On 10 November 2016, the European Union Court of Justice (ECJ) rendered a judgment regarding the "need of repackaging" of pharmaceuticals and the reaffixing of the trade mark by the parallel importer within the European Economic Area (EEA), which includes Norway.

A lot of issues have been raised in the field of parallel import and repackaging and the ECJ has already rendered abundant case-law on this issue.The ECJ ruling of 10 November (C-297/15), remains interesting, however, as it provides for a brief synthesis of previous jurisprudence andgives a clearer idea of the concept of "necessity of repackaging"in cases as delicate as parallel imports.The relevant facts of this case can be summarized as follows:

  • Ferring Lægemidler A/S (Ferring) markets a medicinal product under the trade mark Klyx, of which it is the proprietor, in Denmark, Finland, Sweden and Norway. In all those States, Klyx is sold in identical packaging, namely containers of 120 ml or 240 ml, as well as in packets containing 1 or 10 such containers.
  • In the course of its parallel import business, Orifarm A/S (Orifarm) purchased Klyx in Norway in packets of 10 and sold that product on the Danish market, after having repackaged it in new packets of 1, upon which the mark Klyx was reaffixed (the contested repackaging).
  • Ferring claimed that it could legitimately oppose the contested repackaging as it was not necessary to market the product imported in parallel. Orifarm argued that the repackaging was necessary to gain access to the segment of the Danish market for Klyx packaged in packets of one.

Following points emerge from the judgment:

  • A trademark proprietor’s opposition to repackaging contributes to the artificial partitioning of the markets between the EEA States where the repackaging is necessary to enable the product imported in parallel to be marketed in the importing State;
  • The change brought about by any repackaging of a trade-marked medicinal product - creating by its very nature the risk of interference with the original condition of the product - may be prohibited by the trademark proprietor unless (i) the repackaging is necessary in order to enable the marketing of the products imported in parallel and (ii) the legitimate interests of the proprietor are also safeguarded;
  • It is for the parallel importer to prove the existence of the conditions preventing the trademark proprietor from lawfully opposing further marketing of those medicinal products;
  • The repackaging of the product in new external packaging is allowed, when there is:
    • A rule authorizing packaging only of a certain size or a national practice to the same effect;
    • Sickness insurance rules making the reimbursement of medical expenses dependent on the size of the packaging;
    • Well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions.

  • In casu, the ECJ held that the repackaging of the medicinal product was not necessary as the product at issue can be marketed in the importing State in its original packaging size.