CJEU Issues Guidance On When Parallel Importers Can Rebrand Generics As Branded Medicines

• Jurisdiction: European Union
• Law Firm: William Fry
• Subject Matter: Intellectual Property, Trademark
• Author: Ms Laura Scott, Charleen O'Keeffe, Colette Brady, John Sugrue and Anna Lee Dowling
• Published date: 04 January 2023

In a recent decision, the Court of Justice of the European Union (CJEU) issued new guidance on when parallel importers can rebrand generic medicines with the original trade mark of the reference medicinal product (C-253/20 Impexeco v. Novartis AG and C-254/20 PI Pharma NV v. Novartis AG).

Novartis marketed two different medicinal products, one in Belgium and the Netherlands under the trade mark FEMARA (CASE C-235/20), and the other in Belgium under the trade mark RILATINE and in the Netherlands under the trade mark RITALIN (CASE C-254/20). Novartis' generic division, Sandoz, sold identical medicinal products as generics using the names 'Letrozol Sandoz 2.5 mg' and 'Methylphenidate HC1 Sandoz 10 mg'

In 2016 and 2017, Novartis issued trade mark infringement actions against two Belgian companies, PI Pharma and Impexeco. Both Belgian companies are active in the parallel trade in medicinal products. Impexeco and PI Pharma imported the generic Sandoz products from the Netherlands and then repackaged and rebranded them for sale in Belgium under the Novartis reference product names, 'FEMARA' and 'RILATINE'.

Novartis successfully applied for injunctions before the Brussels Commercial Court. On appeal, the Brussels Court of Appeal referred several questions to the CJEU.

Essentially, the question for the CJEU was whether the owner of trade marks for both a reference medicinal product and a generic medicinal product could prevent parallel imports between EU Member States of the generic products, where the generic products had been repackaged in new packaging that displayed the trade mark of the corresponding reference medicinal product.

The CJEU confirmed that the trade mark owner can prevent such repackaging, except where:

1. the reference and generic medicinal products are identical in all respects; and
2. the replacement of the trade mark satisfies the "BMS conditions".

The CJEU observed that reference and generic products may not always be identical, despite being therapeutically equivalent. It noted that products may be identical in all respects in particular where the reference medicinal product and the generic medicinal product are manufactured by the same entity or by economically linked entities and which, in actual fact, constitute one and the same product marketed under two different sets of rules. The key question is whether it is established that repackaging is objectively necessary in order for the parallel imported medicinal products to be marketed in the...