Supplementary Protection Certificates after Brexit
The UK left the European Union on 31 January 2020. The legislation concerning current and future UK Supplementary Protection Certificates (SPCs) now that the UK has left the European Union is outlined in The Patents (Amendment) (EU Exit) Regulations 2019 2019 No. 801, which is outlined below.
Pharmaceutical or plant protection products need regulatory approval to be sold in the UK and must obtain a marketing authorisation, or product licence. A Supplementary Protection Certificate (SPC) compensates for the delay in obtaining regulatory approval and must be applied for nationally. A UK SPC can be based on a UK patent or a European (UK) patent. This will not change after Brexit.
Existing SPCs 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.
A pending application for an SPC will continue to progress and will not need to be refiled.
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 and therefore the SPC applicant 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 that the application is made.
Marketing authorisations that are valid in the UK currently are central marketing authorisation issued by the European Medicines Agency (EMA) and UK national authorisations issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Post-Brexit, marketing authorisations from the EMA will be converted into equivalent UK authorisations without a fee. Therefore, converted central EMA authorisations and UK national authorisations will be considered valid in the UK.
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 end of the transitional period for the UK leaving the EU), 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.
If you need any advice or assistance, please contact our SPC expert Charlotte Teall.