In December 2020, the UK Intellectual Property Office (“UKIPO”) published new guidance for the operation supplementary protection certificates in the UK following Brexit. The new supplementary protection certificate (“SPC”) regime came into effect from 1 January 2021 following the end of the Brexit transition period.
Territory of SPC applications
SPC applications will now be required to be based on a UK, Great Britain or Northern Ireland (“NI”) marketing authorisation (“MA”), and will be territory-specific to the underlying MA. Where an application for a new SPC meets the statutory requirements, an SPC will be granted which covers the same territory as the underlying marketing authorisation on which the application was based. For example, the protection from a successful SPC application based on a NI MA will cover NI only. If an SPC application based on an MA covering only part of the UK is successful, and the MA is expanded to cover another part or the whole of the UK before the SPC takes effect, that SPC can be expanded to cover the additional territory.
Examination of SPCs
The process for examining SPC applications remains unchanged from the process previously operated before Brexit, namely that the product must not already be covered by an existing SPC, the product must be protected by a basic patent protected, and the MA must be the first MA for that product in the relevant territory and valid for marketing that product.
Existing SPCs and SPC applications
SPCs that have already been granted to a product will continue to be valid in the UK. Pending applications made to the UKIPO before 1 January 2021 will continue unaffected and will be examined under the old framework, even where the underlying marketing authorisation is split from a UK MA into separate GB and NI MAs.
The SPC application process itself remains largely unchanged – the forms have been updated but applications are still submitted to the UKIPO for examination and the applicable fees are the same as under the previous SPC regime. The relevant deadlines are also unchanged, the application window being six months from the later of the date of grant of either the patent or the MA. Where multiple MAs apply, for example a GB and an NI MA, the relevant date for calculating the deadline is the earlier of those MAs. SPC applications may be made based on MAs which pre-date 1 January 2021 provided they were made before the relevant deadline.
How long the SPC lasts is calculated based on the first authorisation to place the product on the market in the UK or anywhere in the European Economic Area. If applied for on the basis of an authorisation which only allows you to sell the product in part of the UK, then the protection provided by the SPC will only extend to that territory, and it cannot be extended further once the SPC takes effect. If that authorisation is later withdrawn, the SPC will lapse. If the SPC relies on more than one authorisation covering different parts of the UK, the protection provided by the SPC will extend to all territories covered by those authorisations. If one of those authorisations is withdrawn, the protection provided by the SPC will cease to apply in that territory, but will continue to apply in territories covered by other prevailing MAs. If all other MAs are withdrawn, the SPC will lapse.
As under the previous European SPC regime, a six-month paediatric extension to an SPC for a product tested for use with children is available. Applications for a paediatric extension will still need to be made no later than two years before the date the SPC is due to expire. Applicants for the paediatric extension no longer need to provide evidence of MAs in the member states of the EU, however, as per the aforementioned principle that pending applications made before 1 January 2021 are subject to the previous framework, the requirement to provide evidence of MAs in the Member States of the EU still applies in this instance.
UK SPC manufacturing waiver
The SPC manufacturing waiver will continue to be available for UK SPCs. In order to rely upon the UK SPC manufacturing waiver, third parties manufacturing SPC-protected products or their ingredients in the UK will need to submit a new form to notify the IPO no later than three months before starting manufacturing. The UK SPC manufacturing waiver will otherwise operate as it did before 1 January 2021, allowing third parties to manufacture SPC-protected products or their ingredients in the UK without requiring the approval of the relevant SPC holder where the purpose of that third party is either to export those products outside of the UK or the EU, or for stockpiling to sell in the UK or the EU once the SPC expires, this latter purpose is limited to stockpiling in the UK only in the final six months of the SPC period).