Summary
Parties
Grounds
Decision on costs
Operative part
Keywords
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1. Acts of the institutions ° Directives ° Direct effect ° Limits ° Possibility of relying on a directive against an individual ° None ° Implementation by Member States ° Obligations of national courts
(EC Treaty, Art. 189, third para.)
2. Free movement of goods ° Industrial and commercial property ° Trade mark ° Product put on the market in a Member State by the trade mark owner or with his consent ° Importation, after repackaging or alteration of the content and appearance of the packaging, into another Member State ° Opposition by the trade mark owner ° Permissibility ° Conditions
(EC Treaty, Art. 36; Council Directive 89/104, Art. 7(2))
Summary
1. Although a directive may not of itself impose obligations on an individual and cannot therefore be relied upon as such against him, the national court which applies national law and is required to interpret it must as far as possible do so, whether the provisions in question were adopted before or after the directive, in the light of the wording and the purpose of the directive so as to achieve the result it has in view and thereby comply with the third paragraph of Article 189 of the Treaty.
2. Article 36 of the Treaty must be interpreted as meaning that a trade mark owner may rely upon his rights as owner to prevent an importer from marketing a pharmaceutical product which was put on the market in another Member State by the owner or with his consent, where that importer has repackaged the product in new external packaging through which the trade mark affixed to the original packaging has been made visible, or where he has modified the contents and the appearance of original external packaging whilst preserving the trade mark affixed thereto by the manufacturer, unless the following conditions are satisfied:
° it is established that reliance on trade mark rights by the owner in order to oppose the marketing of repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States; such is the case, in particular, where the owner has put an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the repackaging carried out by the importer is necessary in order to market the product in the Member State of importation, and also carried out in such conditions that the original condition of the product cannot be affected by it; that requirement does not, however, imply that it must be established that the trade mark owner deliberately sought to partition the markets between Member States;
° it is shown that the repackaging cannot affect the original condition of the product inside the packaging; such is the case, in particular, where the importer has merely carried out operations involving no risk of the product being affected, such as, for example, the removal of blister packs from their original external packaging and their insertion with one or more original packages into new external packaging, or their insertion in another original package, the fixing of self-stick labels on original external packaging or blister packs, or the addition to the packaging of new user instructions or information.
It is for the national court to ascertain whether the cutting of blister packs or the reprinting of batch numbers on them are carried out in such a manner as to exclude any real risk of affecting the original condition of the tablets inside; that must be regarded as being the case where, for example, those operations are authorized and supervised by a public authority with a view to ensuring that the product remains intact; it is also for the national court to verify that the original condition of the product inside the packaging is not indirectly affected, for example, by the fact that the external or inner packaging of the repackaged product or new user instructions or information omits certain important information or gives inaccurate information, or by the fact that the packaging of the repackaged product is not such as to give the product adequate protection;
° the new packaging clearly states who repackaged the product and the name of the manufacturer in print such that a person with normal eyesight, exercising a normal degree of attentiveness, would be in a position to understand; however, it is not necessary to indicate that the repackaging was carried out without the authorization of the trade mark owner;
° the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy; it is for the national court to ascertain whether the insertion into single external packaging of both original external packaging and loose blister packs constitutes an untidy form of packaging liable to damage the reputation of the trade mark; as for the cutting of blister packs, it is for that court to assess in each particular case whether it has been carried out in such a manner that the reputation of the trade mark might suffer; and
° the importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.
That interpretation of Article 36 of the Treaty also applies to Article 7(2) of the First Directive 89/104 on trade marks, the aim of both provisions being identical.
