Patent Expiry Definitions

Year

The year in which the patent expires – this will be either the UK patent expiry or the UK SPC expiry if later.

UK

The date of the expiry of the original UK patent. The basic patent is rarely the only protection involved and other processes, chemical form or formulation patents may be relevant. These may all extend the effective patent life of a product. The basic expiry date can only be taken as a guide to the earliest possible date for any generic form to appear.

SPC

Supplementary Protection Certificate (SPC): this is a mechanism to guarantee a certain marketing exclusivity period for medicines throughout the EU, to allow for the extended development period they require. Current patents in the EU are valid for 20 years; an SPC applies from the date of first marketing of a product within the EU, and extends the effective patent life for up to 5 years, to allow up to a maximum of 15 years exclusivity.

The UK have published the changes to patents and SPCs after the end of the transition period of the UK leaving the EU.

PE

Paediatric extension:   The European Medicines Agency (EMA) allow for a 6 month extension to an SPC (but not a basic patent) if an approved PIP (paediatric investigation plan) is in place for the medicine.   A PIP is a medicine development plan, submitted by a pharmaceutical company to the EMA, aimed at ensuring the necessary data are obtained through studies in children to support the medicine’s authorisation for use in children.  There are some exceptions and restrictions to a PE.  Further information and guidance can be found on the EMA website.

The UK have published the changes to patents and SPCs after the end of the transition period of the UK leaving the EU