Guidance

Changes to SPC and patent law after Brexit

What will change and what will stay the same in relation to Supplementary Protection Certificates (SPCs) and patent law: information for businesses, legal representatives, and UK rights holders.

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The UK is leaving the EU. This page tells you how to prepare for Brexit and will be updated if anything changes.

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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 (“the Patents Regulations”) will come into effect on exit day. 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 Brexit. 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, 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.

After Brexit, 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.

Manufacturing waiver

Since the Patents Regulations were made on 4 April 2019, a new EU law has introduced a manufacturing waiver to the SPC system.

The new law will be retained after Brexit but additional fixes are needed to make sure it works correctly. A call for views on these modifications ran from 5 July to 9 August 2019, and final legislation will be passed through Parliament.

SPC law: what stays the same

Applying for an SPC

After exit day, 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 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 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 exit day will get the same term of protection as it would if filed before exit day. This will still be calculated based on the first authorisation to place the product on the market in either the UK or the EEA.

Fees

After exit day, the IPO will continue to have the power to charge fees on SPCs. The fees will not change on Brexit. 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 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.

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.

Changes to patent law

A few specific areas of the patents process have been adjusted by the Patents Regulations.

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.

After exit day, 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 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 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.

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 UK leaves the EU. 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.

Compulsory licensing

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

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 Brexit.

Judgments of the Court of Justice of the European Union

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 and other retained EU law.

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, UK courts will continue to apply pre-Brexit CJEU case law in any SPC actions. SPC examiners will also take into account of the relevant CJEU case law applicable before exit day. They will examine SPC applications on that basis.

UK 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.

Further information

The database at legislation.gov.uk will contain information on retained EU law and any amendments made to deal with Brexit.

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 exit day.

Published 17 October 2019