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This publication is available at https://www.gov.uk/government/publications/changes-to-spc-and-patent-law-if-uk-leaves-the-eu-without-a-deal/changes-to-spc-and-patent-law-if-the-uk-leaves-the-eu-without-a-deal
Leaving the EU with a deal remains the government’s top priority; this has not changed. However, a responsible government must plan for every eventuality.
If the UK leaves the EU without a deal, the Patents (Amendment) (EU Exit) Regulations 2019 (“the Patents Regulations”) will enter into force on exit day. Under the European Union (Withdrawal) Act 2018, EU law relating to patents will be retained in UK law at that time. These regulations ensure that the retained law makes sense and continues to work as UK law outside the EU.
This guidance relates to patents and Supplementary Protection Certificates (SPCs) and sets out the changes we are making through the Patents Regulations in the event of no deal. This guidance will cover the effect of the legislation on UK right holders, businesses, and other organisations.
This guidance complements the technical notice on patents and SPCs published on 24 September 2018.
Why these changes are needed
Most of UK patent law comes from the Patents Act 1977 and the Patents Rules 2007. Some parts of that law come from, or were written to implement, EU legislation. There are also a few pieces of EU law which relate to patents.
In particular, the SPC system, which provides for an additional period of IP protection for medicines and agrochemicals was set up under EU law which applies across all Member States.
As this legislation was written to apply to the EU, it includes references to the EU, the European Economic Area (EEA) and Member States, as well as to other EU law. Once the UK has left the EU, these references would stop working. In some cases, this would mean that parts of the current system are not able to function. In others, it would make the law more unclear and open to dispute. To avoid this, the Patents Regulations fix all of these references that would otherwise break.
In all cases, the intention is to maintain the current systems and processes, as far as is possible.
What is not affected
You can continue to apply for, and be granted, a patent by the Intellectual Property Office (IPO). The requirements and processes for grant will not change, nor will the rights you obtain when a patent is granted.
There are some specific areas which, although they come from EU law, are not changing. These include the law governing the patenting of biotechnological inventions, and the law allowing use of a patented product to get approval for a generic medicine (the “Bolar exception”). It also includes the privilege given to communications between patent attorneys and their clients, including patent attorneys outside the UK who are on the list of representatives at the European Patent Office.
Also, the UK will continue to be a participating state in the European Patent Convention, this is not an EU treaty, and does not require a country to be an EU Member State to participate. You can therefore 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. European Patent Attorneys based in the UK can continue to represent applicants at the EPO.
Changes to Supplementary Protection Certificate law
Holders of existing SPCs and existing applications
One of the principles of the Withdrawal Act is that anything that has effect under EU law before exit day will continue to have effect under the retained law after exit day, and any ongoing processes will also continue. This will apply to SPCs and applications for SPCs.
Therefore, if you already have a granted SPC, whether it is in force yet or not, it will remain in effect after exit day. SPCs granted but not yet in force will come into force at the end of the associated patent term as normal.
If you have an application for an SPC pending at the IPO, it will continue to progress through the examination process. You will not need to refile.
If you currently rely on an authorisation from the European Medicines Agency as the basis for the SPC, you may be asked to provide information on the equivalent converted UK authorisation, so that this can be recorded on the register.
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, in other words, in the UK.
After exit day, this requirement will not change. You must have a patent in force which 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 will include authorisations granted by the Medicines and Healthcare products Regulatory Agency, and any authorisations granted by the European Medicines Agency which have been converted into UK authorisations. (Guidance on the conversion process is available from MHRA.)
Applying for an SPC
The current EU law states that an application for an SPC should be made to the patent office of the relevant Member State.
After exit day, the law will simply state that the application must be made to the IPO.
You will apply for an SPC in the same way as at present, and the same timescales for when the application must be filed will apply.
You will need to provide the same documentation and evidence as is 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.
Duration of an SPC
The current EU law calculates how long SPC protection applies after the end of the patent term based on the time between filing the patent application and the first marketing authorisation which allows the product to be sold on the market in the EEA. Before exit day, this area includes the UK.
