Study  |  05/28/2018

Study on Supplementary Protection Certificates

A team of researchers around Roberto Romandini examined the legal framework of supplementary protection certificates (SPCs) on behalf of the European Commission. The Institute elaborated reform proposals which aim at more transparency and legal certainty.

The study examines the functioning of the system of SPCs established in the EU by Regulation 1768/92/EEC on SPCs for medicinal products (now: Reg. 469/2009/EC) and Regulation 1610/96/EC on SPCs for plant protection products. The functioning of these Regulations is considered in the context of adjacent legislation concerning marketing authorisation for medicinal products and plant protection products (Directives 82/2001/EC and 83/2001/EC; Regulation 1107/2009/EC). 

Within this context, the study focuses inter alia on:

  • the impact of the CJEU case law on the SPC system and the practice of the national patent offices;
  • the challenges posed by technical developments for the SPC legislation;
  • the impact of the Agreement on a Unified Patent Court on the scope of the Bolar exemption;
  • the models for creating an SPC manufacturing waiver;
  • the interaction between SPCs and the unitary patent package;
  • the options for creating a unitary SPC.

Based on legal analysis, supplemented by a fact-finding process, the study identifies critical issues, explores possible solutions and formulates some recommendations.

The Study on the Legal Aspects of Supplementary Protection Certificates was published on 28 May 2018.

Study and Annexes:
Executive Summary: PDF