SPCs and the Northern Ireland Protocol
How the Northern Ireland Protocol affects supplementary protection certificates (SPCs), and what it means you need to do when applying for an SPC and afterwards.
The Northern Ireland Protocol
The Northern Ireland Protocol is part of the Withdrawal Agreement, which came into effect on 1 January 2021. The Protocol contains provisions to avoid a hard border between Northern Ireland and the Republic of Ireland. These include the requirements which apply when placing goods on the market in Northern Ireland.
As a result, EU legislation regulating medicines and pesticides continues to apply in Northern Ireland. UK domestic legislation applies in Great Britain. Marketing authorisations granted by the European Medicines Agency (EMA) continue to apply in Northern Ireland. In Great Britain, existing EMA authorisations have been replaced by UK authorisations effective in Great Britain only.
You can find links to guidance on medicines and pesticides regulation at the end of this page.
What it means for SPCs
Because the grant of an SPC depends upon marketing authorisations, the SPC legislation reflects the effect of the Northern Ireland Protocol; this guidance explains what that means in practice.
An SPC application can be filed based on any marketing authorisation which allows the patented product to be placed on the market in any part of the UK. Authorisations may be granted under UK or EU law and may cover the UK, Great Britain only, or Northern Ireland only. We refer to these as “UK authorisations”, “GB authorisations”, and “NI authorisations” respectively.
If the application meets the statutory requirements, an SPC is granted. The protection provided by that SPC will cover the same territory as its marketing authorisation (for example, if the marketing authorisation is for Northern Ireland only, the protection will also cover Northern Ireland only).
If a further valid marketing authorisation for the same product covering another part of the UK is granted before the SPC takes effect, then the protection provided by the SPC can be expanded to cover the additional territory.
In each case, the authorisation must be the first authorisation for the product in its specific territory.
The six-month extension which can be given to an SPC for a product tested for use in children (“the paediatric extension”) remains available. The protection it provides depends on the protection provided by the SPC, and the territory of the marketing authorisation which qualifies for the extension.
What you need to do
Existing rights and pending applications
SPCs that have already been granted continue to be valid. You do not need to take any action.
If you filed an application for an SPC before 1 January 2021, and the IPO had not yet granted or refused it by that date, the application continues unaffected. The IPO will examine your application based on a version of the SPC legislation without the effects of the Protocol being applied. You can find details of this version of the legislation further below, under ‘More information’.
The Protocol may mean that the marketing authorisation your SPC or application relies on has changed. For example, a UK marketing authorisation may have been replaced with a combination of GB and NI authorisations. In that case, your SPC or SPC application will continue as though the combination is a single authorisation. The legislation takes this into account. We may ask for the details of the replacement authorisations if they are needed for the processing of your application.
The Protocol does not affect the application process for an SPC. You must submit an application to the IPO for examination, using the standard forms and paying the statutory fees. You must file your application:
- within six months of the marketing authorisation being granted, or
- within six months of the patent being granted, whichever is later
This applies no matter what type of authorisation you are using, including authorisations granted by the EMA.
If you have been granted more than one authorisation covering different parts of the UK when you come to file your application, you must file the application within six months of the earliest of those authorisations being granted. Otherwise, your application may be refused.
You must provide the number and date of all the UK, GB, or NI authorisations granted before you file the application, as well as copies of each.
If you have any authorisations granted in the European Economic Area (EEA) which predate the earliest of your UK, GB, or NI authorisations, you must provide details of the earliest such authorisation. These details are needed to determine the duration of your SPC.
Applying using pre-2021 authorisations
You can file SPC applications based on marketing authorisations granted before 1 January 2021. Your authorisation will be treated in the same way as a UK, GB, or NI authorisation, and your application will be examined on the same basis.
But if the marketing authorisation has been changed as a result of the Protocol, you should apply based on the changed authorisation. For example, if your pre-2021 authorisation has become a combination of GB and NI authorisations, you should apply with both authorisations and provide details of each.
