Gerecht EU, 01-07-2010, nr. T-321/05

In recitals 381 to 386 of the contested decision, the Commission took the view that the therapeutic superiority of PPIs over H2 blockers pointed to the existence of a product market composed solely of PPIs. It thus found that there was a significant patient population suffering from gastrointestinal acid-related conditions for which only PPIs were an appropriate remedy. According to the Commission, doctors increasingly considered that PPIs constituted the most effective and appropriate remedy.

In support of their challenge to the Commission's view that the therapeutic superiority of PPIs constitutes a factor supporting a market definition comprising only PPIs, the applicants claim that PPIs and H2 blockers were used for the same therapeutic purposes, since H2 blockers were to a significant extent prescribed for the same conditions as PPIs. The applicants rely in this respect on written statements from medical experts that they submitted during the administrative procedure in reply to the statement of objections.

Having conducted an examination of the statements of the medical experts which were brought to its attention, the Court finds that those statements agree on the following points:

It is therefore apparent from the statements of the medical experts that, between 1991 and 2000, PPIs and H2 blockers were administered to treat the same conditions. However, it is also apparent from those statements that PPIs were generally prescribed to treat the severe forms of the conditions while H2 blockers were generally prescribed more to treat their mild or less serious forms.

In their statements, the medical experts sometimes stated that H2 blockers and PPIs were alternative first-line treatments, according to whether a ‘step-up’ or ‘step-down’ approach was adopted. However, the fact that PPIs were prescribed at the start of treatment or at a later stage, according to whether a ‘step-down’ or ‘step-up’ approach was chosen, does not change the finding that PPIs and H2 blockers were prescribed in different situations, in the context of a gradation of treatments.

The fact that H2 blockers were prescribed to treat the same conditions as PPIs, or constituted, just as much as PPIs, first-line treatments, is of limited relevance, since it does not make it possible to determine whether, in the light of the therapeutic use of PPIs, which were used above all to treat the severe forms of the conditions, H2 blockers exercised a significant competitive constraint over them. It is absolutely clear from the abovementioned statements that, once it was necessary to control symptoms of a certain degree of severity, H2 blockers were replaced by PPIs, whether at the beginning of the treatment, when a ‘step-down’ approach was adopted, or at the end of it, when a ‘step-up’ approach was chosen.

It is therefore apparent from the statements of the medical experts submitted by the applicants during the administrative procedure that, although they were prescribed to treat the same conditions, PPIs and H2 blockers were used differently. While PPIs were essentially prescribed to treat the severe forms of gastrointestinal acid-related conditions, H2 blockers were prescribed to treat the less severe, or mild, forms of those conditions. It should also be noted, as the Commission observed at the hearing, that that fact was put forward by the applicants themselves in reply to the statement of objections (point 4.41(ii)(b) of the reply to the statement of objections).

The Commission was therefore right to find, in recital 389 of the contested decision, that the fact, put forward by the applicants during the administrative procedure, that PPIs tended to be used only to treat the more severe forms of the conditions supported the conclusion that there was a relevant product market comprising PPIs only.

The applicants cannot claim that the differentiated use of PPIs and of H2 blockers, according to the step-up or step-down in treatment, constitutes a new element which cannot be taken into account in the review of the lawfulness of the contested decision. It is apparent from the contested decision that the Commission did in fact take account of the differentiation in the therapeutic use of those products, in response, indeed, to the arguments put forward by the applicants, as is evident from recitals 389, 490 and 502 of the contested decision.

In this respect, it should also be noted that, on the basis of AZ's internal documents, the Commission found, in recitals 384 and 490 of the contested decision, that the first PPI placed on the market, Losec, prompted the H2 blocker firms to turn their attention towards treatment of the mild forms of the conditions, which have traditionally been treated by antacids and alginates, and even to make their products available on a non-prescription basis.

Moreover, the fact, alleged by the applicants, which rely in this respect on the IMS Health report, that major gastrointestinal conditions still gave rise at the end of the relevant period and in most of the countries to a significant proportion of H2 blocker prescriptions, does not invalidate the conclusion that the therapeutic use of H2 blockers and PPIs was differentiated. Similarly, the assertion that H2 blockers were, to a small extent (the IMS Health report states 10%), prescribed to treat the severe forms of the conditions corroborates the view — which stems from the evidence submitted by the applicants themselves — that the severe forms of gastrointestinal acid-related conditions gave rise, overwhelmingly, to the prescription of PPIs.

The applicants and the EFPIA further claim that the Commission did not carry out any investigation as to doctors' actual prescribing practices and that the Commission chose data selectively from the IMS Health report without rebutting the other data contained in that report.

First of all, it should be recalled that it is important that the Commission bases its assessment on all the relevant data that must be taken into consideration in a specific case (see, to that effect, in relation to control of concentrations, Commission v Tetra Laval, paragraph 33 above, paragraph 39). 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 (see, to that effect and by analogy, GlaxoSmithKline Services v Commission, paragraph 46 above, paragraph 276).

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.

In this case, whilst it is true that the Commission did not undertake its own research into the therapeutic use of PPIs and H2 blockers by the medical community, the applicants produced several statements by medical experts which, as was observed in paragraphs 68 and 69 above, contained consistent evidence and also confirmed the relevant information in AZ's internal documents, to which reference is made in recital 502 of the contested decision. The Court therefore considers that the Commission was entitled, on that point, to take account of that information without carrying out its own investigations.

Next, as regards the alleged selective use of the data in the IMS Health report and the absence of any rebuttal of the other data in that report, and in so far as, by that argument, the EFPIA seeks to call in question the adequacy of the statement of reasons for the contested decision, it should be pointed out that 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 it is settled case-law that the Commission is not required to discuss all the issues of fact and of law which have been raised by the interested party during the administrative proceedings (Joined Cases 43/82 and 63/82 VBVB and VBBB v Commission [1984] ECR 19, paragraph 22; Joined Cases 142/84 and 156/84 BAT and Reynolds v Commission [1987] ECR 4487, paragraph 72; and Case T-2/93 Air France v Commission [1994] ECR II-323, paragraph 92).

Moreover, in so far as the EFPIA complains that the Commission failed to take into consideration certain elements of the IMS Health report, it must be stated that the EFPIA does not specify what those elements are, and the mere reference to the general conclusions of the IMS Health report is in this respect manifestly insufficient to identify any error by the Commission.

It should be noted, first of all, that it is common ground that the ‘inertia’ which characterised doctors' prescribing practices stems from their caution with regard to PPIs, in respect of which they were concerned about possible side effects. As the applicants claim, it is clear from the Lexecon report that doctors generally need time to get to know a new medicine and to be prepared to prescribe it. Similarly, it is apparent from the statements of the medical experts submitted by the applicants that prescribing doctors were concerned about the possible carcinogenic effects of PPIs.

The Court observes, next, that tables 17 to 23 in the Annex to the contested decision show that the number of PPI treatments prescribed increased gradually between 1991 and 2000 and overtook the number of H2 blocker treatments prescribed in Sweden in 1994, in Norway and Belgium in 1996, in Germany and Denmark in 1997, and in the Netherlands and the United Kingdom in 1998. Moreover, tables 9 to 15 in the Annex to the contested decision show that sales of PPIs, estimated in value terms, also increased gradually and overtook sales of H2 blockers in Sweden in 1992, in Belgium in 1994, in Denmark, Norway, the Netherlands and the United Kingdom in 1995 and in Germany in 1996.

The question whether during the relevant period H2 blockers exercised a significant competitive constraint over PPIs is a complex one which, as stated at paragraph 25 of the Notice on market definition, can be determined on the basis of a range of evidence consisting of various items, often of an empirical nature, the Commission having to take into account all relevant available information. In the present case, the applicants allege a manifest error of assessment by the Commission and focus, in the context of this plea, on a single aspect of the analysis carried out by the Commission in order to define the relevant market, namely they argue that the gradual nature of the increase in sales of PPIs at the expense of H2 blockers constitutes a decisive factor showing that, during the relevant period, H2 blockers must have exercised a significant competitive constraint over PPIs.

In order to evaluate the merits of the applicants' arguments, both in principle and in the specific circumstances of this case, it is necessary to place them in the theoretical framework adopted by the Commission in the Notice on market definition for the purposes of determining competitive constraints, in the light of which the Commission aims to assess the various available items of evidence in each specific case.

In paragraphs 15 to 19 of the Notice on market definition, the Commission states that it seeks to assess 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 to evaluate whether that hypothetical increase could be applied profitably by the hypothetical monopolist of the relevant product. According to that economic test, as set out in paragraph 17 of the Notice on market definition, 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, and as is apparent inter alia from paragraph 45 of the Commission Notice establishing Guidelines on the applicability of Article 81 [EC] to horizontal cooperation agreements (OJ 2001 C 3, p. 2), it is often the case that the sales development of a new product substituting, even partly, for an existing product takes a certain amount of time, and accordingly, that those sales develop gradually.

In accordance with the theoretical framework (noted in paragraph 87 above) with which the Commission aims to assess the available items of evidence 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. It should be pointed out that 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 Court finds that the Commission was 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.

Even if that conclusion is founded on reasoning which relies on an economic approach based on the observation of the reaction of demand to relative price changes, it is also applicable to the present case and is not invalidated by the specific features, alleged by the applicants, which characterise pharmaceutical product markets, namely, in particular, that prescribing doctors and patients display only limited sensitivity to price changes. Whatever the actual applicability of the theoretical approach set out in paragraph 87 above to pharmaceutical product markets, and without needing to adopt a position in this respect, the Court notes that the assertion that prescribing doctors and patients are not sensitive to relative price changes does not affect the validity of the view that, in principle, the gradual nature of the increase in sales of a new product substituting for an existing product is not sufficient to conclude that the existing product necessarily exercises a significant competitive constraint over the new one.

In the present case, it is common ground that sales of PPIs increased gradually on account of the caution displayed by doctors towards a medicine whose properties were not yet entirely known to them and of their concerns about its possible side effects. However, the applicants adduce no evidence permitting the inference that that gradual increase in sales of PPIs was caused by a significant competitive constraint exercised by H2 blockers. They merely postulate a presumption of a causal link between the gradual nature of the increase in sales of PPIs and a competitive constraint exercised by H2 blockers over PPIs.

As was explained above, there is no such presumption in principle. Moreover, no element specific to this case gives grounds for the view that there is such a causal link in the present case. The applicants adduce no evidence to show that the caution displayed by doctors or their concerns in relation to PPIs influenced the ability of H2 blockers to exercise a significant competitive constraint over PPIs and, accordingly, the capacity of undertakings marketing PPIs to behave independently of H2 blockers.

It should be noted, in this respect, that it is common ground that the degree of ‘inertia’ of prescribing doctors influenced directly the level of income generated by PPIs and H2 blockers, since that ‘inertia’ slowed down sales of PPIs and, accordingly, the process of substitution of PPIs for H2 blockers. However, that fact alone does not show that H2 blockers exercised a significant competitive constraint over PPIs.

At the hearing, the applicants asserted that it was not possible to take the view that H2 blockers did not exercise any significant competitive constraint over PPIs in 1993, given that PPIs were still entering only tentatively into the market of H2 blockers, as evidenced by the difference between the still modest sales of PPIs and the much higher sales of H2 blockers in Germany, Belgium, Denmark, Norway, the Netherlands and the United Kingdom.

The Court points out, however, that the fact that sales of PPIs were much lower than those of H2 blockers in 1993 does not permit the conclusion that the latter exercised a significant competitive constraint over PPIs during that year. Likewise, the fact that, at a certain point in time, sales of PPIs overtook sales of H2 blockers is not in itself capable of showing that H2 blockers no longer exercised a significant competitive constraint over PPIs at that specific point. None the less, the finding of a trend of asymmetrical substitution characterised by the growth in sales of PPIs and the decrease or stagnation in sales of H2 blockers, in conjunction with the finding of a repositioning in the use of H2 blockers towards the treatment of the milder forms of the conditions, which have traditionally been treated by antacids and alginates, on account of the fact that PPIs were becoming increasingly dominant (see recitals 384 and 490 of the contested decision), supports the view that H2 blockers did not exercise any significant competitive constraint over PPIs.

Moreover, the fact that PPIs exercised a considerable competitive constraint over H2 blockers and, consequently, that PPIs belonged to the H2 blocker market between 1991 and 2000 is irrelevant in the context of this case, since it does not mean that H2 blockers exercised a significant competitive constraint over PPIs and, therefore, that H2 blockers belonged to the PPI market. The definition of the relevant market consists, in the present case, only in identifying the significant competitive constraints on PPIs during the relevant period and is therefore not concerned with the competitive constraints that PPIs might have exercised over other products. As the Commission rightly observed in recital 493 of the contested decision, it is clear from paragraph 3 of the Notice on market definition that 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. Thus, the fact that H2 blockers were Losec's primary competitive focus does not mean that H2 blockers exercised a significant competitive constraint over Losec.

The applicants further claim that ‘inertia’ on the part of prescribing doctors depends on how good the pre-existing medicine is and what advantages the new product has. In this respect, it may be accepted that the quality of the pre-existing product may influence the degree of ‘inertia’ of prescribing doctors, in so far as, where there are doubts about the side effects of the new product, those doctors may consider it more prudent to continue prescribing the pre-existing product if its therapeutic efficacy is deemed sufficient. In the present case, the Court none the less points out that it is evident from the material in the file, and in particular from the Lexecon report and the statements of the medical experts submitted by the applicants themselves, that the ‘inertia’ characterising prescribing practices stems primarily from the caution that normally characterises doctors' attitudes towards a new product with whose properties they are not yet very familiar and, more specifically, from their significant concerns as to the possible carcinogenic side effects of PPIs.

The applicants cannot therefore claim that the ‘inertia’ characterising doctors' prescribing practices is, as a whole, attributable to the therapeutic quality of H2 blockers.

To the extent that the applicants seek to claim that the quality of H2 blockers significantly influenced the degree of ‘inertia’ characterising doctors' prescribing practices, the Court notes that they adduce no evidence to that effect, whereas the material in the file tends to indicate that that was not the case. It is not disputed that the therapeutic power of PPIs is much greater than that of H2 blockers. As the Commission found in recital 382 of the contested decision, PPIs were thus deemed to provide the only effective remedy to treat a number of gastrointestinal acid-related conditions, and more specifically the severe forms of those conditions. The fact that PPIs and H2 blockers were prescribed sequentially in the context of a single course of treatment, depending on whether that treatment was being stepped down or stepped up, does not affect that finding. On the contrary, it tends to confirm it.

Moreover, as the Commission observes, it is apparent from tables 17 to 23 in the Annex to the contested decision that the number of PPI treatments in 2000 was much higher than the number of H2 blocker treatments in 1991 in most of the relevant countries. Thus, the number of PPI treatments in 2000 is considerably higher than the number of H2 blocker treatments in 1991 or 1992 in Denmark, Norway, the Netherlands and in Sweden, and, to a significant extent, in Germany. It is only in Belgium and the United Kingdom that the numerical superiority of PPI treatments in 2000 over H2 blocker treatments in 1991 was less pronounced.

The fact that PPIs were deemed to be the only effective treatment for the severe forms of gastrointestinal conditions, that PPIs and H2 blockers therefore had different therapeutic uses and that the growth in PPIs was in many cases very largely not at the expense of H2 blockers supports the argument that the ‘inertia’ of doctors depended more, as the Lexecon report concluded, on the accumulation and dissemination of information on the properties of PPIs than on the quality of H2 blockers.

The applicants submit that the finding that the number of PPI treatments in 2000 was appreciably higher than the number of H2 blocker treatments in 1991 or in 1992 cannot be taken into consideration in the review of the lawfulness of the contested decision, since that fact was not expressly referred to in that decision. However, the Court points out that that finding was made on the basis of the tables annexed to the contested decision. It cannot therefore be considered to constitute a new element which cannot be taken into consideration, at the stage of the review of the lawfulness of the contested decision, for the purposes of responding to an objection against the Commission's reasoned assessment that the gradual nature of the increase of PPIs does not necessarily show that H2 blockers exercised a significant competitive constraint over PPIs.

The EFPIA also claims that it is not sufficient to show that sales by value of PPIs increased and sales by value of H2 blockers decreased or stagnated in order to conclude that the latter no longer exercise any competitive constraint over PPIs. However, and as is apparent from the examination of the second plea, the Court points out that the Commission's analysis does not rely on that finding alone, the Commission having, on the contrary, based its definition of the relevant product market on a series of factors, namely therapeutic uses, price indicators and the ‘natural events’ observed in Germany and the United Kingdom, and those factors were indeed contested one by one by the applicants and the EFPIA.

Lastly, it is necessary to reject the applicants' argument alleging that the Commission lacked consistency in so far as, in the contested decision, on the one hand, it rejected the relevance of the phenomenon of ‘inertia’ characterising prescribing practices in the context of its analysis of the market definition, and, on the other hand, accepted the relevance of that phenomenon of ‘inertia’ in the context of the assessment of AZ's dominant position. In this respect, the Court notes that, as the Commission observes, ‘inertia’ is a factor which is liable to reinforce the market position of an incumbent product by creating barriers to entry or expansion for competing products newly introduced on the market. That circumstance is not however at odds with the view that the ‘inertia’ of prescribing doctors does not permit the inference that H2 blockers exercised a significant competitive constraint over PPIs.

It follows from all the foregoing that the Commission did not commit a manifest error of assessment in rejecting the argument that the gradual nature of the increase in sales of PPIs at the expense of H2 blockers meant that H2 blockers exercised a significant competitive constraint over PPIs and that H2 blockers had, for that reason, to be included in the relevant product market.

The Court therefore dismisses the applicants' first plea in law with regard to the definition of the relevant market.

The applicants and the EFPIA claim in essence that the Commission relied excessively on a description of the therapeutic characteristics of the products, without taking into account the therapeutic uses of the relevant products, which, in their view, are identical.

The Court observes in this respect that, in recitals 373 to 379 of the contested decision, the Commission began its analysis of the market definition by stating, in the first place, that PPIs and H2 blockers displayed significant differences in terms of mode of action. The Commission thus noted that, on account of their unique mode of action, which was to act directly on the acid-producing proton pump, PPIs were therapeutically superior to H2 blockers. Although it regarded mode of action as the key product characteristic, it was careful to state, in recital 378 of the contested decision, that this factor alone did not suffice to establish a separate market.

In the second place, therefore, the Commission focused on the therapeutic uses of PPIs and H2 blockers. In recital 382 of the contested decision, it found that, in a number of cases involving peptic ulcer diseases, ulcers induced by non-steroidal anti-inflammatory medicine, Zollinger-Ellison-syndrome, gastrointestinal oesophageal reflux and dyspepsia, PPIs were deemed to provide the only effective remedy in terms of symptom relief, healing and long-term prevention of relapse. The Commission also found, in recitals 384 and 490 of the contested decision, that Losec put significant competitive pressure on H2 blockers, which forced H2 blocker firms to focus on milder downstream conditions for which antacids and alginates have traditionally been used. It is inter alia for that reason that H2 blockers could be obtained over the counter during the relevant period.

That finding is to a large extent supported by the statements of the medical experts submitted by the applicants during the administrative procedure, from which it is apparent, as is mentioned in paragraph 68 above, that PPIs were generally used to treat the severe forms of the conditions while H2 blockers were reserved more for their milder forms. In recital 389 of the contested decision, the Commission thus found that the therapeutic superiority of PPIs had led to a hierarchical relationship between PPIs and H2 blockers, those products being used at different stages of the treatments, depending on whether those treatments were being stepped down or stepped up.

Consequently, it emerges unequivocally from the contested decision that the Commission did not confine itself to establishing the therapeutic characteristics of the products for the purposes of defining the relevant market. On the contrary, the mode of action of PPIs was considered an essential factor only in so far as it determined that PPIs were therapeutically superior to H2 blockers. That therapeutic superiority was then considered to be a factor determining the difference in the respective therapeutic uses of PPIs and H2 blockers and, accordingly, the relationship between those products in terms of functional substitutability.

Therefore, although, as is apparent from the Commission's previous decisions referred to in paragraph 108 above, the applicants are justified in observing that 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, they cannot claim that the Commission did not take therapeutic use into consideration in the present case. It is apparent from the contested decision that the Commission took due account of those therapeutic uses in its analysis.

As regards the ground of complaint that the Commission departed from its previous practice of taking account of the third ATC level for the purpose of defining the market, the Court observes first of all that it is apparent from recital 371 of the contested decision that the ATC system classifies pharmaceutical products into different groups, according to the organs or systems on which they act and their chemical, pharmacological and therapeutic properties, and divides them into five different levels. The third ATC level groups pharmaceutical products according to their therapeutic indications, the fourth ATC level normally takes into consideration the mode of action and the fifth level defines the narrowest classes, including active substances taken individually. The Commission stated in the contested decision that, concerning market definition, the analysis generally started from the third ATC level. However, it added that the other ATC levels were also taken into consideration where it appears that sufficiently strong competitive constraints operate at other ATC levels and that, consequently, the third ATC level does not seem to allow a correct market definition.

It is apparent from recital 372 of the contested decision that, for the purposes of this case, the Commission did not take account of the third ATC level, since the A2B class comprised only drugs for treatment of peptic ulcer disease and did not include those for the treatment of two of the three main gastrointestinal acid-related conditions, namely gastrointestinal oesophageal reflux and dyspepsia. The EFPIA does not put forward any argument calling in question the merits of the Commission's assessment on that point. The Court also points out that the taking into account of the ATC level in which the medicines are placed constituted only a preliminary step in the Commission's analysis.

The complaint that the Commission wrongly attached excessive importance to the characteristics of the products and did not take account of their therapeutic use must therefore be rejected.

The applicants and the EFPIA submit that the Commission committed manifest errors in the assessment of price-related factors for the purposes of defining the relevant market.

When assessing the arguments of the applicants and of the EFPIA, it is necessary to bear in mind the regulatory framework of the pharmaceuticals sector, as set out in the undisputed findings in the contested decision.

In the contested decision, the Commission found that, for publicly reimbursed medicines, prices were influenced by the public authorities according to two systems, which are sometimes combined in certain countries. In the first system, the public authorities negotiate a reimbursable price with the manufacturers or unilaterally set the reimbursable price on the basis of information provided by the manufacturers. The factors taken into account by the public authorities include the added therapeutic value, cost-effectiveness, prices for the same or similar products on the domestic or foreign markets, and the research and development costs borne by the manufacturers (recitals 118 and 120 of the contested decision). The Commission found, in this respect, that a firm's ability to obtain high prices is particularly strong to the extent that its product is necessary to adequately treat certain conditions (recital 365 of the contested decision).

In the second system, the reimbursable price is fixed according to a reference price, which is established for each group of products with a similar therapeutic effect on the basis of the relatively low price of one or more products within that group. The reference price constitutes the maximum reimbursement level for all products within the reference category, manufacturers being free to set higher prices, in which case patients must bear the additional cost. In response to the questions put by the Court, the Commission confirmed that that system was normally applied only to products in respect of which a generic version existed. The system may also be accompanied by a substitution mechanism, which allows or obliges pharmacies to replace the product prescribed by the doctor with cheaper equivalent generics (recitals 118 and 119 of the contested decision).

Analysis of the prevailing systems in Germany, Belgium, Denmark, Norway, the Netherlands, the United Kingdom and Sweden led the Commission to take the view that the bargaining position of pharmaceutical companies depended significantly on the added value and efficacy of their products in relation to other products on the market. Breakthrough products which offer significant advantages over existing products are generally able to command a higher price from public authorities (recital 128 of the contested decision). The Commission observed that, in Germany and Denmark (since 1995), the Netherlands (until 1996), the United Kingdom and Sweden, manufacturers were allowed to set prices freely for their reimbursable products. However, manufacturers rarely price their products above the reimbursement level fixed by the public authorities, as demand becomes more elastic where patients are required to bear the amount exceeding the portion of the price which is reimbursed. Under the reference price system, a manufacturer of the original medicine that does not align its price downwards towards a reference price set following the market entry of a generic product may experience significant loss of market share (recital 129 of the contested decision).

In the present case, the Commission found that prices of PPIs were in general significantly higher than those of H2 blockers between 1991 and 2000 (recital 401 of the contested decision).

In the first place, the Court observes that it is apparent from the Commission's findings with regard to regulatory systems under which public authorities influence or determine prices that the price of a new pharmaceutical product depends to a large extent on the public authorities' perception of its relative therapeutic value in comparison with existing products. When a new product offers an added therapeutic value, the national body will tend to grant it a maximum reimbursement level or sale price, according to the system in force in the relevant State, which is significantly higher than those of existing pharmaceutical products with a lesser therapeutic value.

That consideration is moreover consistent with what the Commission found. In recital 369 of the contested decision, it observed that the therapeutic advantages and cost effectiveness of PPIs were key factors in the ability of pharmaceutical companies to negotiate relatively high prices with national authorities. Similarly, in recital 385 of the contested decision, it found that the fact that the price extracted by AZ for Losec was higher than the price of H2 blockers shows that public authorities perceived PPIs as therapeutically superior.

The Court therefore takes the view that the difference between the absolute prices of PPIs and H2 blockers reflects to a large extent the public authorities' perception of a factor which was already taken into consideration by the Commission for the purposes of market definition, namely the greater therapeutic efficacy of PPIs in comparison with H2 blockers.

In the second place, it should be noted, as is apparent from paragraph 39 of the Notice on market definition, that the similarity of price levels and/or their convergence may be relevant for the purposes of defining the relevant product market, since a significant divergence in price between two products may arise where the cheaper product does not exercise any competitive constraint.

The applicants and the EFPIA claim that the gap between prices is irrelevant in the present case, given that prices are not the result of normal competitive interaction, but are strongly influenced by public authorities. In the light of that argument, it is necessary to examine whether the fact that competitive interactions on the basis of prices between H2 blockers and PPIs are determined by public authorities and the national regulatory systems in force makes the differences between the absolute prices of PPIs and H2 blockers wholly irrelevant.

In this respect, the Court observes that it is apparent from the Commission's findings regarding the national regulatory frameworks under which prices are set that, during the relevant period, companies were free to set their prices in Germany, Denmark, Norway, the Netherlands until 1996, in Sweden and, in so far as the profit frameworks agreed with the public authorities allowed it, in the United Kingdom. In Belgium, where a system of maximum prices was in force until 2001, and in the Netherlands, where a system of maximum wholesale prices was introduced in 1996, the freedom of pharmaceutical companies to set prices was limited. Furthermore, in the United Kingdom, the public authorities also set prices for reimbursable generic products (recitals 121 to 129 of the contested decision).

