C-379/97

' 1 . Do Article 7 of Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member 2. The Upjohn group markets clindamycin, States relating to trade marks and/or an antibiotic, in various forms throughout Articles 30 and 36 of the EC Treaty the Community. The name 'Dalacin C' is preclude the proprietor of a trade mark used in all Member States except Denmark, from relying on its right under national Germany and Spain, where 'Dalacin' is trade-mark law as the basis for oppo- used, and France, where 'Dalacine' is used. sing a third party's purchasing a phar- Paranova A/S, a Danish company in the maceutical product in a Member State, Paranova group, purchased clindamycin repackaging it in that third party's own products (capsules and injection fluid) in packaging, to which it affixes trade France and Greece and, after repackaging, mark X belonging to the trade-mark marketed them under the name Dalacin in proprietor, and marketing the product Denmark where Upjohn SA Denmark, the

1 — 'Upjohn SA' has changed its name since the proceedings * Original language: English. were commenced to 'Pharmacia & Upjohn SA'.

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PHARMACIA & UPJOHN V PARANOVA

in another Member State, in the case the trade-mark proprietor, including, in where the pharmaceutical product in particular, requirements of national question is marketed by the trade-mark health authorities or the trade-mark proprietor or with its consent in the rights of third parties?' Member State of purchase under trade mark Y and an identical pharmaceuti­ cal product is marketed by the trade­ mark proprietor or with its consent in the abovementioned second Member State under trade mark X? 4. Written and oral observations were submitted by Upjohn, Paranova, the Neth­ erlands and United Kingdom Governments and the Commission.

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OPINION OF MR JACOBS — CASE C-379/97

7. It is clear that if a trade-mark owner is 2. Paragraph 1 shall not apply where there allowed to use his trade mark to prevent exist legitimate reasons for the proprietor the importation and sale of goods that are to oppose further commercialisation of the lawfully on the market in another Member goods, especially where the condition of the State, that will amount to a quantitative goods is changed or impaired after they restriction or a measure having equivalent have been put on the market.' effect within the meaning of Article 30. Thus it is necessary — on the assumption that the Treaty provisions on the free movement of goods are applicable — to consider whether such action is justified on grounds of the protection of industrial and commercial property.

10. The question whether it is the Directive or the Treaty which applies to this case, which concerns goods put on the market 8. In a series of early cases on the applica- under three distinct, albeit very similar, tion of Article 36 in relation to industrial trade marks, has been addressed in the and commercial property rights, the Court observations of Paranova, the Netherlands developed the principle, known as the and United Kingdom Governments and the exhaustion of rights, that the owner of Commission. such a right (including a trade mark) cannot invoke it in order to prevent the importation and sale of goods which have been placed on the market with his consent in another Member State. 3

13. The Netherlands Government consid­ ers that it is for the national court to determine whether the questions should be 16. That view is perhaps unduly narrow. decided on the basis of Article 7 of the To my mind, there is some force in the Trade Marks Directive or Article 36 of the submissions made by the United Kingdom Treaty, in accordance with the dictum of Government at the hearing. The United the Court in Loendersloot. 5 Kingdom suggested that the term 'trade mark' was not necessarily used in a narrow linguistic sense in all provisions of the Directive, referring by way of illustration to Article 10(2)(a), which for certain pur­ poses (consequences of failure by the pro­ 14. The United Kingdom states that, even if prietor to use a trade mark) equates 'use of the trade-mark proprietor in this case is the trade mark in a form differing in regarded as having exhausted his rights elements which do not alter the distinctive within the meaning of Article 7(1) of the character of the mark' to use of the mark Directive, Article 7(2) may give him itself. More generally, it argued that there grounds to oppose further commercialisa­ was in principle no good reason to exclude tion of the goods: the Court in Bristol- at least very similar marks from the scope Myers Squibb6 stated that its case-law of Article 7: to do so would limit that under Article 36 must be taken as the basis provision in a way in which other provi­ for determining the extent of the trade­ sions of the Directive, for example that mark owner's right under Article 7(2). concerning confusion (Article 5(1)(b)), were not limited.

