Can a trademark holder lawfully object to the continued marketing of a parallel imported, repackaged pharmaceutical product on which its trademark has been reaffixed if the trademark holder has marketed the product in the same volume and packet size in other European Economic Area (EEA) countries?

This question was referred to the European Court of Justice (ECJ) in proceedings between Ferring Lægemidler A/S and Orifarm A/S. On November 10 2016 (C-297/15) the ECJ answered yes in the specific circumstances presented.

Facts

Ferring markets the pharmaceutical product Klyx in, among other places, Scandinavia and Finland in identical packaging and packets of one or 10.

Orifarm purchases Klyx in packets of 10 from Norway and sells these products in Denmark after repackaging them into single packets and reaffixing Ferring's trademark.

Ferring opposed the repackaging, arguing that it was not necessary for marketing the product in Denmark and an attempt by Orifarm to secure a commercial advantage.

Orifarm claimed that the repackaging was necessary in order to gain access to Denmark's single-packet Klyx market, as otherwise, the imported product could be marketed only in a limited section of the Danish market (ie, in packets of 10).

The Maritime and Commercial High Court referred the following questions to the ECJ for a preliminary ruling:

"(1) Must Article 7(2) of Directive 2008/95/EC and the related case-law be interpreted as meaning that a trade mark proprietor may lawfully object to the continued marketing of a medicinal product by a parallel importer, where the importer has repackaged the medicinal product in a new, outer packaging and reaffixed the trade mark in a situation where the trade mark proprietor has marketed the medicinal product in the same volume and packet sizes in all EEA countries where the medicinal product is sold?

(2) Will the answer to the first question be different if the trade mark proprietor in both the country of export and the country of import has marketed the medicinal product in two different packet sizes (10-piece packets and 1-piece packets) and the importer has purchased 10-piece packets in the country of export and repacked them in 1-piece packets, on which the trade mark has been reaffixed before the products are marketed in the country of import?"

Previous interpretations

In previous cases regarding the repackaging of parallel imported pharmaceutical products (Boehringer Ingelheim (C-348/04), Bristol-Myers Squibb (C-427/9) and Upjohn (C-379/97)), the ECJ established that:

  • the repackaging of a product carried out by a third party without the trademark holder's authorisation is likely to create a risk for the guarantee of origin, which is the purpose of a trademark;
  • such repackaging may be prohibited by the trademark holder, unless it is necessary to enable the marketing of the products and the trademark holder's legitimate interests are also safeguarded;
  • such an objection from the trademark holder is unjustified if it hinders effective access to the import market;
  • the trademark holder cannot object to the repackaging when the packet size that it uses in the exporting state cannot be marketed in the importing state;
  • where the trademark holder uses several different packet sizes in the exporting state, the finding that one of those sizes is also marketed in the importing state is not enough to conclude that repackaging is unnecessary, as partitioning of the market exists if the importer can sell the product in only a section of the market; and
  • the importer must prove the existence of the conditions preventing the trademark holder from lawfully opposing further marketing.

Preliminary judgment

The ECJ emphasised that it must be determined whether the packet size used by the trademark holder in the exporting state cannot be marketed in the importing state because of:

  • a rule allowing packaging of a certain size only or national practice to the same effect;
  • sickness insurance rules that reimburse medical expenses based, among other things, on packaging size; or
  • well-established medical prescription practices based on standard sizes recommended by professional groups and sickness insurance institutions.

If this not the case, the trademark holder can oppose the contested repackaging if the product can be marketed in Denmark in the same packaging in which it is marketed in Norway.

Based on the information available, the ECJ was unable to assess whether any of these situations existed in the case at hand or whether other specific circumstances effectively hindered Orifarm's access to the Danish market at the time of marketing.

Further, on the basis of the information provided, the ECJ found it impossible to state that the market for Klyx in packets of 10 represented only a limited section of the Danish market for that product.

The ECJ provided the following answer to the questions referred to it:

"Article 7(2) of Directive 2008/95 must be interpreted as meaning that a trade mark proprietor may object to the continued marketing of a medicinal product by a parallel importer, where that importer has repackaged that medicinal product in a new, outer packaging and reaffixed the trade mark, where, first, the medicinal product at issue can be marketed in the importing State… in the same packaging as that in which it is marketed in the exporting State… and, second, the importer has not demonstrated that the imported product can only be marketed in a limited part of the importing State's market, and those are matters which it is for the referring court to determine."

For further information on this topic please contact Jeppe Brinck-Jensen or Kamilla Kelm Demant at Accura Advokatpartnerselskab by telephone (?+45 3945 2800) or email (jeppe.brinck-jensen@accura.dk or kamilla.kelm.demant@accura.dk). The Accura Advokatpartnerselskab website can be accessed at www.accura.eu.

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