Supplementary protection certificates and paediatric extensions
Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher
Supplementary protection certificates and paediatric extensions

The following Life Sciences practice note produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher provides comprehensive and up to date legal information covering:

  • Supplementary protection certificates and paediatric extensions
  • Supplementary protection certificates (SPCs)
  • What is an SPC?
  • Rationale behind the introduction of SPCs
  • The SPC regulatory framework in the EU
  • The SPC regulatory framework in the UK
  • Conditions for obtaining an SPC in an EU Member State
  • Conditions for obtaining a UK SPC and fees
  • The type of products SPCs are available for
  • Medicinal product SPCs
  • More...

This Practice Note provides an introduction to supplementary protection certificates (SPCs) and paediatric extensions (PEs) and explains the rationale for their introduction, how and when to apply for them and how long they last. This Practice Note also considers the key judgments that have shaped the scope of SPC protection. The cases discussed include the many references to the Court of Justice concerning the interpretation of Regulation (EC) 469/2009 (the EU SPC Regulation) as well as the key cases regarding plant protection products.

Broadly, EU judgments handed down on or before 31 December 2020 continue to be binding on UK courts and tribunals (even if the EU courts later depart from them) until the UK courts exercise their powers to diverge. For the most part, EU case law made after that date is not binding on the UK, although the UK courts and tribunals may continue to ‘have regard to’ EU judgments if relevant. For more detailed information on the treatment of EU case law, see Practice Note: Introduction to retained EU law.

Supplementary protection certificates (SPCs)

What is an SPC?

An SPC extends the protection conferred by a patent to a particular plant protection or medicinal product by up to five years, provided certain conditions are met (see: Conditions for obtaining an SPC in an EU Member State below). It does not extend the patent term in

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