Landmark decision on parallel import and repackaging of medicinal products

On 6 February 2026, the Maritime and Commercial High Court handed down a comprehensive judgment in ten joined cases concerning parallel import of medicinal products and the limits of lawful repackaging in light of the rules on safety features for medicinal products set out in the Falsified Medicines Directive ("FMD"). The court agreed with the originator pharmaceutical companies on all material points at issue.

The cases were brought by several originator companies (Lundbeck, Novartis, Merck Sharp & Dohme and Ferring) against the parallel importers Abacus Medicine, Paranova and 2care4. The disputes concerned whether the parallel importers had infringed the originator companies' trademark rights by repackaging the concerned medicinal products in new outer packaging, instead of relabelling the original packaging.

The case involved a preliminary reference to the CJEU resulting in the CJEU's decision of 17 November 2022 in C-224/20, which clarified the relationship between EU trademark law and the rules on safety features in the FMD. 

The Maritime and Commercial High Court rejected the parallel importers' argument that the FMD rules necessitate repackaging in new outer packaging in general. Following the CJEU's reasoning, the court held that the FMD regime permits the parallel importer to replace the original anti-tampering device with a new device, which must be as effective as the original anti-tampering device, but that it is not a requirement that the new device resembles or has the same technical characteristics as the original anti-tampering device.

The court further held that the mere fact that the replacement of an anti-tampering device may leave visible or tangible traces of opening does not render relabelling unlawful or make repackaging objectively necessary. Nor could repackaging be justified by reference to an alleged doubt among pharmacists as to the origin of such traces of opening.

A central question in the dispute was the Danish Medicines Agency's Q&A having indicated that repackaging in new outer packaging would generally be required in light of the FMD. The Maritime and Commercial High Court fundamentally rejected the relevance of regulatory non-binding guidance in the assessment of trademark infringement, finding that it cannot alter the interpretation of EU trademark law as interpreted by the CJEU. Any assessment of the objective necessity must be carried out in accordance with the criteria developed in the CJEU's case law, irrespective of national regulatory guidance.

The court also rejected the parallel importers' submission that they are entitled to market all the same pack sizes in general as the originator companies in the import country. Instead, repackaging to a different pack size requires a specific assessment demonstrating that the pack size in question cannot, in practice, obtain effective access to the import market, for example due to established prescribing practices.

The Maritime and Commercial High Court further held that the originators' alleged lack of objections to certain notifications from the parallel importers - as well as other considerations relating to forfeiture of rights - are irrelevant to the assessment of infringement. The assessment of damages and other financial claims will be addressed in later proceedings.

On this basis, the Maritime and Commercial High Court concluded that the parallel importers' repackaging of the medicinal products in new outer packaging constituted trademark infringement.

Plesner represented Lundbeck in the proceedings.

Read the decision of the Maritime and Commercial High Court (in Danish)