Parties
In Joined Cases C-71/94, C-72/94 and C-73/94,
REFERENCES to the Court under Article 177 of the EC Treaty by the Bundesgerichtshof for a preliminary ruling in the proceedings pending before that court between
Eurim-Pharm Arzneimittel GmbH
and
Beiersdorf AG (C-71/94),
Boehringer Ingelheim KG (C-72/94),
Farmitalia Carlo Erba GmbH (C-73/94)
on the interpretation of Article 36 of the EC Treaty in relation to trade marks,
THE COURT,
composed of: G.C. Rodríguez Iglesias, President, C.N. Kakouris, J.-P. Puissochet and G. Hirsch (Presidents of Chambers), G.F. Mancini, J.C. Moitinho de Almeida, C. Gulmann (Rapporteur), P. Jann and H. Ragnemalm, Judges,
Advocate General: F.G. Jacobs,
Registrars: H. von Holstein, Deputy Registrar,
L. Hewlett, Administrator,
after considering the written observations submitted on behalf of:
° Eurim-Pharm Arzneimittel GmbH, by Wolfgang A. Rehmann, Rechtsanwalt, Munich,
° Beiersdorf AG, by Rolf Schultz-Suechting, Rechtsanwalt, Berlin,
° Boehringer Ingelheim KG, by Wilhelm Danelzik, Rechtsanwalt, Cologne,
° Farmitalia Carlo Erba GmbH, by Bert J. Bosten and Wolfgang Prinz, Rechtsanwaelte, Cologne,
° the French Government, by Catherine de Salins, Assistant Director in the legal directorate of the Ministry of Foreign Affairs, and Philippe Martinet, Secretary for Foreign Affairs in the same directorate, acting as Agents,
° the United Kingdom Government, by S. Lucinda Hudson, of the Treasury Solicitor' s Department, acting as Agent, assisted by Michael Silverleaf, Barrister,
° the Commission of the European Communities, by Richard Wainwright, Principal Legal Adviser, and Angela Bardenhewer, of its Legal Service, acting as Agents,
having regard to the Report for the Hearing,
after hearing the oral observations of Eurim-Pharm Arzneimittel GmbH, represented by Wolfgang A. Rehmann; Beiersdorf AG, represented by Rolf Schultz-Suechting; Boehringer Ingelheim KG, represented by Wilhelm Danelzik; Farmitalia Carlo Erba GmbH, represented by Bert J. Bosten; the French Government, represented by Philippe Martinet; the United Kingdom Government, represented by Lindsey Nicoll, of the Treasury Solicitor' s Department, acting as Agent, assisted by Michael Silverleaf; and the Commission, represented by Richard Wainwright and Angela Bardenhewer, at the hearing on 4 October 1995,
after hearing the Opinion of the Advocate General at the sitting on 14 December 1995,
gives the following
Judgment
Grounds
1 By orders of 27 January 1994, received at the Court on 25 February 1994, the Bundesgerichtshof (Federal Court of Justice) referred to the Court for a preliminary ruling under Article 177 of the EC Treaty a number of questions on the interpretation of Article 36 of the EC Treaty in relation to trade marks.
2 The questions were raised in three disputes between, on the one hand, Beiersdorf AG (hereinafter "Beiersdorf"), Boehringer Ingelheim KG (hereinafter "Boehringer") and Farmitalia Carlo Erba GmbH (hereinafter "Farmitalia"), which are pharmaceutical manufacturers, and, on the other hand, Eurim-Pharm Arzneimittel GmbH (hereinafter "Eurim-Pharm"), which imports into Germany certain products manufactured by the former companies.
3 Beiersdorf manufactures and markets in Germany a pharmaceutical product under the name of "Kerlone", under licence from the French undertaking Laboratoires Synthélabo France (hereinafter "Synthélabo"), which is the owner of the trade mark "Kerlone" in Germany and other countries. Kerlone is used as an anti-hypertensive drug and sold as tablets in blister packs. Beiersdorf markets Kerlone in packets of 50 and 100 tablets, corresponding to the standard sizes recommended by various professional and commercial groups and by the German sickness insurance institutions.
4 In France, Synthélabo manufactures and markets Kerlone in packets of 28 tablets each, in compliance with French rules which authorize packaging to cover a maximum treatment period of no more than one month. The packets contain blister packs of 14 tablets each, with each blister pack carrying a list of the days of the week in French on the reverse side, so that each tablet corresponds to a given day over a two-week period.
5 Boehringer is owner of the trade mark "Mexitil" in Germany and France. It manufactures and markets in Germany the medicinal product "Mexitil", which is used against cardiac arrhythmia. Mexitil is sold as capsules in blister packs and marketed in Germany in packets of 20, 50 and 100 to comply with the standard sizes recommended in Germany.
6 In France, Mexitil is manufactured under licence by Boehringer Ingelheim France SARL, which is a subsidiary of Boehringer Ingelheim KG. It is sold in France in packets of 30, containing three blister packs of 10 capsules each. In compliance with the French rules, the packet size is adapted to a 10-day course of treatment at the rate of three capsules per day.
7 Farmitalia is the German subsidiary of the Italian company Farmitalia Carlo Erba, which owns the trade mark "Sermion" registered, inter alia, in Germany, Spain and Portugal. Farmitalia markets in Germany, under licence from its parent company, the medicinal products "Sermion" (active ingredient: nicergoline 5 mg) and "Sermion forte" (active ingredient: nicergoline 10 mg), which are used in the treatment of cerebral disturbances and sold as tablets in blister packs. Marketing in Germany is in packets of 50 or 100 tablets, in accordance with the standard sizes recommended in Germany.
8 In Portugal, a sister company of Farmitalia markets Sermion in tablets of 10 mg, but without adding the word "forte", in packets of 60 containing six blister packs of 10 tablets each. The package size is designed for a treatment period of 20 days, and thus attains the upper limit of what is reimbursable under the Portuguese sickness insurance scheme.
9 In Spain, Sermion is sold by Farmitalia' s Spanish sister company in packets of 45 tablets of 5 mg, contained in a single blister pack.
