EU Anti-Counterfeit Regulation Does Not Per Se Allow Repackaging Of Parallel Imported Or Parallel Traded Pharmaceuticals

• Jurisdiction: European Union
• Law Firm: Jones Day
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Trademark
• Author: Mr Edouard Fortunet, Christian Fulda, Jakob Guhn, Rebecca Swindells and Sarah Candelibes
• Published date: 13 January 2023

In Short

The Situation: European Union ("EU") trademark law permits the repackaging of pharmaceuticals that are imported or traded in parallel from one Member State to another only in limited circumstances. In view of recent EU product regulations requiring a safety feature on outer packages, the question has arisen whether parallel importers or parallel traders may repackage a product and affix a new safety feature on the new box, after having opened the original box'in order to make the product otherwise compliant with the regulations for the destination market.

The Result: In three decisions dated November 17, 2022, the Court of Justice of the EU ("CJEU") clarified that the opening of the safety feature alone is not reason enough to repackage a product in a new box. This remains permissible only if this is otherwise required for the product to gain access to the destination market.

Looking Ahead: EU trademark owners may oppose repackaging of parallel imports or parallel trade where pharmaceutical products are merely repackaged on the grounds of the safety feature having been opened.

For pharmaceuticals that are parallel imported (authorized nationally) or parallel traded (authorized centrally), EU case law permits full repackaging in new outer packaging only in limited circumstances. In light of a recent introduction for prescription products to carry a unique identifier and an anti-tampering device, also referred to as a safety feature (EU Directive 2001/83, Article 54 (o) and Delegated Regulation 2016/161, Article 10), the question arose whether the mere fact that parallel traders or importers need to break the seal allows them to use a new outer packaging altogether (affixing a new anti-tampering device).

On November 17, 2022, the CJEU handed down three decisions and answered the questions in the negative (Merck Sharp & Dohme BV and others v. Abacus Medicine A/S and others, C-224/20) ("MSD Case"); Bayer Intellectual Property GmbH v. Kohlpharma GmbH, C-204/20 ("Bayer Case") and Novartis Pharma GmbH v. Abacus Medicine A/S, C-147/20 ("Novartis Case").

Choice of Repackaging Method in Light of the Safety Features

The CJEU specified in the Bayer Case ('52) that full repackaging and (just) relabeling constitute equivalent forms of the safety features required under EU law.

However, based on previous case law, the CJEU recalled (Bayer Case, '65 and 66) that full repackaging constitutes a greater interference with the rights of the trademark owner than...