The UK IPO has now issued guidance on changes to the Supplementary Protection Certificates (SPCs) system in the UK which will take effect from 1 January 2025. These changes are required in light of the implementation of provisions of the Windsor Agreement which change how Marketing Authorisations (MAs) for human medicinal products will be authorised in the UK. The guidance from the UK IPO can be found here.
The changes will simplify the procedure for applying for new SPCs in the UK. Details of only one marketing authorisation in the UK as the basis for your SPC will need to be provided. Any SPC that is granted will generally have effect across the whole of the United Kingdom.
However, the changes will also impact existing SPCs and applications, and requests for paediatric extensions. Transitional arrangements have been put in place and we summarises the main effects of these changes and arrangements below. The article concerns the effects for SPCs on human medicinal products.
Current position
Since Brexit, central authorisations granted by the European Medicines Agency (EMA) have still had an effect in Northern Ireland. Whilst the UK Medicine and Healthcare Products Agency (MHRA) could grant authorisations that covered Great Britian (GB) only (not covering NI), Northern Ireland only, or the whole of the United Kingdom (UK).
This meant that in order for any SPC to cover the full territorial scope of the UK, it was necessary to ensure you had Marketing Authorisations that would also cover the full scope territorial scope of the UK. In practice this has often meant SPCs for human medicinal products in the UK have been based on both a MHRA GB authorisation and a centralised authorisation (for Northern Ireland).
Main changes
From 1 January 2025 the main changes with respect to the authorisation of human medical products are:
-
Centralised authorisations issued by the EMA will no longer have any effect in Northern Ireland
-
Existing GB authorisations will have an effect across the whole of the UK. These will now become UK authorisations. (such authorisations will keep their PLGB prefix identifier)
-
Holders of GB and NI authorisations for the same product must have surrendered their NI authorisation by 30 September 2024.
-
Going forward a single UK authorisation having an effect across the whole of the UK will be the standard for new and innovative drugs in most circumstances.
The guidance from the UK IPO identifies some common scenarios that the UK IPO believe will be relevant to parties in light of these changes, and what if any action may need to taken.
Impact on existing SPCs and applications
SPC relies on a centralised authorisation and a GB authorisation.
SPC relies on a centralised authorisation only (i.e. for covering Northern Ireland only, with no GB related MA). These would be SPCs filed post-Brexit. The centralised authorisation will be treated as being withdrawn on 1 January 2025.
-
If the SPC application is filed but not yet granted, this will not effect the examination of the application. However if the SPC does grant, it will be necessary to have a UK authorisation in place before the patent expires for the SPC to come into effect.
-
If the SPC 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.
-
If 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 Northern Ireland, but it will be based on the GB authorisation that will apply in Northern Ireland as a UK authorisation from 1 January 2025.
If the SPC relies on a GB authorisation only.
If the SPC relies on a NI authorisation and GB authorisation. In this situation for the UK IPO may write to the applicant to confirm the status of the authorisations.
-
If the NI authorisation has been surrendered, there will be no overall effect on the SPC. The GB authorisation will replace it automatically as it takes effect across the whole of the UK.
-
If the NI authorisation has not been surrendered, the SPC will no longer provide protection in Great Britain from 1 January 2025.
If the SPC relies on a UK authorisation.
New SPC applications
From the 1 January 2025, in most situations it will only be possible to base a new SPC application on a UK MHRA. As it will no longer be possible to base an SPC on a centralised EMA MA, the deadline for filing an SPC in the UK may differ from the deadline in EU countries.
However it will be required to provide details of the earliest authorisation for the product in the European Economic Area if that predates that UK authorisation. This is required to determine the duration of the SPC. This will include any centralised authorisation that predates the UK authorisation.
Transitional provisions for new applications
There are transitional provisions where it is still possible to file an SPC at the UK based on a centralised EU MA after the 1 January 2025 for a limited time, if:
-
the MA granted before 1 January 2025;
-
the 6 month deadline for filing the SPC application is set on the basis of the grant of the MA; and
-
the deadline for filing the SPC application expires after 1 January 2025.
This situation will typically apply if centralised MAs were granted between 1 July 2024 and 31 December 2024 and the deadline for filing the application expires at the latest on 30 June 2025. Any GB or UK MA granted before the application must also be filed at the same time. It will not be possible to use such an MA to file a separate application later.
Paediatric extensions
Currently when requesting a paediatric extension compliance statements from both the EMA and MHRA (e.g., based on a centralised and GB authorisation) may be required to ensure the extension covers the full territorial scope of the UK .
After 1 January 2025 a paediatric extension will only be available based on authorisations with proof of compliance from the MHRA. This applies even where the EU agreed the original paediatric investigation plan. The deadline for filing requests for paediatric extensions will not change and remains as 2 years before the expiry of the SPC.
Transitional provisions will provide for existing requests filed before 1 January 2025 based on a centralised authorisation to still be allowed. However, if you have an extension or pending request based on a centralised or NI authorisation, it will still be necessary to file a request to include GB in that extension, if not already done.
-
If a statement of compliance has been issued by the EMA for an SPC based on a centralised authorisation, Applicants may wish to consider filing their request for a paediatric extensions before 1 January 2025, whether or not a compliance statement has also been issued for the GB or UK authorisation. If such a request based on a EMA compliance statement is not filed by the 1 January 2025, it will be necessary to rely on the MHRA compliance statement for the paediatric extension across the whole scope of the UK.
Any extensions already granted or pending requests based on a GB authorisation will automatically extend to cover Northern Ireland. No Action is required.
What is not changing
-
The deadline for filing an SPC application will still depend on whether your patent or marketing authorisation is granted first.
-
You will still need to provide details of the earliest authorisation for the product in the European Economic Area if that predates that UK authorisation. This is required to determine the duration of the SPC.
Summary
The new SPC system will simplify the procedure for new SPC applications going forward. In most situations no additional action will be required to ensure your existing SPCs or pending applications remain pending/in force after 1 January 2025. However, even if the deadline for filing a request for a paediatric extension is still some way off, if a compliance statement from the EMA has already been received, you may wish to consider filing the request before 1 January 2025.
The UK IPO has advised that they consider that the transitional provision and guidance provided should cover all cases and situation that are currently aware, but to do contact them if there are any questions.
If you have any question regarding the changes, and the impact these may have on your existing SPCs or future SPC strategy, including for SPCs for veterinary medicinal products or plant protection products, please don’t hesitate to contact Nick Bassil, Dayle Callaghan, Ben Heller, or your usual Kilburn & Strode advisor.