A new study on the options for a unified supplementary protection certificates (SPCs) system in Europe!

For all of those working with Supplementary Protection Certificates, the need for a review of the system is self-explanatory. The complexity of the legislation and case law, the absence of uniform expertise in the national agencies, and the diverging approaches in examining SPCs  that  result in diverging decisions and a fragmentation of the single market, constitute the background for the need to proceed with changes. These problems that have constituted major weaknesses for SPCs on national patents, will also be equally relevant for those based on unitary patents.

This is the background for the  impressive study conducted by Roberto Romandini (bio here), and commissioned by the European Commission. The study, R. Romandini, Study on the options for a unified supplementary protection certificates (SPCs) system in Europe, European Commission, Brussels 2022 may be found here.

A new era for SPCs? 

The purpose of this study was to develop a model for the examination and grant of  SPCs,  which would be able to satisfy the following requirements:

▪ to include in its operation any European patent with or without unitary effect;

▪ not to postulate for its operation the existence of the UPC, but to interact with and integrate the latter once it became operational;

 ▪ to integrate countries that do not intend to join the unitary patent system;

▪ , to contribute to a uniform grant practice, with a checks and balances system that  does not simply result in an additional avenue for obtaining protection and  a lowering of the standard of eligibility for an SPC  in the strictest jurisdictions to the detriment of generic competition and associated public interests.

To achieve these  purposes, the study recommends establishing a procedure for granting a European certificate that  shall rest on the following pillars:

 ▪ an examining body, similar in structure to the Committee for Medicinal Products for Human Use (CHMP), with each representative from each single national agency having the right to vote on each regional application and to draft a dissenting opinion;

 ▪ a system of appeal against refusals before the General Court supplemented by a Board of Appeal within the agency competent to examine the applications;

 ▪ an option for central attack, to be filed with the agency by any person irrespective of a commercial interest;

 a revisited approach to the principle of coexistence aimed at allowing the applicant to choose between a bundle of national applications and a single regional application for a European certificate, but without the ability to exploit both avenues.

This really is a ‘must read’ for all those working with or interested in SPCs, in particular in times like this, when anything could happen with the grant procedures in the field.


A new study on the options for a unified supplementary protection certificates (SPCs) system in Europe! A new study on the options for a unified supplementary protection certificates (SPCs) system in Europe! Reviewed by Frantzeska Papadopoulou on Monday, October 24, 2022 Rating: 5

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