What are SPCs?

Pharmaceutical or plant products need regulatory approval to be sold in the UK and therefore, in most cases, a marketing authorisation or product license is required. However, obtaining this regulatory approval can take time and can delay a patent owner from using their pharmaceutical or plant products that are protected by their granted patent. In order to compensate for this delay, a Supplementary Protection Certificate (SPC) can be obtained.

An SPC does not extend the term of the patent but provides similar protection in respect of the specific pharmaceutical or plant product that has been authorized. It enters into force once the patent has expired and can last for up to five years. An SPC for a medical active ingredient can be extended for a further six months if it has undergone the appropriate paediatric testing.

 

The Current System for SPCs

There are currently several types of marketing authorisations that are valid in different parts of the UK:

  • Centralised Authorisation issued by the European Medicine Agency (EMA) – valid only in Northern Ireland (prefix identifier – EU/1/);
  • Northern Ireland (NI) Authorisations issued by MHRA – valid only in Northern Ireland (prefix identifier – PLNI);
  • GB Authorisations issued by the MHRA – valid only in Great Britain, excl. Northern Ireland (prefix identifier – PLGB);
  • UK Authorisations issued by the MHRA – valid across the whole of the UK, incl. Northern Ireland (prefix identifier – PL).

Any of the above types of authorisations may currently be used for the basis of an SPC application. The resulting SPC provides protection in the territory covered by the authorisations.

 

Changes Taking Place to Marketing Authorisations from 1st January 2025

From 1st January 2025, the law on how medicines in the UK are authorised changed. This is to bring the whole of the UK in line with The Windsor Framework, the post-Brexit legal agreement formalised between the UK and the EU (seen here).

From 1st January 2025, the marketing authorisation routes will be unified into one approval from the UK’s regulatory approval agency (MHRA), which will apply across the whole of the UK.

Pre-existing, centralised authorisations (previously only valid in Northern Ireland) will no longer be effective in Northern Ireland. Existing GB authorisations will have effect across the whole of the UK. Holders of GB and NI-only authorisations for the same product must surrender their NI authorisation otherwise their GB authorisation will be revoked.

 

Transitional Provisions for SPCs

Existing SPCs and applications

If a centralised authorisation (NI only) and a GB authorisation is held – in most cases no action will be required. The centralised authorisation will no longer be effective in Northern Ireland and the GB authorisation will cover the whole of the UK.

If a centralised authorisation only is held – the authorisation is treated as withdrawn from 1st January 2025.

If a GB authorisation only is held – in most cases no action will be required. The GB authorisation will cover the whole of the UK.

If a GB authorisation and an NI authorisation is held – the NI authorisation must be surrendered, and the GB authorisation will automatically cover the whole of the UK.

New Applications filed after 1st January 2025

It will not be possible to rely on a centralised authorisation as the basis for a new SPC application or paediatric extension filed after 1st January 2025. There are certain exceptions to this where the authorisation was granted before 1st Jan 2025 or where the application deadline is set by Art. 7(1) and that deadline expires after 1st Jan 2025 and no later than 30th June 2025. These special cases will be examined on a case-by-case basis.

 

Effect of Changes to the SPCs

The deadline for filing a SPC will remain determined by the later of: a) the date of the first marketing approval in the UK; and b) the date of grant of the patent. Only the details of one authorisation in the UK will be required for the basis of an SPC application going forwards. However, details of the earliest authorisation of the product in the European Economic Area (EEA) will still be required if that predates the UK authorisation as it will be required to determine the duration of the SPC. A paediatric extension will only be available based on authorisations with proof of compliance from MHRA. This will apply even where the EU agreed the original paediatric investigation plan.

If you have any questions on SPCs, or how they may affect your business, please contact us at mail@bailey-walsh.com.