In a recent case handled by our firm, we observed a parallel importer attempting to bypass the established legal framework by repackaging a client’s pharmaceutical product into a brand-new outer carton without meeting the strict threshold of necessity. This incident serves as a timely reminder for IP decision-makers: despite several years of clear guidance from the Court of Justice of the European Union (CJEU), trademark rights in parallel trade must be actively defended.
It has been nearly three years since the CJEU delivered its landmark rulings in Novartis v Abacus and MSD (Cases C-147/20, C-204/20, and C-224/20). These decisions fundamentally reinforced the position of trademark proprietors. Yet, as our recent case shows, some importers still treat a new outer box as a right rather than an exception.
The BMS Conditions: Your Shield Against Infringement
Under the “BMS conditions”, a trademark owner can legally object to the parallel import of a repackaged product unless the importer fulfills five cumulative requirements:
- Objective Necessity: Repackaging must be essential to access the market. If the importer can simply relabel the original box, a new box is not “necessary”.
- Product Integrity: The repackaging must not affect the original condition of the medicine (e.g., the primary packaging/blisters must remain unopened).
- Clear Identification: The packaging must clearly state both the manufacturer and the repackager/importer.
- Reputation Protection: The presentation must not be “shabby” or of poor quality in a way that damages the trademark’s reputation.
- Notice and Sample: The importer must notify the trademark owner before marketing and provide a sample of the repackaged product upon request.
The FMD Impact: Relabeling is Now the Rule
A major point of contention in recent years has been the Falsified Medicines Directive (FMD). Importers often argued that breaking the required anti-tampering device (ATD) made the original box “defective”, thus justifying a new one.
The CJEU has been clear: Relabeling is a “lesser interference” with trademark rights than repackaging into a new box. The fact that an original seal is broken does not automatically justify a new outer carton if an equivalent safety device can be applied to the original packaging.
The Burden of Proof: “Consumer Resistance”
If an importer insists that a brand-new box is necessary because consumers will not accept a relabeled original box, the burden of proof lies entirely with them.
Importers must demonstrate that a “significant proportion of consumers” would resist the relabeled packaging to such an extent that it hinders effective market access. This resistance cannot be assumed; it must be proven on a case-by-case basis. Without such proof, the use of a new box remains an infringement of your trademark.
Special Consideration: Generics and Reference Brands
Specialists should also remain vigilant regarding attempts to apply a reference brand trademark to a generic product imported from another state. In Impexeco (C-253/20), the CJEU ruled this is only permissible if the generic and the reference product are identical in every respect and the importer satisfies all BMS requirements, including the necessity test.
Strategic Takeaway for IP Decision-Makers
Three years after the 2022 rulings, the legal tide continues to favor trademark proprietors who rigorously audit parallel import notifications. When you receive a notification:
- Challenge the “Necessity”: Ask if the original box can be reused with stickers and a new ATD.
- Request the Evidence: If they claim consumer resistance, demand specific proof.
- Maintain Brand Standards: Ensure the quality of the repackaging does not diminish your brand’s premium standing.
Defending your trademarks in the parallel trade arena requires more than just knowing the rules—it requires the consistent application of the BMS criteria to every notification.