within the scope of Article 7, only the trade mark which is used by the owner in Directive should be considered. 7 There is the State of import but which differs from however in my view no reason to suppose that used by the owner in the State of that the principles developed by the Court export. That issue was considered by the in its case-law under Articles 30 and 36 Court in Centrafarm ν American Home have been affected on this issue by the Products Corporation. 1 1 In that case, the Directive: on the contrary, the Court has Court ruled that, although the trade-mark repeatedly affirmed that Article 36 of the owner was prima facie justified in prevent­ Treaty and Article 7 of the Directive are to ing the imported product from being mar­ be interpreted in the same way. 8 The keted in such circumstances, where the proposition is furthermore illustrated by trade-mark owner's practice of using dif­ the fact that in its most recent statement of ferent marks for the same product was the principles, given in three separate intended to partition the markets artifi­ rulings delivered on the same day in cases cially it would constitute a disguised raising closely related issues, the Court restriction on intra-Community trade con­ reached the same result on the basis of the trary to Article 36 for the owner to oppose same reasoning in one case on the basis of the importer's intervention. 12 Article 7 interpreted in the light of Arti­ cle 36 9 and in the other two cases (where the Directive was not in point) on the basis of Article 36. 1 0 Here it may be sufficient to reply on the basis of both provisions in the same way. 19. According to Upjohn, its decision to give its products different names was taken not with a view to avoiding parallel imports and thus partitioning the markets but because a conflict with another mark made its original plan to use the same name for the product throughout the Community unworkable. It therefore had to add the The case-law of the Court of Justice suffix 'C' in most Member States; however that would have been unlawful in Denmark because of the possible misleading associa­ tion with vitamin C. It has been suggested that the spelling was altered to 'Dalacine' in 18. The issue before the Court in this case France to make pronunciation of the word is the extent of the trade-mark owner's in French closer to the English pronuncia­ rights where a parallel importer affixes the tion of 'Dalacin'.

The early cases

21. The decision in Centrafarm ν American Home Products Corporation cannot in my 23. Once the Court had established the view be considered in isolation, since it is principle of the exhaustion of rights, ques­ one of a series of cases in which the Court tions arose concerning its limits. Pharma­ has developed a number of principles of ceutical products in particular were fre­ Community trade-mark law. quently packaged differently for different markets to comply with national regula­ tions; parallel importers enjoying their freedom to import trade-marked goods sought to facilitate and improve their marketing of the goods by repackaging 22. As indicated above, the Court at an for the new market. The Court was first early stage formulated the principle that the asked to address the issue of repackaging in owner of an industrial or commercial Hoffmann-La Roche ν Centrafarm, decided property right (including a trade mark) in May 1978. Although repackaging as could not invoke it in order to prevent the such is not at issue in the case presently importation and sale of goods which had before the Court, it is useful to set out in been placed on the market with his consent full the relevant parts of the judgment in in another Member State. That principle Hoffmann-La Roche ν Centrafarm since it was first laid down in Deutsche Grammo­ is essential background for an understand­ phon ν Metro 1 4 in relation to copyright, in ing of American Home Products.

13 — Cited in notes 6 and 8. 15 — Case 16/74 [1974] ECR 1183. 14 — Case 78/70 [19711 ECR 487, paragraph 13 of the 16 — Case 15/74 [1974] ECR 1147. judgment. 17 — Case 102/77 [1978] ECR 1139, page 1173.