10 Eurim-Pharm imports the above pharmaceutical products in parallel from France, Portugal and Spain, and markets them in Germany. Before marketing, it repackages the products in order to obtain packets which comply with the recommended sizes in Germany.
11 Kerlone, Mexitil and Sermion imported from Portugal are repackaged in new external packaging designed by Eurim-Pharm, into which are inserted both original packages together with their contents and loose blister packs taken from other original packages.
12 The new external packets carry rectangular holes on the front, which by their size and position allow the trade mark on the original packets to be seen. The new packaging carries, inter alia, the statement that the product was imported, packaged and marketed by Eurim-Pharm. As regards the Sermion imported from Portugal, the word "forte" is printed beneath the rectangular hole.
13 In the case of Kerlone, some of the loose blister packs added have been cut. Where the cutting removes the batch number stamped on the blister pack, the corresponding number is reprinted. Because of the cutting, the list of days of the week on the back of each blister pack, to which the tablets are allotted, is no longer complete.
14 The original packets contained inside the new external packaging carry self-stick labels stating, inter alia, that the product was imported and marketed by Eurim-Pharm. In the case of Mexitil, Eurim-Pharm also affixes on the front of the original packet a self-stick label with the words "active ingredient: mexiletine hydrochloride". In the case of the Sermion imported from Portugal, Eurim-Pharm additionally covers the side and the front of the original packet with self-stick labels which leave uncovered only the Sermion trademark and the word "Farmitalia" and which carry, inter alia, the word "forte".
15 In addition, in the case of the Sermion imported from Portugal, Eurim-Pharm affixes a self-stick label with the word "forte" to the back of each blister pack.
16 In the case of Mexitil, Eurim-Pharm also adds user instructions in German and extra information.
17 In the case of the Sermion imported from Spain, Eurim-Pharm keeps the original packaging and inserts a strip of five tablets cut from an original blister pack and user instructions in German. It attaches to the front of the original packet, below the trade mark "Sermion", a self-stick label with its name, address and additional information (batch number, use-by date, registration number, etc.). The back of the packet carries a self-stick label stating that the product is imported and marketed by Eurim-Pharm. The information in Spanish concerning the number of tablets is covered by a sticker.
18 Beiersdorf and Farmitalia, which have been authorized to bring the actions by their respective licensors, and Boehringer regard Eurim-Pharm' s conduct as trade mark infringements and have brought proceedings for damages and an injunction.
19 The pharmaceutical manufacturers were successful at first instance and on appeal, whereupon Eurim-Pharm applied for review on a point of law by the Bundesgerichtshof, which decided to stay the proceedings and request a preliminary ruling from the Court of Justice. In Case C-71/94, the Bundesgerichtshof referred the following questions:
"1. Is the proprietor of an internationally registered trade mark (I R mark) having effect in Member State A entitled under Article 36 of the EC Treaty, in reliance upon the trade mark, to prevent an importer from buying medicinal products which have been marketed under the trade mark in Member State B by the proprietor of the trade mark and which require a prescription in Member State A, from repackaging them in conformity with the prescribing practices of medical practitioners in Member State A, which are based on a recommendation by prominent organizations (including those representing the pharmaceutical industry) on therapeutically desirable sizes and which differ from the packaging sizes prescribed by statute in Member State B, and from marketing them in Member State A in external packaging styled by the importer, if such packaging contains an original packet with original blister strips from Member State B and a number of additional blister strips which have been cut up and the new packaging has a window through which the I R mark on the original packaging is visible and displays a reference to the packaging and marketing by the importer but no reference to the manufacturer? Is it of relevance for the purposes of the answer to the question that information printed on the back of the original blister strip refers (in, for Member State A, a foreign language) to the days of the week for a 14-day period, which when the blister is cut becomes incomplete?
2. Is it sufficient, for the purpose of establishing a disguised restriction on trade between Member States within the meaning of Article 36 of the EC Treaty, that the use of the national trade mark in conjunction with the marketing system adopted by the proprietor of the I R mark objectively leads to a partitioning of the markets between Member States, or is it necessary for that purpose to show that the proprietor of the I R mark exercises his trade-mark right in conjunction with the marketing system which he employs with the object of bringing about an artificial partitioning of the markets?"
20 In Case C-72/94, the second question referred to the Court is identical to the second question in Case C-71/94. The first question is worded as follows:
"1. Is the proprietor of an internationally registered trade mark (I R mark) having effect in Member State A entitled under Article 36 of the EC Treaty, in reliance upon the trade mark, to prevent an importer from buying medicinal products which have been marketed under the trade mark in Member State B by the proprietor of the trade mark and which require a prescription in Member State A, from repackaging them in conformity with the prescribing practices of medical practitioners in Member State A, which are based on a recommendation by prominent organizations (including those representing the pharmaceutical industry) and which differ from the packaging sizes prescribed by statute in Member State B, and from marketing them in Member State A in external packaging styled by the importer, if such packaging contains an original packet with original blister strips from Member State B and a number of additional blister strips which have been cut up and if the new packaging has a window through which the I R mark on the original packaging is visible and displays a reference to the packaging and marketing by the importer but no reference to the manufacturer?"
