the structures, IMS observes finally that the fact marketing of studies on regional sales of that the customers must incur expenditure medicines in Germany. The matters men- in order to opt for a different product is tioned by the national court are thus only entirely normal and cannot be relevant in some of those which must be taken into establishing whether a refusal to grant a consideration for the purposes of that licence entails an abuse of a dominant assessment. position.

dependency by the pharmaceutical compa- Assessment nies on that structure. In its view, that degree of regular and intense collaboration by customers aimed at the creation of a common structure for the provision of a series of compatible services displays the characteristics of a process leading to the establishment of a de facto standard. 77. For an analysis of the question under examination, it is appropriate to start with the Bronner judgment in which the Court provided certain useful indications in order to establish when a (tangible or intangible) asset or a service may be deemed to be essential for operating on a given market. 75. The Commission goes on to observe that in order to establish whether an infrastructure is essential, it must be assessed whether a competitor of analogous dimensions could create a valid alternative. For the purposes of that assessment, it would however be useful for there to be an attentive examination of the relevant fac- tors on the demand side and in particular of the adjustment efforts to be carried out by 78. In that case the Court specifically ruled customers in order to go over to another out that the only system of home delivery infrastructure. An analysis of the situation existing nationwide in a Member State was from the point of view of both supply and essential for the sale of daily newspapers, demand would in particular be opportune emphasising on the one hand that 'it is in order to establish whether the creation of undisputed that other methods of distribut- an alternative infrastructure is economically ing daily newspapers, such as by post and viable. through sale in shops and at kiosks, even though they may be less advantageous for the distribution of certain newspapers, exist and are used by the publishers of those daily newspapers.' Nor, moreover, were there 'any technical, legal or even economic obstacles capable of making it impossible, or even unreasonably difficult, for any other publisher of daily newspapers to 76. Referring to the assessments carried establish, alone or in cooperation with out in its decision, the Commission high- other publishers, its own nationwide lights the obstacles which in the present home-delivery scheme and use it to dis- case discourage the pharmaceutical compa- tribute its own daily newspapers.' 51 nies from moving to a brick structure incompatible with that of IMS and the extraordinary efforts, not only of a finan- cial nature, which that would entail. 51 — Paragraphs 43 to 44.

82. In my view those aspects must be examined jointly inasmuch as they both manifest themselves ultimately as financial 80. It is therefore clear from that judgment obstacles to the creation of an alternative that, in order to establish whether an 'input' structure. is essential for operating on a given market, it must be assessed whether (a) there are substitute inputs, which may be used to operate (more or less effectively) on the market in question; (b) there are obstacles of a technical, legislative or financial nature which may make it impossible or unrea- 83. In fact, according to the submissions of sonably difficult for any undertaking seek- NDC and the Commission, the intense ing to operate on that market to create involvement of the pharmaceutical under- other inputs possibly in conjunction with takings in the development of the IMS other operators. For there to be obstacles of structure, although not an absolute techni- a financial nature to the creation of alter- cal or legal impediment to a move to an native inputs, it must at least be the case, alternative structure, is one of the causes of the dependency of the pharmaceutical companies on the existing structure. But if 52 — Paragraphs 45 to 46. it is so, the involvement of the pharmaceu-

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tical industries in the development of the such an alternative structure possibly in IMS structure simply explains why those conjunction with other operators. industries have to make exceptional efforts in order to be able to go over to acquiring studies carried out on the basis of a different structure.

85. It must therefore be deduced that the level of participation of the pharmaceutical undertakings in the development of the structure protected by copyright and the 87. As indicated, before concluding I effort to be made by the pharmaceutical would like to devote certain summary undertakings in order to be able to acquire considerations to the problems arising in studies based on a structure other than the the present case with reference to the one protected by copyright are elements to application in this context of Article 82 be taken into account in establishing EC by the national courts and the Commis- whether or not there are obstacles of a sion. Those problems arise inasmuch as the technical, legislative or financial nature judgment to be delivered by the Court in which may make it impossible or extra- the present case, although indicating the ordinary difficult for any other undertaking manner in which Article 82 EC is to be seeking to operate on that market to create interpreted in regard to the questions

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formulated by the national court, will inasmuch as the interim nature of a decision presumably leave to the latter a certain certainly does not detract from its binding margin of appreciation in order to establish force or from the abovementioned duty of whether the refusal by IMS to grant a cooperation. As the Court has, moreover, licence constitutes an abuse of a dominant clarified, the prohibition on adopting deci- position. In theory the national court could sions in breach of Commission decisions give a ruling in conflict with the Commis- applies even where the operation of such sion Decision which established that such decisions is suspended on an interim basis refusal was prima facie contrary to Arti- by an order of the President of the Court of cle 82 EC. First Instance. 55

Conclusion

90. In light of the foregoing considerations I therefore propose that the Court should reply to the Landgericht in the following terms:

(1) Article 82 EC should be interpreted as meaning that the refusal to grant a licence for the use of an intangible asset protected by copyright entails an abuse of a dominant position within the meaning of that provision where (a) there are no objective justifications for such refusal; (b) use of the intangible asset is essential for operating on a secondary market with the consequence that by way of such refusal the owner of the right would ultimately eliminate all competition on that market. However, that is subject to the condition that the undertaking seeking the licence does not wish to limit itself essentially to duplicating the goods or services already offered on the secondary market by the owner of the intellectual property right but intends to produce goods or services of a different nature which, although in competition with those of the owner of the right, answer specific consumer requirements not satisfied by existing goods or services.

(2) The level of participation of the pharmaceutical undertakings in the development of the structure protected by copyright and the effort to be made by the pharmaceutical undertakings in order to be able to acquire studies based on a structure other than that protected by copyright are matters to be taken into account in establishing whether the latter structure is essential for the marketing of studies on regional sales of medicines.

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