Scope

On 27 April 2023, the Commission proposed a comprehensive reform of the SPC regime, including four Regulation proposals. Supplementary protection certificates (SPCs) are intellectual property rights extending the 20-year term of patent protection for medicinal or plant production products by up to five years.

Relevance

The amendments to the Regulation on SPCs for plant and medicinal products are marked as EEA-relevant, but Norwegian authorities have not yet decided on how the changes should be incorporated into Norwegian law. As the EEA states are not part of the unitary patent system, a unitary SPC will not confer rights in the EEA states.

Key takeaways

The new Regulations from the EU on SPCs aims to simplify the EU’s SPC system as regards to national SPC’s for plant production products and medicinal products, as well improve its transparency and efficiency. This reform will replace the existing SPC Regulations with new ones, for medicinal products and plant protection products respectively. Each will establish a centralized SPC filing and examination procedure that will give rise to a bundle of national SPCs in the designated EU member states. The centralized procedure will be available where the basic patent is a European patent, and the product has market authorisation.

Further, two additional proposals also introduce unitary SPCs both for medicinal products and for plant protection products on the basis of unitary patents. It is the European Union Intellectual Property Office (EUIPO) that will handle both unitary SPC applications as well as centralized SPC applications.