As part of the examination process, IPO examiners will check whether your application meets the following requirements:
- that the product is protected by the patent
- that the authorisation (UK, GB, or NI) is valid to place the product on the market
- that the product does not already have an SPC
- that the authorisation is the first authorisation for the product in its particular territory
Notifying the IPO of further authorisations
For the protection provided by the SPC to cover additional territory, you must notify the IPO of the further authorisation:
- within six months of the additional authorisation being granted, and
- before the date your SPC takes effect (that is, no later than the day your patent expires)
To notify the IPO, you must submit form SP6. You must provide the IPO with the number and date of the further authorisation. You must also provide a copy of the authorisation itself.
If you do not provide notification, or if you provide the notification late, the protection provided by your SPC will not cover that part of the UK.
The IPO will publish the information you provide on its register once we receive your notification. We will also publish information on the territory that the further authorisation covers.
What happens when the SPC takes effect
Your SPC will take effect at the point the basic patent expires. How long your SPC lasts will be calculated based on the first authorisation to place the product on the market in the UK or anywhere in the EEA.
If your SPC relies on an authorisation which only allows you to sell the product in part of the UK, then the protection provided by your SPC will only extend to that territory. You will not be able to extend it further once the SPC take effect. If that authorisation is later withdrawn, the SPC will lapse.
If your 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 stop applying in that territory. If all of the authorisations are withdrawn, the SPC will lapse.
You can request that the paediatric extension applies to your SPC by filing form SP4 and paying the associated fee. You must make the request no later than two years before your SPC is due to expire.
You will need to:
- provide a copy of the statement in your authorisation approving the outcome of the paediatric investigation plan
- include information on the territory which that authorisation covers
- identify the SPC or SPC application which the request relates to
(Requests for an extension that were still pending on 1 January 2021 must also provide evidence of authorisations in the Member States of the EU.)
If your SPC relies on more than one authorisation, you can make a single request based on all of them, or separate requests based on each one. You must file all of your requests before the two-year deadline.
If you make the request while the SPC is in force, the paediatric extension will only apply in a territory where the SPC already provides protection. The paediatric extension only extends the duration of your SPC. It does not allow the protection provided by the SPC to cover additional territory on its own.
If you make the request before the SPC takes effect, and your authorisation also allows the protection to cover additional territory, both the SPC and the paediatric extension can apply in the additional territory.
If you only meet the requirements for the paediatric extension in part of the territory your SPC provides protection, the extension will only have effect in that part. If you meet the requirements in another part later, you will be able to make a separate request for the paediatric extension to apply in that territory by filing another form SP4. You must also make this request before the two-year deadline.
The manufacturing waiver was introduced in July 2019. It allows a third party to make an SPC-protected product, or its ingredients, in the UK without needing the approval of the SPC holder. This is only allowed where the purpose is to export the product outside of the UK or the EU, or (in the last six months of the SPC) for stockpiling to sell in the UK or the EU once the SPC expires.
If you are a third party, you must notify the IPO and the SPC holder that you intend to rely upon the waiver no later than three months before starting to do so. In order to notify the IPO, you must complete and submit form SP5.
To help you follow the legislation, the IPO has put together a version of the SPC Regulations as they currently operate. This is an informal consolidation and has no legal effect.
The IPO has also put together a document setting out all of the changes that have been made to the SPC Regulations by various pieces of EU Exit legislation.
If you had filed an application for an SPC before 1 January 2021, and it was still pending on that date, the IPO will examine it based on a different version of the SPC Regulations. These are provided below.
The Manual of Patent Practice will be updated to fully reflect these changes in its October 2021 update. You should continue to consult this page in the meantime.
For more information on the regulatory system in operation in the UK, you should consult:
- the Medicines and Healthcare products Regulatory Agency’s guidance on human medicines regulation
- the Veterinary Medicines Directorate’s guidance on veterinary medicines regulation
- the Health and Safety Executive’s guidance on plant protection product regulation
Last updated 1 June 2021 + show all updates
Updated to reflect that the legislation is in force and the new processes are operating.