The Guidance explains that the types of marketing authorisations that apply in the UK changed on 1 January 2021, pursuant to The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020. Authorisations can now be granted under UK or EU law and will cover the UK, Great Britain (GB) only, or Northern Ireland (NI) only.

An SPC application can now be filed based on any marketing authorisation that allows the patented product to be placed on the market in any part of the UK. If that application meets the statutory requirements, an SPC will be granted.

The protection provided by that SPC will cover the same territory as its marketing authorisation (for example, if the marketing authorisation is for NI only, the protection will also cover NI only).

If a further valid marketing authorisation for the same product covering another part of the UK is granted before the SPC takes effect, then the protection provided by the SPC can be expanded to cover the additional territory.

In each case, the authorisation must be the first authorisation for the product in its specific territory.

The six-month paediatric extension will still be available. The protection it provides will depend on the protection provided by the SPC and the territory of the marketing authorisation that qualifies for the extension.

Pursuant to the Withdrawal Agreement and the NI Protocol, EU legislation regulating medicines and pesticides continues to apply in NI. UK domestic legislation applies in GB. Marketing authorisations granted by the European Medicines Agency (EMA) only apply in NI. In GB, GB authorisations replace existing EMA authorisations.

The Guidance sets out what relevant organisations and businesses now need to do. It covers:

• existing rights and pending applications;
• the application process;
• applying using pre-2021 authorisations;
• the examination process;
• notifying the IPO of further authorisations;
• what happens when the SPC takes effect;
• the paediatric extension; and
• the manufacturing waiver.

To access the Guidance, click here.