Parallel importation of medical devices: necessary repackaging vs “opportunistic” repackaging

A permanent legal conflict is ongoing in the European Union between manufacturers and parallel importers of medical devices, in which single battles are won or lost at the crossroad between trademark protection and freedom of trade in the internal market. The scarce Italian case-law on the matter is entirely produced by the Specialised divisions on Company Matters of the major territorial courts, which have jurisdiction, inter alia, on intellectual property. One such rare decision is recent order no. 30014/2014 of the Specialised division of the Court of Milan, which represents a scoring point on the manufacturers’ side.

First of all, a cautionary note: the decision discussed here was issued upon appeal against an interim seizure and injunction order that the author was not able to review. The main facts of the case, however, seem rather straightforward.

A multinational manufacturer of medical devices found out that an Italian company was importing its One Touch Ultra product from other European markets, consisting of test strips for blood glucose monitoring, and repackaging them; in particular, the parallel importer bought 50 strip packs and repackaged the products for the Italian market into 25 and 100 strip packs (incidentally, One Touch Ultra has already been at the centre of a well-known German case regarding the parallel importation of medical devices, but, as far as the author knows, the facts of the German case were different).

Acting in its capacity as trademark owner and claiming that said repackaging was infringing its trademark rights, the manufacturer had successfully sought against the parallel importer and a retailer (a Milanese pharmacy) interim seizure of the repackaged products and injunction.

The importer and the retailer had immediately lodged appeal, arguing on the merits that the repackaging of the products was necessitated and also claiming lack of danger of irreparable harm, on the grounds that the repackaged product had been on sale since the year prior to the petitioner’s urgent motion.

In ruling upon the appeal, the appeal panel made express reference to principles developed by the ECJ in connection with parallel imports of pharmaceutical products, specifically mentioning ECJ decisions in cases C-379/97 Upjohn and C-348/04 Boehringer. Drawing upon those principles, the panel found that in the case at hand the appellants had failed to establish the necessity for repackaging at the time of marketing the medical device in Italy. The judges noted that it was uncontested that on several European markets the same product was sold in 25 and 100 strip packages, which the parallel importer could have purchased and imported without having to repackage. It followed, according to the judges, that the repackaging was dictated solely by the purpose of securing a commercial advantage, incompatible with the condition of necessity.

On the danger of irreparable harm, the appeal panel noted that the lapse of a certain period of time between the infringement and the filing of a court action does not in itself entail the lack of said danger, when the infringement is current at the time of filing.

On the basis of the above, the judges dismissed the appeal and upheld the first instance interim seizure and injunction.

The ordinary proceedings on the merits, however, might have a different outcome.