It follows from those observations that prices of pharmaceutical products could be set above the reimbursement levels agreed by the public authorities, which is where demand tends to become more elastic. However, nothing in the contested decision makes it possible to determine whether, and to what extent, prices of PPIs in the relevant countries were set above reimbursement levels.

It is therefore necessary to examine the merits of the applicants' argument that, in the present case, the differences between the prices of PPIs and H2 blockers are irrelevant by reference to two situations, namely, first, that in which prices of the pharmaceutical products were set by the public authorities and/or did not exceed the reimbursement levels set by the public authorities and, second, that in which prices of the pharmaceutical products exceeded the reimbursement levels set by the public authorities.

Thus, first, as regards the relevance of the prices of PPIs and H2 blockers in the situation where prices of pharmaceutical products were set by the public authorities and/or did not exceed reimbursement levels, the Court observes first of all that it is apparent from recital 130 of the contested decision that, when national authorities pursued policies aimed at limiting their health expenditure, the means used were generally aimed at encouraging doctors to prescribe generic pharmaceutical products instead of the original versions of those products. Moreover, the reference price system in force in most of the relevant countries, which was applied only if a generic version of a product existed, and the measures aimed at encouraging or even imposing substitution, at the pharmacy level, of original medicines by their generic versions, were such as to enable the generic products, once they had been introduced on the market, to exercise a significant competitive constraint over original PPIs, such as Losec.

However, there is nothing in the documents before the Court to show that the national regulatory systems exerted downward pressure on sales or prices of PPIs on account of the lower price of H2 blockers. It does not appear that the authorities generally promoted or imposed substitution of H2 blockers for PPIs at the stage when the medicines were dispensed in pharmacies. Moreover, it is apparent from the contested decision that, since the reference price system applied, in the relevant States, only to original pharmaceutical products and their generic versions, prices of PPIs or the reimbursement levels granted to them were in no way dependent on the (lower) prices of H2 blockers.

It follows from the foregoing that, although the national regulatory systems to a certain extent prevented normal competitive interaction on prices between pharmaceutical products, the fact remains that they were capable of significantly influencing the income of the pharmaceutical undertakings by setting prices or reimbursement levels by reference to the prices of generic products and by promoting or imposing the substitution of original PPIs by their generic versions at the dispensing stage in pharmacies.

The fact that, in the present case, the regulatory systems did not influence the prices or the amount of sales of PPIs by reference to the lower prices of H2 blockers leads to the conclusion that the reimbursement levels granted to PPIs to a large extent prevented the lower prices of H2 blockers from exercising a competitive constraint over them. It should be recalled in this respect that the purpose of defining the relevant market is to determine the competitive constraints on the product on the basis of which the market is defined. The fact that the absence or insignificance of those competitive constraints is due to the regulatory framework which determines the conditions under, and the extent to, which competitive interactions between products take place does not affect the relevance, in the context of market definition, of 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.

Consequently, the Commission did not commit a manifest error of assessment in finding, in recital 364 of the contested decision, that the initial setting and maintenance of the price of a new category of products at a level significantly higher than that of other products used within the same therapeutic area reflects a low degree of competitive pressure from those other products.

Second, inasmuch as the price of PPIs could be higher than the reimbursement level set by the public authorities and the patient was thus required to bear that excess amount, there was liable to be demand elasticity, even if, as the applicants and the EFPIA assert, it is apparent from all the documents before the Court that such elasticity would in any case have been weak in view of the central role played by doctors in choosing the medicines prescribed and of the importance they attached to the therapeutic efficacy of the products when they did so.

It should be added, in this respect, that the fact — which has not been disputed — that patients and doctors display limited sensitivity to the cost of medicines, even where those costs exceed reimbursement levels, supports the view that H2 blockers did not exercise, by means of their lower prices, a significant competitive constraint over PPIs, and this could be reflected by a significant difference between the absolute prices of those products.

Nevertheless, for the purposes of assessing whether the lower prices of H2 blockers exercised a significant competitive constraint over PPIs, the question whether the price of PPIs exceeded the reimbursement level is of only limited relevance, since the main question is whether or not the non-reimbursed portion of the price of PPIs chargeable to patients is higher than the non-reimbursed portion of the price of H2 blockers that patients must bear.

If the non-reimbursed portion of the price of PPIs chargeable to patients were higher than the non-reimbursed portion of the price of H2 blockers that patients had to bear, the Court would have to find that H2 blockers did not exercise any significant competitive constraint over PPIs, since patients were prepared to bear an additional cost when purchasing PPIs.

Conversely, if the cost ultimately borne by patients when purchasing H2 blockers were higher than that which they bore when purchasing PPIs on account of the high reimbursement level of the latter, it would again be necessary to find, for the reasons set out in paragraphs 174 and 175 above, that the fact that the regulatory system shielded PPIs from the competitive constraint that H2 blockers were able to exercise by means of lower prices does not preclude a definition of the relevant product market which excludes H2 blockers, since this in fact supports such a market definition. In that situation, it would be necessary to find that, because of the high reimbursement level granted to PPIs, the regulatory system to a large extent prevents H2 blockers from exercising a significant competitive constraint over PPIs by means of prices. Such a finding is relevant for the purposes of assessing the competitive constraints on PPIs.

In any event, the Commission cannot maintain, as it does in recital 365 of the contested decision, 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. The Commission has failed to establish, in the present case, that the non-reimbursed portion of the price borne by patients when purchasing H2 blockers was lower than that of PPIs. Nevertheless, for the reasons set out in the preceding paragraphs, that error does not affect the soundness of the conclusions of the Commission, which took the view that, where prices exceeded reimbursement levels, the fact that absolute prices of PPIs were higher than those of H2 blockers showed that H2 blockers did not exercise any significant competitive constraint over PPIs.

It follows from the foregoing that 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 the present case, the Commission found that the degree of price correlation between PPIs and H2 blockers tended to be low throughout the relevant period. By contrast, the degree of price correlation tended in general to be stronger between different active substances within the same class, such as omeprazole and the ‘me-too’ PPI products which entered the market after omeprazole. It found that the degree of price correlation was strongest between products containing the same active substance, such as original substances and their generic counterparts (recital 368 of the contested decision).

The Commission found that it was the price of generic versions of omeprazole which had had the strongest impact on demand for AZ's omeprazole. Moreover, the price of other PPI products was also capable of influencing, to some extent, demand for AZ's omeprazole. By contrast, the much lower price of H2 blockers between 1991 and 2000 did not, according to the Commission, exert any significant competitive constraint on the demand for omeprazole or other PPIs, in view of the upward trend for PPI sales and of the downward or stagnating trend for H2 blocker sales (recital 401 of the contested decision).

The Court takes the view that those findings relate to factors which are not irrelevant in the present case and that the Commission did not commit a manifest error of assessment in considering that those factors, together with the other factors taken into consideration in the contested decision, support the view that H2 blockers did not exercise any significant competitive constraint over PPIs.

The fact, relied upon by the applicants, that non-price factors play a significant role in competitive relationships between pharmaceutical products is in no way at odds with the aforementioned considerations. As was observed above, since doctors are primarily guided by the therapeutic effect of medicines when choosing what to prescribe, the prices of medicines whose therapeutic uses differ have limited impact on their level of consumption. In so far as they determine doctors' choices, non-price factors, such as therapeutic use, therefore also constitute, alongside price-based indicators, a relevant factor for the purposes of market definition; this was indeed duly taken into consideration by the Commission, as was noted in paragraphs 149 to 152 above.

As regards the applicants' argument that the Commission failed to take account of the overall cost of PPI treatment, which is shorter because of its superior efficacy, the Court notes that the applicants are justified in claiming that the amount by which the total cost of PPI treatment exceeds the total cost of H2 blocker treatment is likely to be less than is indicated at first sight by just the difference between the cost for treatments of 28 days, presented in tables 1 to 7 in the Annex to the contested decision.

However, it should be observed that the length of treatment depends in any event considerably on the type of condition in question and is liable to vary from one patient to another. The Commission cannot be expected to take account of the specific actual duration of PPI and H2 blocker treatments, the setting of an average in this respect being moreover a potentially uncertain exercise, in view

Since quantification of cost-effectiveness is likely to be particularly complex and uncertain, it cannot be considered that the Commission committed a manifest error of assessment in taking into account the price of the medicines for an identical period of treatment.

In addition, it is apparent in any event from the findings made in paragraphs 171 to 175, 177 and 178 above, that H2 blockers were not capable of exercising a significant competitive constraint over PPIs by means of lower prices, in view

As regards the applicants' argument that the Commission attached excessive value to the CRA correlation study, the Court would point out, as the Commission contends, that that study was taken into consideration only on a subsidiary basis (recital 407 of the contested decision) and was relied upon to the extent that it tended to support the findings based on other indicia, such as the therapeutic differences between H2 blockers and PPIs and the price differences between those two products. Similarly, the references to that correlation study in recitals 411, 416, 436, 440, 447 and 451 of the contested decision cannot be regarded as being the primary basis for the Commission's findings, since those findings are based above all on sales trends, price differences and, in the case of Germany and the United Kingdom, on the observation of certain ‘natural events’. The references to the correlation study are thus made incidentally in so far as they tend to substantiate prima facie the Commission's view that PPIs and H2 blockers were not competing on price. Such use of that correlation study, whose weaknesses the Commission alluded to, cannot constitute a manifest error of assessment.

The applicants also contest the merits of the Commission's use of value-based data rather than volume data. The Court would point out in this respect that the volume data set out in tables 17 to 23 of the contested decision come from the IMS Health report (recital 63 of the contested decision), from which it is apparent that those data correspond to measurement units based on the concept of ‘treatment day’. As the Commission observed at the hearing, the superior efficacy of PPIs means that fewer treatment days are required to treat a condition when PPIs are used than when H2 blockers are used. On that point, the applicants themselves acknowledge that PPIs treat conditions more rapidly than H2 blockers. Thus, volume-based calculations do not reflect differences in terms of healing times or success rates.

By contrast, as the Commission contends, sales by value take account both of the volume of treatment administered and of the therapeutic superiority of PPIs over H2 blockers. The fact that prices stem from regulatory mechanisms in which public authorities have a significant role does not alter that consideration, since, as was found above, those authorities attach great importance to the added therapeutic value of a product.

The Court therefore holds that the Commission did not commit a manifest error of assessment in finding that value-based data were better able to reflect the relative position of PPIs and H2 blockers.

The applicants complain lastly that the Commission did not carry out any investigation of the process by which PPI prices were agreed in individual Member States. On that point, the Court also takes the view that that lack of any investigation constitutes a lacuna, since price-based indicators constitute an important element of the Commission's definition of the relevant market in the present case. It was incumbent on the Commission to gather precise information on the manner in which prices are either influenced or set by the public authorities.

It is apparent however from recitals 116 to 132 of the contested decision that the Commission conducted a detailed study of the regulatory systems for setting prices or reimbursement levels of pharmaceutical products in the countries concerned. It follows from the foregoing that the Commission's findings make it possible to understand the mechanisms by which prices are influenced or determined by the public authorities, and the competitive constraints by means of prices which those regulatory systems enable the pharmaceutical products in question in the present case to exercise over each other.

The Court notes, in this respect, that the Commission's findings have not been called in question by the applicants and the EFPIA. The fact, alleged by the applicants, that AZ sought a price for PPIs which was equal to twice the price of Zantac on a ‘price per day’ basis is not capable of calling in question the Commission's view that national bodies granted PPIs a higher price than that of H2 blockers in consideration of the added therapeutic value of PPIs. On the contrary, it tends to confirm it.

The Court therefore holds that, in the light of all the factors on which the Commission also based its assessment, that lacuna does not affect, in the present case, the validity of the conclusions that it drew from the gap in prices between PPIs and H2 blockers.

During the administrative procedure, the applicants produced an econometric study, the Lexecon report, which aimed to show that H2 blockers exercised a significant competitive constraint over PPIs in Germany and the United Kingdom. That study presents information on a series of ‘natural’ events that occurred on the German and United Kingdom markets, which the Commission took into consideration for the purposes of its analysis of the relevant product market, the Commission taking the view, in recital 421 of the contested decision, that those events constituted important evidence.

As regards, in the first place, the three ‘natural events’ observed on the German market, it should be recalled that those events related to the market entry of the PPI pantoprazole in 1994, the introduction of the generic H2 blocker ranitidine in 1995 and the introduction of generic omeprazole in 1999.

As regards, first of all, the entry on the German market of pantoprazole in 1994, the Commission found, in recital 422 of the contested decision, that it was accompanied by a reduction in the price of Losec of 16%, but that it did not significantly affect the slowly falling trend in the price level of H2 blockers.

In this respect, it should be noted, once again, that the applicants' assertion 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. In the present case, and as the applicants stated during the administrative procedure (see recitals 427 and 428 of the contested decision), that event tends to show that price competition at the inter-molecular level existed in Germany only in so far as the relevant products had a very similar therapeutic profile, which appeared to be the case with omeprazole and pantoprazole, those products both being PPIs. By contrast, the market entry of pantoprazole does not appear to have significantly influenced the price of H2 blockers. As was held in paragraph 183 above, the fact that competitive interaction on the basis of prices is to a large extent influenced or determined by the regulatory system in force does not affect the relevance of price indicators in the assessment of competitive constraints.

Moreover, the applicants' submission that the decline in the market share of H2 blockers accelerated after the introduction of pantoprazole is not capable of showing that they exercised a competitive constraint over PPIs. On the contrary, that fact tends to confirm the Commission's findings that PPIs exercised a unilateral competitive constraint over H2 blockers.

As regards, next, the entry of the generic H2 blocker ranitidine on the German market in 1995, the Commission observed, in recitals 423 and 424 of the contested decision, that it was clear from the Lexecon study that, over a period starting just before the market entry of that substance and ending three months later, H2 blocker prices declined by roughly 40%, whereas prices of PPIs remained unaffected, and that total PPI sales continued to grow rapidly. Moreover, promotional activity, measured in visits by medical representatives, increased sharply in the H2 blocker segment shortly before the introduction of generic ranitidine and decreased sharply shortly after its introduction. By contrast, the market entry of generic ranitidine did not have any effect on promotional activities or sales of PPIs. The Commission thus inferred from this that intensification of competition between H2 blockers in terms of prices and promotional activity did not affect PPIs.

The applicants and the EFPIA assert that the introduction of the generic H2 blocker ranitidine positively affected sales in volume terms of H2 blockers and had a negative impact on sales in volume terms of PPIs. However, as the Commission observes, it is apparent from table 16 in the Annex to the contested decision that sales by value of PPIs, expressed as a proportion of combined sales of PPIs and H2 blockers, continued to increase between 1994 and 1997, from 32% in 1994 to 42% in 1995, to 57% in 1996 and to 67% in 1997. As was held in paragraph 195 above, where products are differentiated, the Commission is justified in attaching more importance to sales by value than sales by volume, which are the sales on which figures 2 and 3 in the Lexecon report are based.

In any event, table 19 in the Annex to the contested decision indicates that the amount of prescriptions in volume terms of PPIs increased steadily between 1994 and 1997, from over 2 million prescriptions in 1994 to more than 3.3 million prescriptions in 1997.

The applicants rely on figures 2 and 3 in the Lexecon report in submitting that the market shares of H2 blockers increased as a result of the introduction of generic ranitidine, while Losec's market share declined and the market share of other PPIs levelled off. The Court would however point out, as the Commission stated in recitals 462 and 463 of the contested decision, that those figures present the relative shares of sales in volume terms of PPIs and H2 blockers, expressed as a proportion of combined sales of PPIs and H2 blockers, that is to say in an assumed common market for H2 blockers and PPIs. In such a context, because of autocorrelation, an increase in sales of H2 blockers will inevitably adversely affect the market share of PPIs, even if the increase in sales of H2 blockers occurs in market segments that are uncontested by PPIs, such as those consisting of the mild forms of gastrointestinal conditions, where pharmaceutical products are therapeutically relatively weak. The Commission did not therefore commit a manifest error of assessment in taking the view that those data did not serve to establish that H2 blockers exercised a significant competitive constraint over PPIs.

Moreover, the fact, relied upon by the EFPIA, that the reference price system in force in Germany prevented the lower price of generic ranitidine from being able to constrain PPI prices does not alter the finding that PPIs were not significantly constrained by the lower prices of H2 blockers (see paragraphs 174 and 175 above).

As regards the observation of promotional activities, the applicants cannot seriously argue that promotional activity in respect of Losec and the other PPIs increased in reaction to the entry of ranitidine. It is apparent from figures 5 and 6 in the Lexecon report that variations in promotional activity in respect of PPIs were not particularly significant, unlike the clear and significant increase in promotional activity in respect of H2 blockers. On the basis of those observations, the Commission was accordingly justified in taking the view that the market introduction of ranitidine led to increased competition between H2 blockers through increased promotional activity, but that that intensification of competition did not involve PPIs, for which promotional activity remained stable. That event accordingly tends to show clearly the relationship between its separate elements, namely the market entry of ranitidine, the increased competition between H2 blockers, and the lack of any significant effect on promotional activity for PPIs. Although limited in time, that observation therefore supports the conclusion that H2 blockers did not exercise any significant competitive constraint over PPIs.

The Court would also point out that, although the applicants claim that promotional activity may vary according to other factors, they do not specify the factors which, in the present case, would tend to invalidate the conclusions which the Commission drew from the very marked increase in promotional activity in respect of H2 blockers following the market entry of generic ranitidine and the corresponding absence of any particular effect on promotional activity for PPIs.

As regards, lastly, the entry of generic omeprazole in Germany in 1999, the Commission observed, in recital 425 of the contested decision, that that event resulted in a decline in Losec's sales volume of around 60% and negatively affected the sales of the other PPIs.

The Commission rightly states that the very significant impact of the market entry of generic omeprazole both on sales of Losec and on its price must be viewed in conjunction with the absence of any effect of the introduction of the generic H2 blocker ranitidine on prices and sales of PPIs. Although the applicants claim that the Commission could not rule out that H2 blockers exercised a significant competitive constraint over Losec, they have failed to adduce evidence capable of overturning the Commission's findings.

As regards, in the second place, the entry of the generic H2 blocker ranitidine in the United Kingdom in 1997, the Commission observed that, despite that event, PPI sales in absolute terms as well as their share of overall PPI and H2 blocker sales in the United Kingdom continued to increase from 1997 onwards. Moreover, it found that the market entry of generic ranitidine did not influence the increase in price of Losec.

It is apparent from table 16 in the Annex to the contested decision that PPI sales, expressed as a proportion of combined sales of PPIs and H2 blockers, continued to increase after 1997, from 56% in 1996 to 60% in 1997, then to 65% in 1998 and 70% in 1999. Those data reveal, as the Commission observed in recital 454 of the contested decision, that the introduction in 1997 of ranitidine at a significantly lower price on the United Kingdom market did not exercise any significant competitive constraint over sales of PPIs. The Court would point out, moreover, that the decline in sales of PPIs, alleged by the applicants, is not clearly apparent from figure 7 in the Lexecon report. Although the rate of increase in Losec sales slowed slightly, sales of the other PPIs still increased on a sustained basis, thus permitting the inference that, on the whole, sales growth of PPIs was not affected by the market entry of generic ranitidine.

It is also apparent from that figure that the introduction of ranitidine did not exert downward pressure on the price of PPIs. On the contrary, that figure reveals a slight increase in those prices, until they declined in March 1998 by reason of the United Kingdom Pharmaceutical Price Regulation Scheme, which required profits from the sale of selected products to be brought within a determined ceiling (see page 21 of the Lexecon report). The applicants' arguments must therefore be rejected on that point also.

The applicants also submit that, as regards the events observed in Germany and the United Kingdom, the Commission wrongly attributed the changes observed to an individual factor, whereas those changes are affected by many factors simultaneously. In attempting to cast doubt on the Commission's conclusions, the applicants do not however explain, as regards the specific events examined above, the effect that the various factors on which they rely might have had in those specified cases, namely the price of Losec and competing products, the entry on the market of competing products, the number of presentation forms available for Losec and competing products, the promotional activity for all products in the market, the dates when new indications for Losec were approved and the time trend. In those circumstances, and in view of the fact that the Commission's conclusions find support in the information that it analysed, that complaint is not sufficient to identify a manifest error of assessment by the Commission.

Lastly, the applicants claim that the empirical evidence on which the Commission based its assessment is too limited to support the definition of the relevant product market.

It is apparent from the examination of all the pleas and arguments put forward by the applicants against the Commission's definition of the relevant market that the Commission based its assessment on the greater efficacy of PPIs, the differentiated therapeutic use of PPIs and H2 blockers, the trend of asymmetrical substitution that characterised the growth in sales of PPIs and the corresponding decrease or the stagnation in sales of H2 blockers, price indicators, such as they resulted from the regulatory framework in force, and the ‘natural events’ observed in Germany and the United Kingdom.

Following an overall appraisal of the evidence on which the Commission based its assessment, and in the light of the grounds of complaint set out by the applicants and the EFPIA, the Court finds that that evidence, some of which was produced by the applicants themselves, constitutes, in the present case, a body of relevant data that is sufficient to establish to the requisite legal standard the conclusion that the Commission reached, namely that H2 blockers did not exercise a significant competitive constraint over PPIs during the period between 1993 and 2000.

The Court therefore finds that the applicants and the EFPIA have failed to establish that the Commission committed a manifest error of assessment in finding that the relevant product market was composed solely of PPIs in Germany, Belgium and Denmark between at least 1993 and 1999, in Norway, the Netherlands and the United Kingdom between at least 1993 and the end of 2000, and in Sweden.

In view of all the foregoing, the second plea, directed against the market definition, must be dismissed.

The applicants observe that there is no ‘precedent’ establishing that Article 82 EC applies to applications for acquiring or extending an intellectual property right and propose that this question be addressed in the light of three principles.

First, neither a mere intention fraudulently to obtain a patent or SPC, nor an application for a patent or SPC, even if made fraudulently, nor the grant of a patent or SPC, which is incapable of immediate enforcement, can amount to an abuse of a dominant position. The applicants maintain, in that regard, that abuse of a dominant position is an objective concept that does not depend upon intention to cause harm to competition but upon an objective ascertainment of that effect in fact (Hoffmann-La Roche v Commission, paragraph 239 above, paragraph 91, and Case T-128/98 Aéroports de Paris v Commission [2000] ECR II-3929, paragraphs 172 and 173). Accordingly, an intention to restrict competition is not sufficient to prove the requisite effect on competition, since the conduct intended to have that effect must have been engaged in. It follows that conduct that has not actually been implemented or is not capable of having the effect of a restriction on competition does not constitute an abuse. The applicants submit, in particular, that evidence of ‘subjective intention’ to commit an abuse and evidence of conduct preparatory to an abuse, conduct which is not, in itself, capable of restricting competition, are not sufficient to establish the existence of an abuse within the meaning of Article 82 EC.

Second, in the absence of additional elements, the mere acquisition of an exclusive right is not an abuse of a dominant position (Case T-51/89 Tetra Pak v Commission [1990] ECR II-309, paragraphs 23 and 24). The applicants point out that the judgment in Tetra Pak v Commission concerns a specific case relating to the acquisition of an intellectual property right in circumstances where that right is akin to a business. In their submission, the acquisition of an exclusive patent licence constitutes an abuse of a dominant position where

Third, an abuse of a dominant position can only exist where the fraudulently obtained patent is enforced and that enforcement meets the conditions set out in Case T-111/96 ITT Promedia v Commission [1998] ECR II-2937. In that judgment, the Court held that the fact of bringing legal proceedings may constitute an abuse of a dominant position within the meaning of Article 82 EC only in exceptional circumstances, namely where

Those two conditions should be construed and applied strictly, in a manner which does not defeat the application of the general principle of access to the courts.

Consequently, the enforcement of a patent can amount to an abuse of a dominant position only when the undertaking has wilfully acquired or enforced the patent knowing that it is invalid. The applicants add that, although in certain circumstances it is possible for the mere maintenance or defence of a patent, without its active enforcement, to amount to an abuse of a dominant position, such abuse can take place only when the patent's period of protection commences. Allowing, for the purpose of finding an abuse of a dominant position, anything less strict than fraud and knowledge of the invalidity of the patent would result in a ‘freeze’ on patent applications in the European Community, since undertakings would fear that inadvertent error or negligence in patent enforcement could result in the imposition of fines by the Commission.

Patent protection is central to the encouragement of innovation in economically viable conditions and it is therefore necessary to recognise a public policy imperative that undertakings should not be unduly deterred from registering patents in the pharmaceutical sector under the SPC scheme.

In their reply, the applicants claim that it is necessary that the patent should have been enforced or threatened to have been enforced after the SPC was granted, and they maintain, alternatively, that the SPC should at least have been acquired and that its existence must have been capable of influencing the conduct of competitors. Moreover, deliberate and intentional fraud on the patent offices must be proved by means of clear and convincing evidence; mere negligence or inconsistency on the part of the applicant is insufficient.

The applicants add that the national laws and rules governing application for, and correction of, patents and SPCs provide for procedures enabling the courts or the patent offices to rectify, or even withdraw, the registration where errors have been made, whether inadvertently or fraudulently. In that regard, the patent offices and competing undertakings may challenge the patents or SPCs and, in certain circumstances, sue for damages. Consequently, it is not appropriate, in the applicants' submission, to use the competition rules to make remedies possible or impose punishments following acquisitions of patents and SPCs, by virtue of the fact that they are potentially anticompetitive, where such applications do not have any actual effect on competition. The role of competition rules is not to police patent applications, and the rules applicable to patent applications and SPCs are normally sufficient to preclude any anticompetitive effect. Accordingly, the applicants submit that, in order to be able to intervene, the Commission must demonstrate the anticompetitive effects.

In support of their argument, the applicants refer to United States law. In their submission, in the first place, under that law, an antitrust action is justified where the patent was procured by knowingly and wilfully misrepresenting facts to the patent office. In that regard, neither gross negligence nor recklessness, nor the existence of inequitable conduct are sufficient, proof of fraud being required. Wilful misrepresentation amounting to intentional fraud is therefore an essential requirement for liability to be incurred, so that clear and convincing evidence of specific intent is required. Non-disclosure can support an allegation of fraud only in exceptional circumstances, where the intent to deceive and the reliance of the patent office which was induced, by virtue of that omission, to grant the patent are clearly established.

In the second place, in United States law, actual enforcement of the patent is necessary for application of the antitrust rules, mere acquisition of a patent being insufficient, since the immediate cause of the anticompetitive effect must be the conduct of the patent owner and not the action of the public agency. Further, just as in Community law, an action can be regarded as ‘sham’ only where the legal action is objectively baseless in the sense that no litigant could reasonably expect success on the merits.