24. In its judgment the Court observed which is sold to him has not been subject at that, while the Treaty did not affect the a previous stage of marketing to interfer- existence of industrial and commercial ence by a third person, without the author- property rights recognised by the laws of isation of the proprietor of the trade mark, a Member State, the exercise of those rights such as to affect the original condition of might nevertheless, depending on the cir- the product. The right attributed to the cumstances, be restricted by the prohibi- proprietor of preventing any use of the tions contained in the Treaty. Inasmuch as trade mark which is likely to impair the it created an exception to one of the guarantee of origin so understood is there- fundamental principles of the common fore part of the specific subject-matter of market, Article 36 admitted of derogations the trade mark right. from the free movement of goods only to the extent to which such exceptions were justified for the purpose of safeguarding the rights which constituted the specific sub- ject-matter of the industrial and commer- It is accordingly justified under the first cial property sought to be protected. 18 The sentence of Article 36 to recognise that the Court then stated: proprietor of a trade mark is entitled to prevent an importer of a trade-marked product, following repackaging of that product, from affixing the trade mark to the new packaging without the authorisa- 'In relation to trade marks, the specific tion of the proprietor. subject-matter is in particular to guarantee to the proprietor of the trade mark that he has the exclusive right to use that trade mark for the purpose of putting a product into circulation for the first time and It is, however, necessary to consider whe- therefore to protect him against competi- ther the exercise of such a right may tors wishing to take advantage of the status constitute a "disguised restriction on trade and reputation of the trade mark by selling between Member States" within the mean- products illegally bearing that trade mark. ing of the second sentence of Article 36. In order to answer the question whether Such a restriction might arise, inter alia, that exclusive right involves the right to from the proprietor of the trade mark prevent the trade mark being affixed by a putting onto the market in various Member third person after the product has been States an identical product in various repackaged, regard must be had to the packages while availing himself of the essential function of the trade mark, which rights inherent in the trade mark to prevent is to guarantee the identity of the origin of repackaging by a third person even if it the trade-marked product to the consumer were done in such a way that the identity of or ultimate user, by enabling him without origin of the trade-marked product and its any possibility of confusion to distinguish original condition could not be affected. ... that product from products which have another origin. This guarantee of origin means that the consumer or ultimate user can be certain that a trade-marked product Where the essential function of the trade mark to guarantee the origin of the product 18 — Paragraph 6 of the judgment. is ... protected, the exercise of his rights by

the proprietor of the trade mark in order to 26. The Court delivered its judgment in fetter the free movement of goods between October 1978, five months after Hoff­ Member States may constitute a disguised mann-La Roche ν Centrafarm. The Court's restriction within the meaning of the sec­ judgment started by following very closely ond sentence of Article 36 of the Treaty if it that in the earlier case : paragraphs 7 to 11 is established that the use of the trade-mark echo virtually verbatim paragraph 6 and right by the proprietor, having regard to the the first sentence of paragraph 7 in the marketing system which he has adopted, judgment in Hoffmann-La Roche, set out will contribute to the artificial partitioning above. The terms of the judgments diverge of the markets between Member States.' 1 9 thereafter to reflect the fact that American Home Products concerned the affixing of a different trade mark rather than repacka­ ging. The Court stated that the essential function of the trade mark, namely the guarantee of origin, would be jeopardised if a third party were permitted to affix the mark to the product, and that the right granted to the proprietor to prohibit any unauthorised affixing of his mark to his product consequently came with the speci­ fic subject-matter of the trade mark. 2 1 The 25. Shortly after the reference was made in proprietor was accordingly justified pur­ Hoffmann-La Roche, the Court was asked suant to the first sentence of Article 36 in in Centrafarm ν American Home Pro­ opposing the parallel importer's interven­ ducts 2 0 to rule in a case where the importer tion. 2 2 The Court continued: sought not merely to repackage but also to affix a different trade mark. In essence, the facts were similar to those at issue in the present case: American Home Products was the proprietor of the trade marks Seresta, registered in Benelux, and Serenid D, registered in the United Kingdom, both in 'Nevertheless it is still necessary to consider respect of tranquillisers with identical ther­ whether the exercise of that right may apeutic properties which it marketed in the constitute a "disguised restriction on trade Netherlands as Seresta and in the United between Member States" within the mean­ Kingdom as Serenid D. Centrafarm pur­ ing of the second sentence of Article 36. chased tranquillisers in the United King­ dom and marketed them in the Netherlands in new packaging and under the mark Seresta. American Home Products sought an order prohibiting such conduct; the Court was asked whether Articles 30 and 36 prevented the trade-mark owner from In this connection it should be observed asserting his rights under national law to that it may be lawful for the manufacturer oppose such marketing. of a product to use in different Member

