T-60/96

MERCK AND OTHERS v COMMISSION

ORDER OF THE COURT OF FIRST INSTANCE (Fifth Chamber, Extended Composition) 3 June 1997 *

In Case T-60/96,

Merck & Co. Inc., a company governed by the law of the State of New Jersey, established at Whitehouse Station, New Jersey (United States of America),

NV Organon, a company governed by Netherlands law, established at Oss (Neth­ erlands),

Glaxo Wellcome pic, a company governed by English law, established at Green- ford (United Kingdom),

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ORDER OF 3. 6. 1997 — CASE T-60/96

APPLICATION for annulment of Commission Decisions C(95)3316 final/1, C(95)3316 final/2 and C(95)3316 def./2, K(95)3316 endg./3, K(95)3316 endg./4, K(95)3316 endelig. udg./5, C(95)3316 final/6 and C(95)3316 final/7 of 20 Decem­ ber 1995 refusing the authorization sought, respectively, by France, Belgium, Ger­ many, Austria, Denmark, Ireland and the United Kingdom to take protective mea­ sures with regard to pharmaceutical products coming from Spain,

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Fifth Chamber, Extended Composition),

composed of: R. Garcia-Valdecasas, President, V. Tiili, J. Azizi, R. M. Moura Ramos and M. Jaeger, Judges,

Registrar: H . Jung ,

measures with regard to pharmaceutical products coming from Spain (hereinafter 'the contested Decisions') pursuant to Article 379 of the Act concerning the condi­ tions of accession of the Kingdom of Spain and the Portuguese Republic, annexed to the Treaty concerning the accession of the Kingdom of Spain and the Portu­ guese Republic to the European Economic Community, signed on 12 June 1985 (OJ 1985 L 302, p. 9, hereinafter 'the Act of Accession of Spain and Portugal').

2 The addressees of the seven contested Decisions are the Member States listed above. They applied for authorization to take protective measures pursuant to Article 379 of the Act of Accession of Spain and Portugal following the expiry, on 6 October 1995, of the transitional period laid down by Article 47 of that Act.

3 The applicants are three manufacturers of pharmaceutical products, Merck & Co . Inc., a company governed by the law of the State of New Jersey, NV Organon, a company governed by Netherlands law, and Glaxo Wellcome pic, a company gov­ erned by English law.

4 On 22 February 1996 Merck & Co . Inc. received a copy of the contested Decisions in the course of a reference to the Court of Justice for a preliminary ruling (Case C-267/95 Merck and Others).

5 In addition to a question relating to the expiry date of the transitional period laid down in Article 47 of the Act of Accession of Spain and Portugal, that case con­ cerned — like the parallel Case C-268/95 Beecham — the question whether, in view of altered circumstances or other considerations, the Court of Justice should reconsider or amend the principles it had laid down in its judgment of 14 July 1981 in Case 187/80 Merck v Stephar and Exler [1981] ECR 2063 (hereinafter 'Merck v Stephar). Thus the national court asked whether Articles 30 and 36 of the Treaty preclude application of national legislation which grants the holder of a patent for a pharmaceutical product the right to oppose importation by a third party of that product from another Member State in circumstances where the holder first put

8 Thus Article 47 of the Act of Accession of Spain and Portugal essentially provides, by way of derogation from Article 42 thereof, that the rule laid down in Merck v Stephar does not apply to pharmaceutical products during a particular transitional period. Article 42 of that Act, by implied reference to Articles 30 and 34 of the Treaty, abolishes with effect from 1 January 1986 quantitative restrictions on imports and exports and any measures having equivalent effect existing between the Community and Spain.