Finally, the applicants submit that the performance of an act which is capable of restricting competition only if other contingent acts are also carried out cannot constitute an abuse of a dominant position. For the finding of an abuse of a dominant position, there must be a real probability that the act will result in a restriction of competition and a direct causal relationship between the act and the harm to competition. Thus acts that are purely internal to the undertaking concerned, such as a communication within the group, and external acts that are merely preparatory to a potential abuse of a dominant position but which are incapable of having an effect on competitors or competition, cannot be considered to be abusive. The applicants therefore dispute the Commission's assertion that the illegal nature of the behaviour cannot depend on the contingencies of the behaviour of a third party. They argue, by way of example, that a proposal for an agreement that would violate Article 81(1)EC would result in an infringement of the competition rules only if the parties reach agreement in that regard.

The applicants submit that the Commission erred in alleging that AZ's dealings with its patent attorneys revealed fraudulent conduct from 7 June 1993, when AZ communicated instructions to them (recital 774 of the contested decision). The Commission places the commencement of the abuse of a dominant position at a point in time even before the SPC was applied for. Since neither AZ nor its attorneys had yet contacted the patent offices and since AZ had not yet obtained a right or enforced a right, its conduct could not have had any effect on competition. The applicants add that it should not be considered that that conduct commenced in 1993, since the basic patents did not expire until five years later, in April 1999. The effect of that conduct on competition was therefore only very remote, especially as AZ had not yet exercised its rights conferred by those SPCs, for example, in response to a request for a licence. They submit that the Commission cannot justify that date by the fact this was the first act forming part of a chain of acts which was aimed at excluding competitors, since that reasoning would lead to the undertaking's liability being incurred in the absence of any direct effect on competition, in an excessively wide range of circumstances.

As regards the countries in which no SPCs were granted, namely Denmark and the United Kingdom, the applicants submit that the Commission erred in law in considering that AZ committed an abuse of a dominant position in those countries. In so far as the patent offices of those countries rejected AZ's applications and no SPCs were therefore granted, its conduct could not have had any effect on competition in those markets. Consequently, the applicants dispute the Commission's arguments in recitals 763 to 765 of the contested decision and state that it is necessary for the conduct to be capable of having an effect on competition. A mere application for an SPC is in itself not capable of having any actual effect on competition. At the very most, there were acts preparatory to an abuse, or an attempted abuse. In addition, the applicants maintain that the Commission conceded that the abuses ceased in June 1994 in the case of the United Kingdom and in November 1994 in the case of Denmark, that is to say, long before the substance patents expired in April 1999 and therefore long before any grant of an SPC could have been capable of affecting competition. Moreover, no deterrent effect on the entry of competitors in the relevant market could have arisen in those countries.

In that regard, the applicants dispute the Commission's assertion in recital 762 of the contested decision that the grant of SPCs delays the preparations of generic producers which often take several years, and draw attention to the absence of evidence regarding the period needed for those preparations. In the applicants' submission, no deterrent effect arises before the commencement of the extended patent term, or until a time sufficiently close to the date on which that extended term is due to come into force, such that its prospective existence may influence competitors' behaviour. The Commission cannot therefore assert that five to six years prior to the expiration of the basic patent, a deterrent effect on the entry of competitors in the relevant market was capable of arising. Moreover, on the basis of the evidence adduced by the complainants, it was conceded, during the oral procedure, that generic medicines had not been affected by SPCs until after the expiry of the substance patent.

In response to recital 758 of the contested decision, in which the Commission asserts that where an undertaking actually implements a practice, the aim of which is to keep competitors away from the market, the fact that it does not achieve that aim is not enough to avoid the practice being characterised as an abuse of a dominant position, the applicants maintain that the acts implemented must themselves be capable of having that effect. Since the substance patents still had five years to run, the mere application for SPCs could not conceivably have been capable of having such a far-off effect. In addition, even if AZ had succeeded in obtaining SPCs in Denmark and the United Kingdom, it is necessary, in order for competition law to be applicable, for AZ to seek to enforce its rights. Consequently, AZ's attempts to obtain SPCs in Denmark and the United Kingdom are not abusive and, even if it is decided otherwise, the duration of the alleged infringements is far too long because it has as its starting point preparatory acts which were not abusive in themselves.

As regards the countries in which SPCs were granted, the applicants maintain that, contrary to what the Commission contends, the judgment in Tetra Pak v Commission, paragraph 310 above, makes it clear that the mere acquisition of intellectual property rights does not in itself constitute an abuse of a dominant position. Paragraph 139 of the judgment in ITT Promedia v Commission, paragraph 311 above, which refers to the abovementioned judgment, adds nothing to the Tetra Pak judgment.

Moreover, those judgments are to be distinguished from the present case, in so far as they were considering the acquisition by a company in a dominant position of intellectual property rights belonging to another person. There is no ‘precedent’ which makes it possible to state that the acquisition of a patent or an SPC for a company's own inventions is abusive, nor any basis for that view. In the applicants' submission, something more is required, namely the elimination of all competition (Tetra Pak v Commission, paragraph 310 above) or the exercise of the SPC (United States case-law). However, it is clear that the grant of the SPCs did not have the effect of eliminating all competition, since, as the Commission itself has acknowledged, subsequent to the grant of the SPCs, competition increased and AZ lost market shares.

The applicants submit that, prior to the expiry of the substance patents in Belgium, Denmark, Germany, the Netherlands, Norway and the United Kingdom in April 1999, the grant of the SPCs was not capable of having any further restrictive effect on competition, since the market entry of generics was in any event precluded as a result of the existence of the basic patents.

As regards Germany, the Commission conceded that AZ did not have a dominant position after the end of 1997, a time long before the SPCs came into effect. Moreover, in recital 766 of the contested decision, the Commission acknowledges that the SPC granted in Germany had been revoked prior to the expiry of the basic patent, which makes it impossible for AZ's conduct to have had any restrictive effect on competition. Furthermore, it is not at all proven that the brief existence of the SPC in Germany, which was revoked in June 1997, that is, two years before its planned entry into force in April 1999, was capable of deterring competitors from preparing their market entry on that latter date.

The applicants maintain that, as regards the countries for which the dates of 1 January 1985 and 1 January 1982 are laid down by Article 19 of Regulation No 1768/92 as the dates after which the first authorisation to place a product on the market in the Community must have been obtained in order for that product to be granted an SPC, the only effect of the alleged abuse was to extend the duration of the SPCs by 7 months. In Belgium and the Netherlands, the extra time gained as a result of the grant of the SPCs started in April 2002 and finished in September and October 2002 respectively. It was therefore only during that period that the conduct at issue would have been capable of producing an anticompetitive effect. However, on the Commission's definition of the relevant product market, AZ's dominance in those countries ceased at the end of 2000. Accordingly, AZ was not in a dominant position at the time when its conduct was capable of producing an effect. Nor can any deterrent effect on competitors' entering the market be identified in 2002.

Norway is the only country in which AZ could have been dominant at a point in time when its conduct was capable of having an effect on competition. However, the SPC in that country was revoked by the District Court of Oslo in June 1999, two months after the basic patent had expired in April 1999. In the applicants' submission, no competition could have been excluded by reason of the SPC, since AZ had a formulation patent that did not expire until well after the first abuse of a dominant position alleged had terminated.

The Commission contends that the use of public procedures and regulations may, in specific circumstances, constitute an abuse of a dominant position (Joined Cases C-395/96 P and C-396/96 P Compagnie maritime belge transports and Others v Commission [2000] ECR I-1365, paragraphs 82 to 88), in so far as such public regulations may impose potent entry barriers capable of preserving market power over extended periods of time. In the Commission's view, misrepresentations that distort national authorities' decision-making in ways that create or shield market power may inflict severe public harm.

In that context, the limited discretion of the national authorities in question as to the action to be taken in respect of the request is a relevant circumstance which must be taken into consideration (Compagnie maritime belge and Others v Commission, paragraph 329 above, paragraph 82). Where the discretion of the administrative authority is limited, the cause of the anticompetitive effect resulting from a decision based on inaccurate information is not State action, but the misrepresentations.

The Commission observes that the fact that the effects on the market may be dependent on further action by public authorities does not exclude the existence of an abuse, since the abuse exists even if the public authority does not react as requested. The illegal nature of behaviour cannot depend on the contingencies of the behaviour of a third party. It is therefore irrelevant whether or not the public authority actually granted the SPC pursuant to AZ's misleading representations. The Commission adds that if the abuse could be found only in the Member States where a given behaviour was successful, the very same behaviour could constitute an infringement in some Member States but not in others, depending on how the public authority reacted. However, the scope of Article 82 EC covers behaviour which is aimed at or capable of achieving anticompetitive effects, regardless of its success.

From that point of view, it is the date of the implementation of the conduct capable of restricting competition which must be taken as the starting point of the abuse, even if a period of time elapses before that course of conduct produces the desired anticompetitive effects and the achievement of those effects is dependent on third party factors. Any other solution would, in the Commission's view, lead to the inference that the period in which the abuse occurred is a period in which the undertaking does not deploy any behaviour, but in which the effects are produced. Moreover, since the exclusion of the competitor is frequently the point in time when the abuse ends, there is no point, in the Commission's view, in being in a position to continue exclusionary behaviour only from the time when its aim has been achieved. The Commission therefore rejects the applicants' argument that there is no abuse until the SPC comes into effect. The fact that the intended effect was supposed to occur at a later date does not alter the fact that the behaviour intended to achieve that effect was implemented.

The Commission adds that the distinction, advanced by the applicants, between internal and external acts is irrelevant since, depending on the circumstances, what may at first sight appear to be an internal act, when considered in isolation, may, when assessed in its context, be evidence of a Treaty infringement.

In reply to the arguments advanced by the applicants, the Commission points out, first, that, although abuse is an objective concept (Hoffmann-La Roche, paragraph 239 above), the establishment of which does not require the existence of intent, intent is nevertheless not irrelevant. It then explains that its case is not simply based on intent, but on a course of conduct executing that intent and aimed at excluding competitors. Intention is a relevant element in assessing whether behaviour is objectively capable of restricting competition, since, if an undertaking implements a strategy aimed at excluding competitors, or in the knowledge that it is liable to have such effect, its behaviour is capable of restricting competition. In any event, behaviour whose purpose or object is to restrict competition falls within the scope of Article 82 EC, regardless of whether the aim is achieved (Opinion of Advocate General Tizzano in Case C-551/03 P General Motors [2006] ECR I-3173, points 77 and 78, and Case T-203/01 Michelin v Commission [2003] ECR II-4071, paragraphs 241, 242 and 245). The Commission denies, furthermore, that the contested decision is based on mere intention on the part of the applicants, since that decision identified behaviour which was capable of excluding competitors.

It points out the concept of ‘fraud’ does not appear in the contested decision, which uses the expression ‘misleading representations’. In order to be abusive, a representation does not necessarily have to contain false information, originating in a ‘falsehood’, since misleading information is also liable to induce public bodies to act in a way which is capable of excluding competition. In that regard, the Commission argues that a statement which may be true when considered in isolation remains misleading when it is not accompanied by material, qualifying facts.

The Commission submits that the applicants' argument that conduct that has not actually been implemented or is not capable of having the effect of a restriction on competition is not an abuse is irrelevant since its case is based on a course of conduct which was both intended to produce and capable of producing such a restriction. The Commission also states that the acquisition of an exclusive right may constitute an abuse (Tetra Pak v Commission, paragraph 310 above, paragraphs 23 and 24, and ITT Promedia v Commission, paragraph 311 above, paragraph 139). In its view, there is no reason to treat the acquisition of a licence to an industrial process differently from the acquisition of an SPC, since their effect on competition, namely the exclusion of competitors, is the same. In regard to the distinction which the applicants draw between the present case and the cases which gave rise to the judgments in Tetra Pak v Commission, paragraph 310 above, and ITT Promedia v Commission, paragraph 311 above, the Commission contends that the latter judgment does not concern the acquisition by a dominant company of intellectual property rights belonging to another. Moreover, the Commission disputes that the SPC was the applicant's before it was granted and submits that the ‘something more’ to which the applicants refer consists of the pattern of misleading representations. Furthermore, the case-law does not require the elimination of all competition for a finding of abuse. As recitals 758 to 770 of the contested decision show, it is sufficient that the entry of generic medicinal products is prevented or delayed in some markets.

The Commission points out, next, that this case only incidentally concerns court proceedings, since the matters at issue in this case are misleading representations to patent agents and patent offices. It refers, in this regard, to recitals 736 to 740 of the contested decision and asserts that AZ's submissions before the courts are the logical continuation of a proactive exclusionary strategy implemented as of 6 May 1993 at the latest and consisting of misleading representations. Accordingly, in so far as the competitors had to bear the costs and suffer the delays associated with legal proceedings, that was a consequence of the SPCs granted as a result of AZ's misleading representations, which obliged them to engage in extensive litigation.

The Commission denies that the contested decision is liable to have a deterrent effect on patent applications and states that the need to avoid discouraging parties from communicating with public authorities means that simple inaccuracies, negligent misstatements or the expression of debatable opinions must not be regarded as infringements of Article 82 EC. However, in the present case, the behaviour at issue does not consist of simple mistakes or isolated incidents of negligence, but is, on the contrary, characterised by continuity and consistency, indicating ‘subjective intent’ and full knowledge of the misleading character of the representations. The Commission maintains that such misuse of the patent system reduces the incentive to engage in further innovation, since it enables the company in a dominant position to rely on continued rents beyond the period envisaged by the legislator, and runs counter to the purposes of competition. It adds that this case does not concern a patent application, in which a government agency is required to assess numerous factors in order to determine the merits of the claimed invention, but the granting of an SPC under provisions which, at the material time, laid down only formal requirements and prescribed very little verification of the information.

With regard to the existence of specific patent remedies, the Commission points out that these have proved insufficient to deter misuses of the patent system by dominant companies. In 1993, the applicants considered that the only risk incurred by their behaviour was a reduction of the duration of the SPC (recitals 200 and 745 of the contested decision). The Commission further disputes that the fact that Regulation No 1768/92 provides for specific remedies excludes the application of the competition rules and their own remedies. In its view, the concept of abusive conduct cannot be limited to conduct which does not violate other laws or for which no other remedy is available, since actual or foreseeable anticompetitive effects fall within the scope of competition law. Moreover, the scope of the ‘remedy’ provided for by that regulation would have been limited, since it would not have addressed the implementation of the exclusionary strategy in cases where that strategy did not result in the acquisition of an SPC, and would not have taken into account the anticompetitive object of the conduct where it is attributable to a dominant undertaking. Furthermore, competitors could not easily have challenged SPCs obtained by AZ since they did not have ready access to the relevant information concerning the date of technical authorisation in Luxembourg and the date of effective marketing in that country.

With regard to United States law, the Commission submits that it has limited relevance to the present case. In reply to the applicants' assertions, it states that there exists, in United States law, a ‘Noerr-Pennington’ doctrine, according to which misrepresentations in a lobbying campaign in the political context are not subject to Sherman Act liability. However, it notes that the United States Supreme Court held that, when made in the adjudicatory process, such misrepresentations were not eligible for protection under that doctrine and could be subject to Sherman Act liability and, more specifically, that the enforcement of a patent procured by fraud on the Patent Office might be contrary to Section 2 of the Sherman Act. Moreover, many decisions of United States courts have recognised that misrepresentations may be caught by the Sherman Act. The Commission notes that that case-law also covers material omissions. In one of its judgments, the Federal Circuit even used the words ‘inappropriate attempt to procure a patent’ in place of ‘fraudulent procurement’ and stated that fraud involved the ‘intent to deceive’, or at the very least a state of mind so reckless as to the consequences that it is held to be the equivalent of intent. Thus, contrary to the applicants' assertions, United States law does not require, for the purpose of establishing fraud, that the information is false.

The Commission acknowledges that certain courts have accepted that antitrust liability requires that measures are taken to enforce the patent. It points out, however, that other courts have held that the furnishing of false information is enough. Moreover, according to the Commission, although it has been considered in United States law that enforcing a fraudulently obtained patent may be abusive, that does not exclude the possibility that other types of behaviour may also be abusive.

It also submits that, in United States law, a further relevant point is whether the regulatory context surrounding the conduct at issue confers on the government agency a broad discretion or requires it to carry out only ‘ministerial acts’ involving minimal verification. It adds that, in contrast to European competition law, which applies regardless of the actual effects of the behaviour, United States case-law is based on liability in tort for fraud. However, this requires reliance by the authorities on a representation in order to establish a causal link between the misrepresentation and the harm.

It disputes, moreover, that the standard of proof required in antitrust cases based on misrepresentations is higher than the normal standard of proof. It makes the point, in that regard, that ‘circumstantial evidence’ was considered sufficient in the judgment of the Federal Circuit, mentioned in paragraph 340 above, since the court did not consider that intent needed to be proved by direct evidence. The Commission adds that the contested decision is based on a wide and consistent body of evidence covering an extended period of time and bringing to light a consistent course of conduct.

The Commission contends that the sending of instructions on 7 June 1993 cannot be seen as a mere preparatory act, having regard to the context, nature and content of the instructions and applications. As regards, first, the regulatory context, the Commission points out that, under Article 10(5) of Regulation No 1768/92, Member States were not required to verify the date of the first authorisation to place the product on the market in the Community and that, in practice, they carried out limited verification in that regard. It maintains that, contrary to what is applicable in the context of a patent application, it was not the task of the patent offices to carry out a substantive assessment, since they were only obliged to consider a number of formal factual requirements in order to decide on the extension of a patent whose merits had already been assessed in connection with the patent application. Thus, the competent patent authorities had, in this case, only limited scope for assessment. Moreover, only AZ had knowledge of certain facts, such as the date as of which Losec was launched in Luxembourg, and this considerably limited the role of third parties in the process.

In the Commission's view, any misleading representation does not necessarily infringe Article 82 EC, since some representations can have only limited consequences for the granting of an SPC. In order to constitute an abuse of a dominant position, the misleading representation must play a determining role in the decision. In the present case, it is reasonable to assume that, if the applicants had not made those representations, they would not have obtained an SPC in the countries in respect of which the first authorisation to place a product on the market in the Community must be after 1 January 1988, namely Germany, Denmark, Finland and Norway, or would have obtained them for a shorter period in the countries in respect of which the first authorisation to place a product on the market in the Community must be after 1 January 1982, namely Austria, Belgium and Italy, or after 1 January 1985, namely Ireland, the Netherlands, Luxembourg, the United Kingdom and Sweden. The Commission adds that the applicants' SPC applications gave no grounds for assuming that they were not based on the interpretation generally accepted at the time, which took into account the first technical authorisation date. Furthermore, the interpretation relying on the ‘effective marketing theory’ enabled AZ to deceive the public authorities, since it alone held the crucial information, thereby imposing on it an even greater burden to make representations which were not misleading.

Since protection of substances by an SPC has a practically total exclusionary effect on competing generic versions, the date of expiry of a substance patent or an SPC affects the preparations being made by generic manufacturers wishing to launch generic versions, who often strive to be ready to launch their products on the very day the patent or SPC expires. Business decisions by pharmaceutical companies are adopted well before the expiry of the substance patent, as is apparent from the interest expressed by Ratiopharm in AZ's SPC in Germany and the Netherlands in 1996 and 1997. It is therefore incorrect, in the Commission's view, to consider that there can be no abuse until the SPC comes into force. Moreover, the abuse also affected competitors in that it obliged them to incur considerable expenses in order to attempt to have certain of the SPCs revoked.

In the light of the foregoing, the Commission submits that the arguments advanced by the applicants are unfounded. As regards, first, the argument that there is no abuse of a dominant position prior to the actual application for an SPC, the Commission considers that the start of the abuse is the point in time when the applicant first adopts the behaviour objected to. Implementation of the strategy started with the instructions to the patent attorneys on 7 June 1993, which competitors had no way of knowing. The fact that this first act, which is part of a course of conduct, does not suffice, in itself, to achieve the desired effect and that acts by others have to occur for AZ to succeed in its strategy is irrelevant to the finding of an infringement of Article 82 EC, for the reasons set out in paragraph 331 above.

The Commission adds that, in the specific context in which the SPC applications were made, there was a high probability that the patent offices would accept the dates provided by AZ without verifying them. Consequently, the fact, to which attention is drawn by the applicants, that certain authorities, unlike others, were in the end not misled by AZ's representations is also irrelevant. The capacity of AZ's behaviour to restrict competition was the same in all the countries in question and is demonstrated by the fact that SPCs were granted in most of those countries. The fact that no SPCs were granted in Denmark and the United Kingdom simply shows that the effects depended on the behaviour of third parties. However, the patent offices in those latter countries might have been misled in the same way as other offices were.

The Commission disputes that the complainants acknowledged at the hearing that generic medicinal products had felt no effect of an SPC until after the expiry of the substance patent and submits that this is not at all apparent from the document cited by the applicants. On the contrary, the complainants stated that ‘the very knowledge that Astra would benefit from a period of protection covered by the SPC ha[d] a ‘chilling’ effect on those preparing to enter the market’. The Commission again adds that competitors were affected by the fact that they incurred considerable expenses in order to attempt to have the SPCs revoked (recitals 760 and 762 of the contested decision).

Moreover, the Commission disputes that an abuse of a dominant position can be identified only when measures to enforce intellectual property rights are taken. The acquisition of an intellectual property right may be an abuse in itself, since other undertakings are expected to respect the exclusive rights associated with it. In the alternative, the Commission submits that the advertisement placed by AZ in a pharmaceutical journal, by which it made known its intention to ‘ensur[e] that these intellectual property rights are respected and … take legal action against infringers thereof’ is sufficient proof of enforcement in this case. Moreover, AZ brought actions for infringement in Germany on the basis of the SPC, which forced its competitors to incur considerable costs in attempting to have AZ's SPC revoked (see recitals 760 and 766 of the contested decision). The Commission contends that those measures are part of an overall strategy of exclusion, which started with the misleading representations in 1993.

With regard to the situations where AZ was able to prolong the period for which the SPCs were granted, the Commission agrees that the exclusionary effect is shorter in duration. However, that fact does not affect the finding that there was abuse. Moreover, the fact that the effects of the abusive behaviour occur at a time when the company is no longer dominant is equally incapable of affecting the legal assessment of the behaviour implemented when the company was in that dominant position, which is the only relevant circumstance. The Commission adds that there was a strong interrelationship between the components of the abuse, since impacts on the competitive situation in one country could potentially spill over into another country. The fact that AZ's misleading representations continued to produce effects until they were corrected and, moreover, were liable to have effects in other countries means that, in so far as it concerned Belgium, Germany, the Netherlands and Norway, the abuse of a dominant position cannot be limited to the last misleading representation in respect of those countries. In addition, the Commission submits that, taking into account the level of sales of Losec at the time of expiry of the basic patent, the actual supplementary protection in Belgium, the Netherlands and Norway related to considerable interests.

According to settled case-law, an abuse is an objective concept referring to the behaviour of an undertaking in a dominant position which is such as to influence the structure of a market where, as a result of the very presence of the undertaking in question, the degree of competition is already weakened and which, through recourse to methods different from those governing normal competition in products or services on the basis of traders' performance, has the effect of hindering the maintenance of the degree of competition still existing in the market or the growth of that competition (Hoffmann-La Roche v Commission, paragraph 239 above, paragraph 91; AKZO v Commission, paragraph 243 above, paragraph 69; Case T-228/97 Irish Sugar v Commission [1999] ECR II-2969, paragraph 111; and Michelin v Commission, paragraph 334 above, paragraph 54).

In this respect, it should be borne in mind that Article 82 EC is aimed both at practices which may cause damage to consumers directly and at those which are detrimental to them through their impact on an effective competition structure (Europemballage and Continental Can v Commission, paragraph 267 above, paragraph 26).

It follows that Article 82 EC prohibits a dominant undertaking from eliminating a competitor and thereby strengthening its position by using methods other than those which come within the scope of competition on the merits (AKZO v Commission, paragraph 243 above, paragraph 70, and Irish Sugar v Commission, paragraph 352 above, paragraph 111). It is also apparent from the case-law that an abuse of a dominant position does not necessarily have to consist in the use of the economic power conferred by a dominant position (see, to that effect, Europemballage and Continental Can v Commission, paragraph 267 above, paragraph 27, and Hoffmann-La Roche v Commission, paragraph 239 above, paragraph 91).

In the present case, the Court observes that 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 (see, to that effect, Nederlandsche Banden-Industrie-Michelin v Commission, paragraph 30 above, paragraph 57).

It follows from the objective nature of the concept of abuse (Hoffmann-La Roche v Commission, paragraph 239 above, paragraph 91) 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 Court would point out that 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 has been 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, as the Commission asserts, 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.

The Court would also point out, in the light of the applicants' arguments set out in paragraphs 309, 312 and 314 above, that, 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, relied upon by the applicants, that the concept of abuse of a dominant position is an objective concept and implies no intention to cause harm (see, to that effect, Aéroports de Paris v Commission, paragraph 309 above, paragraph 173) 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. As the Commission rightly observes, 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 applied 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 SPCs 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, constituted an abuse of that position. The question whether those representations were objectively misleading must be assessed in the light of the specific circumstances and context of each individual case. In this case, the factual assessment made by the Commission in this respect is the subject of the second plea.

The Court rejects the applicants' 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. 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. Furthermore, to the extent that the applicants argue that an intellectual property right must have been exercised in legal proceedings, that argument would tend to make the application of Article 82 EC conditional on the contravention by competitors of the public regulations by their infringing the exclusive right of an undertaking; that argument must be rejected. Moreover, third parties seldom have information enabling them to know whether an exclusive right has been unlawfully granted.

Consequently, the applicants' arguments, based on the application of the criteria used by the Commission in ITT Promedia v Commission, paragraph 311 above, must also be rejected as irrelevant, since those criteria relate to a possibly abusive exercise of the right to bring legal proceedings against a competitor.

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.

In this respect, the applicants cannot rely on the judgment in Tetra Pak v Commission, paragraph 310 above, in order to submit that elimination of all competition would be necessary. The Court observes, first of all, that the present case and the judgment in Tetra Pak v Commission, paragraph 310 above, concern different situations. Whereas the present situation concerns acts liable to induce public authorities to grant an intellectual property right to which the undertaking in a dominant position is not entitled or to which it is entitled for a shorter duration, the judgment in Tetra Pak v Commission, paragraph 310 above, relates to the acquisition by an undertaking in a dominant position of a company holding an exclusive patent licence which constituted the only means of competing effectively with the undertaking in the dominant position (paragraphs 1 and 23 of that judgment). Next, it is not all apparent from that judgment that Article 82 EC requires the elimination of all competition in order to be applied. In that judgment, the Court merely approved the Commission's assessment that, in the case before it, Article 82 EC did not allow the undertaking in a dominant position, by acquiring an exclusive licence, to strengthen its ‘[already] very considerable’ dominance and to prevent or considerably delay ‘the entry of a new competitor into a market where very little if any competition [was] found’ (paragraph 23 of that judgment).

