欧盟有效SPC框架的原则：迈向统一SPC和集中SPC框架

Towards a Unitary SPC and centralized SPC framework Author:EFPIADate:02/12/2025Version:FINAL Progress on the SPC Legislation The ongoing reform of theSupplementaryProtectionCertificate (SPC) framework—includingboth the recast of national SPC grant procedures as well as the creation of a Unitary SPC (uSPC)—provides Europe with an opportunity to increase its competitiveness and attractivenessfor As the primary organisation representing the research-based pharmaceutical industry in Europe,the European Federation of Pharmaceutical Industries and Associations (EFPIA) has longadvocated for the introduction of a unitary Supplementary Protection Certificate (uSPC) formedicines. Its introduction would fill a criticalgapin fully realizing the benefits of the Unitary EFPIA is, however, concerned about thelegal and practicalchallenges facing advancement of theSPC package.At a time when competitiveness and regulatory simplification are strategicpriorities,we strongly encourage the European Commission and Member States to advancediscussionstoachieve these key policyobjectives.Co-legislators have thus far explored various To ensure the proposed SPC legislative package achieves its goals and supports a well-functioning, competitive SPC framework for Europe, EFPIA has put forward a series of principles Provided these principles are respected,andabsolutelegal certaintyis ensuredwith respect tothe legal basis and compatibility withtheEUlegalframework,EFPIAencouragestheco-legislatorstoevaluateand develop a forward-looking frameworkwith theEuropean Patent Office(EPO)at EFPIA members stand ready to contribute to this process and are hopeful that progresscan bemade balancinglegal certainty,speed,qualityandeffectiveness of the SPC framework. This Principles for an Effective and Competitive SPCFramework While the ultimate arrangement ofinstitutionalcompetence and responsibility could takemultiple forms, EFPIA strongly believes that a well-functioning SPCframeworkshould be built (1)EXAMINATION.A single, centralized examining body (CEB) with the necessary technicalexpertise to ensure EU-wide harmonisation in procedures and outcomes.This body should ThisCEBshouldprimarily operate as a virtual office,relyingonexperienced examiners fromrelevant national patent offices(NPO) currently engaged in substantively examining SPCapplications, to deliver decisions to grant or reject applications for unitary and/or national SPCsthrough the centralized (recast) procedure.Consideringits existingcompetencewith respect to (2)GRANT &JUDICIAL REVIEW.A unified, competent, and efficient forum for handling invalidityrequests and appealsagainst refusalsfor uSPCs.For consistency, this forum should be theUnitary Patent Court (UPC)—with the ability to refer cases to the Court of Justice of the EuropeanUnion (CJEU) when necessary.This would ensure that legal questions would be handled by aforum with the requisiteexpertise, a sufficient scope of review, andadequatetimelines for A legallysound andstraightforward route to both the UPC, and thenon to the CJEUwhenneeded,must be provided.These considerations should help determine which bodygrantsuSPCs:aviableoptionwouldentrustthe EPOwith the formal grant of uSPCs, according to CEB examination and (3)PROCEEDINGS.Efficient, timely, and uniform proceedings for both unitary and nationalSPCs, ensuring predictability and reducing administrative complexity.In this vein, EFPIAspecifically believes that a pre-grant opposition procedure is unnecessary, as it would add unduecomplexity and weaken the system without addressing any identified substantive need.It iscritical to bear in mind that, currently, less than 1% of granted SPCs ever face a revocation action; (4)CONSISTENCY.To maximize harmonization, coherence, and legal certainty, the uSPC systemand the national procedure (SPC recast) legislative proposals should advance together as muchas possible, as an overall consideration.Aviable uSPC proposal that incorporates the above keyprinciples couldeasilybecombined andexpandedthrough the SPC Recast legislation,to national In summary, in line with European strategic priorities of competitiveness and regulatorysimplification, it is imperative to establish a well-functioning SPC framework that is simple,effective and efficient. To that purpose, it would be logical for the unitary SPC system to alignwith the existing Unitary Patent regime.EFPIA thus urges the co-legislators to focus on We believe this option, subject to legal feasibility, is themost likely routeto a viable and effectivesystem, such that European applicants can fully benefit not only from a harmonized SPCframework but also, critically, from the unitary patent system and theestablishment of theUPC.