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MERCK AND OTHERS v COMMISSION

9 Protocol No 8 to the Act of Accession of Spain and Portugal, on Spanish patents, requires the Kingdom of Spain to adjust its patent law so as to make it compatible with the level of protection of industrial property attained in the Community. For that purpose, it provides that Spain must, by 7 October 1992 at the latest, accede to the Munich Convention of 5 October 1973 on the European patent and make provision in its domestic legislation for pharmaceutical products to be patentable. By Law No 11/1986 of 20 March 1986 on patents, Spain made pharmaceutical products patentable as from 7 October 1992. By judgment of 5 December 1996 in Joined Cases C-267/95 and C-268/95 Merck and Others [1996] ECR I-6285, the Court of Justice confirmed that the transitional period provided for in Article 47(2) of the Act of Accession expired on 6 October 1995.

10 Article 379 of the Act of Accession of Spain and Portugal provides as follows:

'1 . If, before 31 December 1992, difficulties arise which are serious and liable to persist in any sector of the economy or which could bring about serious deteriora­ tion in the economic situation of a given area, a new Member State may apply for authorization to take protective measures in order to rectify the situation and adjust the sector concerned to the economy of the common market.

[...]

3. The measures authorized under paragraph 2 may involve derogations from the rules of the EEC Treaty [...] and of this Act to such an extent and for such periods as are strictly necessary in order to attain the objectives referred to in paragraph 1. Priority shall be given to such measures as will least disturb the functioning of the common market.

[...]'

1 1 In each of the contested Decisions (see paragraph 1 above), the first recital in the preamble states that the Member State concerned has sought from the Commission authorization to apply Article 379 of the Act of Accession of Spain and Portugal in order to take protective measures prohibiting the importation to that Member State of pharmaceutical products from Spain, which are protected by a product patent in the Member State concerned but not in Spain.

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MERCK AND OTHERS v COMMISSION

1 4 Article 1 of the Decisions addressed to France and Belgium rejects the application for protective measures made by the addressee Member State in the following words: 'The application for safeguard measures made by [the Member State con­ cerned] under Article 379 of the Act of Accession, aimed at refusing the importa­ tion [to the Member State concerned] of pharmaceutical products from Spain which are protected by patent [in the Member State concerned] but not in Spain, is rejected.' Article 1 of the Decisions addressed to Denmark, Ireland and the United Kingdom rejects the application for protective measures in similar terms, specify­ ing that the measures sought aimed at 'solving the problem caused by the expiry of the transitional period provided for by Article 47 of the Act of Accession'. Article 1 of the Decisions addressed to Germany and Austria is similarly framed, but specifies that the measures sought were 'to extend the transitional period pre­ scribed by Article 47 of the Act of Accession'.

15 The applicants effectively submit that, since on average ten years elapse between the moment when the molecules are patented and the date on which the pharma­ ceutical product containing the molecules is put on the market, products patented

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ORDER OF 3. 6. 1997 — CASE T-60/96

in Spain are not expected to be put on the market until about the year 2002. Con­ sequently, so far as concerns pharmaceutical products from Spain, there is a need to adopt protective measures in derogation from the principle of the free move­ ment of goods, until 2002.

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MERCK AND OTHERS v COMMISSION

18 The Commission, in its objection as to admissibility, claims that the Court should:

— declare the application inadmissible;

— order the applicants to pay the costs.

19 On 6 September 1996, 3 October 1996 and 9 October 1996, three associations of importers of pharmaceutical products — the Bundesverband der Arzneimittel- Importeure e. V., the Asociación de Exportadores Españoles de Productos Farma­ céuticos and the Vereniging Euro Spécialités — applied for leave to intervene in support of the form of order sought by the Commission. The parties raised no objections in respect of those applications.

a particular undertaking is considered to distinguish that undertaking individually (Codorniu, cited above, and Case C-358/89 Extramet Industrie v Council [1991] ECR I-2501, paragraph 17).

22 The applicants argue that it is possible to distinguish a restricted category of phar­ maceuticals manufacturers to whom the contested Decisions are of individual con­ cern, namely those who sell their products in Spain and in other Member States, and whose products sold in Spain are protected by patent in other Member States, in particular in the States to which the contested Decisions are addressed. The fact that these manufacturers are not in a position to withdraw their products from the Spanish market further identifies them as a 'restricted category'. The applicants refer to paragraphs 112 and 113 of the Opinion of Advocate General Fennelly in the Merck and Beecham cases, cited above, in which he describes the significant commercial damage which a decision of this nature can entail for manufacturers similarly placed.