Furthermore, the Court rejects the applicants' argument that the existence of specific remedies which make it possible to rectify, or even annul, patents and SPCs granted unlawfully justifies application of the competition rules only where an anticompetitive effect is demonstrated. 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, in cases of behaviour such as that at issue in the present case, proof of the anticompetitive effects produced by such behaviour.

Nor can the applicants object that a finding of an abuse of a dominant position in cases where misleading representations have been made to patent offices for the purposes of obtaining intellectual property rights to which an undertaking is not entitled, or to which it is entitled for a shorter period, would result in a ‘freeze’ on patent applications and would run counter to the public interest in encouraging innovation. It is quite clear that, where established, such behaviour is indeed contrary to the public interest, as weighed up and applied by the legislator. As the Commission observes, such misuse of the patent system potentially reduces the incentive to engage in innovation, since it enables the company in a dominant position to maintain its exclusivity beyond the period envisaged by the legislator.

Lastly, with respect to the applicants' arguments based on United States law, suffice it to note that the position adopted by the latter cannot take precedence over that adopted by European Union law (Atlantic Container Line and Others v Commission, paragraph 243 above, paragraph 1407).

As regards the date on which the abuse of a dominant position — if established — is deemed to have started, the Commission took the view that, in the case of Germany, Belgium, Denmark, the Netherlands and the United Kingdom, that abuse started to be implemented on 7 June 1993, when the final instructions for the SPC applications in respect of omeprazole were sent to the patent attorneys in those countries (see recitals 179, 651 and 774 of the contested decision). As the applicants observe, the Commission thus puts the commencement of the alleged abuse of a dominant position at a point in time even before the SPC applications were filed with the patent offices.

The Court considers however that instructions sent to patent attorneys to file SPC applications cannot be regarded as equivalent to the filing of SPC applications themselves before patent offices. The desired outcome of the alleged misleading nature of the representations, namely the grant of the SPC, can arise only from the time that the SPC applications are filed before the patent offices, and not when the patent attorneys, who in this case have only an intermediary role, receive the instructions regarding those applications.

The Court also notes that the Commission's position as regards the date on which the alleged first abuse started in Germany, Belgium, Denmark, the Netherlands and the United Kingdom is not consistent with its approach as regards Norway. The Commission found that, in Norway, the alleged first abuse started on 21 December 1994, namely when the patent attorney transmitted the SPC application to the Norwegian patent office (see recitals 234 and 774 of the contested decision).

The applicants are therefore justified in claiming that the Commission erred in law in considering that the alleged first abuse of a dominant position committed by AZ in Germany, Belgium, Denmark, the Netherlands and the United Kingdom started on 7 June 1993, when instructions were transmitted to the patent attorneys to file the SPC applications before the patent offices.

That error is not however capable of affecting the lawfulness of the contested decision as regards the existence of the alleged abusive practice from the time when the SPC applications were transmitted to the national patent offices. In this respect, according to recital 185 of the contested decision, the SPC applications were transmitted to the patent offices in Germany, Belgium, Denmark, the Netherlands and the United Kingdom between 12 and 30 June 1993. The consequences of that error for the amount of the fines will, where appropriate, be assessed below, in the part dealing with the applicants' plea on that point.

The applicants dispute that AZ's misleading representations before the patent offices were of an anticompetitive nature and claim that they were not capable in themselves of restricting competition.

The Court would point out, first of all, that, as was observed in paragraph 355 above, the acquisition, by means of conduct liable to mislead the public authorities, 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. The assessment of whether representations made to public authorities for the purposes of improperly obtaining exclusive rights are objectively misleading must be undertaken with due regard to the specific features of the case.

The applicants claim that an abuse of a dominant position can be identified only where the behaviour in question has a direct effect on competition and that, in this case, the unlawful SPC applications had only remote effects on competition. In this respect, the Court would point out that it is not at all apparent from the case-law that, in order to constitute an abuse of a dominant position, behaviour must have a direct effect on competition. In a situation such as that of the present case, 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, and as the Commission observes, 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.

The applicants dispute that a finding of an abuse of a dominant position in Germany, Belgium, Denmark, Norway, the Netherlands and the United Kingdom can be made and rely, in this respect, on arguments of a factual nature designed to persuade the Court that the acquisition of SPCs was not capable of having a restrictive effect on competition. In so far as those arguments are essentially factual in nature, the Court will examine them in paragraphs 601 to 607 below, in the context of the examination of the second plea, which is devoted to review of the Commission's assessment of the facts constituting the first abuse of a dominant position.

In so far as those arguments concern questions of principle, the applicants cannot rely on the fact that in Belgium and the Netherlands AZ was no longer in a dominant position at the time when the SPCs conferred supplementary protection. The fact that AZ was no longer in a dominant position at the time when its abusive behaviour was able to produce its effects does not alter the legal classification to be attached to its acts, since those acts were committed at a time when AZ was under a special responsibility not to allow its behaviour to impair genuine undistorted competition on the common market.

Lastly, the fact, relied upon by the applicants on several occasions, that the effect on competition of the misleading representations and the resulting grant of the SPCs would be felt only several years later, when the basic patents expired, does not cause the behaviour in question — if it is established — to lose its abusive character, in view of the exclusionary effect on competitors that may be expected when those SPCs are granted and are not subsequently revoked. Furthermore, as regards the objection to recital 762 of the contested decision, in which the Commission relies on the fact that the mere existence of the SPCs delays the preparations of generic producers, it follows from the foregoing that, even assuming that there is no such effect or it is on a lesser scale, objectively misleading representations whose object it is to obtain unlawful SPCs are in themselves — if they are established — liable to restrict competition.

In view of all the foregoing, the Court upholds the first plea in so far as it alleges an error of law by the Commission in its assessment of the date when the alleged first abuse of a dominant position started in Germany, Belgium, Denmark, the Netherlands and the United Kingdom. In those countries, the alleged first abuse did not start when AZ sent its instructions to the patent attorneys, but when the SPC applications were transmitted to the national patent offices. In those circumstances, and in the light of recital 185 of the contested decision, the Court finds that the first abuse of a dominant position — if it is established — started on 30 June 1993 at the latest.

However, the Court dismisses the first plea as to the remainder.

The applicants submit that the Commission's allegations relating to a strategy of making deliberate misrepresentations must be proved by evidence of the ‘clearest nature’. Under the principle of the presumption of innocence, those allegations cannot be based on surmise and inference from circumstances which do not of themselves necessarily lead to a finding of fraud. In that regard, the applicants refer to United Kingdom and United States law and point out, in particular, that, contrary to what the Commission claims, the judgment of the Federal Circuit, referred to in paragraph 340 above, also requires ‘clear and convincing’ evidence of specific intent, evidence demonstrating gross negligence being insufficient. The applicants thus cast doubt on the relevance of the case-law relating to cartels. In the context of cartels, it is possible to infer intent or the existence of an agreement from the holding of meetings between competitors. However, in the context of relatively routine acts of patent prosecution, evidence which may seem to support the existence of fraud could equally well be consistent with gross negligence or inadvertence.

However, the Commission based its arguments on evidence which does not meet the required standard. In that regard, the applicants maintain that a series of insufficiently founded allegations, tenuous inferences and insinuations does not amount, even taken together, to clear and convincing proof. The Commission made selective references to documentary evidence, sometimes taking them out of context, and gave biased interpretations of them. Nor did it ever meet either AZ's employees or the authors of the documents on which it relies, and conducted no enquiries of experts, of the relevant patent offices or of patent attorneys.

It is insufficient for a finding of abuse merely to show that AZ did not proactively disclose the legal interpretation on the basis of which it was making its patent extension applications. That is, in any event, insufficient to demonstrate the intentional nature of an abuse of this type if, on the one hand, the interpretation of the regulatory context was held reasonably and in good faith and, on the other, that interpretation was revealed in response to a request for information on the part of the public authority. Consequently, the fact alleged by the Commission that the head of the patent department knew that the representations were incomplete or not wholly transparent is clearly inadequate for a finding of an abuse of this nature.

The applicants argue that AZ had interpreted ‘first authorisation to place the product on the market’ in Article 19 of Regulation No 1768/92 as meaning the date of completion, in any one Member State, of all the administrative steps which are necessary to make the launch of the product possible in that Member State. AZ thus considered that there was a first authorisation only when the national authority had approved the price of the product, so that the product could actually be marketed. Henceforth, the concept of authorisation to place a product on the market, as interpreted by AZ in the present case, will be referred to as ‘effective marketing authorisation’.

The applicants submit that this interpretation was adopted in good faith and cannot be considered to be unreasonable, having regard to the imprecision of the legislation in question. AZ consulted two lawyers, whose opinions supported its interpretation of Regulation No 1768/92. [confidential]

[confidential]

In the applicants' submission, the fact that those distinguished lawyers adopted the same interpretation of Regulation No 1768/92 as AZ is a significant consideration in support of the claim that AZ's interpretation was reasonably held and, therefore, bona fide. They deny, moreover, that AZ brought pressure to bear on its corporate lawyers and refer, in this respect, to a witness statement from a lawyer.

The applicants add that the reasonableness and bona fides of that interpretation of Regulation No 1768/92 are supported by the fact that the Bundesgerichtshof (Federal Court of Justice, Germany) considered that that regulation was sufficiently imprecise for questions to be referred to the Court of Justice for a preliminary ruling on the interpretation and validity of that regulation.

They further assert that AZ's interpretation of Regulation No 1768/92 is consistent with its purpose, namely to make up for the reduction in the period of economic exploitation of the patent. Taking the example of France, they state that the French technical authorisation, which was the first technical authorisation granted in the Community, was granted in April 1987, whereas the price was not approved until two and a half years later, in November 1989, the date from which it was possible to market omeprazole in France. In support of their assertions, the applicants produce 10 witness statements from current and former AZ employees and 10 witness statements from patent attorneys and lawyers.

The applicants therefore submit that the Commission is wrong to assert, in recital 666 of the contested decision, that AZ had knowingly made false representations, since those representations were, on the contrary, made in good faith. They also complain that, in recitals 151 and 152 of the contested decision, the Commission described Article 8 of Regulation No 1768/92 while inserting, in that description, matters relating to the interpretation of that provision, so as to create the impression that the regulation in question clearly indicated that the date of technical authorisation was the same as that of the marketing authorisation.

The applicants submit that the Commission was not entitled to maintain that the national patent offices did not verify the information submitted by SPC applicants in relation to the dates of first marketing authorisations. The Commission took as its basis the practice in only two States, namely Finland and Norway, and the evidence dates from mid-1994, that is, well after the initial applications for SPCs were made, in June 1993. Moreover, the Commission does not allege abuse of a dominant position in Finland. In addition, no evidence was adduced of lack of verification in other Member States, in particular Germany and Denmark, at the time that the first applications were filed, in June 1993. The Commission did not even approach the national authorities in question in order to prove this point. Indeed, the Commission's assertion is invalidated by the fact that AZ's applications were challenged by many authorities. The applicants add that it does not necessarily follow from the fact that, under Article 10(5) of Regulation No 1768/92, Member States were not required to verify the first marketing authorisation date in the Community that they would not carry out such verification.

Nor has the Commission shown that AZ knew about the alleged absence of verification. The applicants maintain that AZ expected to have to discuss the basis of its applications with its patent attorneys and to defend its interpretation of Regulation No 1768/92 before the patent offices. In that regard, the applicants refer to the evidence given by the head of the patent department at the oral procedure before the Commission, and to the statements of patent attorneys.

The applicants state that the Commission is correct to find that the three memoranda of 16 March 1993 show that AZ had noticed that the first technical authorisation date in the Community for omeprazole, felodipine and omeprazole sodium appeared to be before 1 January 1988. They also admit that the immediate reaction of certain AZ staff had been to believe that AZ could not obtain SPCs in Germany and Denmark. However, they state that AZ was aware of a school of thought that considered that the date of the first marketing authorisation was the effective marketing authorisation date (see the third memorandum of 16 March 1993). Accordingly, the Commission is wrong to assert that AZ knew that the technical authorisation date was necessarily the determinative date for the application and that AZ could not obtain SPCs in the countries in respect of which the first authorisation to place a product on the market in the Community must be after 1 January 1988. On this point, the applicants refer to paragraphs 6 and 7 of the witness statement of Ms D.

As regards the information collected by AZ from its local marketing companies, the selectivity of which is criticised by the Commission in recital 636 of the contested decision, in so far as that information concerned only the ‘problem products’ and focused only on the cases where technical authorisations had been issued before 1 January 1988, the applicants state that AZ only needed information regarding the products and countries in relation to which the effective marketing authorisation date might matter, since the question of whether SPCs could be issued did not arise for the other products whose technical authorisation dates were subsequent to 1988. They explain that AZ had limited resources and that the different record-keeping methods in the marketing companies made it difficult to check the correct dates of effective marketing authorisations. Making sensible use of limited resources, AZ therefore chose to request only information regarding the products whose authorisation dates were potentially problematic. The applicants add that, although AZ's approach may be characterised as inconsistent, it is not evidence either of an intention to mislead or of a deliberate fraud.

The applicants observe that the Commission failed to note that the letter of 17 December 1987, relating to the price approval for omeprazole in Luxembourg and mentioned in recital 637 of the contested decision, had been stamped by Astra Belgium on 31 December 1987. Furthermore, the letter from the marketing company confirmed that this was during the office's Christmas closure, so that it would have been impossible for Astra to act on that letter before Monday 4 January 1988. Accordingly, that letter of 17 December 1987 provided Astra with the information that the first effective marketing authorisation date for omeprazole capsules in the Community was bound to be after 1 January 1988 in Luxembourg, that is, after the relevant cut-off date for Germany and Denmark.

The applicants claim that it is clear from the words ‘will argue before’, contained in the memorandum of 29 March 1993, that AZ anticipated that the basis of the applications made to the German and Danish patent offices might be the subject of some controversy, and that it was preparing to defend its interpretation of Regulation No 1768/92 before the patent offices. They therefore deny both that AZ anticipated that the patent offices would merely rubber stamp its applications and accept the dates shown on the applications without verification and that AZ sought to conceal the basis for its applications. In that regard, the applicants refer to page 83 of the transcript of the oral procedure before the Commission.

The applicants reiterate their arguments set out in paragraphs 393 and 394 above and submit that the Commission cannot allege that AZ was seeking to conceal the legal basis of the dates it had submitted, since the contention that the degree of verification was, by and large, limited is insufficient in that regard. Furthermore, the fact that AZ intended to discuss authorisation dates with its patent attorneys and the patent offices is supported by the fact, accepted by the Commission itself, that the patent attorneys for the United Kingdom and Ireland were informed of the interpretation of Regulation No 1768/92. Similarly, the Luxembourg and French patent attorneys were also informed.

The applicants dispute the Commission's allegation that the memorandum of 29 March 1993, paragraph 398 above, contains a proposal by Mr H. to be proactive and to draw AZ's theory to the attention of patent offices, and point out that the Commission does not adduce any evidence in that regard. They claim that that memorandum merely shows that Astra had anticipated that it would find it necessary to present and defend its interpretation of Regulation No 1768/92. The applicants add that the Commission's dismissal of the statement on oath of the head of the patent department that he had many conversations with the patent attorneys reverses the burden of proof and is incompatible with the principle of the presumption of innocence.

Moreover, it is clear from the memorandum of 30 March 1993, to which the Commission refers in recitals 639 to 641 of the contested decision, that Hässle had considered that the effective marketing authorisation date was the decisive date for the purposes of Article 19(1) of Regulation No 1768/92. Hässle informed AZ's patent department that the date of publication of the official price was the effective marketing authorisation date for Luxembourg and that this date could not have been before 2 January 1988. Finally, Hässle proposed to obtain the effective marketing authorisation dates for all other countries.

The applicants state that, by memorandum of 7 April 1993, headed ‘Re: Submission of SPC application’, Hässle forwarded to the patent department further information from the Belgian and French marketing companies, among which was a document described as listing the authorised products in Luxembourg and dated March 1988. That document (‘the Luxembourg list’) contained a page of a list which included, among other products, Losec capsules and injectable products and was dated 21 March 1988. On 6 May 1993, Hässle decided on the instructions to be sent to patent attorneys for the SPC applications for omeprazole, as evidenced by the memorandum of 29 March 1993. The applicants deny that those instructions were misleading and maintain that the annotations that were made to the memorandum of 29 March 1993 simply implemented the approach adopted by Astra and Hässle of indicating on SPC applications the effective marketing authorisation dates in Luxembourg and France. Those amendments were made on the basis of materials gathered by the patent department, from which it was clear that Luxembourg had been the first Member State to grant effective marketing authorisation, on 21 March 1988, and that the marketing authorisations in the other Member States were granted at a later date, so that there was no need to make any further investigations. In support of their claims, the applicants refer to paragraphs 10 to 12 of the witness statement of Dr V., President of Astra Hässle at the material time.

The applicants submit that the Commission's accusations in recitals 643 and 665 of the contested decision are unwarranted and result from a subjective interpretation of the relevant documents. They deny that AZ sought to conceal the dates of the technical authorisations granted in France and Luxembourg, since the company simply considered that the relevant date was that of the effective marketing authorisation.

The applicants argue that the fact that AZ stipulated in its instructions that the March 1988 date be used for all applications filed in all countries demonstrates the absence of intention to mislead the national patent offices. In their submission, if AZ had intended to mislead those authorities, it would only have used the March 1988 date for the applications filed in Denmark and Germany. Moreover, the allegation that AZ concealed the nature of the Luxembourg authorisation is unjustified, since it is clear from the face of the Luxembourg list attached to the SPC applications that that document was not a technical authorisation.

The applicants claim that the insertion of the technical authorisation number for Luxembourg resulted from an error by AZ and was made by the Luxembourg patent office. They state that the head of Astra's patent department appeared at the oral hearing and testified to the bona fides of AZ.

With regard to the use of the Luxembourg law relating to technical authorisation under the ‘Legal Provision’ section of the instructions of 7 June 1993, the applicants maintain that AZ inserted that provision on the advice of the patent attorneys in Luxembourg. They refer, in that regard, to the witness statement of the Luxembourg patent attorney.

As regards the inconsistency stemming from the fact that the final instructions from Astra's patent department used three different types of authorisation dates when filing the SPC applications for different products, the applicants again maintain that this is due to the limited resources and time constraints which affected AZ. The technical authorisation dates relating to products other than omeprazole and omeprazole sodium were in or after 1988. Consequently, the effective marketing authorisation dates in the Community were necessarily later. By using the technical authorisation dates, Astra was assured that, in any event, an SPC would be granted, albeit of a shorter duration than that to which it believed it was entitled. As regards felodipine, the technical authorisation date was 29 December 1987, which would have precluded obtaining an SPC in Denmark or Germany. AZ therefore inserted the date of first publication of the technical authorisation.

The applicants deny that AZ knew that the date on the Luxembourg list was wrong. Hässle's memorandum of 30 March 1993 noted that the decisive date was that of publication of the price of the product and confirmed that, in Luxembourg, the price of a product had to be officially published before the product could be sold in pharmacies. On 7 April 1993, in the memorandum headed ‘Re: Submission of SPC Applications’, Hässle provided the patent department with further information which it had received from AZ's Belgian marketing company, and which included the Luxembourg list dated March 1988. The Belgian marketing company identified that list as a copy of an official paper listing the authorised products in Luxembourg. The applicants submit that Hässle could reasonably conclude that the information provided by the Belgian marketing company concerned the date of publication of the price of the product in Luxembourg.

Since the cover sheet of the Luxembourg list was dated March 1988 and the date on the relevant page of the list was 21 March 1988, it was reasonable to infer that 21 March 1988 was the effective marketing authorisation date. Accordingly, the Commission's finding that, even on its effective marketing interpretation of Regulation No 1768/92, AZ could not reasonably rely on the Luxembourg list is manifestly incorrect. In support of their assertions, the applicants refer to paragraphs 8 to 11 of the witness statement of Ms C. As regards the fact, relied on by the Commission, that Ms D. did not know about the ‘effective marketing theory’, the applicants maintain that it cannot constitute evidence of a deliberate attempt to use a wrong date.

The applicants add that the Commission is wrong to maintain that the legal advice provided by one of the law firms consulted did not deal with the Luxembourg list and was therefore irrelevant. [confidential] Finally, while the applicants accept that there were inconsistencies in the instructions of 7 June 1993 and regret that they occurred, they firmly deny that those inconsistencies were part of a strategy designed to hide the basis of the SPC applications and the interpretation of Regulation No 1768/92, and submit that there is no proper basis or evidence for the Commission to sustain that allegation.

The applicants further dispute the Commission's assertion that the explanation of the head of the patent department in paragraph 34 of his witness statement as to the reason why the French marketing authorisation date was used in the instructions to patent attorneys conflicts with the explanations provided by AZ in paragraph 6.84 of its reply to the statement of objections.

In reply to the Commission's objections relating to the fact that the Danish marketing authorisation date was not used in the SPC application for felodipine, the applicants maintain that the document on which the Commission bases its assertion that AZ knew the effective marketing date for that product as early as 30 March 1993, namely a fax of that date from Hässle to the patent attorneys at Astra, shows that the situation in relation to felodipine in Denmark was not straightforward and that Astra was still considering what position to adopt. They explain that felodipine was a product in relation to which the authorisation date was likely to pose a problem, since the technical authorisation date was too early for an SPC to be obtained. It was therefore important for AZ to establish the legally relevant date.

The applicants claim that the Danish effective marketing date was not used in the SPC application for felodipine because it was irrelevant, since it was neither the first Danish authorisation under Directive 65/65 nor the first authorisation in the Community. They dispute that the head of the patent department maintained at the oral procedure before the Commission that he would have liked to use the effective marketing dates for all products, since he in fact maintained that he ‘would have liked to have had all eight applications to be based on the efficient, the first proper full market approval process with price and everything’. They maintain, finally, that the Danish patent attorney and the Danish patent office were informed of the basis upon which AZ had made its SPC application for felodipine, as was indicated in the reply to the statement of objections.

In general, the applicants deny that AZ relied on its interpretation of the regulatory framework a posteriori in order to justify the use of the March 1988 date, and refer, in that regard, to Hässle's memorandum of 30 March 1993. They submit that the Commission is inconsistent when it asserts that AZ developed its interpretation of Regulation No 1768/92 after making the SPC applications and in the context of the litigation ensuing after the grant of the SPCs. It is clear from recitals 239 to 245 and 705 of the contested decision that, between March and June 1994, AZ sought legal advice on the interpretation of that regulation. Moreover, the Commission itself admitted, in recital 697 of the contested decision, that, by September 1993, AZ had decided to defend its ‘effective marketing theory’ before the United Kingdom patent office in order to obtain an SPC. The applicants also point out that, in recital 222 of the contested decision, the Commission noted that the litigation in the Ratiopharm case in Germany, which was regarded as the first court proceedings in which AZ had defended its SPC strategy, commenced from 18 June 1996. In support of their claims, the applicants refer to the witness statement of Mr W.

The Court notes, as a preliminary point, that the burden of proof of the existence of the circumstances that constitute an infringement of Article 82 EC is borne by the Commission (Microsoft v Commission, paragraph 32 above, paragraph 688). 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 for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950, which is one of the fundamental rights which, according 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 (see, by analogy, judgment of 12 September 2007 in Case T-36/05 Coats Holdings and Coats v Commission, not published in the ECR, paragraphs 68 to 70 and the case-law cited).

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, to that effect and by analogy, Joined Cases T-67/00, T-68/00, T-71/00 and T-78/00 JFE Engineering and Others v Commission [2004] ECR II-2501, paragraphs 179, 180 to 275, and Joined Cases T-44/02 OP, T-54/02 OP, T-56/02 OP, T-60/02 OP and T-61/02 OP Dresdner Bank and Others v Commission [2006] ECR II-3567, paragraphs 62 and 63 and the case-law cited).

As a preliminary point, it should be recalled that, although the Commission noted the single and continuous nature of the first abuse of a dominant position, it distinguished, as is stated in paragraphs 306 and 307 above, two stages in that abuse. The first stage identified by the Commission concerns AZ's misleading representations when sending instructions, on 7 June 1993, to the patent attorneys through whom the SPC applications were filed in seven Member States, amongst them Germany, Belgium, Denmark, the Netherlands and the United Kingdom (see recital 628 of the contested decision). The second stage identified by the Commission consists

As regards the first stage of the abuse, the Court would recall the factual circumstances surrounding the first stage of the behaviour that the Commission classified as abusive, as they emerge both from the contested decision and the documents produced before the Court. It is common ground, in the present case, that, in a memorandum of 16 March 1993, the patent department stated that the first ‘market registration’ in the Community for omeprazole had been issued in France in April 1987. The patent department therefore stated that it did not consider that it was possible to obtain an SPC in Germany and Denmark, as the first market registration was before 1988. The same difficulty was identified in relation to omeprazole sodium and felodipine (see recitals 634 and 635 of the contested decision).

It should be noted, in this respect, that, under the transitional rule contained in the second subparagraph of Article 19(1) of Regulation No 1768/92 (see paragraph 299 above), in Germany and Denmark, products eligible to receive a SPC were those whose first authorisation to be placed on the market in the Community had been obtained after 1 January 1988.

As of mid-March 1993, AZ's patent department collected information, via Hässle, from the local marketing companies. That collection of information focused solely on products which presented problems as regards the issue date of the first technical authorisation, namely omeprazole, omeprazole sodium and felodipine, as that date was prior to 1 January 1988. On 22 March 1993, the Belgian marketing company sent Hässle a copy of the technical marketing authorisation for omeprazole in Luxembourg of 16 November 1987, and a copy of the decision approving the price of omeprazole in that country, of 17 December 1987 (see recitals 170, 636 and 637 of the contested decision).

In a memorandum by the patent department of 29 March 1993, the first market registration in the Community was identified as being that which had been issued in France in April 1987. However, the patent department stated in that memorandum that, for the purposes of the SPC applications in Germany and Denmark, it would claim before the patent offices that the first marketing authorisation in the Community had not taken place before 1 January 1988 (see recital 638 of the contested decision).

