Multiple Supplementary Protection Certificates for Medicinal Products: Towards a New Approach?

Abstract The granting of multiple Supplementary Protection Certificates (SPCs) for the same active ingredient has generated significant controversy in EU law. Regulation 469/2009 originally established a strict “one SPC per product per holder” rule to balance pharmaceutical innovation incentives against public access to medicines. However, CJEU case law has progressively liberalised this framework, permitting multiple SPCs under increasingly broad circumstances. This article critically analyses the proposal to amend Art. 3(c) of Regulation 469/2009 as part of the planned EU reform (“Pharmaceutical Package”), which would limit the possibility of granting multiple SPCs for the same medicinal product exclusively to economically unrelated entities. The proposed amendment aims to counteract the imbalance in the SPC system, which, due to evolving jurisprudence, allows multiple protection for the same product. The author examines the current interpretation of Art. 3(c) in light of the case law of the Court of Justice of the European Union and national courts, comparing it with the literal interpretation and related provisions of Art. 3(a), (b), and (d). The legislative amendment could help restore balance in the protection of pharmaceutical innovations; however, whilst necessary, it represents an incomplete solution. Further legislative action may be necessary, including codification of current jurisprudence or creating precise criteria and a test for Art. 3(c) to ensure consistency and predictability in the application of the law. The article proposes a four-element test for assessing multiple SPC applications that balances innovation incentives with the public interest.