Supplementary protection certificates (SPCs) are a critical form of intellectual property (IP) protection for pharmaceutical investment in Europe, providing a limited period of additional patent term to innovative medicinal products. The SPC Manufacturing Waiver, introduced by Amending Regulation (EU) 2019/933, allows manufacturing activities during the SPC term for two purposes: (i) export to third countries where IP protection does not exist or has expired (Export Exemption); and (ii) stockpiling during the final six months of the SPC term to enable immediate market entry in the EU upon SPC expiry (EUStockpiling Exemption).
The Danish Maritime and Commercial High Court has referred Case C-371/26 to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the Export Exemption under the Waiver. This case involves Johnson & Johnson companies (J&J) and SamsungBioepis NL B.V. (Samsung) and AGC Biologics A/S (AGC), concerning the manufacture and export of a biosimilar product to the UK while a J&J-held SPC was still in force.
Key points of the case include:
- Narrow Interpretation of Export Exemption: The CJEU should interpret the Export Exemption narrowly, limiting it to actual and imminent exports rather than general or strategic stockpiling. This aligns with the Waiver's purpose of facilitating exports to rights-free markets and maintains the balance of rights established by the SPC system.
- Marketing Authorization Requirement: A valid marketing authorization must be granted at the time of notification to allow the SPC holder to verify the lawfulness of the products. Incomplete or blank notifications undermine this verification process.
- Export to Rights-Free Markets: The Export Exemption should only apply to exports to third countries where IP protection is not in force and where markets are open to competition. Allowing exports to countries with active IP rights would create an unfair advantage for EU-based manufacturers over local competitors.
The CJEU's interpretation will have significant implications for the enforcement of SPC rights, legal certainty, and the balance between innovation incentives and patient access to generic and biosimilar medicines. A narrow reading of the Export Exemption ensures the Waiver fulfills its purpose without weakening incentives for pharmaceutical innovation in the EU.
