I often run into questions that are a mixture of problems relating to parallel imports of medical devices, repackaging/relabelling, trademark law and internet sales. Obviously, manufacturers do not like it when another party adapts the packaging and other aspects of the labelling of a medical device to be able to sell it in another country. Apart from the case law on repackaging of medicinal products for the purpose of parallel imports there was never any EU case law that gave good pointers as to how this question should be addressed under EU law. The MHRA is for example quiet in this point in its guidance on parallel imports, in which it explicitly only addresses medical devices rules related matters.

The problem with the medicinal products case law was that parallel imports are only possible to countries where a valid marketing authorisation is in effect and the label, IFU etc have been approved for that market in the language concerned by the authorities. This is different with medical devices, where a manufacturer can have its IFU and label checked for one EU member state only in the process of CE marking, while the device is subsequently allowed free circulation in the entire EU.

A case pending at the European Court about repackaging of cosmetic products that were sold via the internet after having been stripped of the original packaging may shed some light on this problem. The European Court’s Advocate General gave an opinion in that case today. The court found this a sufficiently important even to warrant a press release and it does not do that with all opinions given by its A-G’s. Let me quote from that opinion what I consider the important part on the interface between regulatory obligations relating to the label and trademark law:

“73. First it must be remembered that, pursuant to Article 7 of Directive 89/104 [the EU Trademark Directive], exhaustion is the main rule. Consequently the possibility for the trade mark proprietor to oppose further commercialisation of his goods after he has already realised the economical value inherent in the trade mark in relation to those goods must be interpreted narrowly.

74. Secondly, it cannot be excluded that the outer package even of cosmetic products is such that its removal neither impairs the functions of the trade mark of indicating the origin and quality of goods nor damages its reputation. This may be so for example with less-expensive cosmetic products.

75. Hence, the existence of legitimate reasons for the trade mark proprietor to oppose further removal has to be analysed case by case. In this respect the High Court has raised two scenarios, namely that of unboxed goods without the information required by Directive 76/768 on cosmetic products and the case where absence of such information would constitute a criminal offence in the Member State where they are offered for sale or sold.

76. In my opinion the requirement of compliance with the cosmetics directive, or in fact any other EU measure relating to product safety or consumer protection is inherent in the protection of the reputation of a trade mark. Damage to the reputation of a cosmetic product could be caused for example by severe allergic reactions of a group of consumers where the list of ingredients is omitted. However, whether selling of unboxed cosmetics is or is not criminalised in national law is irrelevant in this respect. What may damage the reputation of the trade mark is the absence of pertinent consumer information required by the harmonised European rules, not the consequences national legislation of Member States entail in such cases for the traders.

77. Hence, even if trade mark law does not protect in itself the objectives of Directive 76/768 [the EU cosmetics directive] as such, further commercialisation of trade mark protected products not complying with that directive can, as such, as has rightly been pointed by Advocate General Stix-Hackl, seriously damage the reputation of the trade mark and thus form a valid reason for the proprietor to oppose.”

In other words, reselling a medical device of which the label containing the OEM’s trademark has been removed or altered significantly as to render it non-compliant under medical devices rules is infringing the OEM’s trademark. Anyway, the European Court has the final word on this, so let’s first see if this opinion is followed by the court. Chances are high though, as the court usually follows its Advocate General.