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Detailed guide: Changes to SPC and patent law after the transition period

Government Digital Service

January 30
16:49 2020

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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 UKs 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

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.

Fees

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 th

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