In a memorandum sent to the patent department on 30 March 1993, Hässle communicated the information received regarding the dates relating to the authorisations for omeprazole in France and Luxembourg and felodipine in Denmark. As regards omeprazole in Luxembourg, that memorandum confirmed the information received on 22 March 1993 from the Belgian marketing company, namely that the Luxembourg technical marketing authorisation was issued on 16 November 1987 and that the decision approving the price of that product was taken on 17 December 1987, but stated that the date of publication of the price was not yet known. That memorandum also confirmed that the marketing authorisation for omeprazole in France took place in April 1987, and added that the price negotiations were completed in spring 1989 and that the price was published in the Journal officiel de la République française on 22 November 1989 — although that memorandum refers to the date of ‘22.11.1988’, the Court considers that the Commission was correct to find, in recital 171 of the contested decision, that that reference was the result of a clerical error and that the author of the memorandum intended to refer to the date of 22 November 1989. As regards felodipine in Denmark, Hässle stated that the marketing authorisation was issued on 29 December 1987, that that authorisation was published on 21 January 1988 and that the price was published on 29 February 1988 in the Specialitetstaksten (price list of proprietary medicinal products).

In that memorandum, Hässle stated that, in France, Luxembourg and Denmark, prices had to be set and published before a product could be marketed. Hässle thus considered that ‘that date [was] decisive’. It stated that it was trying to obtain the same information concerning the other countries, in order to determine the date using the same criteria in the different countries (see recitals 639 to 641 of the contested decision).

On 5 April 1993, the Belgian marketing company sent Hässle the cover page and page 246 of the Luxembourg list, and referred to a copy of an official document of March 1998 (which should read ‘March 1988’) listing the authorised products in the Grand Duchy of Luxembourg. That document was forwarded to the patent department by memorandum of 7 April 1993 (see recitals 172, 173 and 658 of the contested decision).

As the Commission observed in recital 173 of the contested decision, the cover page of the Luxembourg list is entitled ‘Ministère de la Santé — Spécialités pharmaceutiques — Liste des spécialités pharmaceutiques admises à la vente dans le Grand-Duché de Luxembourg’ (‘Pharmaceutical specialities — List of pharmaceutical specialities approved for sale in the Grand Duchy of Luxembourg’). At the bottom of the cover page the following items are mentioned: ‘éditeur: CEFIP sàrl Luxembourg — Tout droit réservé — Modification au 24.2 comprise — Mars 1988’ (‘editor: CEFIP sàrl Luxembourg — All rights reserved — Modification to 24.2 included — March 1988’). A list of names of 23 pharmaceutical products in alphabetical order starting with the letters ‘lo’, then the letters ‘lu’, and including inter alia two references to Losec, in respect of omeprazole capsules and the injectable preparation of omeprazole (omeprazole sodium), appears on page 246 of that document. No prices appear alongside the products mentioned. The following date appears in the top left hand corner of page 246: ‘21/03/88’. It appears that that page comes from a document listing medicinal products approved for sale over several hundred pages.

The Commission also stated that AZ had admitted before the Norwegian courts in May 1999 that it did not possess the complete list, or a part of it comprising the price for Losec, despite the efforts made to procure that document (recitals 241 and 661 of the contested decision). Similarly, it observed that, before the Finnish courts, AZ admitted on 30 June 1999 that the situation in Luxembourg ‘was unclear’ (recitals 245 and 661 of the contested decision). The Commission also considered that AZ's internal documents confirmed that AZ did not know whether Losec might have been marketed before March 1988. The Commission referred, in this respect, to an internal memorandum of 14 February 1994 (recitals 210, 211 and 661 of the contested decision) and to a document from in-house lawyers (recital 230 and footnote 302 and recital 661 of the contested decision).

The Commission observed that the date of the alleged effective marketing, namely the date of publication of the price of the product, was not used in all the SPC applications. In fact, that date was used only for omeprazole and omeprazole sodium. As regards felodipine, the date of the first publication of the technical marketing authorisation was used, namely in Denmark on 21 January 1988. For five other products, AZ used the technical marketing authorisation dates, which are all subsequent to 1 January 1988 (see recitals 643 to 645 of the contested decision).

As regards the SPC applications for omeprazole, the Commission considered that the misleading representations stemmed from Hässle's decision of 6 May 1993, which was taken in the form of three handwritten annotations in Swedish on the patent department's memorandum of 29 March 1993 (recital 648 of the contested decision). Those handwritten annotations stated that, as regards Luxembourg, the date of March 1988 was to be communicated to the patent offices as the first authorisation in the Community and that, as regards France, the date of 22 November 1989 was to be provided.

That decision of 6 May 1993 was implemented in the instructions of 7 June 1993, which were transmitted to the patent attorneys for the omeprazole SPC applications. The Commission's view that those final instructions were misleading is based on the fact that, without notifying the patent attorneys and national patent offices, AZ gave, in relation to France and Luxembourg, dates which did not correspond to the issue of the technical marketing authorisation, but to what AZ calls the ‘effective marketing authorisation’, that is to say the alleged date of publication of the price of the medicinal product (recital 651 of the contested decision).

The replacement of the issue dates of the technical marketing authorisations in France and Luxembourg by those corresponding to the publications of the price of the medicine in those countries was, in the Commission's view, liable to mislead the patent offices for three reasons. First, the dates given on the application form in relation to seven other countries concerned the issue of the technical marketing authorisation, so that it could be presumed that the dates given for France and Luxembourg also corresponded to the technical marketing authorisations. Second, the numbers corresponding to the French and Luxembourg technical marketing authorisations were retained. Consequently, those numbers appeared alongside the dates of the ‘effective marketing authorisations’, thus suggesting that those dates corresponded to the technical authorisations. The numbers of the technical authorisations were moreover given for seven other countries. Third, for the purposes of meeting the requirements of Article 8(1)(c) of Regulation No 1768/92, AZ referred to Luxembourg legislation which did not relate to the date of March 1988, but to the technical marketing authorisation, which cites that legislation (see recitals 653 to 655 of the contested decision). Furthermore, for the purposes of producing the copy of the publication of the authorisation in the national official journal required by Article 8(1)(c) of Regulation No 1768/92, AZ communicated the cover page and page 246 of the Luxembourg list (see recital 656 of the contested decision).

It follows from the foregoing that nothing in the manner in which the information in the instructions of 7 June 1993 was presented was of such a nature as to suggest that the dates given in respect of France and Luxembourg did not relate to the technical marketing authorisations. In this respect, even assuming that it were possible to put forward alternative interpretations of the concept of ‘authorisation to place the product on the market’ in Regulation No 1768/92, it is common ground that both the patent offices and the patent attorneys construed that concept as referring to the ‘technical’ authorisation. The memorandum of 16 March 1993 indeed clearly suggests that that was also AZ's understanding of that concept, since it initially took the view that the acquisition of SPCs in Germany and Denmark was impossible (see paragraph 479 above).

The Court therefore finds that, in view of the context in which those representations to the patent attorneys and patent offices were made, AZ could not reasonably be unaware that, in the absence of an express disclosure of the interpretation that it intended to adopt of Regulation No 1768/92 which underlay the choice of the dates provided in relation to France and Luxembourg, the patent offices would be prompted to construe those representations as indicating that the first technical marketing authorisation in the Community had been issued in Luxembourg in ‘March 1988’. Thus, there was no need for the Commission to demonstrate AZ'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, to that effect, Nederlandsche Banden-Industrie-Michelin v Commission, paragraph 30 above, paragraph 57).

Accordingly, the dispute between the parties on the issue whether the misleading nature of the SPC applications stemmed from AZ's bad faith is irrelevant. In any event, the applicants' multiple arguments based on the alleged absence of bad faith on the part of AZ, as regards both the interpretation that it chose to adopt of Regulation No 1768/92 and the manner in which the SPC applications were presented, or the significance that it attached to the Luxembourg list, cannot constitute objective justification for the absence of proactive disclosure of the nature of the dates mentioned in relation to the Luxembourg and French marketing authorisations, on the one hand, and of the interpretation of Regulation No 1768/92 which led to the choice of those dates, on the other.

Thus, as regards, first of all, the claim that AZ intended to discuss with the patent offices the dates provided and that AZ expected the patent offices to put questions to it in this respect, the Court finds that those considerations are in any event irrelevant, in view of the highly misleading nature of the representations made to the patent offices for the purposes of the SPC applications. The view cannot be taken that the SPC applications were presented in such a way as to invite the patent offices to put questions regarding the date given in relation to the French authorisation (22 November 1989). Only the imprecise nature of the date mentioned regarding the marketing authorisation granted in Luxembourg (March 1988) might have prompted requests for clarifications in this respect. As the Commission observes, the fact remains that in reply to the requests for clarifications of the patent offices in relation to the authorisation date in Luxembourg, and apart from in its exchanges with the United Kingdom and Irish patent offices, AZ refrained from disclosing with the requisite transparency, first, all the relevant dates for the purposes of the issue of the SPCs, and in particular the date of authorisation issued in France on 15 April 1987, which constituted the first technical marketing authorisation issued in the Community, and, second, the interpretation of Regulation No 1768/92 that underlay the dates given for France and Luxembourg. The applicants' claim that AZ intended to discuss with the patent offices the relevant date for the purposes of Regulation No 1768/92 is not therefore supported by the facts. AZ's conduct over the long term suggests on the contrary rather that it was motivated by the intention of misleading the patent offices, as is apparent from the second stage of this abuse.

Next, AZ's purported good faith in its interpretation of Regulation No 1768/92 and the reasonableness of that interpretation are irrelevant. As the Commission rightly observes in recital 666 of the contested decision, the merits of the interpretation of the regulatory framework are not at all an issue in the first abuse. The fact, put forward by the applicants, that an alternative interpretation of Regulation No 1768/92 could be adopted is not necessarily liable to affect the objectively misleading nature of AZ's SPC applications, since AZ specifically refrained from disclosing that interpretation to the patent offices, as well as the date of 15 April 1987 relating to the technical marketing authorisation issued in France, which was the first technical marketing authorisation issued in the Community. Consequently, it is also irrelevant that, subsequent to the instructions sent to the patent attorneys for the purposes of filing the initial SPC applications with the national patent offices, law firms drafted notes supporting AZ's interpretation of Regulation No 1768/92.

As regards, lastly, AZ's purported good faith in the significance that it attached to the Luxembourg list, it is sufficient, here again, to note that that cannot remedy the absence of disclosure to the patent offices of its ‘effective marketing theory’ and of the date of issue in France of the technical marketing authorisation of 15 April 1987. Moreover, as the Commission found in recital 663 of the contested decision, the Luxembourg list is a document which does not lend itself, by its appearance, to being regarded as the publication of the price of omeprazole in Luxembourg. The Court would point out, in this respect, that no prices appear alongside the products mentioned in the list (see paragraph 486 above). Moreover, in view of the fact that page 246 of that list sets out in alphabetical order the products whose names begin with the letters ‘lo’, then the letters ‘lu’, it is not credible that those products would have been authorised for marketing on the same day, namely on 21 March 1988.

For the sake of completeness, the Court would point out, as the examination of the second stage of the abusive behaviour suggests, that the fact that AZ continued to assert the relevance of the Luxembourg list and of the date of 21 March 1988 even though it was in possession of information indicating that Losec had been marketed before that date and that its price had never officially been published (see inter alia recital 700 of the contested decision) tends to discredit the applicants' claims regarding AZ's good faith.

As regards the inconsistencies concerning the use by AZ of different types of dates, namely the alleged date of publication of the price of the product for omeprazole and omeprazole sodium, the date of the first publication of the technical marketing authorisation for felodipine and the technical marketing authorisation dates for five other products, it must be observed that those inconsistencies are not directly relevant as regards the first abuse, which concerns only the misleading representations to obtain SPCs for omeprazole. The Commission made mention of those inconsistencies (recitals 643 to 646 of the contested decision) in order to demonstrate that there was an overall strategy for the SPC applications which was designed to conceal knowingly from the patent offices the dates prior to 1 January 1988.

Although those findings may have the merit of establishing the context in which AZ's conduct took place, the Court would however point out that they are not strictly necessary for the purposes of demonstrating the first abuse, which consists, during the first stage identified by the Commission, in AZ's notification to the patent offices of the alleged dates of publication of the price of omeprazole in France and Luxembourg without informing them of its interpretation of Regulation No 1768/92 and of its ‘effective marketing theory’ underlying the choice of the dates provided. Consequently, all the applicants' arguments seeking to explain those inconsistencies and to dispute that they stem from AZ's bad faith are irrelevant, since they can have no bearing on the abusive nature of the lack of transparency which AZ displayed when filing the SPC applications.

The Commission also identified a series of representations that it also considered to be misleading and that it grouped together in a second stage of the abuse as a direct extension of the conduct identified in the first stage of the abuse. That second stage consists of misleading representations made in 1993 and in 1994 before patent offices, in reply to their questions on the SPC applications filed by AZ, of misleading representations made in December 1994 during the second round of SPC applications in three EEA countries, namely Austria, Finland and Norway, and of misleading representations made subsequently before other patent offices, as well as before national courts, in the context of proceedings brought by competing generic manufacturers with a view to invalidating the SPCs in those countries (see recital 629 of the contested decision).

Since the applicants contest each of the Commission's findings, it is necessary to review the findings of facts and the Commission's subsequent assessment of those facts in respect of each of the representations made by AZ at issue in this second stage.

It follows from the examination of the two stages of the first abuse that AZ's conduct consisted, first of all, in notifying to the patent offices in Germany, Belgium, Denmark, Ireland, Luxembourg, the Netherlands and the United Kingdom the date of ‘March 1988’ as date of the first marketing authorisation in the Community, without informing them either of the basis on which that date had allegedly been chosen, namely the alternative interpretation that AZ wished to adopt of the concept of ‘authorisation to place the product on the market’ used in Regulation No 1768/92, or of the existence of the marketing authorisation issued in France on 15 April 1987. The Commission was right to consider that that first notification to the patent offices was misleading, in view of its overall presentation, which gave the impression that ‘March 1988’ related to the date of issue of the first technical marketing authorisation in the Community.

On the basis of that first communication, and following a clarification regarding the exact date to which ‘March 1988’ was referring, an SPC was granted in Germany on 10 November 1993, with an expiry date of 21 March 2003.

AZ's conduct consisted, next, in failing to disclose the date of 15 April 1987, relating to the French marketing authorisation, following requests for clarifications from the patent offices regarding ‘March 1988’. That absence of disclosure prompted the Belgian, Luxemburg and Dutch patent offices to consider that the date of 16 November 1987, corresponding to the issue of the technical marketing authorisation in Luxembourg, had to be taken into account as date of the first marketing authorisation in the Community. They therefore granted SPCs on the basis of that date.

It must be observed in this respect that AZ did not subsequently intervene at those patent offices in order to rectify the SPCs, even though

The Court would point out, however, that, following the questions put by the United Kingdom and Irish patent offices, AZ disclosed the existence of the French technical marketing authorisation of 15 April 1987. Because of the contact between the Danish patent office and the United Kingdom patent office, AZ found it necessary to withdraw its SPC application in Denmark.

AZ none the less continued to make misleading representations for the purposes of obtaining SPCs on the basis of the date of 21 March 1988 before the patent offices of the EEA countries (Austria, Finland and Norway). Those representations prompted those patent offices to issue SPCs on the basis of the date of 21 March 1988.

Lastly, AZ's conduct consisted in defending the validity of the SPCs which had been granted on the basis of its misleading representations before the German, Finnish and Norwegian courts.

It follows from all the foregoing that AZ adopted a consistent and linear course of conduct, characterised by the communication to the patent offices of misleading representations for the purposes of obtaining the issue of SPCs to which it was not entitled (Germany, Finland, Denmark and Norway), or to which it was entitled for a shorter period (Austria, Belgium, Luxembourg, Ireland and the Netherlands).

The numerous items of evidence in the documents before the Court and the extent of the conduct in question, which lasted from June 1993, when the SPC applications were filed before the national patent offices (recital 185 of the contested decision), to June 1999, the time of AZ's defence before the Helsinki District Court of the validity of the SPC granted in Finland, and which was implemented more or less consistently and with varying degrees of success in nine Member States of the Community and of the EEA, permits the conclusion that the Commission was right to find that AZ had deliberately tried to mislead the patent offices.

In view of all the documentary evidence on which the Commission relies, the Court finds that those considerations cannot be called in question by the statements submitted by the applicants for the purposes, inter alia, of defending AZ's good faith. Apart from the fact that those statements tend, in certain respects, to corroborate the correctness of the contested decision, they do not make it possible, in any event, to discount the significant quantity of documentary evidence and body of facts found, which, assessed in their entirety, conclusively support the Commission's findings.

In the light of the examination of all the factual elements carried out in this plea, a response must be given, to the extent still necessary, to the applicants' arguments put forward in the first plea which seek to dispute the existence of an abuse of a dominant position in Germany, Belgium, Denmark, Norway, the Netherlands and the United Kingdom on the basis that the misleading representations did not produce any effects.

As regards, first of all, the degree of success of the anticompetitive practices identified, the Court would point out that the fact that those misleading representations did not enable AZ to obtain SPCs in Denmark or, on the basis of a date which did not correspond to that of the first marketing authorisation granted in the Community, in the United Kingdom, does not mean that its conduct in those countries was not an abuse, since it has been established that those representations were very likely to result in the issue of SPCs.

It follows from the examination of this plea and the documentary evidence submitted by the parties that, although AZ displayed a more transparent attitude before the United Kingdom patent office, to which it openly disclosed its alternative interpretation of the concept of marketing authorisation and the existence of the French technical marketing authorisation of 15 April 1987, the initial SPC application was objectively misleading and was designed to obtain an SPC on the basis of a date which did not correspond to the first marketing authorisation granted in the Community (see paragraphs 548 and 549 above).

As regards Denmark, it is also apparent from the documentary evidence submitted to the Court that AZ withdrew its SPC application there in order to avoid a rejection decision by the patent office, which would create a precedent which might prejudice its chances of obtaining an SPC in Germany, a country which, like Denmark, did not grant SPCs in respect of products which had a first technical marketing authorisation prior to 1 January 1988 in the Community (see paragraph 554 above). However, as the Commission observes, the ability of the misleading representation to the Danish patent office to result in the issue of an unlawful SPC is confirmed by the fact that SPCs were issued by the patent offices in Germany, Belgium, Norway and the Netherlands on the basis of the misleading representations that AZ submitted to them.

Similarly, the fact that, in Germany, the SPC was revoked in June 1997, prior to the expiry of the basic patent, as a result of a legal action brought by Ratiopharm, a generic manufacturer, does not affect the legal classification of the conduct of AZ, which obtained an SPC in those countries on the basis of its misleading representations. That SPC was destined to continue after the expiry of the basic patent and to extend the exclusivity conferred by that patent. If no proceedings had been brought by competitors, that SPC would have thus produced significant anticompetitive effects, assuming that the mere existence of an SPC were not already, in itself, able to produce such effects even prior to the expiry of the basic patent.

Furthermore, the fact that the additional period of supplementary protection obtained in Belgium and the Netherlands on the basis of the misleading representations extends from April 2002 to September and October 2002 respectively, that is after AZ's dominant position had ceased in those Member States, does not, for the reasons set out in paragraph 379 above, affect the classification of the conduct in question as an abuse of a dominant position.

With regard, lastly, to Norway, as was observed in paragraphs 559 and 596 above, it is common ground that AZ was granted an SPC by the Norwegian patent office on 14 April 1997 on the basis of the date of 21 March 1988 (see also recital 234 of the contested decision). That SPC was revoked on 29 June 1999, as a result of a legal action brought by a competitor. Consequently, even assuming that AZ held a formulation patent which still prevented the market entry of generic products on the day that the SPC was revoked, AZ's misleading representations enabled the issue of an SPC to which it was not entitled. Those misleading representations were objectively of such a nature as to restrict competition and constitute, for that reason, an abuse of a dominant position. For the sake of completeness, it is apparent from both recital 16 of the contested decision and the replies of the parties to questions put by the Court that the ability of a formulation patent to confer exclusivity on a product is not equivalent, in any event, to that of a substance patent, since an active substance can be incorporated into different formulations.

Lastly, the Court would point out that it follows from the examination of the second plea that the misleading representations made by AZ for the purposes of obtaining SPCs to which it was not entitled, or to which it was entitled for a lesser period, constituted 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 SPCs in a manner contrary to the regulatory framework establishing SPCs.

It follows from all the foregoing that the Commission did not err in concluding that AZ had abused its dominant position within the meaning of Article 82 EC in Germany, Belgium, Denmark, the Netherlands and the United Kingdom and within the meaning of Article 54 of the EEA Agreement in Norway.

It is therefore necessary to reject all the second plea relating to the first abuse of a dominant position.

However, the contested decision contains an error in so far as, in its recital 774, it was found that, in Germany, Belgium, Denmark, the Netherlands and the United Kingdom, that abuse had commenced on 7 June 1993, when AZ transmitted its instructions to the patent attorneys. As the Court held in paragraphs 370 to 372 above, that abuse started when the SPC applications were transmitted to the national patent offices.

Consequently, as found in paragraph 381 above, the Court finds, in the light of recital 185 of the contested decision, that the first abuse of a dominant position started on 30 June 1993 at the latest.

On the other hand, the applicants have failed to show that the Commission's other conclusions in recital 774 of the contested decision are vitiated by error inasmuch as they find that the abuse ended in Germany at the end of 1997, in Belgium and the Netherlands at the end of 2000, in Denmark on 30 November 1994 and in the United Kingdom on 16 June 1994. Similarly, the applicants have failed to demonstrate the existence of errors which would vitiate the Commission's view that, in Norway, the abuse occurred between 21 December 1994 and the end of 2000.

The applicants state that, although the Commission stated in recital 830 of the contested decision that it did not take issue with AZ's interpretation of Community pharmaceutical law, the Commission's interpretation of the regulatory framework, set out in recitals 255 to 264 of the contested decision, is not consistent with that of AZ. The applicants set out, in this respect, the content of the relevant regulatory framework, as it appears from Articles 3 and 4 and Article 10(1) of Directive 65/65, and from Chapter Va of Directive 75/319.

The applicants claim that the purpose of the introduction by Directive 87/21 of the abridged procedure referred to in point 8(a)(i) to (iii) of the third paragraph of Article 4 of Directive 65/65 was to create a limited exception to the general principle that the original applicant should be exclusively entitled to the benefit of its own data. That exception was not intended to facilitate the authorisation of generic products, but to protect innovation until a reasonable time had elapsed, during which the company concerned could recoup its investment, after which cross-referral to information already provided would be allowed in order to avoid unnecessary repetition of tests on humans or animals.

They submit that, as the Commission acknowledged in recitals 832 and 833 of the contested decision and argued in the proceedings in Case C-94/98 Rhône-Poulenc Rorer and May & Baker [1999] ECR I-8789, the holder of a marketing authorisation is entitled to withdraw it as it pleases, or to let it expire, without being obliged to provide a reason in this respect and without concerning itself with the effect of that decision on generic manufacturers or parallel importers.

The applicants state that, in Denmark, AZ obtained a marketing authorisation for Losec capsules in 1989, and for Losec MUPS tablets on 22 September 1997. On 23 February 1998, the complainants applied for a marketing authorisation under the abridged procedure for a generic version of Losec capsules. On 6 April 1998, the marketing authorisation for Losec capsules was withdrawn at the request of AZ. On 30 September 1998, the complainants were granted a marketing authorisation for a generic version of Losec capsules. AZ challenged the grant of the marketing authorisation before the Danish courts, on the ground that, at the time of that grant, there was no marketing authorisation in force for the reference product in the Member State concerned. In answer to a question submitted in a reference for a preliminary ruling, the Court of Justice held that the marketing authorisation of the reference medicinal product had to be in force in the Member State concerned at the date of the application (AstraZeneca, paragraph 617 above, paragraph 58).

The applicants submit that in the contested decision there is a lack of legal analysis of the abuse of a dominant position identified. They submit that the Commission's legal reasoning is to be found solely in recital 820 of that decision, in which it considered that an undertaking in a dominant position which has a specific entitlement, such as a marketing authorisation, has a duty to make reasonable use of it and not to use it with the clear purpose of excluding competitors. However, in the applicants' view, the case-law relied on by the Commission in order to make that argument concerned different situations.

As regards, first, Compagnie maritime belge transports and Others v Commission, paragraph 242 above, the company in a dominant position entered into an agreement that granted it an exclusive right and then took steps to ensure that it enjoyed the exclusivity provided for by that agreement. The circumstances are different in the present case, since AZ did not enter into an agreement in order to obtain exclusivity in the market. AZ was required to obtain a marketing authorisation in order to place Losec capsules on the market, which did not confer any exclusivity on it in the market. The marketing authorisation did not prevent competition from generics or parallel imports, or the placing of rival PPIs on the Danish, Norwegian and Swedish markets. The applicants add that that case did not concern property rights of any kind, and that the finding of abuse of a dominant position did not involve the imposition of positive obligations on the abusers, whereas, in this case, maintaining the marketing authorisations would impose continuing pharmacovigilance obligations.

The applicants maintain, next, that the circumstances of the present case are different from those in Case 226/84 British Leyland v Commission [1986] ECR 3263, in so far as, in the present case, the holder of a marketing authorisation is subject to significant obligations relating to ‘updating’ and pharmacovigilance while that authorisation remains in force. In addition, AZ did not enjoy an administrative monopoly as a result of obtaining an authorisation for Losec capsules. Moreover, that authorisation was not indispensable for competing products to be able to enter the market and its withdrawal did not have any automatic effect on existing authorisations for generics and on approvals for parallel imports. The applicants add that another distinguishing feature lies in the fact that, in the present case, AZ did not encourage the development either of trade in generic copies of Losec or of parallel imports, whereas in the proceedings in British Leyland v Commission, British Leyland had allowed a trade in left-hand-drive Metros to develop. Finally, there were no proprietary rights in commercially confidential information at stake in that case, in contrast to the present case.

In Hilti v Commission, paragraph 242 above, the Court found that Hilti had abused its dominant position because it was not prepared to grant licences of right on a voluntary basis. The abuse of the dominant position also consisted in demanding fees six times higher than the amount ultimately set by the relevant public body, thereby needlessly protracting the proceedings for the grant of licences of right. However, in the applicants' submission, in the present case, the marketing authorisation did not confer on AZ any exclusive right and it was entitled to request the withdrawal of its marketing authorisation at any time. In addition, AZ was subject to a number of significant positive obligations in relation to ‘updating’ and pharmacovigilance.

