
Following Brexit 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. From 1st January 2025 that unusual situation will end when the Windsor Framework is implemented. That change will simplify human medicine approvals in the UK, and so UK SPCs, by making a single UK-wide marketing authorisation the norm again. However, innovators should take care they are not caught out by the transitional provisions that were published by the UK Government on 31 October 2024. In most cases no new action is required by innovators in relation to their SPCs, but some elements of the current two stage regime will continue to apply long into the future. In addition, any innovators who can request a six-month SPC extension on the basis of a PIP compliance statement issued by the EMA should do so in the UK before 1st January 2025.
The current system for UK approvals and SPCs
Currently, centralised marketing authorisations issued via the European Medicines Agency (EMA) are valid in Northern Ireland (NI) but not in Great Britain (GB, i.e. England, Scotland and Wales). Our previous article here describes in detail the interplay between the marketing authorisation and SPC procedures currently operating in the UK. In summary, all UK SPCs are currently based on one or more of the following types of marketing authorisation:
- EMA authorisations issued via the centralised procedure, which are valid in Northern Ireland but not Great Britain
- ‘NI authorisations’ issued by the MHRA, which are valid in Northern Ireland only, typically as part of the EU’s decentralised procedure. These authorisations are assigned a number beginning with “PLNI”
- ‘GB authorisations’ issued by the MHRA, which are valid in Great Britain only. These authorisations are assigned a number beginning with “PLGB”
- ‘UK authorisations’ issued by the MHRA, which are valid across the whole of the UK. These authorisations are assigned a number beginning with “PL”.
UK SPCs are filed based on the first approval that takes effect anywhere in the UK. However, the geographical scope of a UK SPC might not include all parts of the country. Instead, the geographical scope of the UK SPC corresponds to the geographical scope of the marketing authorisation(s) which the SPC application was originally based on plus any further marketing authorisation that takes effect anywhere in the UK. The further authorisation issued after filing must be 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 marketing authorisation. This often results in a two stage process for filing an SPC in the UK, 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 is informed of a GB approval when it is issued by the MHRA.
What’s changing for human medicine approvals in the UK?
From 1st January 2025 the only route to a UK marketing authorisation for a human medicinal product will be an approval from the UK’s regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA). Those authorisations will take effect across the entirety of the UK.
From 1st January 2025 existing in force EMA authorisations will cease to apply in Northern Ireland. Simultaneously, the geographical scope of GB authorisations granted by the MHRA will expand to cover NI (i.e. they will then cover the whole of the UK). At a practical level, old GB authorisations will retain their “PLGB” authorisation numbers.
However, in the unusual situation where a GB authorisation exists in parallel with an NI authorisation also granted by the MHRA for the same product, the GB authorisation will expand to cover the whole of the UK only if the NI authorisation was surrendered by 30th September 2024. If the NI authorisation was not surrendered by 30th September 2024, the GB authorisation will be revoked and there will no longer be an authorisation that applies in Great Britain.
These changes to the UK’s regulatory regime require changes to UK SPC law, as set out below.
Changes for UK SPCs filed before 1st January 2025
In most cases, the geographical scope of a UK SPC will not change as a result of the above changes to the UK’s regulatory regime. In particular, in the common situation where an SPC was previously based on an EMA MA (for NI) and an MHRA MA (for GB), the SPC will continue to cover the whole UK (provided the existing rules regarding notifying the UK IPO had been followed correctly). However, in some cases the geographical scope of a UK SPC will change 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 | Effect of changes on geographical scope of 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 + MHRA NI authorisation (if surrendered by 30th September 2024) | No change – the SPC will still cover the whole of the UK. |
GB authorisation + MHRA NI authorisation (if not surrendered by 30th September 2024) | The SPC will still provide protection in NI but will no longer provide protection in GB. |
GB authorisation only | The SPC will still provide protection in GB. Provided the SPC has not come into force before 1 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 is 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 has not come into force before 1 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 and before the basic patent expires, in which case the SPC will cover the whole of the UK. If the SPC has come into force by 1st January 2025, it will lapse 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. |
Effect of changes on SPC applications filed after 1st January 2025
After 1st January 2025 the vast majority of UK SPC applications 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 to account for the following two scenarios.
The first scenario relates to 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. In essence, the current regime has been preserved such that 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 is granted and provided with the initial SPC application or notified to the UK IPO before the expiry of the basic patent and within six months of the approval being granted. The UK authorisation can be a GB authorisation that was granted by the MHRA before 1st January 2025 and will have become effective across the UK on 1st January 2025, or it can be a UK authorisation granted by the MHRA after 1st January 2025.