21 In Case C-73/94, the second question referred to the Court is identical to the second question in Cases C-71/94 and C-72/94. The first question is worded as follows:
"1. Is the proprietor of an internationally registered trade mark (I R mark) having effect in Member State A entitled under Article 36 of the EC Treaty, in reliance upon the trade mark, to prevent an importer from buying medicinal products which have been marketed under the trade mark in Member State B by an undertaking belonging to the same group as the proprietor of the trade mark and which require a prescription in Member State A, from repackaging them in conformity with the prescribing practices of medicinal practitioners prevailing in Member State A, which are based on a recommendation by prominent organizations (including those representing the pharmaceutical industry) on therapeutically desirable sizes and which differ from the standard sizes in Member State B and
(a) from marketing them in Member State A in external packaging styled by the importer, if such packaging contains an original packet with original blister strips from Member State B and a number of additional original blister strips and the new packaging has a window through which the trade mark on the original packet is visible and displays a reference to the repackaging and marketing by the importer but no reference to the manufacturer, or
(b) from marketing them in Member State A in the original trade-marked packaging from Member State B if it is supplemented by the importer with stickers showing his firm' s name and further particulars (batch number, use-by date, registration number, etc.) and with a strip containing five capsules cut from an original blister strip?"
22 By order of the President of the Court of 15 March 1994, the above cases were joined for the purposes of the written procedure, the oral procedure and the judgment.
23 In these questions, which it is convenient to examine together, the national court is essentially asking in what circumstances a trade mark owner may, in accordance with Article 36 of the Treaty, rely on his rights as owner to prevent an importer from marketing a pharmaceutical product which was put on the market in another Member State by the owner or with his consent, where that importer has repackaged the product in new external packaging through which the trade mark affixed to the original packaging has been made visible, or has altered the contents and appearance of original external packaging while preserving the trade mark affixed to it by the manufacturer. In particular, the Court is asked to explain the significance and content of the concepts of "artificial partitioning of the markets" and adverse effect on "the original condition of the product" established by its case-law, and to rule on the existence of certain further conditions which the importer must fulfil.
24 Before considering those questions, it should be mentioned that it has been argued before the Court that the national legislation in question should be assessed in the light not of Article 36 of the Treaty but of Article 7 of the First Council Directive (89/104/EEC) of 21 December 1988 to approximate the laws of the Member States relating to trade marks (OJ 1989 L 40, p. 1; hereinafter "the directive"). That directive was to be transposed into national law not later than 31 December 1992, the time-limit fixed by Council Decision 92/10/EEC of 19 December 1991 postponing the date on which the national provisions applying Directive 89/104/EEC to approximate the laws of the Member States relating to trade marks are to be put into effect (OJ 1992 L 6, p. 35).
25 Since the national court has not referred any question on the interpretation of Article 7 of the directive, the following two observations will suffice in that regard.
26 First, the consistent case-law of the Court shows that a directive may not of itself impose obligations on an individual and cannot therefore be relied upon as such against an individual (see, in particular, Case 152/84 Marshall v Southampton and South-West Hampshire Area Health Authority [1986] ECR 723, paragraph 48; Case C-106/89 Marleasing v La Comercial Internacional de Alimentación [1990] ECR I-4135, paragraph 6; Case C-91/92 Faccini Dori v Recreb [1994] ECR I-3325, paragraph 20). According to that case-law, however, when applying national law, whether adopted before or after the directive, the national court that has to interpret that law must do so, as far as possible, in the light of the wording and the purpose of the directive so as to achieve the result it has in view and thereby comply with the third paragraph of Article 189 of the EC Treaty.
27 Next, as stated in the judgment of the Court today in Joined Cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb and Others v Paranova, paragraph 40, Article 7 of the directive, like Article 36 of the Treaty, is intended to reconcile the fundamental interest in protecting trade mark rights with the fundamental interest in the free movement of goods within the common market, so that those two provisions, which pursue the same result, must be interpreted in the same way.
28 As for the interpretation of Article 36 of the Treaty, prohibitions or restrictions on imports justified on grounds of the protection of industrial and commercial property are authorized by that article, provided they do not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.
29 The Court' s case-law shows that Article 36 allows derogations from the fundamental principle of the free movement of goods within the common market only in so far as such derogations are justified in order to safeguard the rights which constitute the specific subject-matter of the industrial and commercial property in question.