25 One of the applicants, Merck, also claims to have been differentiated from all other manufacturers of pharmaceutical products by virtue of its participation in the pro­ ceedings before the national court which raised the questions on which the Court of Justice gave a preliminary ruling in the Merck and Beecham cases, cited above.

26 The applicants maintain that, even supposing that none of the factors cited above, considered in isolation, is sufficient to distinguish the applicant companies indi­ vidually in relation to the Decisions, that is nevertheless the effect produced if all those factors are taken together.

27 Lastly, the applicants deny that a finding that their application is admissible would be tantamount to granting a virtually unlimited number of undertakings the right to contest a decision of general application, thus setting a precedent inviting abuse of procedure of the kind alluded to by the Court of First Instance in Case T-398/94 Kahn Scheepvaart v Commission [1996] ECR II-477, paragraph 50.

28 The Commission contends that the contested Decisions are of general application in relation to all persons other than the Member States addressed.

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ORDER OF 3. 6. 1997 — CASE T-60/96

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MERCK AND OTHERS v COMMISSION

33 As regards the applicants' argument based on the judgments in the Piraiki-Patraiki and Antillean Rice Mills cases, cited above, and the fact that the wording of Article 379 of the Act of Accession of Spain and Portugal is identical to that of Article 130 of the Act of Accession of Greece, the Commission points out that, according to those judgments, its duty to take into account the interests of the undertakings concerned in those cases was predicated on the existence of circumstances which differentiated those undertakings from all other traders.

34 The Commission also challenges the applicants' arguments based on their partici­ pation in the procedure leading to the adoption of the contested Decisions. Such participation would have distinguished them individually in relation to those Deci­ sions only if the Commission had been required to hear their views. According to the Commission, none of the relevant provisions in the Act of Accession of Spain and Portugal requires the Commission, prior to the adoption of a measure such as the contested Decisions, to follow a procedure in which persons in a category cor­ responding to that of the applicants have the right to be heard.

35 Lastly, the Commission rejects the argument drawn by Merck from the fact that it was party to the proceedings before the national courts which gave rise to the rul­ ing of 5 December 1996 in the Merck and Beecham cases. According to the Com­ mission, for Merck thereby to be distinguished individually in relation to the con­ tested Decisions, that circumstance would have to have some relevance in the context of the adoption of those decisions, that is to say, there would have to be a link between the contested measures and the fact that Merck was party to those domestic proceedings.

39 It is settled law that the adoption of protective measures in the form of decisions addressed to the Member States is a legislative measure in relation to the undertak­ ings concerned (order of the Court of First Instance of 21 February 1995 in Case T-117/94 Associazione Agricoltori della Provincia di Rovigo and Others v Commis- sion [1995] ECR II-455, paragraphs 23 to 25, Antillean Rice Mills, cited above, paragraphs 180 to 186, Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, paragraphs 87 and 88, and Kahn Scheepvaart, cited above, paragraph 39). A decision refusing to allow the adoption of such measures is equally of general application in relation to the undertakings concerned.

40 Both the Court of Justice and the Court of First Instance have consistently held that, in certain circumstances, even a measure which is legislative in character by virtue of its being generally applicable to the traders concerned, may nevertheless be of individual concern to some of them {Extramet Industrie, cited above, para­ graphs 13 and 14, and Codorniu, cited above, paragraph 19; order of the Court of First Instance of 11 January 1995 in Case T-116/94 Cassa Nazionale di Previdenza ed Assistenza a favore degli Avvocati e Procuratori v Council [1995] ECR II-1 , paragraph 26; Exporteurs in Levende Warkens, cited above, paragraph 50). Thus it

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MERCK AND OTHERS v COMMISSION

is possible in such cases for a Community measure to be of a legislative character while at the same time being in the nature of a decision vis-à-vis some of the trad­ ers affected.