The applicants further observe that, in proceedings before the Court of Justice relating to the issue of whether or not the holder of a marketing authorisation was entitled to request its withdrawal, the Commission has consistently submitted that the concept of a compulsory licence was unknown in Community pharmaceutical law. The applicants also maintain that the abovementioned judgments, on which the Commission relies, do not deal with the case made by AZ and that the Commission has failed to take account of the case-law concerning ‘refusal to supply’ and ‘essential facilities’. In the applicants' submission, even if the facts as found by the Commission are correct, AZ's conduct cannot constitute an abuse of a dominant position in the light of the case-law on the exercise of intellectual property rights and ‘essential facilities’. They draw attention, in that regard, to the case-law resulting from the judgments in Magill and IMS Health, paragraph 229 above, Case C-7/97 Bronner [1998] ECR I-7791 and Case T-504/93 Tiercé Ladbroke v Commission [1997] ECR II-923, paragraph 131.

The applicants claim that the data packages that AZ submitted in order to obtain marketing authorisations for Losec capsules pursuant to Directive 65/65 contained commercially confidential information which was entitled to legal protection. However, point 8(a)(i) and (iii) of the third paragraph of Article 4 of Directive 65/65 created an exception to the confidentiality of data to which AZ was entitled, in so far as it excused a subsequent applicant from being required to provide its own data package. The applicants observe that it is common ground that AZ was entitled to request the withdrawal of its marketing authorisation for Losec capsules and that the effect of the case-law is that the abridged procedure in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 is inapplicable after withdrawal of the marketing authorisation of the reference medicinal product. After that withdrawal, AZ therefore retained the right to enforce the confidential nature of its data package.

In that regard, the applicants dispute the Commission's assertion that, once the period of 6 to 10 years of data exclusivity has expired, a producer of generics does not need to go through the entire marketing authorisation procedure, since the national authority can rely on the data available to it under the original authorisation. That interpretation of Directive 65/65 is irreconcilable with the judgment in AstraZeneca, paragraph 617 above (paragraphs 48 and 50), the effect of which is that a national authority may rely on the data from the original application for authorisation only if that authorisation is still in force at the time of the application relating to the generic product. The applicants add that the original applicant has a property right in the data packages submitted to the national authorities, on which point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 constitutes a limited restriction, in that it creates an exception to the original applicant's right to control the use of those rights (Case C-368/96 Generics (UK) and Others [1998] ECR I-7967, paragraphs 77 to 87, and the Opinion of Advocate General Ruiz-Jarabo Colomer in that case, point 68). Apart from that exception, the original applicant retains the right to prohibit the unauthorised use of its confidential information by a national authority or a third party.

In the applicants' submission, those considerations undermine the Commission's argument that the case-law on ‘essential facilities’ is inapplicable in this case as a result of the fact that AZ's property rights have expired, so that it no longer enjoys property rights. In reply to the Commission's argument based on Case T-65/98 Van den Bergh Foods v Commission [2003] ECR II-4653, the applicants maintain that, in the present case, there is a de facto transfer of assets, in the sense that generic manufacturers could benefit from the confidential information without AZ's consent, since the latter would not even be able to require payment for use of that information. In their view, the fact that, in recital 820 of the contested decision, the Commission fails to recognise the property right enjoyed by AZ warrants the annulment of the contested decision in that respect.

In the alternative, the applicants claim that access to AZ's data package was not indispensable for the access of other products to the market. In that regard, they note that a number of competing PPIs entered the market during the relevant period. Moreover, the withdrawal of the marketing authorisation obtained by AZ did not prevent the emergence of a new product for which there was consumer demand. By definition, the abridged procedure under point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 is available only to products that are essentially similar to AZ's Losec capsules. The applicants point out that the withdrawal of the marketing authorisation was justified in the light of the fact that AZ was subject to ongoing ‘updating’ and pharmacovigilance obligations in respect of an authorisation for which it had no further commercial use. In any event, the withdrawal of the marketing authorisation for Losec capsules did not exclude all competition on the relevant market, given that AZ faced competition from generics, parallel imports and rival PPIs.

The applicants also dispute the relevance of the fact that AZ asked for the withdrawal of its authorisations rather than waiting for them to expire. The practical effect of withdrawal of an authorisation is the same as that of its expiry, in that the authorisation holder regains control of its confidential data package. They therefore reject the Commission's contention that the Magill case-law, paragraph 229 above, is inapplicable to the present case because what is involved here is not a refusal to assist competitors, but active behaviour on the part of AZ to prevent competitors from entering the market.

The applicants deny having conceded that requesting withdrawal of the marketing authorisations for Losec capsules was part of a strategy in which a key goal was to prevent, or at least delay, the entry of generic omeprazole capsules onto the markets concerned and to prevent parallel imports of Losec capsules into those markets.

They submit that even a company in a dominant position should not be required to maintain its marketing authorisations in force so that it is easier for generics and parallel imports to come onto the market and compete with it. That is particularly the case where the company no longer has a commercial interest in selling the product to which the marketing authorisation relates and, therefore, has no further interest in maintaining that authorisation in force in a situation where such maintenance would impose upon it continuing ‘updating’ and pharmacovigilance obligations.

In that regard, the applicants dispute the Commission's assertion that compliance with pharmacovigilance obligations in one Member State can be transposed to another Member State; that is because of the nature of the obligations imposed and because of the diversity of views of the national authorities as regards the implementation of those obligations.

Furthermore, during the administrative procedure, AZ submitted to the Commission reports produced by a law firm and by Professor S., which demonstrate that the published literature exemption would have been available to potential competitors of AZ by early 1998. In that regard, the applicants dispute the Commission's arguments set out in recitals 851 and 852 of the contested decision. They state that, contrary to what the Commission claims, it is not true that the published literature exemption is seldom applied. Moreover, that circumstance, just as the fact that the Commission was not aware of any such applications having been made in relation to omeprazole, is in any event irrelevant, since AZ has demonstrated that that exemption was available in relation to Losec and the Commission has not produced any evidence to the contrary. For that same reason, the Commission cannot assert that a generic application in respect of omeprazole during the first part of 1998 would have constituted ‘very much a borderline case’. Nor, in the applicants' view, does the Commission's assertion that the published literature exemption involves complex assessment rebut the evidence produced by AZ.

The applicants add that the requirement, for the purpose of applying the published literature exemption, of at least a decade of use was only introduced by Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ 1999 L 243, p. 9). In any event, by 1998 omeprazole had been in use for more than a decade.

The applicants also argue that the Commission's assertion in recital 853 of the contested decision that AZ's internal documents made no reference to the availability of the published literature exemption is irrelevant, since they have in any event demonstrated that fact. As regards the assertion set out in recital 854 of the contested decision, the applicants observe that the Commission does not give any indication as to the length of the delays suffered by generic manufacturers as a result of the withdrawal of the marketing authorisations. The Commission's admission of its ignorance as to the length of that delay thus renders its argument hypothetical. The applicants also add that any delay arising from the assessment of an application for marketing authorisation cannot be open-ended, since the applicable legislation requires assessment under point 8(a) of the third paragraph of Article 4 of Directive 65/65 to be completed within 120 days or, in exceptional cases, within 210 days (Article 7 of that directive). Since the assessment of the delay suffered in relation to making an application under the published literature exemption would have to take account of those time-limits, the maximum hypothetical delay could only be a few months at the most, which cannot justify the finding of an abuse lasting several years.

Finally, the applicants submit that it follows from the judgment in ITT Promedia v Commission, paragraph 311 above (paragraph 56), that AZ's challenging of the right of its competitors to benefit from the abridged procedure under Directive 65/65 in order to protect itself from parallel imports and generics is not conduct that can be characterised as abusive. They state that, in recital 502 of the statement of objections, the Commission accepted that AZ's conduct to protect its marketing authorisations was not objectionable.

As a preliminary point, the Commission states that recital 830 of the contested decision does not mean that it agrees with AZ's presentation and interpretation of Directive 65/65. That recital simply stands for the proposition that AZ's interpretation of Community pharmaceutical law is not part of the second abuse of a dominant position and that the second abuse does not depend on the correct interpretation of the regulatory framework.

The Commission argues that point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 strikes a balance between the interests of innovative firms and those of producers of generics by introducing an abridged authorisation procedure for medicinal products that are essentially similar to a product already authorised, while allowing for a period of 6 or 10 years of data exclusivity, which starts to run from the grant of the first marketing authorisation in the Community, during which the abridged procedure is not available to generic products, thereby allowing the original applicant to benefit from the results of the pharmacological and toxicological tests and clinical trials placed in the file concerning the product. The Commission refers, in that regard, to the AstraZeneca judgment, paragraph 617 above (paragraphs 42 to 44 and 52).

The Commission states that the legislature was aware of the danger that the period of data exclusivity could result in an artificial prolongation of the effects of a patent, and point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 sought to address this concern by preserving the liberty of Member States ‘not to apply the … six-year period beyond the date of expiry of [the] patent’. The Commission disputes that the legislature envisaged that provision as an exception to, or encroachment on, property rights in commercially confidential information, as claimed by the applicants. The applicants' approach would lead to the conclusion that the data contained in the file on the original medicinal product could never be relied on by the pharmaceutical authorities either before or after the 6- or 10-year period. Moreover, the use by a pharmaceutical authority of the pharmacological, toxicological or clinical references in the file on an original medicinal product is not such as to interfere with the confidentiality of certain commercial information, since the latter is never made public or disclosed to the second applicant.

The Commission rejects the applicants' argument that generic competition is somehow ‘parasitic’. In its view, the rewards for innovation are primarily ensured by the systems of patents and SPCs, which confer on the producer of an original product a temporary monopoly in the commercial exploitation of its invention. The threat of the entry of generic products forces companies to innovate so as to be rewarded in the form of patents, SPCs and data exclusivity.

AZ's second abuse of a dominant position undermined that system. AZ withdrew the marketing authorisation for Losec capsules so that, despite the expiry of the 6- or 10-year period of data exclusivity and the impending expiry of the patent relating to omeprazole, the abridged registration route would not be available to producers of generic omeprazole. In so doing, AZ sought to maintain artificially its market exclusivity by seeking to nullify the right not to provide data contained in the files of initial applications which the regulatory framework confers on the second and subsequent applicants when the period of data exclusivity ends.

The Commission makes clear that, in the contested decision, it does not state that the introduction of a new product formulation (tablets) and the decision to stop marketing Losec capsules in Denmark, Norway and Sweden, were abusive in themselves, considered singly or in combination. The introduction of Losec tablets and the withdrawal of capsules are necessary but not sufficient conditions for the abuse of a dominant position to be established. The abuse became apparent when that switch operation was combined with the requests for deregistration. The Commission therefore stresses that, as is apparent from Article 1(2) of the contested decision, the abuse consists of three elements, namely the requests for deregistration in Denmark, Norway and Sweden, combined with the launch of Losec MUPS tablets and the withdrawal of Losec capsules in those three countries. In the light of that analysis, the Commission challenges what it considers to be an attempt on the part of the applicants to dissociate the elements of the abuse of a dominant position, and in particular the requests for deregistration of the marketing authorisations. Moreover, in the contested decision, the Commission does not call in question AZ's interpretation of Directive 65/65 or to its having brought actions for the protection of its patents or its marketing authorisations.

The Commission disputes, first, that the legal reasoning in the contested decision is limited to recital 820. It refers, in that regard, to recitals 325 to 328, 817 and 818, and 788 to 847 of the contested decision.

Secondly, the Commission recalls that the case-law has found it abusive for a dominant company to procure advantages on the market through the exploitation of government procedures or regulation. It contends that the case in British Leyland v Commission, paragraph 626 above, presents significant similarities to the second abuse of a dominant position found in the contested decision. The applicants cannot maintain that the approach adopted in that judgment is not applicable in the present case on the ground that the validity of the marketing authorisation for Losec capsules was not indispensable for competing products to be able to enter the market. The judgment in British Leyland v Commission, paragraph 626 above, does not lay down any conditions in that regard. That judgment does not suggest that the product in question did not face any competition or was in a market of its own. On the contrary, whether with or without parallel imports, the company concerned faced competition from dozens of other car manufacturers. The Commission also observes that that judgment concerned conduct which goes beyond that at issue in the present case, in that it relates to British Leyland's inaction upon the expiry of a national type approval certificate, whereas the present case concerns positive steps to procure deregistration.

In reply to the applicants' observations relating to the fact that, in contrast to AZ, British Leyland allowed parallel trade to develop, the Commission adds that an abuse of a dominant position resulting in eviction of competitors from the market is no less an abuse than an abuse preventing competitors from entering the market. It disputes, in any case, that parallel trade in Losec in the three countries concerned did not develop before deregistration was requested (tables 25, 28 and 29 in the Annex to the contested decision). Moreover, regarding the applicants' argument that the British Leyland case did not involve any intellectual property rights in commercially confidential information, the Commission points out that obtaining type approval for a vehicle under Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (OJ, English Special Edition 1970 (I), p. 96) also requires the provision of expensive and technically complex information through a time-consuming procedure. Parallel importers could nevertheless be exempted from that requirement, inasmuch as the authorities already had a technical file the contents of which they were careful not to disclose. The confidentiality rights which AZ has are therefore not different in any respect from those of British Leyland.

As regards the judgment in Hilti v Commission, paragraph 242 above, the Commission contends that it also concerns the instrumentalisation of a regulatory scheme by a dominant company in order to gain an advantage on the market, since that company exploited the procedural arrangements for the granting of licences in the exercise of its right to negotiate fees. Moreover, the case which gave rise to the judgments of the Court of Justice and the Court of First Instance in Compagnie maritime belge transports and Others v Commission, paragraphs 329 and 242 above, is also relevant, in that it concerns a dominant company which relied on a legal entitlement derived from a contract in order to exclude competitors.

As regards the case-law on ‘essential facilities’, the Commission submits that it is not applicable in this case. The judgments in Magill and IMS Health, paragraph 229 above, and Tiercé Ladbroke v Commission and Bronner, paragraph 628 above, deal with the refusal by a dominant company to deal with other companies and to allow them, through contractual means, to utilise an asset in respect of which the legal system in principle gives an exclusive right. As the applicants themselves agree, the marketing authorisation did not confer on AZ any exclusive right apart from the 6- to 10-year exclusivity period for the data and information submitted to the authorities. However, that period had expired in this case. The Commission contends that, once the period of exclusivity has expired, the second applicant is entitled not to provide data which are known to the authorities since they are in the file of the initial application. However, AZ sought to nullify that right.

The Commission observes, furthermore, that the case-law on ‘essential facilities’ is not relevant to situations which do not involve any question for the dominant company of transferring an asset or concluding contracts with persons which it has not selected (order in Case C-552/03 P Unilever Bestfoods v Commission [2006] ECR I-9091, and judgment in Van den Bergh Foods v Commission, paragraph 631 above, paragraph 161). The Commission disputes that allowing the pharmaceutical authorities to refer to the information available in the original file, but without disclosing it to competitors and third parties, can be considered to entail a transfer of an asset. In its view, the present case does not involve any intellectual property rights and does not concern a passive refusal to assist competitors by dealing with them, but active behaviour designed to prevent competitors from entering the market. In this case, the dominant company actively sought to exclude its competitors from the market at a point in time when its proprietary rights and exclusive rights had expired, using the regulatory framework in such a way as to impede the system provided for in it, which allows the entry of generics when the exclusivity period for information filed with the medical authorities has expired.

With regard to the applicants' position that the distinction between positively deregistering marketing authorisations and allowing those authorisations to expire is irrelevant for the purposes of Article 82 EC, the Commission points out, first, that, in the contested decision, it does not address a hypothetical situation in which AZ would have let the marketing authorisations expire, since it only found an abuse of a dominant position in the factual circumstances of the present case. It nevertheless adds that, in any event, the judgment in British Leyland v Commission, paragraph 626 above, provides support for the argument that allowing the authorisation to expire as part of an exclusionary strategy displaying the characteristics found in this case could constitute an abuse of a dominant position. That being the case, such an exclusionary strategy displaying all the characteristics found in this case apart from the active requests for deregistration is unlikely, given that an essential element of an exclusionary strategy, which must ensure the synchronisation of a number of factors, is the timing of termination of the authorisations, since the desired objective is to exclude generics and parallel trade. In that regard, the Commission observes that, in contrast to the request for deregistration, the expiry of an authorisation as a result of its non-renewal is a foreseeable event.

In addition, the Commission submits that the request for deregistration of the product in Denmark, Norway and Sweden with the aim of excluding competition was not an action within the scope of the substance of AZ's marketing authorisation, but quite the opposite, an attempt to maintain the exclusion of competitors when the company no longer enjoyed exclusive rights capable of excluding them. It refers, on this point, to recital 843 of the contested decision.

The Commission submits, in addition, that, although analogies may be drawn with the cases involving refusals to give access to assets covered by property rights, it is noteworthy that AZ's strategy consisted in preventing the introduction of a product which it no longer offered, despite the existence of a demand for that product; that constitutes a case of abuse of a dominant position identified in Volvo, paragraph 229 above, and in Case 53/87 CIRCA and Maxicar [1988] ECR 6039. In that regard, the Commission disputes that generic producers or parallel importers intended to duplicate the product already offered by AZ.

The Commission also rejects the applicants' argument relating to the lawfulness of the request for deregistration in pharmaceutical law. It points out in that regard that the illegality of abusive conduct under Article 82 EC is unrelated to its compliance or non-compliance with other legal regimes and that, in the majority of cases, abuses of dominant positions consist of behaviour which is otherwise lawful under branches of law other than competition law. Thus, in the contested decision, the Commission does not call into question the applicants' interpretation of pharmaceutical law. It finds only that it is contrary to Article 82 EC for a dominant company to request early deregistration of marketing authorisations for Losec capsules in the context of a general plan intended and likely to prevent the market entry of generics and parallel imports (recitals 817 to 820 of the contested decision).

The Commission denies, first, that the contested decision imposes a positive obligation on AZ to request the renewal of the marketing authorisation. The abuse consisted in requesting early deregistration of the marketing authorisation for omeprazole capsules in Sweden, Denmark and Norway, which must be distinguished from allowing the authorisation to lapse without requesting its renewal. It makes clear that the contested decision does not contain any finding to the effect that it would have been abusive for AZ not to request renewal of the marketing authorisation.

The Commission rejects the justification put forward by the applicants for requesting early deregistration of the marketing authorisations in the three countries concerned, namely the significant obligations incumbent on the holder of a marketing authorisation under the pharmacovigilance system. The Commission points out that AZ was in any case required to comply with pharmacovigilance obligations as holder of the marketing authorisation for Losec capsules in Spain, Italy, Austria, France, Germany and the Netherlands and that it was therefore obliged to compile and transmit the same information to the authorities in the various Member States. The additional cost or bureaucratic burden which would have been faced by AZ if it had not made the requests for early deregistration would therefore have been negligible.

Moreover, pharmacovigilance satisfying the requirements of Directive 75/319 can ordinarily be guaranteed through cooperation with the national authorities of the other Member States by means of access to the documents and data produced by the manufacturer in respect of the old version of the product in the Member States in which that version is still marketed on the basis of a marketing authorisation still in force (Case C-172/00 Ferring [2002] ECR I-6891, paragraphs 36 and 38). The Commission observes, in addition, that AZ did not request deregistration of the marketing authorisations in Germany and the Netherlands, despite the capsules having been withdrawn from those markets. Furthermore, none of AZ's strategy documents mentioned the alleged burden of maintaining the marketing authorisations as a consideration to be taken into account in deciding on their deregistration.

Secondly, the Commission rejects the applicants' argument that AZ's competitors could have relied on the published literature in order to obtain a marketing authorisation, in accordance with the procedure referred to in point 8(a)(ii) of the third paragraph of Article 4 of Directive 65/65. The Commission submits that the applicants' analysis relies erroneously on the assumption, derived from the ‘essential facilities’ theory, that requests for deregistration cannot be abusive unless the abridged procedure was indispensable for generic products and parallel imports to enter the market. In its view, the fact that the regulations make available an alternative route to obtain registration does not legalise behaviour seeking to prevent competitors from using the abridged procedure intended by the legislature to facilitate access of generics to the market. Moreover, the theoretical availability of an alternative route cannot be dissociated from the degree of uncertainty as to success and from the cost and time involved in attempting to obtain authorisation by such a route. As was set out in recitals 851 and 852 of the contested decision, that route has rarely been used in general and has never been used in connection with omeprazole. The prospects of success of that option were uncertain since the circumstances of this case constituted a ‘borderline case’ and would at any rate have entailed a time-consuming process. The Commission adds that the applicants do not dispute its findings set out in recitals 852 to 854 of the contested decision. It maintains that the considerable difficulties involved in that route are a relevant factor which must be taken into account, since they determine how exclusionary AZ's behaviour was likely to be in practice.

The Commission submits, in that regard, that the second abuse of a dominant position is a textbook example of behaviour raising competitors' costs. From that perspective, the fact that competitors were also able to follow the full marketing authorisation procedure does not take away the abusive character of the behaviour.

As regards the applicants' argument alleging that the Commission did not give any indication of the length of the delay in the market entry suffered by competing products as a result of using the published literature procedure, the Commission states that it is impossible to estimate it on account of the hypothetical nature of that alternative route. In any event, the delay caused to competitors using that possibility would have been considerable, amounting to several months, and not limited to the period of 210 days applicable at the material time (and not 120 days, as the applicants assert), since generic producers were informed about deregistration only after the event and only then had to start the process of researching, acquiring and compiling the data. Any delay caused to competitors represented further, very large sales revenue, given the volume of Losec sales which were involved. The Commission points out, in addition, that the delay was relevant, since it served to extract higher reimbursement prices in the negotiations concerning esomeprazole, the following generation of PPIs that AZ intended to launch on the market.

The Commission observes that AZ itself considered that the use of the published literature procedure in respect of omeprazole was a negligible risk since it did not devote the slightest attention to it in its strategic analysis of how best to prevent entry of generics on the market (recital 853 of the contested decision).

In addition, the Commission challenges the relevance of Mr S.'s witness statement. It points out that there is no evidence that Mr S. made a detailed review of all the available literature and observes that he does not contest that filing an application based on ‘well-established medicinal use’ would take time. The Commission also refers to the Danish Agency's defence before the Danish courts, which argues that, in the procedure referred to in point 8(a)(ii) of the third paragraph of Article 4 of Directive 65/65, the applicant is required to establish the harmlessness and efficacy of the medicinal product by submitting bibliographical documentation based on an extensive and costly study, which cannot always necessarily be carried out.

The Commission argues, finally, that the second abuse of a dominant position does not relate to litigation in which AZ may have been involved to protect its marketing authorisations, but to the requests for deregistration of the marketing authorisations for Losec capsules filed in order to prevent or delay the market entry of generic omeprazole and parallel imports.

As a preliminary point, the Court observes that point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 established an abridged procedure aimed at enabling the manufacturers of medicinal products which are essentially similar to already authorised medicinal products to save the time and expense needed to gather data relating to the results of pharmacological and toxicological tests and of clinical trials and to avoid the repetition of tests on humans or animals where not absolutely necessary. However, in laying down the conditions which must be met in order to have recourse to that abridged procedure, the legislature also took account of the interests of innovating firms, in particular by making that procedure subject to the condition that the reference medicinal product has been authorised within the Community for 6 or 10 years (Generics (UK) and Others, paragraph 630 above, paragraphs 4, 72 and 73, and AstraZeneca, paragraph 617 above, paragraphs 42 and 43).

That provision therefore 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 on that product for a period of 6 or 10 years from the grant of the first marketing authorisation in the Community. That period of exclusivity is the result of a balancing by the legislature of the interests of innovative firms, on the one hand, and those of manufacturers of essentially similar products, and of the interest in avoiding repetition of tests on humans or animals unless necessary, on the other (see, to that effect, Generics (UK) and Others, paragraph 630 above, paragraphs 81 and 83).

Consequently, after the expiry of a period of 6 or 10 years which starts to run from the grant of the first marketing authorisation, 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. On the contrary, it allows that information to be taken into account by the national authorities for the purposes of granting marketing authorisations for essentially similar products under the abridged procedure provided for in point 8(a)(iii) of the third paragraph of Article 4 thereof.

However, the Court of Justice has held that the interest of safeguarding public health, which constitutes a primary purpose of Directive 65/65, required, 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, that the marketing authorisation of the reference medicinal product still be in force in the Member State concerned on the date that that application is lodged, and therefore precluded the continued availability of the abridged procedure after withdrawal of the marketing authorisation of the reference medicinal product (AstraZeneca, paragraph 617 above, paragraphs 49 to 54).

It follows from this that, for reasons relating to the safeguarding of public health, the deregistration of the marketing authorisation of the original proprietary medicinal product has the effect of preventing the applicant for a marketing authorisation in respect of an essentially similar medicinal product from being exempted, pursuant to point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65, from having to carry out pharmacological and toxicological tests and clinical trials for the purposes of demonstrating the harmlessness and efficacy of that product. Thus, in the present case, although the legislation no longer conferred on AZ the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials placed in the file, the strict public health protection requirements which have informed the Court of Justice's interpretation of Directive 65/65 enabled it to prevent or make more difficult, by the deregistration of its marketing authorisations, the acquisition, by way of the abridged procedure under point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65, of marketing authorisations for essentially similar medicinal products, to which the manufacturers of generic products were none the less entitled.

Article 82 EC imposes on an undertaking in a dominant position, irrespective of the reasons for which it has such a dominant position, the special responsibility not to impair, by using methods other than those which come within the scope of competition on the merits, genuine undistorted competition in the common market (see, to that effect, Nederlandsche Banden-Industrie-Michelin v Commission, paragraph 30 above, paragraph 57; Case T-83/91 Tetra Pak v Commission [1994] ECR II-755, paragraph 114, and Compagnie maritime belge transports and Others v Commission, paragraph 242 above, paragraph 106, read in conjunction with AKZO v Commission, paragraph 243 above, paragraph 70).

Thus, 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 (Case T-65/89 BPB Industries and British Gypsum v Commission [1993] ECR II-389, paragraph 69), 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.

The applicants' arguments

In the present case, the Court observes, as the applicants claim, that the data relating to the results of the pharmacological and toxicological tests and of the clinical trials which AZ carried out for the purposes of obtaining an original marketing authorisation are the fruit of an investment that it had to make for the purposes of being able to market Losec capsules. Such an investment is characteristic of practices which come within the scope of competition on the merits and which are liable to benefit consumers. As was noted in paragraphs 666 to 668 above, 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 could 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, it must be stated that, after the expiry of the period of exclusivity referred to above, the 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 was not based in any way on the legitimate protection of an investment which came within the scope of competition on the merits, precisely because, under Directive 65/65, AZ no longer had the exclusive right to make use of the results of those pharmacological and toxicological tests and clinical trials.