28. It seems clear that the difference in the formulation was deliberate, since the rele­ vance of intention was specifically It is for the national court to settle in each addressed by the parties in American Home particular case whether the proprietor has Products (although it is interesting to note followed the practice of using different that most commentators at the time appar­ marks for the same product for the purpose ently considered that the word 'artificial' in of partitioning the markets.' 23 the test laid down in Hoffmann-La Roche meant that the Court required some inten­ tion to partition the markets 2 4 ). The ques­ tion whether the objective test laid down by Hoffmann-La Roche should be changed to a subjective test in the light of American 27. The Court thus distinguished between Home Products was raised in a subsequent situations in which a parallel importer case, Pfizer ν Eurim-Pharm. 25 The Court sought to affix a different mark and those did not rule on that question. 2 6 Advocate in which an importer sought to repackage: General Capotorti, however, proffered the in the latter situation the trade-mark own­ er's prima facie right to rely on his trade­ 24 — See F. Castillo de la Torre, 'Trade marks and free move­ mark rights to oppose the parallel impor­ ment of pharmaceuticals in the European Community: to partition or not to partition the market', European Intellectual Property Review, 1997, 304, at p. 306. 25 — Case 1/81 [1981] ECR 2913. 23 — Paragraphs 19 to 23 of the judgment. 26 — See paragraph 14 of the judgment.

29. If the objective criteria laid down in 31. In Bristol-Myers Squibb the Court first Hoffmann-La Roche still applied in their referred to the early cases and restated the original form, it may be that that explana­ basic principle of the exhaustion of tion would still hold. However, the princi­ rights. 30 After making the point that ples established by the Court in Hoffmann- '[t]rade-mark rights are not intended to La Roche, and in particular the criterion allow their owners to partition national that the trade-mark owner's use of his markets and thus promote the retention of trade-mark rights would contribute to the artificial partitioning of the markets, have 28 — Cited in notes 6 and 8. 29 — See, for example, Question 3 in Bristol-Myers Squibb and Question 2 in Eurim-Pharm. 27 — Pages 2934 and 2935 of the Opinion. 30 — Paragraphs 42 to 45 of the judgment.

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OPINION OF MR JACOBS — CASE C-379/97

Finally, contrary to the argument of the plaintiffs in the main actions, the Court's The trade-mark owner cannot therefore use of the words "artificial partitioning of oppose the repackaging of the product in the markets" does not imply that the new external packaging when the size of importer must demonstrate that, by putting an identical product on the market in varying forms of packaging in different 31 — Paragraph 46 of the judgment. Member States, the trade-mark owner 32 — Paragraphs 47 and 48 of the judgment. deliberately sought to partition the markets 33 — Paragraph 51 of the judgment. between Member States. By stating that the

I - 6940

PHARMACIA & UPJOHN V PARANOVA

partitioning in question must be artificial, 33. In all three decisions the Court went on the Court's intention was to stress that the to rule that the effect of Article 7(2) of the owner of a trade mark may always rely on Trade Marks Directive or Article 36 of the his rights as owner to oppose the marketing Treaty was that the trade-mark owner may of repackaged products when such action is legitimately oppose the further marketing justified by the need to safeguard the of a pharmaceutical product where the essential function of the trade mark, in importer has repackaged the product and which case the resultant partitioning could reaffixed the trade mark unless inter alia: not be regarded as artificial.' 34

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OPINION OF MR JACOBS — CASE C-379/97

where the repackaging takes place in such a applied equally to such cases. That result is way that the legitimate interests of the to my mind correct as a matter of principle trade-mark owner are observed. Protection for a number of reasons, to which I now of those legitimate interests means in turn. particular that the original condition of the product must not be affected and that the repackaging is not done in such a way that it may damage the reputation of the mark and its owner; the importer must moreover comply with the requirements as to informing the trade-mark owner of the repackaging, supplying him with a speci- men of the repackaged product and stating The relevance of intention on that product the person responsible for the repackaging. 40 There will be no artifi- cial partitioning where action by the trade- mark owner is needed to safeguard the essential function of the mark. 36. A continued requirement of intention is undesirable on several grounds.