45 The extent of the protection conferred on patent holders is determined by the combined application of Articles 30 and 36 of the Treaty, as interpreted by the Court of Justice, notably in Merck v Stepkar, cited above. According to that case- law, the substance of the right on which the patent holder may rely lies essentially in according him an exclusive right to put the product on the market for the first time, including the possibility of releasing it in a Member State where the law does not provide patent protection for the product in question (Merck v Stepbar, cited above, paragraphs 9 and 10). If the patent holder decides to do this, he must then accept the consequences of his choice as regards the free movement of the product within the common market and, in particular, the fact that he cannot rely on a patent held in one Member State in order to prevent the importation of the prod­ uct marketed freely by him in another Member State where that product was not patentable (Merck v Stephar, cited above, paragraphs 11 and 13). As the Court of Justice pointed out in paragraph 38 of the judgment in the Merck and Beecham cases, cited above, it is in the light of this case-law that the transitional measures provided for by Article 47 of the Act of Accession of Spain and Portugal were adopted.

46 Accordingly, the right which the applicants derive from their status of patent hold­ ers does not include an entitlement to rely on the patent in order to prevent the importation of pharmaceutical products from Spain after the transitional period has expired.

51 Consequently, the fact that the applicants' economic position has been impaired because the situation brought about by the transitional period provided for in Article 47 of the Act of Accession of Spain and Portugal has come to an end is not enough to differentiate them, in relation to the contested Decisions, from all other traders.

52 Furthermore, the applicants have not established that their actual position is analo­ gous to that of the applicant in Extramet Industrie, cited above, which was the main importer, end user and principal competitor of the sole Community producer of the product covered by the anti-dumping Regulation contested in that case. Accordingly, the applicants' argument based on that judgment cannot be accepted either.

53 Merck argues that the fact that it was party to the proceedings before the national courts which led to the ruling of 5 December 1996 in Merck and Beecham, distin­ guishes it individually in relation to the contested Decisions.

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ORDER OF 3. 6. 1997 — CASE T-60/96

54 It should be borne in mind that the questions on which the Court of Justice was asked to give a preliminary ruling concerned not only the duration of the transi­ tional arrangement provided for in the Act of Accession of Spain and Portugal but also the question whether the principle of the exhaustion of patent rights, as laid down by the Court of Justice in Merck v Stephar, cited above, had to be recon­ sidered in view of the particular circumstances referred to in the order for refer­ ence (Merck and Beecham, cited above, paragraph 14).

and Others v Council [1996] ECR I-615, paragraphs 33 and 34, and Case T-489/93 Unifruit Hellas v Commission [1994] ECR II-1201, paragraphs 25 to 27, Antillean Rice Mills, cited above, paragraphs 73 to 76, Case T-482/93 Weber and Others v Commission [1996] ECR 11-609, paragraphs 63 to 65, and 69, Case T-298/94 Roquette Frères v Council [1996] ECR 11-1531, paragraphs 41 to 43). First, the traders in question must be in a situation which distinguishes them from all other traders concerned by the contested act. Secondly, the change in their situation — the factor which defines them by closing the limited class — must have its origin in the adoption of the contested measure. Thirdly, the institution adopting the con­ tested act must have been under an obligation to take account, at the time of the measure's adoption, of the particular circumstances of those traders (see Piraiki- Patraiki, cited above, paragraph 31, and Case C-152/88 Sofrimport v Commission [1990] ECR 1-2477, paragraph 11).

59 Thus, in paragraph 31 of its judgment in Piraiki-Patraiki, cited above, the Court of Justice held that the applicants could be regarded as individually concerned as members of a limited class of traders particularly affected by the decision at issue authorizing the adoption of protective measures, for three reasons: first, the exist­ ence of contracts the terms of which had already been agreed and which were to be performed during the period of the decision's application; secondly, the fact that performance of those contracts had been prevented by the decision at issue; and, thirdly, the fact that those traders were identified or identifiable by the Commis­ sion, having regard to the stipulation in Article 130(3) of the Act of Accession of Greece of the need to make a prior evaluation.