30 Trade mark rights, the Court has held, constitute an essential element in the system of undistorted competition which the Treaty is intended to establish. In such a system, undertakings must be able to attract and retain customers by the quality of their products or services, which is possible only thanks to the existence of distinctive signs allowing them to be identified. For the trade mark to be able to fulfil that function, it must constitute a guarantee that all products which bear it have been manufactured under the control of a single undertaking to which responsibility for their quality may be attributed (see Case C-10/89 CNL-SUCAL v HAG GF [1990] ECR I-3711 ("HAG II"), paragraph 13, and Case C-9/93 IHT Internationale Heiztechnik v Ideal Standard [1994] ECR I-2789, paragraphs 37 and 45).
31 Thus, as the Court has recognized on many occasions, the specific subject-matter of a trade mark is in particular to guarantee to the owner that he has the exclusive right to use that trade mark for the purpose of putting a product on the market for the first time and therefore to protect him against competitors wishing to take advantage of the status and reputation of the trade mark by selling products bearing it illegally (see Case 102/77 Hoffmann-La Roche v Centrafarm [1978] ECR 1139, paragraph 7; Case 1/81 Pfizer v Eurim-Pharm [1981] ECR 2913, paragraph 7; HAG II, paragraph 14; and IHT Internationale Heiztechnik, paragraph 33).
32 It follows that the owner of a trade mark protected by the legislation of a Member State cannot rely on that legislation in order to oppose the importation or marketing of a product which was put on the market in another Member State by him or with his consent (see, in particular, Case 16/74 Centrafarm v Winthrop [1974] ECR 1183, paragraphs 7 to 11; HAG II, paragraph 12; and IHT Internationale Heiztechnik, paragraphs 33 and 34).
33 Trade mark rights are not intended to allow their owners to partition national markets and thus promote the retention of price differences which may exist between Member States. Whilst, in the pharmaceutical market especially, such price differences may result from factors over which trade mark owners have no control, such as divergent rules between the Member States on the fixing of maximum prices, the profit margins of pharmaceutical wholesalers and pharmacies, or the maximum amount of medical expenses which may be reimbursed under sickness insurance schemes, distortions caused by divergent pricing rules in one Member State must be remedied by measures of the Community authorities and not by another Member State introducing measures which are incompatible with the rules on the free movement of goods (see, in particular, Winthrop, paragraphs 16 and 17).
34 In answering the question whether a trade mark owner' s exclusive rights include the power to oppose the use of the trade mark by a third party after the product has been repackaged, account must be taken of the essential function of the trade mark, which is to guarantee to the consumer or end user the identity of the trade- marked product' s origin by enabling him to distinguish it without any risk of confusion from products of different origin. That guarantee of origin means that the consumer or end user can be certain that a trade-marked product offered to him has not been subject at a previous stage of marketing to interference by a third person, without the authorization of the trade mark owner, in such a way as to affect the original condition of the product (Hoffmann-La Roche, paragraph 7; Pfizer, paragraph 8).
35 Therefore, the right conferred upon the trade mark owner to oppose any use of the trade mark which is liable to impair the guarantee of origin so understood forms part of the specific subject-matter of the trade mark right, the protection of which may justify derogation from the fundamental principle of the free movement of goods (Hoffmann-La Roche, paragraph 7; Pfizer, paragraph 9).
36 In Hoffmann-La Roche, the Court held, applying those principles, that Article 36 of the Treaty must be interpreted as meaning that a trade mark owner may rely on his rights to prevent an importer from marketing a product put on the market in another Member State by the owner or with his consent, where that importer has repackaged the product in new packaging to which the trade mark has been reaffixed, unless:
° it is established that reliance on the trade-mark right by the owner, having regard to the marketing system which he has adopted, will contribute to the artificial partitioning of the markets between Member States;
° it is shown that the repackaging cannot adversely affect the original condition of the product;
° the owner of the mark receives prior notice before the repackaged product is put on sale; and
° it is stated on the new packaging by whom the product has been repackaged.
37 Moreover, in Pfizer, the Court held that Article 36 of the Treaty is to be interpreted as not authorizing a trade mark owner to rely on his rights as owner in order to prevent an importer from marketing a pharmaceutical product which was put on the market in another Member State by the owner or with his consent, when that importer repackaged the product merely by replacing the external packaging without touching the inner packaging, while leaving visible, through the new external packaging, the trade mark affixed by the manufacturer on the inner packaging and at the same time clearly indicating on the external packaging that the product was manufactured by the owner' s subsidiary and repackaged by the importer.
38 With regard to the arguments raised in these cases, there is no reason in principle to distinguish between the situation where a third party reaffixes the trade mark after repackaging the product, and the situation where, after the product has been repackaged, he uses the trade mark affixed to the original packaging by the manufacturer by leaving it visible through new external packaging or by retaining the original external packaging itself.
