Supplementary protection certificates and paediatric extensions
Produced in partnership with Nicole Jadeja and Chris Leung, Fieldfisher
Supplementary protection certificates and paediatric extensions

The following IP guidance note Produced in partnership with Nicole Jadeja and Chris Leung, Fieldfisher provides comprehensive and up to date legal information covering:

  • Supplementary protection certificates and paediatric extensions
  • Supplementary protection certificates (SPCs)
  • What is an SPC?
  • The current SPC regulatory framework
  • Rationale behind the introduction of SPCs
  • Conditions for obtaining an SPC
  • The type of products SPCs are available for
  • SPC manufacturing waivers
  • How long do SPCs last?
  • When and how to apply for an SPC
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

Supplementary protection certificates (SPCs)

What is an SPC?

A supplementary protection certificate (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 below). It does not extend the patent term in relation to products outside the scope of the SPC, and is not, therefore, a ‘patent term extension’ as such.

An SPC is a national right and therefore provides protection only in the Member State in which it has been granted.

The rights granted by an SPC in relation to the protected product are the same