16/12/2024
On 1 January 2025, new legislation will come into effect to implement the Windsor Framework. This will affect how supplementary protection certificates (SPCs) are obtained in the United Kingdom (UK) and their coverage.
The Windsor Framework is an agreement between the UK and European Union (EU) that concerns the supply of goods, including human medicines, from Great Britain (GB) to Northern Ireland (NI). The Windsor Framework aims to overcome some of the problems with the previous Northern Ireland Protocol, in order to protect the supply of human medicines to NI, and involves changes to how human medicines are authorised. As SPCs require a valid marketing authorisation, which must be the first marketing authorisation in the territory, changes to how human medicines are authorised affects SPCs for human medicines in the UK. However, the process for obtaining SPCs for veterinary medicines and for plant protection products remains unchanged; the Windsor Framework concerns only human medicines.
Currently, centralised authorisations granted by the European Medicines Agency (EMA) have effect in NI. However, centralised authorisations will be treated as withdrawn in relation to the territory of NI from 1 January 2025.
In addition, on 1 January 2025, GB marketing authorisations granted by the Medicines & Healthcare products Regulatory Agency (MHRA) will become transitioned UK marketing authorisations and their territorial scope will expand automatically to cover NI. Holders of a NI marketing authorisation issued by the MHRA for the same product as a GB authorisation must have surrendered their NI authorisation by 30 September 2024 for the GB authorisation to have effect across the whole of the UK.
SPC applications pending on 1 January 2025
For anyone with a pending SPC application on 1 January 2025 there are five likely scenarios:
- SPC application relying on a centralised authorisation and a GB authorisation: on 1 January 2025 the centralised marketing authorisation will be treated as withdrawn in relation to the territory of NI and the GB marketing authorisation will become a transitioned UK marketing authorisation covering NI. Therefore, the territorial scope of the SPC application will remain the same, with no action required.
- SPC application relying on a GB authorisation only: on 1 January 2025 the GB marketing authorisation will become a transitioned UK marketing authorisation covering NI. Therefore, the territorial scope of the SPC application will automatically extend to NI. No action is required, unless a centralised authorisation or NI authorisation is granted before 1 January 2025. If so, the UKIPO needs to be notified within six months of the grant of the authorisation.
- SPC application relying on a NI authorisation issued by the MHRA and a GB authorisation: provided the NI authorisation has been surrendered, on 1 January 2025 the GB marketing authorisation will be a transitioned UK marketing authorisation covering NI. Therefore, the territorial scope of the SPC application will remain unchanged. If the NI authorisation has not been surrendered, the SPC application will not cover GB from 1 January 2025.
- SPC application relying on a centralised authorisation only: on 1 January 2025 the centralised marketing authorisation will be treated as withdrawn in relation to the territory of NI. The SPC application will still be examined by the UKIPO, however if the SPC application is granted, a UK marketing authorisation will be required. This UK marketing authorisation needs to be granted before the patent expires. It is necessary to notify the UKIPO of the UK marketing authorisation within six months of the grant of the authorisation.
- SPC application relying on a UK authorisation only: such applications will be unaffected by the change in legislation on 1 January 2025.
SPC applications filed on or after 1 January 2025
There are also changes to the filing of new SPC applications on or after 1 January 2025. Centralised authorisations granted on or after 1 January 2025 cannot support a UK SPC application filed on or after 1 January 2025. However, in certain situations centralised authorisations granted before 1 January 2025 can be used to support UK SPC applications.
Whether or not you can use a centralised authorisation depends on whether the deadline for filing an SPC is set by the grant of the marketing authorisation or the grant of the patent.
Where the deadline for filing an SPC is set by the grant of the marketing authorisation, it is possible to rely on a centralised authorisation granted before 1 January 2025, provided that the SPC application is filed in the normal six month period from grant of the authorisation. The SPC application will be examined, but, in order for the SPC to come into force, a UK marketing authorisation needs to be granted before the patent expires. It is necessary to notify the UKIPO of the UK marketing authorisation within six months of the grant of the authorisation.
Where the deadline for filing an SPC is set by the grant of the patent, it is not possible to rely on a centralised marketing authorisation. The SPC application can rely on UK, GB or NI authorisations granted by the MHRA, including any transitioned UK marketing authorisation. Any centralised authorisation will not be considered when assessing Article 3d Regulation (EC) No 469/2009, i.e. any centralised marketing authorisation would not count against you when determining if your marketing authorisation is the first one granted for the product in the UK.
Paediatric extensions
Changes to paediatric extensions also come into force on 1 January 2025. For requests for a paediatric extension on or after 1 January 2025, it will not be possible to rely on a centralised authorisation.
Whilst the change in law leads to a number of transitionary provisions, going forwards the process for obtaining a UK SPC will be undoubtedly simpler.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