39 In each case, the question is whether, having regard to the essential function of a trade mark, the power of the owner to oppose the use of the trade mark by a third party after the product has been repackaged falls within the specific subject-matter of the trade mark right.
40 That question is essentially answered by the Hoffmann-La Roche judgment, which shows that the owner may legitimately oppose such use of his trade mark, unless the four conditions set out in that judgment are satisfied.
41 That case-law must, however, be clarified further in the light of the arguments raised in these cases, and in Bristol-Myers Squibb and Case C-232/94 MPA Pharma v Rhône-Poulenc, in which the Court has also given judgment today.
Artificial partitioning of the markets between Member States
42 Reliance on trade mark rights by their owner in order to oppose marketing under that trade mark of products repackaged by a third party would contribute to the partitioning of markets between Member States in particular where the owner has placed an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the product may not, in the condition in which it has been marketed by the trade mark owner in one Member State, be imported and put on the market in another Member State by a parallel importer.
43 The trade mark owner cannot therefore oppose the repackaging of the product in new external packaging, or the modification of the contents of an original external packet, when the packet size used by the owner in the Member State where the importer purchased the product cannot be marketed in the Member State of importation by reason, in particular, of a rule authorizing packaging only of a certain size or a national practice to the same effect, sickness insurance rules making the reimbursement of medical expenses depend on the size of the packaging, or well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions.
44 Where, in accordance with the rules and practices in force in the Member State of importation, the trade mark owner uses many different sizes of packaging in that State, the finding that one of those sizes is also marketed in the Member State of exportation is not enough to justify the conclusion that repackaging is unnecessary. Partitioning of the markets would exist if the importer were able to sell the product in only part of his market.
45 The owner may, on the other hand, oppose the repackaging of the product in new external packaging where the importer is able to achieve packaging which may be marketed in the Member State of importation by, for example, affixing to the original external or inner packaging new labels in the language of the Member State of importation, or by adding new user instructions or information in the language of the Member State of importation.
46 The power of the owner of trade mark rights protected in a Member State to oppose the marketing of repackaged products under the trade mark should be limited only in so far as the repackaging undertaken by the importer is necessary in order to market the product in the Member State of importation.
47 Finally, contrary to the argument of the pharmaceutical manufacturers, the Court' s use of the words "artificial partitioning of the markets" does not imply that the importer must demonstrate that, by putting an identical product on the market in varying forms of packaging in different Member States, the trade mark owner deliberately sought to partition the markets between Member States. By stating that the partitioning in question must be artificial, the Court' s intention was to stress that the owner of a trade mark may always rely on his rights thereunder in order to oppose the marketing of repackaged products when such action is justified by the need to safeguard the essential function of the trade mark, in which case the resultant partitioning could not be regarded as artificial.
Whether the original condition of the product is adversely affected
48 It should be clarified at the outset that the concept of adverse effects on the original condition of the product refers to the condition of the product inside the packaging.
49 The trade mark owner may therefore oppose any repackaging involving a risk of the product inside the package being exposed to tampering or to influences affecting its original condition. To determine whether that applies, account must be taken, as the Court held in paragraph 10 of the Hoffmann-La Roche judgment, of the nature of the product and the method of repackaging.
50 As regards pharmaceutical products, it follows from the same paragraph in Hoffmann-La Roche that repackaging must be regarded as having been carried out in circumstances not capable of affecting the original condition of the product where, for example, the trade mark owner has placed the product on the market in double packaging and the repackaging affects only the external layer, leaving the inner packaging intact, or where the repackaging is carried out under the supervision of a public authority in order to ensure that the product remains intact.
51 It follows from that case-law that the mere removal of blister packs from their original external packaging and their insertion with one or more original packages into new external packaging or their insertion into another original package cannot affect the original condition of the product inside the packaging.
52 The pharmaceutical manufacturers have argued nevertheless that even operations of that kind entail the risk of adversely affecting the original condition of the product. Thus, blister packs coming originally from different packages and grouped together in single external packaging might have come from different production batches with different use-by dates.
53 Those arguments cannot be accepted. It is not possible for each hypothetical risk of isolated error to suffice to confer on the trade mark owner the right to oppose any repackaging of pharmaceutical products in new external packaging, or any modification in the contents of the original external packet.
54 It is for the national court to determine whether the cutting of blister packs or the reprinting of batch numbers on them are carried out in such a manner as to exclude any real risk of affecting the original condition of the tablets inside. That will be so in particular where those operations are authorized and supervised by a public authority in order to ensure that the product remains intact.
55 As for operations consisting in the fixing of self-stick labels to original external packaging or blister packs, or the addition to the packaging of new user instructions or information in the language of the Member State of importation, there is nothing to suggest that the original condition of the product inside the packaging is directly affected thereby.
