Keywords
Summary

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.