Parallel traders must rebox medicinal products bearing an anti-tampering device

The new EU rules on the placement of anti-tampering devices on medicinal products probably mean that it is objectively necessary for parallel traders to rebox medicinal products into new outer packages to effectively access the Swedish market.

Setterwalls represents a parallel trader that was sued for alleged trademark infringement. The trademark owner i.a. requested a preliminary injunction prohibiting the parallel trader under the penalty of a fine from reboxing a number of medicinal products bearing EU trademarks belonging to the trademark owner. The Patent and Market Court (PMC) decided, in July 2019, to grant the request and issue a preliminary injunction. The parallel trader appealed the decision to the Patent and Market Court of Appeal (PMAC), which first suspended the preliminary injunction and thereafter by its decision of 6th September 2019 agreed with the parallel trader and reversed the decision of the lower instance court. The PMAC held that the parallel trader had made probable that it is objectively necessary to rebox medicinal products bearing an anti-tampering device to access the Swedish market. The decision of the PMAC may not be appealed.

The case has dealt with which consequences the new EU rules on anti-tampering devices will have for parallel distribution of medicinal products to Sweden. The new rules entered into force on 9th of February 2019 with the purpose of preventing the entry of falsified medicinal products into the legal supply chain. In principle the rules implicate that all medicinal products that are sold within the EU shall bear a unique identifier and an anti-tampering device that makes it possible for wholesalers, pharmacy personnel and others to easily check if packages have been opened or manipulated.

The parties agreed that the parallel trader must open the trademark owner’s original packages and i.a. replace the original patient information leaflets with Swedish leaflets in order to parallel distribute the medicinal products to Sweden. The case has dealt with if the opening of the packages (and breaking of the anti-tampering devices) makes it objectively necessary to rebox the medicinal products into new outer packages bearing new anti-tampering devices or if the parallel trader can instead reseal the opened original packages with new anti-tampering devices. The PMAC held that the conditions on the Swedish market are decisive for the assessment. Referring to statements from i.a. the Swedish Medical Products Agency and the Swedish Pharmacy Association, the PMAC held that the parallel trader had made probable that it is objectively necessary to rebox the relevant medicinal products to access the Swedish market. The reboxing did therefore not constitute trademark infringement.

The preliminary review will be followed by a complete review before PMD. We expect that a final judgement will be issued during spring 2020 at the earliest.