56 It should be recognized, however, that the original condition of the product inside the packaging might be indirectly affected where, for example:
° the external or inner packaging of the repackaged product, or a new set of user instructions or information, omits certain important information or gives inaccurate information concerning the nature, composition, effect, use or storage of the product, or
° the packaging of the repackaged product is not such as to give the product adequate protection.
57 It is for the national court to assess whether that is so, in particular by making a comparison with the product marketed by the trade mark owner in the Member State of importation. The possibility of the importer providing certain additional information should not be excluded, however, provided that information does not contradict the information provided by the trade mark owner in the Member State of importation, that condition being met in particular in the case of different information resulting from the packaging used by the owner in the Member State of exportation.
The other requirements to be met by the parallel importer
58 If the repackaging is carried out in conditions which cannot affect the original condition of the product inside the packaging, the essential function of the trade mark as a guarantee of origin is safeguarded. The consumer or end user is not misled as to the origin of the products, and does in fact receive products manufactured under the sole supervision of the trade mark owner.
59 Whilst, in these circumstances, the conclusion that the trade mark owner may not rely on his rights as owner in order to oppose the marketing under his trade mark of products repackaged by an importer is essential in order to ensure the free movement of goods, it does nevertheless confer on the importer certain rights which, in normal circumstances, are reserved for the trade mark owner himself.
60 In the interests of the owner as proprietor of the trade mark, and to protect him against any misuse, those rights must therefore, as the Court held in Hoffmann-La Roche, be recognized only in so far as the importer complies with a number of other requirements.
61 Since it is in the trade mark owner' s interest that the consumer or end user should not be led to believe that the owner is responsible for the repackaging, an indication must be given on the packaging of who repackaged the product.
62 As the Court has already stated, that indication must be clearly shown on the external packaging of the repackaged product (Hoffmann-La Roche, paragraph 12, and Pfizer, paragraph 11). That implies, as the Advocate General pointed out in paragraph 128 of his Opinion, that the national court must assess whether it is printed in such a way as to be understood by a person with normal eyesight, exercising a normal degree of attentiveness.
63 It is, however, not necessary to require that the further express statement be made on the packaging that the repackaging was carried out without the authorization of the trade mark owner, since such a statement could be taken to imply, as the Advocate General pointed out in paragraph 88 of his Opinion, that the repackaged product is not entirely legitimate.
64 Nevertheless, as paragraph 11 of the Pfizer judgment shows, a clear indication may be required on the external packaging as to who manufactured the product, since it may indeed be in the manufacturer' s interest that the consumer or end user should not be led to believe that the importer is the owner of the trade mark, and that the product was manufactured under his supervision.
65 Even if the person who carried out the repackaging is indicated on the packaging of the product, there remains the possibility that the reputation of the trade mark, and thus of its owner, may nevertheless suffer from an inappropriate presentation of the repackaged product. In such a case, the trade mark owner has a legitimate interest, related to the specific subject-matter of the trade mark right, in being able to oppose the marketing of the product. In assessing whether the presentation of the repackaged product is liable to damage the reputation of the trade mark, account must be taken of the nature of the product and the market for which it is intended.
66 In the case of pharmaceutical products, that is certainly a sensitive area in which the public is particularly demanding as to the quality and integrity of the product, and the presentation of the product may indeed be capable of inspiring public confidence in that regard. It follows that defective, poor quality or untidy packaging could damage the trade mark' s reputation.
67 However, the requirements to be met by the presentation of a repackaged pharmaceutical product vary according to whether the product is sold to hospitals or, through pharmacies, to consumers. In the former case, the products are administered to patients by professionals, for whom the presentation of the product is of little importance. In the latter case, the presentation of the product is of greater importance for the consumer, even if the fact that the products in question are subject to prescription by a doctor may in itself give consumers some degree of confidence in the quality of the product.
68 It is for the national court to ascertain, in the light of the above, whether, in particular, the insertion into single external packaging of both original external packaging and loose blister packs constitutes an untidy form of packaging liable to damage the reputation of the trade mark. As for the cutting of blister packs, it is for that court to assess in each particular case whether it has been carried out in such a manner that the reputation of the trade mark might suffer.
69 Finally, as the Court pointed out in Hoffmann-La Roche, the trade mark owner must be given advance notice of the repackaged product being put on sale. The owner may also require the importer to supply him with a specimen of the repackaged product before it goes on sale, to enable him to check that the repackaging is not carried out in such a way as directly or indirectly to affect the original condition of the product and that the presentation after repackaging is not such as to damage the reputation of the trade mark. Similarly, such a requirement affords the trade mark owner a better possibility of protecting himself against counterfeiting.