40 — See Loendersloot, cited in note 5, paragraphs 28 to 30 of 41 — Paragraph 57 of the judgment, set out above at paragraph the judgment. 31.

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PHARMACIA & UPJOHN V PARANOVA

damage the reputation of the mark or of its mark and a disguised restriction on owner. 42 I can see no reason why the need trade.' 43 to safeguard the essential function of the mark and prevent damage to reputation should not be the critical test in other areas where the trade-mark owner is seeking to rely on his rights to oppose marketing.

42 — Paragraph 75 of the judgment. 43 — Paragraph 82.

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OPINION OF MR JACOBS — CASE C-379/97

depend on the subjective intentions of intention, then there was disguised restric- another person.' 44 tion within the meaning of Article 36. That, as I have just explained, is in my view still the case. It does not follow from such a proposition that, where there is no intention, there can never be disguised restriction. It may be noted that, as the Commission points out, it appears to have 41. Although that comment was made in been assumed by the Court in Loender- the context of repackaging, I consider that sloot45 that the test in American Home the argument is equally valid where the Products was in fact wider than has been trade-mark owner has placed identical suggested: see paragraph 28 of the judg- products on several markets in different ment where the Court referred to its Member States under different trade marks. previous case-law including American Home Products as authority for the propo- sition that:

I - 6944

PHARMACIA & UPJOHN V PARANOVA

45. It will be remembered that the Court in Member States, the Court in Bristol-Myers Bristol-Myers Squibb did not simply Squibb stated that the power of the trade- exclude the requirement of intention: it mark owner to oppose the marketing of also reformulated the test determining repackaged products should be limited only whether the trade-mark owner could rely in so far as the repackaging was necessary on his rights to oppose repackaging. The in order to market the product in the State Court concluded that, where reliance by of importation. 48 The Court reiterated that the owner on his trade-mark rights was notion in Loendersloot, 49 where it stated justified by the need to safeguard the that in cases involving repackaging the essential function of the trade mark, the national courts must consider whether resulting partitioning could not be regarded circumstances in the markets of their own as artificial. 47 Thus the trade-mark owner's States made repackaging objectively neces- fundamental right to take action where the sary. essential function of his mark is threatened is preserved. This, together with the trade- mark owner's right to oppose the market- ing where it may damage the reputation of the mark should ensure that the mere fact that the proprietor has used different trade marks will not automatically preclude him from relying on his trade-mark rights to prevent a parallel importer from changing 47. The Commission and the United King- the mark. The Court's clarification in dom Government have argued that the test Bristol-Myers Squibb of what is meant by of necessity for marketing the products in 'artificial partitioning of the markets' and the State of import, laid down by the Court its recognition of the trade-mark owner's in the case of repackaging, should apply legitimate interest in opposing marketing equally to cases such as the present where which may damage the mark's reputation the trade-mark owner has marketed iden- have in my view resolved the problem tical products in different Member States identified by Advocate General Capotorti. under different marks and the importer seeks to replace the mark used by the owner in the State of export with that used by the owner in the State of import.