It appears, however, as will be examined in more detail in the second plea, that AZ's deregistration of the marketing authorisations was 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 provided for in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 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 examination of the question whether, in view of the relevant factual and legal context in the present case, the Commission has demonstrated to the requisite legal standard that the deregistration of the marketing authorisations for Losec capsules was such as to exclude parallel imports of that product will be carried out in the examination of the second plea.

Furthermore, the fact, relied on by the applicants, that AZ was entitled to request the withdrawal of its marketing authorisations for Losec capsules in no way causes that conduct to escape the prohibition laid down in Article 82 EC. As the Commission observes, the illegality of abusive conduct under Article 82 EC is unrelated to its compliance or non-compliance with other legal rules. It must be observed, in this respect, that, in the majority of cases, abuses of dominant positions consist of behaviour which is otherwise lawful under branches of law other than competition law.

The applicants further claim that the compatibility with Article 82 EC of the conduct objected to must be assessed according to the criteria set out in the case-law on ‘essential facilities’.

On that point, the Court notes, as a preliminary point, that 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 on the common market (see, to that effect, Opinion of Advocate General Jacobs in Bronner, paragraph 628 above, paragraphs 57 to 65, and the judgment in Microsoft v Commission, paragraph 32 above, paragraphs 331 to 333).

In this respect, it should be observed, for the reasons set out in paragraph 668 above, that Directive 65/65 no longer conferred on AZ the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials placed in the file, but, on the contrary, allowed that information to be taken into account by the national authorities for the purpose of granting marketing authorisations for essentially similar products under the abridged procedure provided for in point 8(a)(iii) of the third paragraph of Article 4. As was noted in paragraph 667 above, the period of 6 or 10 years during which the owner of an original medicinal product has the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials contained in the file is the result of a balancing by the legislature of the interests of innovative firms, on the one hand, and those of manufacturers of essentially similar products, and of the interest in avoiding unnecessary repetition of tests on humans or animals, on the other.

Inasmuch as, as the applicants claim, that information were to be considered to be the property of the undertaking which produced it, given that, as the Commission observes, it is in any event never made public or disclosed to applicants for marketing authorisation in respect of essentially similar products, the fact remains that Directive 65/65 in any event restricted any such property right by establishing, in point 8(a)(iii) of the third paragraph of Article 4 thereof, an abridged procedure which enables national authorities to rely on the data produced in the original application for marketing authorisation.

Thus, the conduct at issue is not a refusal to give access to the results of the pharmacological and toxicological tests and clinical trials contained in the file, since AZ 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. Instead, the conduct at issue relates to the steps by which the marketing authorisations were deregistered 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 and, consequently, the restriction which that provision effected with regard to the exclusive use of the information derived from the pharmacological and toxicological tests and clinical trials.

As is apparent from AstraZeneca, paragraph 617 above (paragraphs 49 to 54), the reason for the fact that the abridged procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 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.

In those circumstances, the case-law on ‘essential facilities’ to which the applicants refer cannot be applied to the facts at issue in the present case.

The applicants plead that AZ no longer had a commercial interest in selling Losec capsules and, therefore, in maintaining the marketing authorisation in a situation where such maintenance imposed upon it continuing ‘updating’ and pharmacovigilance obligations.

In this respect, it should be observed at the outset that that plea of objective justification is being raised for the first time at the stage of the proceedings before the Court. The Court would point out that, 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 (see, to that effect, Case C-95/04 P British Airways v Commission [2007] ECR I-2331, paragraph 69, and Microsoft v Commission, paragraph 32 above, paragraph 1144). 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.

According to settled case-law, 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, therefore, can rely on matters of fact which were not put forward in the course of the administrative procedure (see, to that effect, Joined Cases 15/76 and 16/76 France v Commission [1979] ECR 321, paragraph 7; Case T-58/05 Centeno Mediavilla and Others v Commission [2007] ECR II-2523, paragraph 151; and Case T-268/06 Olympiaki Aeroporia Ypiresies v Commission [2008] ECR II-1091, paragraph 55).

In this respect, as the Commission maintains, the burden arising from the pharmacovigilance obligations was never mentioned in AZ's internal documents relating to its commercial strategy. That absence of any mention in those documents of that objective ground of justification meant that the Commission was unable to take cognisance of it and in any event makes it scarcely credible that the deregistration of the marketing authorisations was due to that ground.

Moreover, it is common ground that AZ had not requested the deregistration of its marketing authorisations in Germany, Austria, Spain, France, Italy and the Netherlands. The Court finds that the applicants have failed to demonstrate before it that the additional burden on AZ, if it had not deregistered its marketing authorisations in Denmark, Norway and Sweden, would have been so significant that it would have constituted an objective ground of justification.

As the Commission pointed out at the hearing, Article 29d of Directive 75/319 requires the undertaking responsible for placing the medicinal product on the market

Reports on other suspected adverse reactions must be submitted immediately upon request, or, where the marketing authorisation was granted more than five years previously, at five-yearly intervals together with the application for renewal of the authorisation.

It is common ground that, when its requests for deregistration of the marketing authorisations for Losec capsules were made in Denmark, Norway and Sweden, on 19 March, 12 October and 20 August 1998 respectively, AZ had had those authorisations for well over five years. Accordingly, it can be reasonably assumed that there was a low probability that serious adverse reactions — of which there had been none until then — might appear in connection with Losec capsules.

Furthermore, the obligation to submit, at five-yearly intervals, reports on other suspected adverse reactions does not constitute such a significant pharmacovigilance burden that it could constitute a serious objective ground of justification. Whilst it is true that Article 29d of Directive 75/319 does not prevent Member States from laying down additional requirements when granting marketing authorisations, the applicants have failed to show, in their replies to the Court's questions, that the Danish, Norwegian and Swedish authorities laid down such significant additional obligations. Quite to the contrary, as the Commission observed at the hearing, it is apparent from the actual replies of the applicants to the Court's questions that, in Germany, a country in which AZ had never ceased to market Losec capsules, the public authorities laid down stricter pharmacovigilance obligations than in Denmark, Norway or Sweden.

Similarly, the applicants have not shown that the Danish, Norwegian and Swedish authorities applied the pharmacovigilance obligations set out in Chapter Va of Directive 75/319 so differently from the other countries in which Losec capsules were still marketed that significant additional pharmacovigilance burdens would have resulted from this for AZ.

For all those reasons, it is therefore necessary to reject the applicants' argument, put forward for the first time at the stage of the proceedings before the Court, that, in the present case, the pharmacovigilance obligations to which AZ was subject in Denmark, Norway and Sweden constitute an objective ground of justification for the requests for deregistration of the marketing authorisations for Losec capsules in those countries.

The applicants also maintain that the behaviour objected to cannot be classified as an abuse of a dominant position, since, in any event, potential competitors could have followed the procedure provided for in point 8(a)(ii) of the third paragraph of Article 4 of Directive 65/65, which enables the applicant to demonstrate, merely by detailed references to published scientific literature, that the proprietary medicinal product for which a marketing authorisation has been applied has recognised efficacy and an acceptable level of safety. They also complain that the Commission did not assess the delay suffered by competing undertakings manufacturing generic products. The merits of those arguments, which are reiterated in the second plea, will be examined in paragraphs 829 to 835 below, when that plea is examined.

Without prejudice to the examination of the merits of that last set of arguments, it must be held, for all the foregoing reasons, that none of the applicants' arguments reveal an error of law by the Commission in classifying the second course of conduct objected to as an abuse of a dominant position. It is therefore necessary to reject the first plea, but without prejudice to the merits of the arguments cited in the previous paragraph which will be examined later.

The applicants maintain that Losec MUPS was developed because it was a better product. They explain that the active ingredient in Losec, omeprazole, degrades rapidly and loses its efficacy if it is exposed to the acid conditions of the stomach. Consequently, Losec capsules, launched in 1988, comprise enteric-coated beads in a gelatine-based capsule, which do not release the active substance in the stomach and allow its absorption in the small intestine. However, those Losec capsules had certain shortcomings [confidential].

In 1991, Astra undertook a feasibility study into developing a new dispersible Losec tablet containing several hundred enteric-coated beads of omeprazole, known as the ‘Multiple Units Pellets System’ (MUPS) and, in 1994, after several years of further research, decided to launch its development. Patent protection for the new manufacturing process was applied for under the reference WO 96/1623, whose ‘priority date’ was 8 January 1994. The applicants explain that AZ still encountered a number of difficulties in developing a satisfactory tablet formulation, and Losec MUPS was eventually ready for launch in 1998. They maintain that the decision not to launch Losec MUPS earlier was driven by the time taken to develop MUPS and prepare the comprehensive data file for the local regulatory authorities.

The applicants submit that, although the decision to develop Losec MUPS was taken by Astra centrally on account of the fact that it involved the mobilisation of considerable research and development resources, it was for the local marketing companies to decide on the timing and method of launch of the product in the light of local circumstances. AZ's central marketing team encouraged local companies to launch Losec MUPS because of the advantages which that product offered, and supervised the timetable for the launch of Losec MUPS and, where relevant, for the withdrawal of Losec capsules in order to ensure the orderly and timely supply of both products to the markets.

Losec MUPS was launched in different national markets on different dates because of the different conditions which prevailed in those markets and the variable lengths of time taken to deal with applications for marketing authorisations. The decision not to launch that product in Spain, Italy, Greece, Austria, Portugal and France is justified by commercial reasons. The applicants maintain that the local marketing companies did not decide on their strategies by reference to the effects of their decisions on parallel trade or generic entry and did not expect to prevent generic entry. They do not deny, however, that AZ's central marketing team envisaged that withdrawing Losec capsules entailed the risk of enabling generic capsules to gain ground at the expense of the MUPS product if the latter did not meet with success. Moreover, AZ's central team also looked at the implications of the decisions adopted by the local marketing companies for generic entrants and parallel importers. That being so, the Commission itself acknowledged that the legal challenges brought against the marketing of generics and against parallel imports, following the local marketing companies' decisions to withdraw the marketing authorisations, did not constitute an abuse.

In the United Kingdom, [confidential].

Following that meeting, AZ's central coordinating team examined the implications of the withdrawal of the Losec capsule marketing authorisations for generic manufacturers and parallel traders. The applicants maintain, however, that it was for the local marketing companies, not Astra's central coordinating team, to decide whether Losec MUPS should be placed on the market, whether Losec capsules should be withdrawn from the market and, if so, whether the related Losec capsule marketing authorisation should be withdrawn.

As regards Sweden, the applicants explain that, in June 1995, Astra circulated a memorandum, known as ‘Minisignal’, to the marketing companies worldwide, informing them of the development of Losec MUPS and adding a questionnaire regarding the respective marketing companies' plans as to the new product. In February 1996, the Swedish marketing company answered the Minisignal, stating that Losec capsules and Losec MUPS would both be available in Sweden, but that Losec capsules would be withdrawn over time depending on consumer acceptance of the new formulation.

In January 1997, the marketing companies were informed by fax that the Losec MUPS dossier was available for them to use for making applications for marketing authorisations and would be distributed to them upon request. It was therefore up to the local marketing companies to request the file and, consequently, to decide whether and when to apply for a marketing authorisation and whether and when to launch the product.

A marketing authorisation was sought in Sweden by Astra Sweden for Losec MUPS on 2 May 1997 and was granted on 19 December 1997. The applicants maintain that that marketing company decided to withdraw Losec capsules over time following four market research studies (including a study conducted in spring 1998) and a patient preference test. As Astra Sweden stated in answer to the Minisignal, it was clear from those studies that Losec capsules should be completely replaced by Losec MUPS. There was thus no reason to keep that product on the market.

As regards the marketing companies established in Norway and Denmark, they also determined for themselves the launch strategy for Losec MUPS in their national markets. The applicants point out that there is no discussion in the files of those marketing companies as to whether the Losec capsule authorisations should be withdrawn or allowed to lapse. They submit that this reflects the fact that there was no need to maintain an authorisation for a product which had been withdrawn from the market and that there was no reason to take account of any other considerations in that regard.

The applicants point out that Astra's central marketing team [confidential]. On the other hand, Astra's central coordinating team was responsible for evaluating the legal implications [confidential].

The applicants explain that Astra's central coordinating team decided not to market Losec MUPS in Spain and Italy. [confidential].

[confidential]

[confidential]

[confidential]

The applicants challenge the evidence on the basis of which the Commission justified its conclusion that the introduction of Losec MUPS and the withdrawal of the Losec capsule marketing authorisations was in the nature of a general strategy designed to prevent the entry of generics and parallel imports into the market. With regard to the minutes of an internal meeting of the Marketing Advisory Council (MAC) that took place on 9 August 1996, referring to work being done on the Losec Post-Patent Strategy (‘the LPP Strategy’) (see recital 266 of the contested decision), the applicants claim that that term must be understood as meaning that Astra proposed to plan how certain matters should be dealt with, but that there is no basis for presuming that any bad faith was involved. They claim that the fact that AZ was looking at the competitive threat and ways of ‘countering’ it is part of the everyday commercial life of a company. In their submission, in so far as that document discussed ‘legal ways … to disturb/delay generic approval/introduction’, it does not reveal any concern unconnected with competition on the merits. They further add that none of the documentary evidence relied on by the Commission shows that AZ operated a malevolent strategy to withdraw the marketing authorisations in Denmark, Norway and Sweden in order to delay market entry by generics and prevent parallel trade.

The applicants reiterate that Astra coordinated centrally the legal actions brought against generic competitors, recommended the launch of the Losec tablets and provided support to national marketing companies in obtaining marketing authorisations and in producing and supplying Losec. However, the local marketing companies produced their marketing plans individually. The applicants refer to Chapter 7 of AZ's reply, and in particular paragraphs 7.108 to 7.155, and to the witness statements of Dr N., Executive Vice President of AstraZeneca plc and President and Chief Executive Officer of AstraZeneca AB (pages 104 to 119 of the transcript of the oral procedure of 16 and 17 February 2005).

As regards the questionnaire sent out to the local marketing companies in 1996, cited in recital 267 of the contested decision, by which Astra asked that the legal ways of disturbing or delaying generic approval or introduction be identified for it, the applicants submit that those are legitimate questions for the central marketing team to put. They stress that it was a question of lawful legal means and that the Commission has not shown that Astra intended to resort to unlawful means. In addition, the Commission did not raise any objection to the court proceedings brought by Astra in order to establish the extent to which applications for marketing authorisations for generic products or applications for parallel import licences would be affected by the withdrawal of the marketing authorisation on which they depended (paragraph 502 of the statement of objections).

The applicants maintain that the Astra central marketing team and the Astra central coordinating team did not coordinate an exclusionary strategy for Denmark, Sweden and Norway and stress the decentralised nature of AZ's organisation. They refer, in that regard, to the witness statement of Dr N., a member of the board of AZ at the material time, from which it is apparent that external consultants had described Astra's organisation as ‘strangely decentralised’. They submit that the Commission cannot disregard that witness statement without demonstrating that it is not trustworthy.

They dispute that the mere fact that the companies established in Denmark, Norway and Sweden were wholly owned by AZ is sufficient for the latter to be considered to have exercised a decisive influence over their commercial policy. It should, in their view, be ascertained whether the parent company was in a position to exert a decisive influence and whether it did exert a decisive influence (Case 107/82 AEG-Telefunken v Commission [1983] ECR 3151, paragraphs 48 to 50). They point out, in that regard, that a subsidiary is not under the decisive influence of its parent where the subsidiary can determine its own market behaviour autonomously (Europemballage and Continental Can v Commission, paragraph 267 above).

As regards the examination of Astra's overall strategy, set out in recitals 268 to 274 of the contested decision, which relies on the LPP Strategy document dated 29 April 1997 and on a speech dated October 1999, the applicants note that the Commission considered that the strategy fell into three phases, namely

They maintain that the Commission cannot assert that it is objectionable to take action to protect volumes of sales, since that amounts to asserting that it is objectionable to compete. Astra simply sought to enforce its intellectual property rights, such as its formulation patents, to ensure that the legal rules relating to the grant of marketing authorisations for generic products were observed and to improve its own ulcer-healing product range by extending that line and by creating a new generation of products. Such behaviour is not abusive.

In that regard, the applicants point out that the Commission does not take issue, in recital 830 of the contested decision, with Astra's interpretation of the legal rules on the granting of marketing authorisations. Further, in recitals 502 and 458 respectively of the statement of objections, the Commission accepted that Astra's conduct to protect its marketing authorisations was not objectionable and that Astra's legal actions to protect its intellectual property rights were not abusive. The applicants submit that, by launching Losec MUPS and withdrawing Losec capsules, Astra was seeking to gain a legitimate competitive advantage in the market. In that respect, they observe that, in recital 793 of the contested decision, the Commission itself conceded that that commercial behaviour was not, as such, abusive.

With regard to the six elements of the second phase of Astra's strategy, set out in recital 271 of the contested decision, the applicants submit that there is nothing illegitimate in them. As regards, firstly, document protection, this reflects Astra's legitimate interest in protecting the confidential information supplied to national authorities in connection with applications for marketing authorisations. As regards, secondly, upgrading of product quality, that behaviour fell within the scope of competition based on the merits of products. With regard to securing additional offensive and defensive patents, there is nothing objectionable in the filing of such patents. The surveillance programme to keep under review the activities of competitors marketing generics is also a legitimate practice, since the granting of interim relief in infringement proceedings is often dependent on the claimant's acting diligently. With regard to the bringing of legal actions, these are intended to enforce Astra's intellectual property rights and are brought only on the basis of solid legal grounds. Finally, as regards the total switch from Losec capsules to Losec tablets, this is behaviour consistent with competition on the merits of products.

The applicants challenge the Commission's argument that Astra intended to market Losec tablets in markets where its substance patent was about to expire. They claim that it was Astra's intention and in its interests to introduce a tablet formulation of Losec as early as possible because of the disadvantages of Losec capsules, but that it encountered technical difficulties in the course of developing Losec MUPS. The applicants concede that Astra's desire to launch a tablet formulation gained urgency as the expiry dates of the omeprazole substance patent approached. However, that urgency does not mean that the timing of the launch of Losec tablets was designed to coincide with the patent's expiry, or that the purpose of that launch was to prevent the market entry of generics.

The applicants deny that the speech given in October 1999 to a meeting of AZ's management, referred to by the Commission in recital 273 of the contested decision, demonstrates that AZ was operating an anticompetitive strategy. That document shows only that AZ operated a strategy of defending its industrial property. They also submit that the ‘Losec Post-Patent Strategy’ document shows that Astra was engaged in competition based on the merits of products, [confidential].

The applicants submit that the Commission's claim, in recital 274 of the contested decision, in reference to a set of slides dated May 1997, that Astra was wrong to contemplate how it could prevent parallel trade in Losec from markets in which the patent had expired, is ill-founded. They maintain that those slides do not contribute to proving an abuse of a dominant position since they do not suggest that Astra had any intention of using illegitimate or unlawful means, or that it did so.

With regard to recitals 275 to 306 of the contested decision, in which the particular facts relating to the launch of Losec MUPS tablets, the withdrawal from the market of Losec capsules and the withdrawal of the Losec capsule marketing authorisations are examined, the applicants maintain that, since the Commission conceded, in recital 793 of the contested decision, that the launch of Losec MUPS and the withdrawal of Losec capsules did not, as such, constitute an abuse of a dominant position, it was obliged to produce evidence that deregistration in Denmark, Norway and Sweden was intended to exclude generics and parallel imports from the market. However, no such evidence was produced.

It is apparent from the ‘Losec® MUPS STEPSUM’ document, cited by the Commission in recital 276 of the contested decision, and in fact dated January 1997, that the Astra central marketing team had drawn the attention of local marketing companies to the fact that there were commercial risks in withdrawing Losec capsules and that a decision to withdraw the capsules needed to be carefully judged in each market. Consequently, Astra's central marketing team invited each local marketing company to make its own decision on whether and when to withdraw the Losec capsules. That document demonstrates that the decision to withdraw Losec capsules from the market, in Sweden, Denmark and Norway in particular, stemmed from an independent and rational commercial strategy on the part of the local companies, implemented on the ground that it was the best way to market Losec MUPS, and not from a plan to prevent the market entry of generics or parallel imports.

The applicants submit that the Commission's inference, in recital 278 of the contested decision, from the minutes of an internal meeting which took place on 18 September 1997, that Astra's decision to launch MUPS was motivated by a desire to restrict competition, is ill-founded. They accept that Astra's central coordinating team had looked into the national regulatory issues relating to a launch of Losec tablets and a withdrawal of the capsules. However, they point out that those minutes simply stated that a proposal for an MUPS strategy was to be prepared for 3 October 1997. Moreover, the Commission has not demonstrated that the regulatory considerations determined Astra's central strategy or the decisions of the local marketing companies. The applicants add that the author of that document, Dr N., provided oral evidence and a witness statement affirming that there was no strategy on AZ's part.

With regard to the fax headed ‘MUPs’, cited by the Commission in recital 279 of the contested decision, the applicants explain that it contains a report of a meeting held on 24 September 1997 and records a compilation of all the national plans to convert sales of Losec capsules to sales of Losec MUPS. They claim that AZ explained, in its written reply (reply, chapter 7, section V, paragraphs 7.143 to 7.147), that those decisions were taken for legitimate commercial reasons and that they contain no suggestion that the launch of Losec tablets and the withdrawal of Losec capsules were decided on by the local marketing companies, for other reasons.

With regard to the draft document dated 3 October 1997 called ‘Losec MUPS Strategy’, cited in recital 280 of the contested decision, the applicants submit that it simply shows that Astra intended to introduce a better-quality product into the market, which is entirely in keeping with competition on the merits. Moreover, as the covering memorandum to the document indicates, the document was intended to introduce the discussion and contained no agreed plan.

It follows from the foregoing that the Commission is wrong to maintain, in recital 281 of the contested decision, that Astra had a central plan to restrict competition by taking advantage of the legal implications of a withdrawal of capsule authorisations and that it directed the local marketing companies accordingly. Moreover, the passages of documents cited in that recital show that Astra did not intend to act in disregard of competition law and that it took legal advice from national experts.

With regard to recital 282 of the contested decision, the applicants submit that there is nothing illegitimate in the fact that Astra's priority was to launch MUPS in markets in relation to which expiry of the substance patents was imminent, since the intention of that decision was to compete positively by launching the Losec MUPS tablets, and not to compete negatively by deregistering the capsules. Moreover, Astra's decision to avoid launching Losec MUPS first in a low-priced market is justified by the concern to ensure that the pricing of that product by the national authorities of other countries was not influenced downwards. The geographic selectivity which characterised the Losec MUPS marketing strategy was thus governed by financial and commercial and not by regulatory considerations or by the desire to impede parallel trade or market entry by generics.

As regards recitals 283 to 285 of the contested decision, in which the Commission cites an in-house counsel's advice as to the likely effects of withdrawal of the capsule authorisations, the applicants submit that this advice does not show that the decision on marketing Losec MUPS and withdrawing the capsules from the market was taken by reference to the likely effects of withdrawal of a marketing authorisation, or that the decisions in respect of Denmark, Sweden and Norway were taken centrally. It shows only that Astra's central coordinating team looked into the legal issues raised by the withdrawal of the capsule marketing authorisations. Similarly, the passage cited in recital 285 of the contested decision shows at the very most that Astra was aware of the competition rules at the time of the launch of Losec tablets and the withdrawal of Losec capsules.

The applicants state that, in recitals 286 to 295 of the contested decision, the Commission quoted passages from three documents, namely, that dated 29 April 1998 headed ‘Losec/H 199 Scenario’, a memorandum of 30 November 1998 headed ‘Draft Paper for GITA [gastrointestinal therapeutic area] Team Meeting 4 December 1998’ (‘the GITA team’) and a document dated 12 May 1999 headed ‘The Gastrointestinal Franchise Plan, Horizon 1–3, 1999–2007 (and beyond)’. On the basis of those documents, the Commission endeavoured to show that Astra, firstly, had launched Losec MUPS with the intention of delaying or disrupting generic market entry and parallel trade, secondly, had launched line extensions in order to maintain its leading market position until it was ready to launch an entirely new esomeprazole product (Nexium) and thirdly, had intended to draw attention to any deficiencies in the quality of generic products on the market.

The applicants do not dispute the Commission's allegations on those matters, but stress that Astra used only legitimate means to exclude and damage its competitors. In their submission, it is clear from the ‘Losec/H 199 Scenario’ document that Astra was engaging only in competition on the merits. Losec MUPS was a superior product compared with Losec capsules, a fact which had the effect of dampening demand for the latter, whether they were generics or parallel imports. Moreover, the applicants point out that AZ explained, at paragraphs 70 to 74 of the reply to the letter of facts, that the Commission had erred in citing that document in order to show an admission on the part of Astra that deregistration of marketing authorisations was unprecedented and exclusionary. Reference is also made, in that regard, to the witness statement of Mr R., concerning the representations made by him in the legal proceedings in Denmark.

As regards the internal draft GITA team meeting document, the applicants submit that that document shows Astra's desire to compete on the merits, by legitimate means. They further maintain that a close analysis of the document headed ‘The Gastrointestinal Franchise Plan, Horizon 1–3, 1999–2007 (and beyond)’ does not reveal any malevolent intent on the part of Astra to exclude illegally competition from generics and parallel imports in Denmark, Norway and Sweden. They then give a detailed account of the content of that document before concluding that it shows only that Astra centralised the information concerning intellectual property and regulatory issues and disseminated it to the local marketing companies.

The applicants also maintain that the fact that Astra regarded Losec MUPS as an intermediate product between Losec capsules and Nexium is irrelevant, since there was no reason to prevent the launch of Losec MUPS merely because Nexium was in prospect. In addition, the competitive nature of the market did not allow Astra to delay marketing Losec MUPS for any significant length of time. Moreover, in 1997 and 1998, Astra did not know whether Nexium would secure marketing authorisations and had therefore not yet decided to launch it.

The applicants repeat that the reason for the marketing companies' decision to withdraw the marketing authorisations for Losec capsules is connected with the fact that the authorisations were no longer needed. There is no obligation on AZ to protect the interests of companies marketing generics or of parallel importers wishing to take advantage of the data filed in support of applications for marketing authorisations. There was therefore no intention on the part of AZ to withdraw the marketing authorisations in order to prevent competition from generics. Astra's central team even envisaged that one of the risks of withdrawing Losec capsules was that generic capsules would gain ground at the expense of the MUPS product if the latter was not a success.

With regard to the findings made by the Commission in recitals 296 to 303 of the contested decision, the applicants do not deny that Astra intended, by launching line extensions such as Losec MUPS, to delay generic market entry and parallel trade in order to maintain its leading market position until it was ready to market Nexium. Nor do they deny that Astra intended to launch Losec MUPS before generic omeprazole products entered the market in large volumes and drove prices down to lower levels. They submit, however, that those objectives did not constitute an abuse of a dominant position, since no unlawful means were used.