70 Accordingly, the answer to the questions referred must be that Article 36 of the Treaty must be interpreted as meaning that a trade mark owner may rely upon his rights as owner to prevent an importer from marketing a pharmaceutical product which was put on the market in another Member State by the owner or with his consent, where that importer has repackaged the product in new external packaging through which the trade mark affixed to the original packaging has been made visible, or where he has modified the contents and the appearance of original external packaging whilst preserving the trade mark affixed thereto by the manufacturer, unless:
° it is established that reliance on trade mark rights by the owner in order to oppose the marketing of repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States; such is the case, in particular, where the owner has put an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the repackaging carried out by the importer is necessary in order to market the product in the Member State of importation, and also carried out in such conditions that the original condition of the product cannot be affected by it; that requirement does not, however, imply that it must be established that the trade mark owner deliberately sought to partition the markets between Member States;
° it is shown that the repackaging cannot affect the original condition of the product inside the packaging; such is the case, in particular, where the importer has merely carried out operations involving no risk of the product being affected, such as, for example, the removal of blister packs from their original external packaging and their insertion with one or more original packages into new external packaging, or their insertion in another original package, the fixing of self-stick labels on original external packaging or blister packs, or the addition to the packaging of new user instructions or information; it is for the national court to ascertain whether the cutting of blister packs or the reprinting of batch numbers on them are carried out in such a manner as to exclude any real risk of affecting the original condition of the tablets inside; that must be regarded as being the case where, for example, those operations are authorized and supervised by a public authority with a view to ensuring that the product remains intact; it is also for the national court to verify that the original condition of the product inside the packaging is not indirectly affected, for example, by the fact that the external or inner packaging of the repackaged product or new user instructions or information omits certain important information or gives inaccurate information, or by the fact that the packaging of the repackaged product is not such as to give the product adequate protection;
° the new packaging clearly states who repackaged the product and the name of the manufacturer in print such that a person with normal eyesight, exercising a normal degree of attentiveness, would be in a position to understand; however, it is not necessary to indicate that the repackaging was carried out without the authorization of the trade mark owner;
° the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy; it is for the national court to ascertain whether the insertion into single external packaging of both original external packaging and loose blister packs constitutes an untidy form of packaging liable to damage the reputation of the trade mark; as for the cutting of blister packs, it is for that court to assess in each particular case whether it has been carried out in such a manner that the reputation of the trade mark might suffer; and
° the importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.
Decision on costs
Costs
71 The costs incurred by the French and United Kingdom Governments and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the actions pending before the national court, the decision on costs is a matter for that court.
Operative part
On those grounds,
THE COURT,
in answer to the questions referred to it by the Bundesgerichtshof by orders of 27 January 1994, hereby rules:
Article 36 of the EC Treaty must be interpreted as meaning that a trade mark owner may rely upon his rights as owner to prevent an importer from marketing a pharmaceutical product which was put on the market in another Member State by the owner or with his consent, where that importer has repackaged the product in new external packaging through which the trade mark affixed to the original packaging has been made visible, or where he has modified the contents and the appearance of original external packaging whilst preserving the trade mark affixed thereto by the manufacturer, unless:
° it is established that reliance on trade mark rights by the owner in order to oppose the marketing of repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States; such is the case, in particular, where the owner has put an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the repackaging carried out by the importer is necessary in order to market the product in the Member State of importation, and also carried out in such conditions that the original condition of the product cannot be affected by it; that requirement does not, however, imply that it must be established that the trade mark owner deliberately sought to partition the markets between Member States;
° it is shown that the repackaging cannot affect the original condition of the product inside the packaging; such is the case, in particular, where the importer has merely carried out operations involving no risk of the product being affected, such as, for example, the removal of blister packs from their original external packaging and their insertion with one or more original packages into new external packaging, or their insertion in another original package, the fixing of self-stick labels on original external packaging or blister packs, or the addition to the packaging of new user instructions or information; it is for the national court to ascertain whether the cutting of blister packs or the reprinting of batch numbers on them are carried out in such a manner as to exclude any real risk of affecting the original condition of the tablets inside; that must be regarded as being the case where, for example, those operations are authorized and supervised by a public authority with a view to ensuring that the product remains intact; it is also for the national court to verify that the original condition of the product inside the packaging is not indirectly affected, for example, by the fact that the external or inner packaging of the repackaged product or new user instructions or information omits certain important information or gives inaccurate information, or by the fact that the packaging of the repackaged product is not such as to give the product adequate protection;
° the new packaging clearly states who repackaged the product and the name of the manufacturer in print such that a person with normal eyesight, exercising a normal degree of attentiveness, would be in a position to understand; however, it is not necessary to indicate that the repackaging was carried out without the authorization of the trade mark owner;
° the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy; it is for the national court to ascertain whether the insertion into single external packaging of both original external packaging and loose blister packs constitutes an untidy form of packaging liable to damage the reputation of the trade mark; as for the cutting of blister packs, it is for that court to assess in each particular case whether it has been carried out in such a manner that the reputation of the trade mark might suffer; and
° the importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.
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