63 Secondly, the change in the factual situation in which the applicants found them­ selves prior to the expiry of the transitional period provided for in Article 47 of the Act of Accession of Spain and Portugal is not a result of the adoption of the contested Decisions but of the expiry of the transitional period and the subsequent application of Articles 30 and 36 of the Treaty.

64 Thirdly, so far as concerns any obligation incumbent on the Commission to take into account the applicants' particular circumstances, it should be borne in mind, above all, that the applicants have failed to establish the existence of any such spe­ cial circumstances. Nevertheless, since the applicants have also maintained that the Commission was under a duty to take into account their interests when adopting the contested Decisions, the merits of this argument should be examined.

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MERCK AND OTHERS v COMMISSION

65 The applicants base that argument on Piraiki-Patraiki, cited above, and on the fact that the wording and purpose of Article 130(3) of the Act of Accession of Greece are identical to those of Article 379(3) of the Act of Accession of Spain and Por­ tugal.

66 Although the wording and purpose of those two articles are indeed identical, both the facts giving rise to the Piraiki-Patraiki case and the nature and content of the act adopted by the Commission are radically different from the circumstances of the present case.

70 On the other hand, the adoption of a decision refusing authorization to take pro­ tective measures does not have a sudden impact on market conditions and does not provoke disturbances on the market which are inherent in all protective measures. Therefore, the evaluation for the purposes of choosing the measures which least disturb the functioning of the common market — in which the obligation incum­ bent on the institution to take account of the particular situation of traders triggers all its distinguishing effects — does not have to be carried out.

71 It follows that, in the absence of any such obligation on the part of the Commis­ sion, and of the other circumstances required by the settled case-law of the Court of Justice and this Court, the applicants do not form part of a limited class of trad­ ers individually concerned by the contested Decisions.

72 The applicants further maintain that, by reason of their contacts, both direct and indirect, with the Commission and their participation in the procedure leading to the adoption of the contested Decisions, they are differentiated from all other traders in relation to those Decisions.

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MERCK AND OTHERS v COMMISSION

73 It is settled case-law of this Court that the fact that a person participates in one way or another in the process leading to the adoption of a Community act does not distinguish that person individually in relation to the act in question unless the relevant Comunity legislation has laid down specific procedural guarantees for such a person (order of the Court of First Instance of 9 August 1995 in Case T-585/93 Greenpeace and Others v Commission [1995] ECR II-2205, paragraphs 56 and 63; Exporteurs in Levende Varkens, cited above, paragraph 55, and Kahn Scheepvaart, cited above, paragraphs 48 and 49, and the case-law cited therein).

78 The application must therefore be dismissed as inadmissible.

79 In the light of the foregoing, there is no need to rule on the applications to inter­ vene made by the Bundesverband der Arzneimittel-Importeure e. V., the Asocia­ ción de Exportadores Españoles de Productos Farmacéuticos and the Vereniging Euro Spécialités in support of the form of order sought by the Commission.

Costs

80 Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs, if they have been asked for in the successful party's pleadings. Since the applicants have been unsuccessful, they must, having regard to the form of order sought by the Commission, be ordered jointly and severally to pay the costs.

81 Under Article 87(6) of the Rules of Procedure, where a case does not proceed to judgment, the awarding of costs is at the discretion of the Court. The Court con­ siders that, in the circumstances of the present case, the parties seeking to intervene must bear their own costs.

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3. The applications to intervene need not be considered.

4. The Bundesverband der Arzneimittel-Importeure e. V., the Asociación de Exportadores Españoles de Productos Farmacéuticos and the Vereniging Euro Specialités are to bear their own costs.

Luxembourg, 3 June 1997.

H. Jung R. García-Valdecasas

Registrar President

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