may however fall to be applied differently governing in particular the quantities in in the two situations. which the product is normally prescribed and dispensed. In contrast, rebranding will more often be needed in order to avoid confusion in the importing State where ex hypothesi an identical product has pre- viously been sold under a different mark. That purpose is of course entirely consis- 49. Guidance as to the circumstances in tent with the essential function of a trade which repackaging by the importer may be mark as a guarantee of origin. regarded as 'necessary' may be found in Bristol-Myers Squibb. The Court in its judgment in that case referred to the impossibility of marketing in the Member State of importation by reason, in particu- lar, of rules or national practices, sickness insurance rules governing the reimburse- ment of medical expenses, and well-estab- lished medical prescription practices. Cer- tainly where such circumstances also ren- 51. In such circumstances, where the use in dered marketing impossible without the importing State of the mark used in the rebranding, rebranding would similarly be exporting State would be liable to confuse regarded as necessary: thus if any such consumers and other relevant parties such practices or rules in the Member State of as, in the case of pharmaceutical products, import have the effect that the importer pharmacists and doctors, rebranding may cannot market the products under the trade well be regarded as necessary. Such confu- mark they bear in the State of export, the sion might arise either because the mark trade-mark owner will not be able to rely used in the exporting State was liable to be on his trade-mark rights to prevent the confused with an existing mark for a importer from affixing the trade mark used different product in the importing State or by the owner for identical goods in the because, as perhaps in this case, consumers, State of import. pharmacists or doctors were liable to be confused by the existence on the market of an identical product bearing a different, albeit similar, mark. It seems to me that the requirement of necessity would be satisfied in such cases. 50. However, there may well be circum- stances in which rebranding could be regarded as justified although repackaging would not be so regarded. That distinction flows from the different contexts in which the importer will be driven to rebrand or repackage. In the case of pharmaceutical products, repackaging, as the Court sug- gested in Bristol-Myers Squibb, will fre- 52. In this connection I would refer to a quently be needed in order to comply with point I made in my Opinion in Bristol- rules and practices in the importing State Myers Squibb concerning a specific issue

54. It has been argued that the quest by the importer for a mere commercial advantage or greater marketing convenience will not fall within the concept of necessity. I do not find it helpful to postulate a category of 'purely commercial reasons' which can never fall within the concept of necessity, as the Commission seems to suggest. The 'It is clear... that Eurim-Pharm may in decisive test is whether in a given case principle sell in Germany under the mark prohibiting the importer from rebranding "Sermion" a product which the owner of would constitute an obstacle to effective that mark has placed on the market in access by him to the markets of the Portugal under the mark 'Sermion'. But if importing State. Numerous and diverse that would cause confusion, since the factors may give rise to impediments to product is twice as strong as the product market access, some of which may natu­ known as "Sermion" in Germany, it is rally be regarded as commercial and others clearly necessary, from everyone's point of not. To my mind any rigid categorisation of view, that Eurim-Pharm should be allowed which specific reasons for rebranding may to remove the confusion by making it clear be regarded as necessary risks prejudicing that the product corresponds to the product the national court's duty to determine on a known in Germany as "Sermion forte".' 5 1 case-by-case basis whether the intervention

50 — Case C-73/94, cited in note 8. 52 —Case C-251/95 SABEL ν Puma [1997] ECR I-6191, 51 — Paragraph 126 of the Opinion. paragraph 63 of the Opinion.

55. In general — at least where the impor- ter is doing no more than using in the The relevance of other factors importing State the mark used by the proprietor there for identical products — the necessity test will be satisfied in the case of rebranding, since in most circumstances rebranding is consistent with the essential function of the mark because it serves to 57. In its third question, the national court avoid confusion. has asked whether it has any bearing on the reply to its first question whether the trade- mark owner's use of different marks in the importing and exporting State is attributa- ble to objective circumstances beyond his control, including, in particular, require- ments of national health authorities or the 56. Whether rebranding is necessary must trade-mark rights of third parties. in my view be assessed at the time of the rebranding. It is in my view both logical and consistent with the purpose of trade marks for the lawfulness of the parallel importer's conduct, and hence the extent of the trade-mark owner's rights, to be deter- mined by reference to circumstances obtaining at the time of that conduct. I 58. I have given several reasons why I do would concur with the oral submissions not consider it necessary, in order for the made on behalf of the United Kingdom parallel importer to be able lawfully to Government to the effect that the activity change the trade mark in certain circum- which constitutes an impediment to the free stances, for it to be shown that the trade- movement of goods is not the mere fact of mark owner's practice of using different having registered different trade marks, for trade marks was intended to partition which there may or may not have been markets. It is to my mind equally clear that good reasons at the time, but the taking of the existence of other, objective, factors action by the trade-mark owner to oppose which led the trade-mark owner to adopt rebranding by the importer. The relevant that practice is irrelevant to determining moment for determining whether rebrand- the scope of the parallel importer's rights. ing is necessary to enable the importer to As I have stated above, if a trade-mark owner were permitted to rely on his trade- mark rights in order to oppose parallel 53 — See, for example, Loendersloot, cited in note 5, paragraph imports where there was no threat to the 38 of the judgment. essential function of the mark or to its