After exit day, this will still be calculated based on the first authorisation to place the product on the market in the territory of the UK or the EEA. As a result, an SPC filed after exit day will get the exact same term of protection as it would if filed before exit day.
The current EU law states that Member States “may” charge fees for certain SPC-related processes. We currently use the powers provided to the IPO in the Patents Act to charge such fees.
After exit day, we will continue to rely on those Patents Act powers as the basis for charging fees on SPCs. We are not changing the fees themselves, which remain as set out in the Patents (Fees) Rules 2007.
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. Similarly, 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).
After exit day, you will still be able to bring these actions before the IPO or the courts on the same grounds as before. The Patents Regulations only replace the general references to national bodies with specific references to the UK authorities.
The Patents Regulations also allow for the jurisdiction of the Unified Patent Court over SPCs to be recognised, in the event it comes into force. The UPC will have exclusive jurisdiction over SPCs based on patents granted by the European Patent Office.
After exit day, 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; however, CJEU judgments will still have relevance in this area, as set out below.
The current EU law provides for a six-month extension to SPCs which protect medicines which have been tested for paediatric use. This is available based on requirements which are set out in EU Regulation 1901/2006.
After exit day, the availability of this extension will be determined based on equivalent provisions being introduced into 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 two years before the SPC expires.
You will need to meet the same requirements to be given the extension. The product must have been the subject of a paediatric investigation plan, and the marketing authorisation must contain the statement that the relevant authority is satisfied that the plan has been complied with.
The only exception is that you will no longer need to provide evidence of authorisations covering the product across the EEA.
If you have already been granted an extension, or have an application for a paediatric extension pending before the IPO, the existing requirement will apply; so, 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 to ensure it is clear which version of the requirement applies in a particular case.
Judgments of the Court of Justice of the European Union
Under the Withdrawal Act, judgments of the CJEU that were issued before exit day will continue to apply to the retained EU law. The amendments made by the Patents Regulations are written to have the same meaning as the original EU legislation, so that existing case law on its interpretation still applies.
After exit day, the courts will continue to apply pre-exit CJEU case law in any SPC actions. SPC examiners will also take into account all of the relevant CJEU case law applicable before exit day, and examine SPC applications on that basis.
The courts will not be required to follow judgments of the CJEU issued after exit day, as these will not be binding. They may be taken into account, but it will be for the court to determine the extent to which the post-exit case law applies. This will also apply to hearings before the IPO on SPC-related matters.
Changes to patent law
A few specific areas of the patents process have been adjusted by the Patents Regulations to reflect the UK leaving the EU
Address for service
The Patents Rules require businesses to provide an address for service when communicating with the IPO. This is usually their legal representative. The address must be in the UK, another EEA state, or the Channel Islands.
After exit day, 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 make a minor change only to clarify that the UK will not be an EEA state after exit.
We will be updating our Patents Forms in due course to reflect this change.
Cross-licensing with plant variety rights
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. This is based on EU legislation. The rights eligible include Community plant variety rights granted by the EU.
After exit day, Community plant variety rights will no longer have effect in the UK, and so 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 rights that are converted to UK rights on exit day.
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.
After exit day, the UK will fall outside of those arrangements, and so the exception will no longer apply. The Patents Regulations remove the exemption for EEA residents, so that any person resident outside the UK may be subject to an order for security.
Unitary Patent and Unified Patent Court
The Unitary Patent and Unified Patent Court are not yet in force. Changes to the relevant law are therefore not needed for a no deal exit at this time. We intend to explore staying in the systems with our European partners. Whether changes are required, and what they will do, will depend on the outcome of those discussions.
If there is a deal
The Withdrawal Agreement provides for an implementation period, where existing EU law will continue to apply. If that Agreement is approved, the changes set out here will not be needed before the end of that period.
More information can be found on our IP and Brexit guidance, which contains links to technical notices and guidance related to other areas of intellectual property.
The database at legislation.gov.uk will contain information on retained EU law and any amendments made to deal with our departure from the EU. The IPO’s unofficial consolidations of the Patents Act, Patents Rules, and the patents specific sections of the Copyright, Designs and Patents Act will also be updated with the relevant changes in time for exit day.