Sweden is spearheading efforts to establish a Unitary Patent System across the European Union, aiming to enhance innovation and competitiveness in the pharmaceutical sector. Alongside ten other EU member states, Stockholm is urging the Danish presidency to finalize a system that would streamline and strengthen patent protection for medicines.
Supplementary Protection Certificates (SPCs) have long been used to extend patent rights for medicines by up to five years, compensating pharmaceutical companies for delays caused by regulatory testing and approval. However, under the current framework, each EU member state must grant SPCs individually, leading to a patchwork of regulations and inconsistent outcomes across the bloc.
This fragmentation creates legal uncertainty, increases administrative burdens, and hampers the efficient development and distribution of new drugs. Companies face lengthy and costly processes to secure protection in multiple jurisdictions, slowing down innovation and market entry.
In response, the European Commission proposed a unitary SPC system in 2023. This system would apply to the 18 countries participating in the Unitary Patent System, providing a single, harmonized procedure for extending patent protection.