What will change and what will stay the same after the transition period in relation to Supplementary Protection Certificates (SPCs) and patent law: information for businesses, legal representatives, and UK rights holders.
Stay up to date
The UK has left the EU. This page tells you what you need to do from 1 January 2021. Follow current information about SPCs and patents until then.
This guidance is relevant if you:
- own a patent or supplementary protection certificate (SPC) in the UK
- license or use others’ UK patents or SPCs
- are applying for a patent or SPC which will have effect in the UK
- are involved in legal proceedings relating to a UK patent or SPC
The Patents (Amendment) (EU Exit) Regulations 2019 (“the Patents Regulations 2019”) will come into effect at the end of the transition period on 31 December 2020. These regulations will bring current EU legislation into UK law as far as possible, to maintain current systems and processes.
Changes to SPC law
Authorisations from the European Medicines Agency
Authorisations from the European Medicines Agency will be converted into equivalent UK authorisations on 1 January 2021. Guidance on the conversion process is available from MHRA.
If you rely on an authorisation from the European Medicines
Agency as the basis for the SPC, you may be asked to provide information on the converted UK authorisation after 1 January 2021, so that this can be recorded on the register. This will not affect the validity of your SPC.
New applications for a paediatric extension
Current EU law provides for a 6-month extension to SPCs which protect medicines that have been tested for paediatric use.
From 1 January 2021, the availability of this extension will be determined based on equivalent provisions in the UK’s Human Medicines Regulations 2012.
The process of applying for an extension will remain the same. You will still be able to make the request at the same time as filing the SPC application, or at any point up to 2 years before the SPC expires.
You will need to meet the same requirements to be given the extension. The only exception is that you will no longer need to provide evidence of authorisations covering the product across the EEA.
In July 2019, a new EU law introduced a manufacturing waiver to the SPC system.
As this new law came into force after the Patents Regulations 2019 were made on 4 April 2019, it has not been fixed by those Regulations so that it works correctly as UK law after the transition period. A call for views on draft modifications to fix the manufacturing waiver law ran from 5 July to 9 August 2019. We are considering the final form of legislation to be laid before Parliament in light of these responses.
SPC law: what stays the same
The Withdrawal Agreement ensures that SPC applications which are pending at the end of the transition period will be examined under the current framework. Any SPC which is granted based on those applications will provide the same protection as existing SPCs.
Applying for an SPC
From 1 January 2021, you will apply for an SPC in the same way: by submitting an application to the Intellectual Property Office (IPO).
The same timescales for when the application must be filed will apply.
You will need to provide the same documentation and evidence as currently required. This includes information on both the UK marketing authorisation and the earliest marketing authorisation for this product in the EEA, if it predates the UK authorisation.
Existing SPCs and SPC applications
If you have an SPC that has already taken effect, it will remain in effect after 31 December 2020. SPCs granted but not yet in force will come into force at the end of the associated patent term as normal.
If you have a pending application for an SPC, it will continue to progress. You will not need to refile.
Requirements for getting an SPC
The current EU law states that an SPC can only be granted if the product is protected by a patent, and covered by a marketing authorisation, in the member state where SPC protection is being sought. This will not change.
You must have a patent that is valid in the UK, and a marketing authorisation which allows the product to be sold on the UK market at the time you apply for an SPC.
This includes authorisations granted by the Medicines and Healthcare products Regulatory Agency (MHRA), and any authorisations granted by the European Medicines Agency which have been converted into UK authorisations.
Duration of an SPC
An SPC filed after the end of the transition period will get the same term of protection as it would if filed before. This will still be calculated based on the first authorisation to place the product on the market in either the UK or the EEA.
After the end of the transition period, the IPO will continue to have the power to charge fees on SPCs. The fees will not change on 1 January 2021. They will remain as set out in the Patents (Fees) Rules 2007.
Existing paediatric extensions
If you have already been granted a paediatric extension to an SPC or have an application for one pending before the IPO, the existing requirements will still apply.
This means that proof of authorisations in all EEA states will still be needed before the extension can be granted, and existing extensions can still be challenged on this basis.
A transitional provision is included in the Patents Regulations 2019 to ensure it is clear which version of the requirement applies in any particular case.
Challenging and enforcing SPC rights
The current EU law states that the validity of an SPC or a paediatric extension can be challenged before whichever national body is responsible for handling patent revocation actions.
Infringement of an SPC is to be dealt with in the same way as infringement of the original patent. In the UK, this is normally through the civil courts or, in theory, before the IPO.
From 1 January 2021, you will still be able to bring these actions before the IPO or the courts on the same grounds as before.
The Patents Regulations 2019 only replace the general references to national bodies with specific references to the UK authorities.
Changes to patent law
A few specific areas of the patents process have been adjusted by the Patents Regulations 2019.
Cross-licensing with plant variety rights
At present, UK law allows holders of overlapping patents and plant variety rights to apply for compulsory licences to prevent one right from interfering with the use of the other.
From 1 January 2021, Community plant variety rights will no longer have effect in the UK. You will not be able to use them to get a compulsory licence on a patent in the UK.
You will still be able to do so based on UK plant breeders’ rights. This will include Community plant variety rights that are converted to UK rights at the end of the transition period.
Security for costs
The Patents Rules contain provisions on when a party to proceedings before the IPO can be required to provide security for costs or expenses incurred by the other side.
The EU’s arrangements for civil judicial cooperation mean that an EEA resident cannot be the subject of an order to provide such security.
From 1 January 2021, the UK will fall outside of those arrangements and the exception will no longer apply.
The Patents Regulations 2019 remove the exemption for EEA residents, so that any person resident outside the UK may be subject to an order for security.
Patent law: what stays the same
Patent applications and existing rights
You can continue to apply for, and be granted, a patent by the Intellectual Property Office (IPO).
Pending applications for patents will continue to be assessed on the same basis.
The requirements and processes for grant will not change, nor will the rights you obtain when a patent is granted. Any existing rights and licences in force in the UK will remain in force after the transition period. If legal proceedings involving these rights or licences are underway, they will continue unaffected.
UK patent protection and representation at the European Patent Office
You can continue to apply to the European Patent Office (EPO) for patent protection which will cover the UK.
Existing patents from the EPO are also unaffected.
UK-based European Patent Attorneys can continue to represent applicants at the EPO. Please see the notice published by the European Patent Office.
The UK will continue to be a participating state in the European Patent Convention.
Patenting biotechnological inventions
The conditions for patenting biotechnological inventions will remain in place.
UK, EU and third country businesses as patent holders, third parties and applicants can continue to make decisions on the basis of the current legislation.
Patent examiners will continue to apply the same law when scrutinising patent applications in this area. Third parties who wish to challenge the validity of a patent will be able to do so on the same grounds as at present.
UK, EU and third country businesses will continue to be able to obtain a compulsory licence for manufacturing a patented medicine to meet a specific health need in a developing country.
Pharmaceutical product testing
UK, EU or third country businesses can continue to rely on the exceptions from patent infringement provided for various studies, trials and tests carried out on a pharmaceutical product.
You will not need to change your legal representative, which can still be located in the UK, Isle of Man, or the EEA. Communications between patent attorneys and their clients will remain privileged, as this is not subject to EU membership.
Address for service
From 1 January 2021, you will continue to be able to use an address for service located in the UK, EEA, or the Channel Islands, and these will continue to be accepted by the IPO.
The Patents Regulations 2019 make a minor change only to clarify that the UK is no longer an EEA state.
Judgements of the Court of Justice of the European Union
After the Transition Period, it will no longer be possible for UK courts to make references to the Court of Justice of the European Union (CJEU) for interpretation of the SPC legislation and other retained EU law.
Judgements of the CJEU issued before 31 December 2020 will continue to apply to the retained EU law after the transition period. The amendments made by the Patents Regulations 2019 are written to have the same meaning as the original EU legislation, so that existing case law still applies.
From 1 January 2021, UK courts will continue to apply this existing CJEU case law in any SPC actions. SPC examiners will also take account of this existing CJEU case law when examining SPC applications. In addition, if the UK courts have referred a question to the CJEU before the end of the transition period and this question is still pending on 1 January 2021, then it will remain before the CJEU until its resolution.
Other than these pending referrals, UK courts will not be required to follow judgements of the CJEU issued from 1 January 2021 onwards. They may be taken into account, but it will be for the court to determine the extent to which the post-transition period case law applies. This will also apply to hearings before the IPO on SPC-related matters.
The database at legislation.gov.uk will contain information on retained EU law and any amendments made to it.
The IPO’s unofficial consolidations of the Patents Act, Patents Rules, and the patents specific sections of the Copyright, Designs and Patents Act will be updated with the relevant changes in time for the end of the transition period.