Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence medicines across the whole of the UK. The changes to the UK licensing regime will have knock-on effects on the Supplementary Protection Certificate (SPC) framework. To accommodate for this, The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (the Windsor Framework SPC Regulations) were laid before Parliament on 31 October 2024 to come into force on 1 January 2025. This will amend the existing assimilated Regulation (EC) No 469/2009 as it applies in the UK.
Although the UK SPC application process will eventually be simplified, the Windsor Framework SPC Regulations insert new definitions and additional provisions, as well as an Annex setting out transitional arrangements to address issues relating to territorial scope, validity, duration, expiry and paediatric extensions.
Windsor Framework key changes to licensing regimes
We provided a summary of the key principles of the Windsor Agreement in this BioSlice Blog. Notably for this blog, from 1 January 2025, centralised marketing authorisations granted by the European Commission (EUMAs) will no longer have effect in Northern Ireland. Current marketing authorisations covering Great Britain (GBMAs) will automatically have effect throughout the UK. Where a medicinal product is covered by both a Great Britain and Northern Ireland marketing authorisation, a choice should have been made as to whether to surrender the Northern Ireland marketing authorisation (NIMA) by 30 September 2024, as otherwise the GBMA will be revoked. From 1 January 2025, a single UK authorisation (UKMA) will generally (though not always) be the standard for new medicinal products.
The marketing authorisation (MA) scenarios for pending SPC applications, granted SPCs and new SPC applications filed on or after 1 January 2025 are summarised below:
Granted SPCs and pending SPC applications
Whether any action is required after 1 January 2025 will depend upon the type of MA relied upon and whether further MAs are granted in the UK before an SPC comes into effect.
- UKMA only
Where the SPC was sought on the basis of a UKMA, no action will be required.
- EUMA together with a GBMA
No action required. EUMA will no longer be effective in Northern Ireland. The GBMA will take effect throughout the UK and the territorial scope of the SPC based on that authorisation will continue to cover the UK unless a GBMA was granted after the SPC came into force, in which case the SPC will cover Northern Ireland only.
- EUMA only
Any SPCs already in force will be deemed to be withdrawn. Where you have a pending application, examination will proceed as normal but the UK Intellectual Property Office (UKIPO) will need to be notified of the existence of a valid UK authorisation within six months of its grant and before the patent expires so that the SPC can come into effect.
- NIMA together with a GBMA
SPCs will no longer be valid or take effect in Great Britain, unless the NIMA is surrendered by 30 September 2024 in which case the SPC will continue to be valid throughout the UK. Similarly, SPC applications will only take effect throughout the UK if the NIMA is surrendered by 30 September 2024.
- GBMA only
No action required in most cases. If an EUMA or NIMA is granted before 1 January 2025, notification to the UKIPO will be needed within six months of grant of the authorisation. If no notification is made, the SPC will not apply in Northern Ireland.
The scenarios described above are summarised below:
New SPC applications after 1 January 2025
An SPC application must be submitted on the basis of a valid MA. Therefore, new SPC applications should generally not rely on a EUMA from January 2025. There is a limited exception if:
- the EUMA was granted before 1 January 2025;
- the application deadline is set by the grant of the MA; and
- the SPC application deadline is no later than 30 June 2025.
In the above scenario, a valid UK authorisation must be in place by the time the patent expires for the SPC to come into effect. UKIPO notification requirements will also apply to this authorisation.
Moreover, if the patent is granted after the grant of the MA, a EUMA will not negatively impact the assessment of whether the authorisation is the first granted for the product in the UK.
Implications for Paediatric Extensions (PE)
When submitting new PE applications after 1 January 2025, it will no longer be possible to rely on a EUMA. However, applications made before that date will be assessed in accordance with the existing (pre-reform) law.
PEs which have already been granted will be valid across the whole of the UK if based on a GBMA. However, where the PE was granted based on a NIMA, a request will need to be made to include Great Britain in the extension, presuming there is such an authorisation in place.
SPC Duration
Regrettably, a post-Brexit anomaly has not been addressed by the Windsor Framework SPC Regulations – if an MA is granted anywhere in the EEA that predates the first MA granted in the UK for that product, the MA granted in the EEA will need to be filed before the UKIPO and will be determinative for calculating the duration of the SPC.
We would be happy to provide further guidance if you would like to discuss the impact of the Windsor Framework SPC Regulations on your SPC portfolio.