Parallel imports of medicinal products and medical devices – avoiding trademark infringement

Permissible repackaging of parallel-imported medicinal products and medical devices

Trademark-relevant “repackaging”

A trademark infringement therefore first requires that there has been relevant repackaging. Repackaging parallel-imported medicinal products and medical devices includes relabelling (Court of Justice of the European Union, judgment of 26. 4. 2007 - C-348/04 Boehringer Ingelheim/Swingward Ltd). However, repackaging requires that the packaging be altered. Attaching a small sticker showing the parallel importer’s contact details, barcode and pharmaceutical central number to an unprinted part of the unopened packaging does not amount to repackaging (Court of Justice of the European Union, judgment of 17.5.2018 – C-642/16 Junek/Lohmann & Rauscher). Even covering the manufacturer’s barcode and pharmaceutical central number with a parallel importer’s sticker does not constitute repackaging. Unlike a trademark, the pharmaceutical central number does not guarantee the origin of the goods; rather, it is used to organise the distribution of goods through pharmacies and facilitate pharmacies’ billing with health insurers (Federal Court of Justice, judgment of 11.10.2018 – I ZR 259/15 – Curapor; Federal Court of Justice, judgment of 11.10.2018 – I ZR 178/15 - Gazin).

Repackaging parallel-imported medicines and medical devices is permitted under certain conditions

Even where repackaging is relevant under trade mark law, repackaging parallel-imported medicinal products and medical devices is permitted under certain conditions (see ECJ, judgment of 11 July 1996 – Joined Cases C–427/93, C–429/93 and C–436/93 – Bristol-Myers Squibb):

• The assertion of a trademark by its owner contributes to an artificial partitioning of markets between Member States. This is particularly the case where the trademark owner has marketed the same medicinal product in different packaging in different Member States, and repackaging by the importer is necessary both to enable the product to be marketed in the Member State of import and is carried out under conditions that cannot affect the product’s original condition;
• repackaging cannot affect the original condition of the goods contained in the packaging;
• the new packaging clearly states who repackaged the medicinal product and who the manufacturer is;
• the repackaged medicinal product is not presented in a way that could damage the reputation of the trade mark and its proprietor. The packaging must therefore not be damaged, poor quality or untidy;
• the importer has informed the trademark owner in advance of the planned offer of the repackaged medicine and, upon request, supplies a sample of the repackaged product.

Repackaging into pack sizes or standard sizes required under national law

A trade mark proprietor cannot prevent the repackaging of parallel-imported medicinal products and medical devices, even if packs of the size used in the EEA Member State where the importer purchased the goods cannot be sold in the importing state, in particular because only packs of a specific size are permitted there or a corresponding national practice exists, because health insurance reimbursement rules make coverage of treatment costs dependent on pack size, or because established prescribing practices are based, among other things, on standard pack sizes recommended by professional associations and health insurance providers (Court of Justice of the European Union, judgment of 10 November 2016 – C-297/15 – Ferring Lægemidler A/S/Orifarm A/S).

However, repackaging parallel-imported medicinal products is not necessary if the packaging can simply be opened, a German-language package leaflet inserted, and the outer packaging resealed with a new security feature (OLG Cologne of 5.12.2018 - 6 W 121/18 - 0.75 mg tablet).

> MORE INFORMATION ABOUT MEDICINAL PRODUCT BRANDS