The second scenario relates to SPC applications where the filing deadline is six months from grant of the basic patent, i.e. the product was approved before patent grant, and where the first approval in the UK was an EMA authorisation granted before 1st January 2025. The applicant will not be able to rely on the EMA authorisation at the time of filing the SPC application, because it will have lapsed on 1st January 2025 and thus will no longer be a valid authorisation in the sense of Article 3(b) of the retained SPC Regulation. Instead, they will have to rely on an MHRA authorisation. This causes an issue because the MHRA authorisation will not be the first authorisation in the UK in the sense of Article 3(d) in view of the previous existence of the EMA authorisation, but the transitional provisions that will come into force on 1st January 2025 fix this issue by discounting the EMA authorisation as the first MA in the UK.
It should be noted that it would be possible in the second scenario for the SPC filing deadline to have been set by grant of the basic patent but for there not to be a valid marketing authorisation allowing the SPC to be filed because no MHRA authorisation has been granted yet. Applicants should therefore avoid allowing the basic patent to grant before an MHRA authorisation has been granted.
Changes for six-month SPC extensions
The EU SPC system provides the option for an SPC to be extended by six months after the regulator has issued a compliance statement regarding a paediatric investigation plan (PIP) for the medicinal product. This six-month SPC extension was retained in the UK following Brexit with revisions to accommodate the EMA’s jurisdiction over PIPs and compliance statements for NI (with the MHRA taking responsibility for these in the rest of the UK). Currently, the geographical scope of a six-month SPC extension in the UK corresponds to the geographical scope of the compliance statement relied upon in the request, with the option to expand the geographical scope of the six-month SPC extension by notifying the UK IPO of a further compliance statement for other parts of the UK at a later date (provided the SPC itself has effect in the relevant parts of the UK). The deadline for filing the initial six-month extension request, or a subsequent request to expand the geographical scope of the extension, is two years prior to SPC expiry. To add additional complexity, UK national case law allows SPC holders in some cases to file the request for a six-month extension by the deadline and provide the updated marketing authorisation and PIP compliance statement after the deadline, once these have been issued.
While six-month SPC extensions will continue to be available in the UK after 1st January 2025, the relevance of compliance statements from the EU and/or MHRA varies depending on the dates involved.
The current system for six-month SPC extensions, including the possibility to rely on compliance statements issued by the EMA, will continue to apply after 1st January 2025 to any granted six-month extensions filed before 1st January 2025. The current system will also apply to pending applications for six-month extensions filed before 1st January 2025 where the requirements for grant of the six-month extension were met before 1st January 2025 or the deadline for requesting the six-month extension fell before 1st January 2025. Where the initial six-month extension request was based on a PIP compliance statement for GB only there will no longer be any requirement to notify the UK IPO of a further compliance statement for the rest of the UK because from 1st January 2025 the six-month extension will automatically extend to cover NI (in line with the expansion of the GB marketing authorisation as a whole).
Applications for a six-month extension filed after 1st January 2025 will be available on the basis of an updated MHRA authorisation only (either a GB authorisation granted before 1st January 2025 or a UK authorisation) and will then cover the whole of the UK. Pending applications for a six-month extension filed before 1st January 2025 where the deadline fell on or after 1st January 2025 and the requirements for grant of the six-month extension were not met before this date will also be granted on the basis of an updated MHRA authorisation only. This ensures that innovators cannot pre-emptively file a six-month extension application before 1st January 2025 in order to preserve the opportunity to obtain a six-month extension on the basis of an EMA PIP compliance statement if this is issued later.
This means that an EMA compliance statement can be used to obtain a six-month extension covering Northern Ireland only if the request is filed before 1st January 2025 and (i) meets the requirements for grant of the six-month extension before 1st January 2025 or (ii) the deadline for filing the six-month extension application expires before 1st January 2025. Consequently, if an EMA PIP compliance statement has already been issued, and there is a chance that it will not be possible to file a valid six-month extension application after 1st January 2025 because an MHRA PIP compliance statement may not be issued by the deadline for filing a six-month extension application (i.e. two years prior to unextended SPC expiry), an application based on the EMA PIP compliance statement should be filed before 1st January 2025 to ensure that a six-month extension will at least apply in Northern Ireland. Similarly, if the deadline for filing the six-month extension application expires before 1st January 2025 and a PIP compliance statement is expected to be issued by the EMA but not the MHRA by the deadline for filing a six-month extension application, it may be beneficial to file an application based on the expected EMA PIP compliance statement prior to 1st January 2025.
Effect of changes on term and filing deadlines for SPCs
The deadline for filing a UK SPC will remain 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 will remain determined by the date of the first approval in the UK or EEA. Consequently, EMA authorisations issued after 1st January 2025 will no longer be relevant to SPC filing deadlines in the UK (because these will no longer constitute a first approval in the UK), but they will remain relevant to the term of UK SPCs.
Summary
So, while the objective is a clear new system in which a single UK approval from the MHRA results in a single SPC, the journey to get there will be quite complex.
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 MHRA 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. Innovators should also consider the applicability of the niche scenario discussed above in which it may be beneficial to file a six-month extension application by 1st January 2025.