Changes to the UK SPC system from 1 January 2025

The UK IPO has issued guidance on changes to Supplementary Protection Certificates (SPCs) which will take effect from 1 January 2025, available here. These changes take account of provisions of the Windsor Framework that change how Marketing Authorisations (MAs) for human medicinal products will be authorised in the UK from 1 January 2025.

In short, on 1 January 2025:

• a single UK authorisation will be the standard for new and innovative drugs, in most circumstances
• Existing GB authorisations will become UK authorisations and have effect across the whole of the UK, i.e. including Northern Ireland (they will still have a PLGB prefix if that was assigned at the time of application)
• Centralised (EMA) authorisations will no longer be effective in Northern Ireland.
• Holders of GB and NI authorisations for the same product must have surrendered their NI authorisation by 30 September 2024. Where they have, the GB authorisation will have effect across the whole of the UK. Otherwise, the GB authorisation will be revoked

Current System and Existing SPCs

Brexit resulted in two routes to marketing authorisations covering different parts of the UK.  Central authorisations granted by the European Medicines Agency (EMA) have still had an effect in Northern Ireland, but not in Great Britain (GB, i.e. England, Scotland and Wales). The UK Medicine and Healthcare products Regulatory Agency (MHRA) could grant authorisations that covered either Northern Ireland (NI) only, GB only, or the whole of the UK (GB and NI).

Typically, UK SPCs covering NI have been filed based on EMA authorisation valid in NI. The UK IPO is subsequently notified of the MHRA GB authorisation (typically granted after EMA authorisation), to provide a UK SPC that covers NI and GB.

On 1 January 2025, MHRA UK authorisation (i.e. GB and NI) will be the sole route to a UK marketing authorisation. Existing MHRA GB authorisations will become MHRA UK authorisations.  EMA authorisations will no longer be effective in Northern Ireland.

If an MHRA GB authorisation exists in parallel with an MHRA NI authorisation for the same product, the GB authorisation will expand to cover the whole of the UK only if the NI authorisation was surrendered by 30 September 2024. If the NI authorisation was not surrendered by 30 September 2024, the GB authorisation will be revoked and there will no longer be an authorisation that applies in Great Britain.

To summarise the effect on UK SPCs filed before 1 January 2025:

• SPC based on EMA authorisation and MHRA GB authorisation: No Change
• SPC based on MHRA UK authorisation: No Change
• SPC based on MHRA GB authorisation and MHRA NI authorisation surrendered by 30 September 2024: No Change
• SPC based on MHRA GB authorisation and MHRA NI authorisation not surrendered by 30 September 2024: SPC will still provide protection in NI but will no longer provide protection in GB
• ​​​SPC based on EMA authorisation (for NI) only (i.e. no GB related authorisation):
  • If the SPC application is filed but not granted before 1 January 2025, this will not affect the examination of the application. If the application is granted, it will be necessary to have a UK authorisation in place before the patent expires for the SPC to come into effect.  The UK IPO will need to be notified within 6 months of the grant of the UK authorisation.
  • If the SPC application is granted, but not yet in effect, it will be necessary to have a UK authorisation in place before the patent expires for the SPC to come into effect.  The UK IPO will need to be notified within 6 months of the grant of the UK authorisation.
  • In the unusual situation that the SPC is already in force and a GB authorisation was granted for the product after the SPC was in force, special provisions will apply. The SPC will remain limited to NI, but it will be based on the GB authorisation that will apply in Northern Ireland as a UK authorisation from 1 January 2025.

New SPC Applications after 1 January 2025

EMA authorisations will no longer be effective in NI on 1 January 2025 and so it will generally not be possible to rely on EMA authorisations as the basis for a new SPC application from 1 January 2025.

It will be possible to file an SPC application after 1 January 2025 that relies on an EMA authorisation, if:

• the EMA authorisation was granted before 1 January 2025;
• the application deadline is set by Article 7(1) (i.e., by the grant of that authorisation or the equivalent GB authorisation); and
• that deadline expires after 1 January 2025.

In other words, if your centralised authorisation was granted between 1 July 2024 and 31 December 2024 and your application deadline expires no later than 30 June 2025, then the SPC application must be filed within the normal six-month period.

Any MHRA GB or UK authorisation granted before making the application must also be filed with that application. It will not be possible to file a separate application later based on these MHRA GB or UK authorisations.

Paediatric Extensions

After 1 January 2025, paediatric extensions will only be available based on proof of compliance with a paediatric investigation plan from the MHRA.  It will not be possible to rely on an EMA authorisation to support a request for a paediatric extension.  The deadline for filing requests for paediatric extensions remains two years before the expiry of the SPC.

Paediatric extension requests that have already been granted will continue to rely on the current law.

Requests for a paediatric extension filed before 1 January 2025 will still be allowed, if they meet the relevant requirements.

Any granted or pending paediatric extension requests based on a MHRA GB authorisation will automatically extend to cover Northern Ireland on 1 January 2025.

For paediatric extension requests or pending requests based on an EMA or MHRA NI authorisation, it will be necessary to file a request under Article 13B to include Great Britain in that extension. This would be on the basis of a UK or GB authorisation.

Summary

The new UK SPC system will simplify the UK SPC application process.  For SPC holders, no new action is needed in most situations.  However, if the deadline for filing a paediatric extension request falls before 1 January 2025 and the request has not yet been filed, action may be necessary.

Please reach out to your usual Venner Shipley contact if you have any questions about these changes or their impact on your existing or future SPCs.