The European Commission is currently assessing whether the SPC Regulations for medicinal products and plant protection products should be recalibrated. In that context, the Max Planck Institute was given the task to prepare a “Study on the Legal Aspects of Supplementary Protection Certificates” to enable “an overall evaluation of the SPC system in the EU”; and “to inform the decision on whether to revise the existing SPC legislation.” The MPI published its Final Report on 28 May 2018. This Report contains a comprehensive overview of the positions of the National Patent Offices and of the state of play of the jurisprudence of the Court of Justice of the European Union and national courts, including ‘open questions’ raised by the application and interpretation of the SPC Regulations. The present analysis reviews the key findings of the MPI Report and explains why the stakeholder feedback gathered by MPI, on balance, supports an evolutionary approach to the SPC Regulations rather than a ‘reopening’ of the Regulations.
No Need to Reopen the Core Provisions of the SPC Regulation
March 25, 2019