Repackaging and relabelling of imported medicinal products

Repackaging means, for a parallel importer, placing the medicinal product in new packaging, and relabelling means affixing to the original packaging labels written in the language of the State of import. These operations are required by labelling rules, but they concern a product bearing the holder’s trade mark. They are governed by the rule of exhaustion of rights, laid down in Article L. 713-4 of the French Intellectual Property Code, Article 15 of Regulation (EU) 2017/1001 and Article 15 of Directive (EU) 2015/2436, which preserve the proprietor’s legitimate reasons to oppose further commercialisation.

Conditions of lawfulness laid down by the Court of Justice

The Court of Justice of the European Union holds that the trade mark proprietor may oppose the marketing of a medicinal product repackaged by a parallel importer unless the following conditions are met.

• Repackaging is necessary for effective access to the market of the State of import.
• It does not affect the original condition of the product.
• The new packaging clearly states who repackaged the product and the name of the manufacturer.
• The presentation is not liable to damage the reputation of the trade mark or of its proprietor.
• The importer gives the proprietor notice before the product is put on sale and supplies a specimen on request.

Necessity and method of repackaging

Necessity is assessed in light of genuine obstacles to marketing, such as rules requiring certain pack sizes or strong resistance from patients and pharmacists to relabelled products, and does not cover the mere pursuit of a commercial advantage. Relabelling, which is less intrusive, must be preferred where it is sufficient, and replacing the original trade mark with the one used in the State of import is subject to the same requirement. The safety features required under the falsified medicines regime have revived this debate, the Court of Justice having been asked to clarify whether a new anti-tampering device affixed to the original packaging is sufficient or whether full repackaging becomes necessary.

Procedure and sanctions

Prior notice must give the proprietor a reasonable period to react, the Court of Justice having held that fifteen working days is in principle sufficient. The burden of proving the conditions lies with the importer, who may, as regards the original condition of the product and the absence of harm to reputation, rely on evidence that reasonably suggests they have been met. Failure to meet any one of the conditions makes the marketing an act of trade mark infringement.

Key points

Repackaging an imported medicinal product is lawful under strict conditions, of which necessity and prior notice to the proprietor are the most disputed. The proprietor has every interest in responding to each notice within fifteen working days, identifying precisely the failures observed. For the importer, documenting the necessity of the chosen method of repackaging, in light of the import market, is the best protection against an infringement action.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation