What is changing

The types of marketing authorisations that apply in the UK will be changing on 1 January 2021. 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.

Because the grant of an SPC depends upon marketing authorisations, changes to the SPC legislation are necessary as a result. You can find the legislation on the legislation website this guidance explains what that means in practice.

From 1 January 2021, 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. If that application meets the statutory requirements, an SPC will be 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”) will still be available. The protection it provides will depend on the protection provided by the SPC, and the territory of the marketing authorisation which qualifies for the extension.

Why it is changing

The UK left the European Union on 31 January 2020. There is currently a transition period, where existing EU law continues to apply. The transition period ends on 31 December 2020. On 1 January 2021, the terms of the Withdrawal Agreement will come into effect.

The Northern Ireland Protocol is part of the Withdrawal Agreement. 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 will continue to apply in Northern Ireland. UK domestic legislation will apply in Great Britain. Marketing authorisations granted by the European Medicines Agency (EMA) will only apply in Northern Ireland. In Great Britain, GB authorisations will replace existing EMA authorisations.

You can find links to guidance on the changes to medicines and pesticides regulation at the end of this page.

What you need to do

Existing rights and pending applications

SPCs that have already been granted will continue to be valid. You will not need to take any action.

If you filed an application for an SPC before 1 January 2021, and the IPO has not yet granted or refused it, the application will continue unaffected. The IPO will examine your application based on the legislation without the changes discussed here being applied.

The Protocol may mean that the marketing authorisation your SPC or application relies on changes. For example, a UK marketing authorisation may be 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 will take this into account. We may ask for the details of the replacement authorisations if they are needed for the processing of your application.

Application process

The application process will not change significantly. You will still submit your application to the IPO for examination, using updated versions of the existing forms. The fees you pay will remain the same.

The current deadlines for filing an application for an SPC will also still apply. You must file the 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 will need to 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 will also need to 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 continue to file new SPC applications based on marketing authorisations granted before 1 January 2021. They will continue to be accepted, although your application will be examined under the new process. Your authorisation will be treated in the same way as a UK, GB, or NI authorisation.

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.

Examination process

The examination process will remain the same. The requirements your application must meet will be the same as before:

• the product must be protected by the patent
• the authorisation must be valid to place the product on the market
• the product cannot already have an SPC
• the authorisation must be 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. (This form will be available on the Patent forms and fees from 4 January 2021.) 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. 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, as normal. 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.

Paediatric extension

You will continue to be able to request that the paediatric extension apply to your SPC. You will continue to make a request using updated versions of the existing forms and paying the existing fees.

You will still need to make the request no later than two years before your SPC is due to expire, on form SP4. 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

You will no longer need to provide evidence of authorisations in the Member States of the EU. (Applications for the extension which are pending on 1 January 2021 must still meet this requirement.)

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.

Manufacturing waiver

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 that you intend to rely upon the waiver no later than three months before starting to do so.

From 1 January 2021, you must do this by completing and submitting form SP5. (This form will be available on the Patent forms and fees from 4 January 2021.) If you have already submitted a notification under the old form, the IPO will treat it as though you filed it using SP5.

There are no other changes to how the waiver operates.

More information

To help you follow the changes to the legislation, the IPO has put together a version of the SPC Regulations as they will operate from 1 January 2021. This is an informal consolidation and has no legal effect.

• Consolidated version of Regulation 469/2009 (RTF, 366KB)
• Consolidated version of Regulation 1610/96 (RTF, 164KB)

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.

• Marked up version of Regulation 469/2009 (RTF, 653KB)
• Marked up version of Regulation 1610/96 (RTF, 180KB)

If you have already filed an application for an SPC, and it is still pending on 1 January 2021, the IPO will examine it based on a different version of the SPC Regulations. These are provided below.

• Transitional version of Regulation 469/2009 (RTF, 299KB)
• Transitional version of Regulation 1610/96 (RTF, 130KB)

The Manual of Patent Practice will be updated to reflect these changes in its April 2021 update. You should consult this page in the meantime.

For more information on the changes to the regulatory system, you should consult:

• the Medicines and Healthcare products Regulatory Agency’s guidance on changes to human medicines regulation from 1 January 2021
• the Veterinary Medicines Directorate’s guidance on changes to veterinary medicines regulation from 1 January 2021
• the Health and Safety Executive’s guidance on changes to plant protection product regulation from 1 January 2021