The applicants submit that the conclusions which the Commission draws, in recital 296 of the contested decision, from a fax sent by Astra on 29 May 1998, distort the facts. It is apparent from that fax that Astra suggested to the local marketing companies that they draw up individual plans to defend the Losec patent and guard themselves against the launch of generics. That fax thus shows that the decision-making process for the launch of Losec tablets was decentralised, although Astra centrally took responsibility, on the one hand, for coordinating legal actions against generic competitors who had infringed its intellectual property rights and, on the other, for evaluating the legal implications of the withdrawal from the market of Losec capsules and the deregistration of the related authorisations. Moreover, the fact that the author of that fax complains that Astra's activities were not coordinated corroborates the fact that the decision-making process regarding the launch of Losec MUPS was largely left to the local marketing companies.

The applicants state that the author of the fax wanted Astra to take all steps legitimately available to it to prevent generic companies from infringing its rights. In reply to the Commission's arguments, they explain that that fax does not concern the implementation on a country-by-country basis of a plan to withdraw the marketing authorisations, but Astra's activities in defending its Losec patents. They further note that by the date of that fax, namely 29 May 1998, Losec capsules had already been replaced by Losec MUPS tablets and the marketing authorisation had already been withdrawn in Denmark, that Losec MUPS had already been launched in Sweden and that a marketing authorisation for Losec MUPS had been applied for in Norway. For that same reason, the fax of 27 May 1997 and the letter of 22 October 1998, which are cited by the Commission, cannot support its argument that AZ coordinated the withdrawal of the marketing authorisations, since those documents look at coordinating patent activity after 27 May 1998.

As regards recitals 304 to 306 of the contested decision, the applicants set out, in a table, all the dates, in 15 countries, relating to the launch of Losec MUPS, the withdrawal from the market of Losec capsules, the applications for withdrawal of capsule marketing authorisations and the actual revocation of those authorisations. They assert that the withdrawal of Astra Denmark's marketing authorisation was not effected until 6 April 1998, not 19 March 1998 which is when the Commission alleges that the second abuse of a dominant position commenced. The dates in question in the various countries show that the local marketing companies acted differently according to the particular circumstances in the national markets. The applicants observe, in particular, that the dates for the launch of Losec tablets were approximately nine months apart between Sweden and Norway and approximately eight months apart between Denmark and Norway, and that the withdrawals of the marketing authorisations were approximately five months apart between Sweden and Denmark and approximately seven months apart between Denmark and Norway. They also point out that Astra's intention to impede the activities of generic entrants and parallel importers is refuted by the fact that it did not request withdrawal of the Losec capsule authorisations in the Netherlands and in Germany, the latter having been the first country in which generics were introduced.

In the applicants' submission, the fact that Astra took a central decision not to market Losec tablets in Greece, Luxembourg, Portugal, Italy and Spain does not support the conclusion that the decisions about the launch of Losec MUPS, the withdrawal from the market of Losec capsules and the withdrawal of the marketing authorisations in Denmark, Norway and Sweden were adopted centrally. No document proves the existence of a central strategy or that, if there was such a strategy, it was operated with the intention of restricting competition. Similarly, the evidence of the existence of abuse of a dominant position on which the Commission seeks to rely does not demonstrate that the subsidiaries in Denmark, Norway and Sweden were more under the influence of AZ than the subsidiaries in Belgium, the Netherlands or the United Kingdom, which did not deregister the marketing authorisations. However, if AZ did in fact exercise a decisive influence over its subsidiaries, it would have been logical for the subsidiaries in Belgium and the Netherlands to withdraw the marketing authorisations, since they were the first to face competition from generics. In addition, the fact that only three of AZ's 33 marketing companies worldwide withdrew the marketing authorisations is not consistent with the allegation that AZ exercised a decisive influence over its subsidiaries.

As regards the effects of Astra's conduct in Denmark, the applicants submit that the Commission did not establish, in recitals 307 to 311 of the contested decision, that market entry of generic products was delayed by the withdrawal of the Losec capsule marketing authorisation, and that the Commission erred in attributing the difficulties encountered by generic entrants to the withdrawal of the authorisation. They argue that generic companies could readily have relied on the published literature exemption under Directive 65/65, as the Commission conceded in recital 830 of the contested decision. AZ adduced evidence in that regard, showing that the competent authorities in the relevant Member States would have granted marketing authorisations on the basis of that exemption to companies applying for them. Reference is made, on this point, to the witness statement given by Professor S. prior to the oral procedure and the submission made by Mr D.-S. at the oral procedure on 16 and 17 February 2004. The applicants dispute, for those reasons, the Commission's assertion that the fact that one generic company has been excluded means that further applications for authorisation of generics could not succeed, that assertion being, furthermore, unsubstantiated.

Moreover, since Astra holds a formulation patent until 2007, withdrawal of the Losec capsule authorisation would have had no effect on the degree of generic competition attainable in Denmark. In reply to the Commission's argument that AZ itself considered that those patents would not hold up in Denmark after the substance patent expired in April 1999, the applicants maintain that the question of how third parties perceive the strength of the patent and the effect of the presence of that patent on third parties is alone decisive. They further assert that that patent was sufficiently strong for AZ to obtain injunctions.

The applicants admit that four parallel importers who had been selling Losec capsules in Denmark since 1995 left the market when Astra withdrew the Losec capsule marketing authorisation. They submit, however, that the Commission has failed to show the reasons for those departures. Moreover, the contention that maintaining the parallel import licences in Denmark would have resulted in significant sales of Losec capsules is without foundation. AZ explained, in chapter 7, section VII, paragraph 7.241, of its written reply that, because of the success of Losec MUPS, sales of Losec capsules declined substantially between 1998 and 2000 in Sweden, Norway and the Netherlands, whereas in Sweden, parallel importers were permitted to maintain their import licences for capsules even after the withdrawal of the marketing authorisations, and, in the Netherlands, no abuse of a dominant position was identified by the Commission. The applicants dispute that the causal link between the withdrawal of the marketing authorisations and the cessation of parallel trade can be merely presumed. Moreover, the Commission has not shown that, if the authorisation had stayed in place, there would have been an appreciable demand for parallel imports of Losec capsules. The applicants argue, in that regard, that, on the basis of what has happened in other markets, there is very unlikely to be a material demand for parallel imports of Losec capsules.

Similarly, the applicants submit that the Commission erred, in recitals 312 and 313 of the contested decision, in attributing the absence, in Sweden, of generic omeprazole capsules to the difficulties faced by generic product companies in obtaining marketing authorisations. Generic product companies were unable to sell generic omeprazole capsules in Sweden because of the SPCs held by Astra until 4 February 2003 in respect of omeprazole sodium and the omeprazole substance. Moreover, the Commission took no account of the fact that generic product companies could have obtained marketing authorisations on the basis of the published literature in respect of omeprazole. The applicants further observe that, in recital 855 of the contested decision, the Commission conceded that the complainant in this case was able to access the market prior to the withdrawal of the marketing authorisation in Sweden. Thus, the withdrawal of the marketing authorisation had no effect on generic entry in Sweden. Similarly, in its pleadings, the Commission admits that it does not know the extent to which the obtaining of marketing authorisations by other generic producers was obstructed in Sweden as a direct result of the withdrawal of AZ's authorisation.

With regard to the effect of the withdrawal of the marketing authorisation on parallel trade, the applicants point out that the Commission itself concedes, in recital 857 of the contested decision, that it is not able to say with any certainty what effect that withdrawal had, since the drop in imports of Losec capsules may be due, inter alia, to the popularity of Losec MUPS tablets. Moreover, in that same recital, the Commission conceded that the parallel trade licences were withdrawn and then reinstated in Sweden.

Those observations are also valid with regard to Norway, a country in relation to which the Commission failed to show any more conclusively, in recital 323 of the contested decision, that withdrawal of the marketing authorisation foreclosed market access for generic products. The applicants reiterate, firstly, that generic product companies could have obtained marketing authorisations on the basis of the published literature and, secondly, that the Commission conceded, in recitals 855 and 858 respectively of the contested decision, on the one hand, that the complainant was able to access the market prior to the withdrawal of the marketing authorisation in Norway and that the Commission could not ascertain the extent to which the obtaining of marketing authorisations was obstructed solely as the result of withdrawal of the authorisation, and, on the other, that Astra's strategy was unsuccessful in respect of parallel imports.

The applicants add that the Commission's contention that the withdrawal of the marketing authorisations in Denmark, Norway and Sweden had a direct effect on competition in those countries is not consistent with recitals 830 and 842 of the contested decision, in which, respectively, it considered, on the one hand, that generic producers and parallel importers were not dependent on the existence of a marketing authorisation in order to be able to compete with the holder of a former authorisation and supply the same or similar products and, on the other, that it was not the purpose of marketing authorisations to facilitate the market entry of generic products. Moreover, it is essential that the Commission should be able to identify the effects that flowed from the withdrawal of the marketing authorisations. However, it has failed to demonstrate those effects.

The Court would point out, first of all, that, as regards conduct such as that at issue in the present case — 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.

In the present case, it was established in paragraphs 675 and 812 above that the deregistration of the Losec capsule marketing authorisations was not based on the legitimate protection of an investment which was part of competition on the merits and, moreover, was not required by the conversion of AZ's sales of Losec capsules to Losec MUPS.

Consequently, in so far as it is established that in Denmark, Norway and Sweden the deregistrations of the marketing authorisations were capable of constituting an obstacle to the market entry of generic products and to parallel imports, the applicants' arguments disputing the effects of those deregistrations in practice cannot affect the classification of the conduct in question as an abuse of a dominant position.

However, those arguments are capable of calling in question the merits of that classification in so far as the applicants maintain that the Commission has failed to establish to the requisite legal standard that, in view of the objective context in which that conduct was implemented, that conduct was such as to delay or prevent the introduction on the market of generic products and parallel imports. It is therefore necessary to examine that point in the light of the applicants' grounds of complaint.

As regards, in the first place, the ability of the deregistration of the Losec capsule marketing authorisations to impair the introduction on the market of generic versions of omeprazole capsules, it should be recalled that the Court of Justice has held that, 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, the marketing authorisation of the reference medicinal product must be in force, at the very least, on the date when that application is lodged (AstraZeneca, paragraph 617 above, paragraph 49). AZ's conduct therefore made the abridged procedure referred to in that provision unavailable and was, consequently, such as to delay the grant of authorisations for the marketing of generic products in Denmark, Norway and Sweden.

The applicants assert however that potential competitors could have followed the procedure provided for in point 8(a)(ii) of the third paragraph of Article 4 of Directive 65/65, which enables the applicant to demonstrate, just by detailed references to published scientific literature, that the proprietary medicinal product for which a marketing authorisation has been applied has recognised efficacy and an acceptable level of safety. In this respect, the Court would point out, as the Commission observes, that 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.

In this respect, it should be recalled, once again, that the basis for AZ's deregistering its marketing authorisations was not the legitimate protection of an investment designed to contribute to competition on the merits, since AZ no longer had the exclusive right to use the results of the pharmacological and toxicological tests and clinical trials which it had carried out and those deregistrations were not required by the conversion of AZ's sales of Losec capsules to Losec MUPS.

Moreover, the Court would point out that the fact that the Commission was not able to evaluate precisely the delay caused to competitors in gaining access to the market does not affect the finding that the conduct at issue was such as to restrict competition, since it is established that that deregistration resulted in the unavailability of the abridged procedure provided for in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65.

Furthermore, the fact that Article 7 of Directive 65/65 provides for a maximum period of 210 days in respect of procedures for granting authorisations to place proprietary medicinal products on the market does not mean that the delay caused to competitors in entering the market cannot be greater than that period. As the Commission observed in recital 854 of the contested decision, unless they were informed in advance about AZ's deregistrations of the marketing authorisations, producers of generic products could have been aware of them only once they had taken place. There is every reason to consider that it is only once the competitors became aware of those deregistrations that they would begin their research into collecting the published scientific literature for the purposes of obtaining the marketing authorisations in accordance with the procedure referred to in point 8(a)(ii) of the third paragraph of Article 4 of Directive 65/65. Before the procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of that directive was made unavailable, manufacturers of generic products had no reason to envisage using the published literature procedure.

The Court would also point out, as the Commission maintains, that the procedures other than that referred to in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65, such as the published literature procedure or the hybrid procedure (an intermediate procedure between the full marketing authorisation procedure and the procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65), require conditions to be satisfied — such as the submission of additional data — that go beyond those required by the procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of that directive. Those other procedures are therefore more burdensome for manufacturers of generic products and necessarily take more time than the abridged procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65.

The deregistrations of the marketing authorisations were therefore such as to enable AZ to delay, at least temporarily, the significant competitive pressure that generic products were to exert on it. It is apparent from the internal documents of AZ examined by the Commission that such a delay could be very useful for AZ, so as to ensure that prices were as high as possible pending the introduction on the market of esomeprazole at an advantageous price (see paragraphs 765 and 767 above). In addition, in view of the sales volumes at stake, any delay in the entry of generic products onto the market was worthwhile for AZ (see paragraph 764 above).

It follows from the foregoing that the fact, relied on by the applicants, that AZ's competitors could have obtained marketing authorisations by means of the published literature procedure does not suffice to make the deregistration of the Losec capsule marketing authorisations non-abusive, since that conduct solely served to exclude from the market, at least temporarily, competing manufacturers of generic products.

Furthermore, the fact, relied on by the applicants, that, first, AZ held a formulation patent in Sweden until 2007, and SPCs in respect of omeprazole sodium and the omeprazole substance until 4 February 2003 and, second, obtained injunctions against its competitors on the basis of its formulation patents or its SPCs in Denmark, Norway and Sweden, is irrelevant to the issue whether the deregistration of the marketing authorisations was anticompetitive. The fact that AZ had at its disposal various regulatory or judicial means — some of which were legitimate when viewed from the perspective of competition on the merits — to create obstacles to the introduction on the market of generic products and, therefore, that the conduct objected to was not the only course of conduct able to produce, or which did produce, the intended restriction of competition in no way makes that conduct non-abusive, since it is established that that conduct was in any event such as to restrict competition.

In addition, the fact that the complainants could have obtained the marketing authorisations on the basis of the abridged procedure referred to in point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65, to the extent that they had filed their applications before the deregistrations of AZ's marketing authorisations became effective, is clearly incapable of making the conduct objected to non-abusive. Indeed, AZ is charged specifically with making that abridged procedure unavailable to any manufacturer of generic omeprazole capsules wishing to file an application for marketing authorisation after the effective deregistration of AZ's marketing authorisations.

As regards, in the second place, the ability of the deregistrations of the marketing authorisations to restrict parallel imports, the applicants dispute that those deregistrations are the cause of the decline in parallel imports of Losec capsules and maintain that the decline in those parallel imports is due to the success of Losec MUPS. It is necessary to examine the merits of that argument in relation to Denmark, Norway and Sweden respectively.

It should be borne in mind, in this respect, as was stated, in essence, in paragraphs 474 and 475 above, that it is incumbent on the Commission to adduce evidence capable of demonstrating the existence of the circumstances constituting an infringement of Article 82 EC (Microsoft v Commission, paragraph 32 above, paragraph 688), and any doubt of the Court must benefit, in proceedings for annulment of a decision finding an infringement and imposing a fine, the undertaking to which that decision is addressed (see, by analogy, Coats Holdings and Coats v Commission, paragraph 476 above, paragraphs 68 and 69).

With respect to Denmark, the Court observes that, in recital 311 of the contested decision, the Commission merely noted that an internal AZ Denmark board document indicated that the introduction on the market of Losec MUPS and the withdrawal from the market of Losec capsules ‘meant exclusion of all omeprazole parallel import’. In the contested decision, the Commission does not therefore specify whether the parallel import licences for Losec capsules were revoked in Denmark by the public authorities.

The Commission maintains however that it is reasonable to take the view that there is a causal link between the deregistration of the marketing authorisation for Losec capsules in Denmark and the exclusion of parallel trade in that country.

In this respect, the Court would point out that, in reply to requests for preliminary rulings submitted to it by the Finnish and Swedish courts, the Court of Justice held that the withdrawal of marketing authorisations for reasons other than public health did not justify the automatic cessation of the parallel import licence where the protection of public health which pharmacovigilance seeks to ensure can be secured by alternative means, such as cooperation with the national authorities of the other Member States. Consequently, Articles 28 EC and 30 EC preclude the withdrawal of the marketing authorisation of a pharmaceutical product from entailing, of itself, the withdrawal of the parallel import licence granted for the medicinal product in question, if there is no risk to human health from maintaining that medicinal product on the market of the Member State of importation (Case C-15/01 Paranova Läkemedel and Others [2003] ECR I-4175, paragraphs 25 to 28 and 33, and Case C-113/01 Paranova [2003] ECR I-4243, paragraphs 26 to 29 and 34; see, also, Ferring, paragraph 659 above, paragraphs 38 to 40).

The Court would point out that the contested decision does not contain any indication that, before those judgments were delivered by the Court of Justice, it was the Danish authorities' practice to automatically withdraw parallel import licences following the withdrawal of the marketing authorisations for the relevant product for reasons unrelated to public health. In those circumstances, the Commission's argument that it is reasonable to take the view that there is a causal link between the deregistration of the marketing authorisations for Losec capsules in Denmark and the exclusion of parallel trade in that country amounts to postulating a presumption that the Danish authorities had withdrawn the parallel import licences, possibly in violation of European Union law.

In this respect, in reply to the Court's questions, the Commission maintains that the deregistration of the marketing authorisation created a situation of legal uncertainty as regards the validity of the parallel import licences for Losec capsules, and that it must therefore be found that that deregistration was capable of producing restrictive effects on competition. According to the Commission, it is clear that, had the marketing authorisations not been deregistered, the national authorities would undoubtedly have allowed parallel trade in Losec capsules to continue.

The Court would however point out, as was held in paragraph 824 above, that the classification as an abuse of a dominant position of conduct such as that at issue in the present case, which consists in the use of regulatory procedures without any basis in competition on the merits, requires at the very least evidence that, in view of the economic or regulatory context surrounding that conduct, that conduct is such as to restrict competition.

In accordance with the judgment in Coats Holdings and Coats v Commission, paragraph 476 above, paragraphs 68 and 69, it is therefore incumbent on the Commission to adduce tangible evidence showing that, in the present case, in view of the regulatory context in question, the national authorities were liable to withdraw or did usually withdraw parallel import licences following the deregistration, at the request of their holder, of the marketing authorisations for the relevant product.

However, in relation to Denmark, the Commission has not adduced any evidence showing to the requisite legal standard that the Danish authorities were likely to withdraw, in violation of Articles 28 EC and 30 EC, the parallel import licences following AZ's deregistration of its marketing authorisations. Furthermore, the Court would point out that, in the contested decision, the Commission did not even establish that the Danish authorities had revoked the parallel import licences for Losec capsules.

In this respect, the Court would point out that, in view of the regulatory context in the present case, the memorandum of 22 October 1997 (see paragraphs 779 and 780 above), in which AZ's in-house counsel expressed the opinion that ‘several of the Scandinavian authorities generally would take’ the position that the parallel import licences could not be upheld after deregistration of the marketing authorisations (see recital 283 of the contested decision), cannot constitute sufficient evidence. That document reflects only the personal opinion, or the expectations, of AZ employees regarding the reaction of ‘several of the Scandinavian authorities’, but does not establish that the Danish authorities were actually inclined to withdraw, potentially in violation of Articles 28 EC and 30 EC, the parallel import licences as a result of AZ's deregistration of its marketing authorisation for reasons unrelated to public health. Furthermore, that document is insufficient to establish that the cessation of parallel imports in Denmark is caused by AZ's deregistration of the Losec capsule marketing authorisation.

At the very most, there are grounds for considering that that document shows AZ's intention to exclude parallel imports by deregistering the Losec capsule marketing authorisation. However, the Court would point out that, although the intention of an undertaking in a dominant position to restrict competition by methods falling outside the scope of competition on the merits may be taken into consideration in the identification of an abuse of a dominant position, that identification must first and foremost be based on the objective finding of conduct which, in the context in which it is implemented, is such as to restrict competition.

Moreover, the reference to an AZ Denmark board document (recital 311 of the contested decision), in which it is stated that ‘[i]n March 1998, Losec MUPS was introduced and in April Losec capsules [were] withdrawn from the market[, which] meant exclusion of all omeprazole parallel import’, cannot establish to the requisite legal standard that the deregistration of the Losec capsule marketing authorisations was capable of resulting in the cessation of those parallel imports. In that document, no link is established between the deregistration of the Losec capsule marketing authorisation and the exclusion of parallel imports.

At most, that document indicates a link between, on the one hand, the swing of AZ's sales of Losec capsules towards Losec MUPS and, on the other, the exclusion of parallel imports of Losec capsules. However, the applicants specifically claim that the decline in, or cessation of, parallel imports of Losec capsules is due to consumers migrating towards Losec MUPS and, therefore, to the decline in consumption of Losec capsules. As is apparent from the documents before the Court, that was the effect sought by AZ in its strategy of tilting its activities towards the sale of Losec MUPS.

Accordingly, in the absence of any indication in this respect in the contested decision and in view of the fact that it is not even established that the Danish authorities revoked the parallel import licences for Losec capsules, a presumption of a causal link between the deregistration of the Losec capsule marketing authorisation in Denmark and the cessation of the parallel imports of that product in that country is incompatible with the principle that doubt must operate to the advantage of the addressee of the decision finding the infringement, as held by the Court in Coats Holdings and Coats v Commission, paragraph 476 above (paragraphs 68 to 70). Similarly, in view of the judgments in Paranova Läkemedel and Others, Paranova, paragraph 842 above, and Ferring, paragraph 659 above, the Commission was not entitled to find, in the absence of any evidence on that point, that the deregistration of the marketing authorisation was such as to lead to the withdrawal of the parallel import licences in Denmark.

The Commission further claims that the applicants admit that the deregistration of the marketing authorisation resulted in the prohibition on parallel trade by the public authorities. The Court finds however that such an explicit admission by the applicants cannot be identified in their pleadings and that such an admission cannot be inferred a contrario without creating the risk of distortion or misrepresentation of their arguments.

The Court must also reject the Commission's claim that the applicants do not contest, in their pleadings, that the Commission established a causal link between the deregistrations of the Losec capsule marketing authorisations in Denmark, Norway and Sweden and the decline in parallel imports in those countries. In their pleadings, the applicants do indeed dispute that the Commission established that causal link.

The Court therefore considers that the Commission has failed to establish to the requisite legal standard that the deregistration in Denmark of the Losec capsule marketing authorisation was capable of excluding parallel imports of those products.

As regards Norway, the Court observes that, in recital 321 of the contested decision, the Commission noted that parallel imports of Losec had fallen sharply from 1998 onwards, but had not entirely disappeared. The Commission found that the Norwegian authority had allowed parallel imports of Losec capsules to continue by reference to AZ's marketing authorisation for Losec MUPS, which was itself based on the marketing authorisation for Losec capsules.

In this respect, the Court observes that, in its judgment in Rhône-Poulenc Rorer and May & Baker, paragraph 622 above (paragraph 48), the Court of Justice held that, in circumstances similar to those at issue in the present case, the national authority of a Member State of importation was entitled to grant an import licence for the first version of a pharmaceutical product in respect of which the reference marketing authorisation had been withdrawn in that State, where a marketing authorisation for the second version of that pharmaceutical product had been granted in that Member State of importation. Thus, in the present case, the Norwegian authority's allowing parallel imports of Losec capsules to continue by reference to AZ's marketing authorisation for Losec MUPS is consistent with the regulatory practice allowed by the Court of Justice.

Although, as the Commission observes in recital 321 of the contested decision, parallel imports fell sharply in Norway, it cannot be presumed in the present case, for the reasons set out in paragraphs 842 and 846 above, that the deregistration of the Losec capsule marketing authorisation in those countries caused that fall. The fact that the Norwegian authority upheld the parallel import licences for Losec capsules also tends to show that the fall in parallel imports was not necessarily caused by the deregistration of the marketing authorisations.

Thus, for the reasons set out in paragraph 852 above, namely that it is incumbent on the Commission to establish evidence capable of demonstrating the existence of an abuse of a dominant position, the Commission was not entitled, in the present case, without evidence, to take the view that the deregistration of the Losec capsule marketing authorisation in Norway for reasons unrelated to public health was such as to lead to the withdrawal of the parallel import licences for that product in that country, or presume that the sharp fall in parallel imports of Losec capsules had been caused by the deregistration of the marketing authorisation pertaining to that product.

In order to assess the anticompetitive nature of the conduct in question with respect to parallel imports, it was therefore incumbent on the Commission to establish, at the very least, what the practice of the Norwegian authorities was in relation to the conditions for granting parallel import licences.

The Court therefore considers that the Commission has also failed to establish to the requisite legal standard that the deregistration in Norway of the Losec capsule marketing authorisation was capable of excluding parallel imports of Losec capsules.

As regards Sweden, on the other hand, it is not disputed that the Swedish Medical Products Agency considered that parallel import licences could be granted only if valid marketing authorisations were in place (recital 315 of the contested decision). Furthermore, it is also established that that agency withdrew the parallel import licences as a result of the deregistration of the Losec capsule marketing authorisation, although an extension of six months of an authorisation was granted to a parallel importer (see paragraph 798 above). It is unambiguously clear from this that the deregistration of the marketing authorisations was such as to impede parallel imports.

The fact that the Commission is not in a position to evaluate precisely the effect that that deregistration had on parallel imports does not affect the abusive nature of that conduct, since it is established that that conduct was capable of impeding parallel imports and that, moreover, it did indeed impede them in the present case.

In the light of all the foregoing, the Court holds that the Commission did not err in finding that AZ's deregistration of the Losec capsule marketing authorisations in Denmark, Norway and Sweden, in conjunction with the swing in AZ's sales from Losec capsules towards Losec MUPS in those countries, amounted to an abuse of a dominant position, inasmuch as it was such as to restrict access to the market of generic products in those countries. Similarly, the Commission did not err in taking the view that that conduct constituted an abuse of a dominant position in Sweden, inasmuch as it was such as to restrict parallel imports of Losec capsules in that country.

The second plea must however be upheld to the extent that it alleges an error by the Commission inasmuch as it considered that the conduct objected to constituted an abuse of a dominant position in Denmark and in Norway in so far as it restricted parallel trade in Losec capsules. The Commission has failed to establish to the requisite legal standard that the deregistration of the Losec capsule marketing authorisations was capable of restricting parallel imports of Losec capsules in those two countries.