The Brexit transition period in the UK ended on 1st January 2021. Following this, the UK was left with two different regulators for human medicines able to grant marketing authorisations covering different parts of the UK, resulting in a complex two stage filing process for UK SPCs. However, that unusual situation ended with the implementation of the Windsor Framework on 1st January 2025. This change has simplified human medicine approvals in the UK, and so UK SPCs, by making a single UK-wide marketing authorisation the norm again. In most cases no new action is required by innovators in relation to their SPCs, but innovators should take note that some elements of the initial two stage regime will continue to apply long into the future.
UK marketing authorisations and SPCs between 1st January 2021 and 31st December 2024
Our previous article here describes in detail the interplay between the marketing authorisation and SPC procedures operating in the UK between 1st January 2021 and 31st December 2024. In summary, most UK SPCs were based on one or more of the following types of marketing authorisation:
- European Medicines Agency (EMA) authorisations issued via the centralised procedure, which were valid in Northern Ireland (NI) but not Great Britain (GB – i.e. the UK without NI).
- ‘GB authorisations’ issued by the MHRA (The Medicines and Healthcare products Regulatory Agency), which were valid in GB only.
- ‘UK authorisations’ issued by the MHRA, which were valid across the whole of the UK.
The geographical scope of the UK SPC corresponded to the geographical scope of the first approval that took effect anywhere in the UK plus any further approval that was notified to the UK Intellectual Property Office (UK IPO) before the expiry of the basic patent and within six months of grant of that further approval. This often resulted in a two-stage process for filing a UK SPC, for example with the SPC being filed on the basis of an EMA authorisation valid in NI, followed by a later step where the UK IPO was informed of a GB approval when it had been issued by the MHRA.
Changes for human medicine approvals in the UK
On 1st January 2025, previously existing EMA authorisations ceased to be in force in NI. Simultaneously, the geographical scope of GB authorisations granted by the MHRA expanded to cover NI (i.e. they now cover the whole of the UK). Since 1st January 2025, only UK-wide authorisations issued by the MHRA have been available for human medicines. These changes to the UK’s regulatory regime required changes to UK SPC law.
UK SPCs filed before 1st January 2025
In most cases, the geographical scope of an existing UK SPC will not have changed as a result of the changes to the UK’s regulatory regime. In particular, in the common situation where an SPC was previously based on an EMA authorisation (for NI) and an MHRA GB authorisation, the SPC continues to cover the whole of the UK. However, in some cases the geographical scope of a UK SPC changed to reflect a change in the geographical scope of the underlying marketing authorisations, as set out in the table below:
| Type of authorisation(s) filed for the UK SPC | Changes to geographical scope of the UK SPC |
| UK authorisation | No change – the SPC will still cover the whole of the UK. |
| GB authorisation + EMA authorisation (for NI) | No change – the SPC will still cover the whole of the UK. |
| GB authorisation only | The SPC will still provide protection in GB. Provided the SPC did not come into force before 1st January 2025, it will additionally provide protection in NI. “Comes into force” refers to the point the SPC takes effect after the basic patent reaches the end of its 20-year term. However, if an EMA or MHRA NI-only authorisation was granted before 1st January 2025, it must still be notified to the UK IPO before the basic patent expires and within six months of grant of that authorisation or else the SPC will not provide protection in NI. |
| EMA authorisation (for NI) only | If the SPC did not come into force before 1st January 2025, the SPC will not come into force unless a UK authorisation is granted and is notified to the UK IPO within six months of grant of that authorisation and before the basic patent expires, in which case the SPC will cover the whole of the UK. If the SPC did come into force by 1st January 2025, it will have lapsed unless a GB authorisation was granted in the period between the SPC coming into force and 1st January 2025, in which case the SPC will continue to provide protection in Northern Ireland only. No notification is required in this scenario. |
UK SPC applications filed after 1st January 2025
The vast majority of UK SPC applications filed after 1st January 2025 and from now on will simply be based on a single UK-wide marketing authorisation granted by the MHRA and the resulting SPC will thus automatically cover the whole of the UK. However, the new provisions for UK SPC applications filed after 1st January 2025 still reference the possibility that an EMA authorisation may have been granted before 1st January 2025.
For example, where the SPC filing deadline is set by the date of the first approval in the UK, i.e. the basic patent was granted before the first approval was granted, then the date of approval by the EMA must still be considered. If the first approval in the UK was an EMA approval that took effect in NI in the last six months of 2024, then a UK SPC application must still be filed within six months of that EMA approval. However, the SPC will come into force only if an authorisation valid across the UK has been granted and notified to the UK IPO before the expiry of the basic patent and within six months of that authorisation being granted.
Term and filing deadlines for UK SPCs
The deadline for filing a UK SPC remains determined by the later of (i) the date of the first approval in the UK, and (ii) the date of grant of the basic patent. In addition, the term of a UK SPC remains determined by the date of the first approval in the UK or EEA. Consequently, EMA authorisations issued from 2025 onwards are no longer relevant to SPC filing deadlines in the UK (because these no longer constitute a first approval in the UK), but they remain relevant to the term of UK SPCs.
Six-month SPC extensions
Requests for six-month SPC extensions filed after 1st January 2025 will no longer be granted on the basis of an EMA authorisation. Where there is a six-month SPC extension based on a GB authorisation granted before 1st January 2025 or a UK authorisation granted before or after 1st January 2025, the six-month SPC extension will cover the whole of the UK automatically (i.e. there are no notification requirements). Where there is a six-month SPC extension based on an EMA authorisation granted before 1st January 2025, the six-month SPC extension will cover Northern Ireland only unless a GB or UK authorisation is notified to the UK IPO by two years before SPC expiry (calculated without the extension).
Summary
By and large the transitional provisions mean that no new action is required by SPC holders, although the current notification requirements will remain in force for some time as discussed above. It is therefore important to link in-house regulatory and IP teams so that new UK approvals are still communicated, not just for new SPCs but also because these may need to be notified to the UK IPO even where the SPC was filed some time before. In particular, innovators should take note of the continued obligation to notify the UK IPO of the grant of an MHRA approval (by the earliest of expiry of the basic patent or six months from grant of the approval) where an SPC has been filed solely on the basis of an EMA authorisation, regardless of whether the SPC application was filed before or after 1st January 2025.
Originally published in the CIPA Journal