European Commission consultation on unitary supplementary protection certificates (SPCs)

Building on the momentum of the final push towards launch of the UPC, the EPO has launched a stake-holder consultation on a proposal to unify the "fragmented" system for SPC registration. 

The purpose of the SPC Regulations (Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96) is to compensate patentees for the lengthy process of achieving marketing authorisation for a medicinal or plant product. SPCs are national rights that provide an additional period of protection for a medicinal product protected by a patent. The EU SPC Regulation provides a maximum of 5 years additional protection based on the first marketing authorisation for the product in the European Economic Area (EEA). In the current system, following approval of a medicinal or plant product, innovators must apply separately for SPC protection in each of the patent offices of the EEA member states where the product is approved. 

A 2020 report from the European Commission expounded the benefits of the SPC system, and the European Commission takes pains to note that the current system is considered fit for purpose. Nonetheless, the 2020 report concluded that the main shortcoming of the current system is "the fact that SPCs are nationally administered and managed". As readers of this blog will be familiar, divergent interpretations of the SPC regulations by national courts, coupled with sometimes less than crystal clear guidance from the CJEU, is a hallmark of the current SPC system (IPKat). The EC 2020 report also found agreement from the majority of industry respondents to a previous consolation on the topic that a unified SPC system would boost investment, reduce red-tape relating to litigation and registration, reduce maintenance costs, and make licensing easier. 

European Commission

Clearly spurred on by the approaching finish line for the UPC, the European Commission now proposes to tackle the perceived problems of the current SPC system. The UPC will allow for the grant of a unified European patent in UPC participating countries. Post-grant infringement and revocation proceedings for unified patents will fall under the jurisdiction of the Unified Patent Court. The original proposals establishing the groundwork for the UPC made no reference to extending the system to SPCs. However, SPCs based on unitary patents that are not opted out, will be enforced via the UPC. The latest call for evidence by the European Commission is clearly based on the EU desire to extend the "EU unitary patent package" to SPC registration. 

The introduction of a centralised system for SPC regulation will be complicated by the less than perfect overlap between the coverage of the basic patent (e.g. whether this is a unitary patent or has been opted out of the UPC), and the marketing authorisation(s) for the product in the EU on the basis of which an SPC is sought (e.g. whether this has been obtained by centralised, decentralised or national procedures). 

The European Commission consolation is currently open, and will close on 5 April 2022. The call for evidence is not a public consultation as such (the EC have also ruled out the need for a broader public consultation), but invites stakeholders to submit their views on the unitary SPC proposal. Stakeholders in this context include EU innovator companies, generics companies, national patent offices, IP agents and attorneys. Feedback from the Commission is expected within the first half of 2022.