C-71/94

EURIM-PHARM v BEIERSDORF

JUDGMENT OF THE COURT 11 July 1996 *

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 Bundes­ gerichtshof for a preliminary ruling in the proceedings pending before that court between

Eurim-Pharm Arzneimittel GmbH

and

JUDGMENT OF 11. 7. 1996 — JOINED CASES C-71/94, C-72/94 AND C-73/94

THE COURT ,

composed of: G. C. Rodriguez 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,

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having regard to the Report for the Hearing,

after hearing the oral observations of Eurim-Pharm Arzneimittel GmbH , repre­ sented by Wolfgang A. Rehmann; Beiersdorf AG , represented by Rolf Schultz- Siichting; Boehringer Ingelheim KG, represented by Wilhelm Danelzik; Farmitalia Carlo Erba GmbH , represented by Bert J. Bosten; the French Government, rep­ resented by Philippe Martinet; the United Kingdom Government, represented by Lindsey Nicoli, 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

4 In France, Synthelabo manufactures and markets Kerlone in packets of 28 tablets each, in compliance with French rules which authorize packaging to cover a max­ imum 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 man­ ufactures 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 rec­ ommended 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

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JUDGMENT OF 11. 7. 1996 —JOINED CASES C-71/94, C-72/94 AND C-73/94

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, pack­ aged and marketed by Eurim-Pharm. As regards the Sermion imported from Por­ tugal, 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 corre­ sponding 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.

1 4 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 hydrochlo­ ride'. In the case of the Sermion imported from Portugal, Eurim-Pharm addition­ ally 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.

'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 recommenda­ tion by prominent organizations (including those representing the pharmaceu­ tical 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

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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 sys­ tem adopted by the proprietor of the I R mark objectively leads to a partition­ ing 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?'

'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 prevail­ ing 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 man­ ufacturer, 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,

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use-by date, registration number, etc.) and with a strip containing five cap­ sules cut from an original blister strip?'

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.

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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-l06/89 Marleasing v La Comercial Internacional de Alimentación [1990] ECR 1-4135, paragraph 6; Case C-91/92 Faccini Dori v Recreh [1994] ECR 1-3325, 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 inter­ pret that law must do so, as far as possible, in the light of the wording and the pur­ pose 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 prop­ erty are authorized by that article, provided they do not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.

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 market­ ing 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 mar­ kets and thus promote the retention of price differences which may exist between Member States. Whilst, in the pharmaceutical market especially, such price differ­ ences 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

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schemes, distortions caused by divergent pricing rules in one Member State must be remedied by measures of the Community authorities and not by another Mem­ ber 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 con­ fusion 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 per­ son, 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).

— 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 inter­ preted 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 pack­ aging without touching the inner packaging, while leaving visible, through the new external packaging, the trade mark affixed by the manufacturer on the inner pack­ aging 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

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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.

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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 cer­ tain 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 prod­ uct in only part of his market.

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 orig­ inal 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 affect­ ing 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 supervi­ sion of a public authority in order to ensure that the product remains intact.

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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 inac­ curate 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 ade­ quate 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 infor­ mation resulting from the packaging used by the owner in the Member State of exportation.

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 indica­ tion 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, exer­ cising 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 Advo­ cate General pointed out in paragraph 88 of his Opinion, that the repackaged product is not entirely legitimate.

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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.

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68 It is for the national court to ascertain, in the light of the above, whether, in par­ ticular, the insertion into single external packaging of both original external pack­ aging 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 repack­ aged 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 con­ dition 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 packag­ ing 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 exter­ nal packaging whilst preserving the trade mark affixed thereto by the manufacturer, unless:

— 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 fix­ ing 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 con­ dition of the product inside the packaging is not indirectly affected, for exam­ ple, 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 repack­ aged 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;

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.

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 market- ing a pharmaceutical product which was put on the market in another

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— 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 blis­ ter packs, or the addition to the packaging of new user instructions or infor­ mation ; it is for the national court to ascertain whether the cutting of blis­ ter 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 auth­ ority 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

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external or inner packaging of the repackaged product or new user instruc­ tions or information omits certain important information or gives inaccu­ rate information, or by the fact that the packaging of the repackaged prod­ uct is not such as to give the product adequate protection;

Delivered in open court in Luxembourg on 11 July 1996.

R. Grass G. C. Rodríguez Iglesias

Registrar President

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