European Commission Looks to Harmonise Rules Governing Supplementary Protection Certificates for Medicines and Plant Protection Products

• 25/03/2022
• Articles

Earlier this month, the European Commission (the Commission) opened what it refers to as a call for evidence regarding the need to adopt a new Regulation governing Supplementary Protection Certificates (SPCs). The proposed regime would create a unitary SPC and/or establish a single procedure for granting national SPC’s.

SPCs are intellectual property rights which extend patent protection for specific medicinal and plant protection products. Back in November 2020, the Commission’s intellectual property action plan had already decried the fragmented nature of the regulatory framework governing SPCs which, according to the Commission, “translates into inefficiencies and a lack of transparency and predictability, which hampers innovators and generic producers, and eventually harms patients” (COM (2020) 760 final, at p. 5). SPCs are granted and managed on a national basis. In an additional layer of complexity, they are bolted to national patents and depend on product marketing authorisations that – for medicines - may have been obtained by centralised, decentralised, or national procedures.

The impetus for this Commission initiative is the approaching opening of the Unified Patent Court (UPC) the single patent court that will cover 24 countries and will allow for the grant of a unitary European patent in the participating countries. Post-grant infringement and revocation proceedings for unitary patents will fall under the jurisdiction of the UPC. When the UPC was initially developed, no formal thought was given to extending the system to SPCs. However, SPCs based on unitary patents that are not opted out, will be enforced via the UPC. The call for evidence by the European Commission would seem to reflect a Commission desire to extend the EU unitary patent package to SPC registration.
 
The call for evidence will close on 5 April 2022.