55 — The conditions laid down in Eurim-Pharm and MP A 54 — Paragraph 73. Pharma, both cited in note 8, were to the same effect.

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not been subject at a previous stage of 64. In my view, however, it would not be marketing to interference by a third person, appropriate to extend this condition to without the authorisation of the trade- cases involving replacement of a trade mark owner, in such a way as to affect mark. As the United Kingdom Government the original condition of the product. 56 pointed out at the hearing, there is a risk that such a requirement would contribute to customer confusion: for example, an indication on a pharmaceutical pack to the effect that the parallel importer replaced the trade mark may cause puzzlement and concern among users. I consider that the other conditions here discussed adequately protect the interests of the trade-mark 62. It is difficult to see how that require- owner and the public interest. ment could be applied to rebranding, although the Court has made it clear that, to the extent that the rebranding involves, for example, fixing adhesive labels on the inner packaging with the new mark, or inserting new instructions showing the new mark, this requirement would be satis- fied. 57 Those examples would, however, in any event be regarded as repackaging.

tion can equally be applied to cases invol- of repackaging, both under Article 36 of ving the affixing of a different mark. As the the Treaty and under Article 7 of the Court stated in Bristol-Myers Squibb, this Directive. As I there indicated, the question requirement enables the trade-mark owner of proof is a procedural matter and is thus to check both that the repackaging or governed, in accordance with the principle rebranding has not been carried out in such of procedural autonomy, by national law, 60 a way as directly or indirectly to affect the provided that two requirements are met: original condition of the product and that namely, that the procedural rules applicable the presentation after the repackaging or to claims founded on Community law must rebranding is not likely to damage the not be less favourable than those governing reputation of the mark; it also affords the similar actions of a domestic nature and trade-mark owner a better possibility of may not be arranged in such a way as to protecting himself against counterfeiting. 58 render the exercise of rights flowing from Community law practically impossible or excessively difficult. 61 The points I made in my Opinion as to what those requirements mean for national courts applying their rules as to the burden of proof are equally valid in the context of the present case where, before concluding that the trade- mark owner may not rely on his trade-mark rights to oppose rebranding by the parallel importer, the national court must be satis- The burden of proof fied that neither the essential function nor the reputation of the mark is threatened and that the rebranding is necessary to enable the importer to market the products in the State of importation.

Articles 30 and 36 of the Treaty and Article 7(1) and (2) of First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks mean that, where an importer imports into a Member State pharmaceutical products which have been marketed in another Member State with the consent of the trade-mark owner and replaces the trade mark under which the products were marketed in the Member State of export with the mark under which identical products are marketed in the Member State of import, the owner of the mark may rely on his trade-mark rights to prevent the importer from marketing the products in the Member State of import unless :

— such use of his trade-mark rights by the owner would contribute to the artificial partitioning of the markets between the Member States; that condition does not, however, imply that it must be established that the trade- mark owner deliberately sought to partition the markets between Member States;

— changing the mark is necessary in order to market the product in the Member State of import, in the sense that prohibiting the importer from rebranding would constitute an obstacle to effective access by him to the markets of the State of import;

— presentation of the product is not liable to damage the reputation of the trade mark and of its owner; I - 6952

PHARMACIA & UPJOHN V PARANOVA

— the importer gives notice of the rebranding to the trade-mark owner before the rebranded product is put on sale, and, on demand, supplies him with a specimen of the repackaged product; and