A Supplementary Protection Certificate (SPC) extends patent protection for qualifying authorised medicines for up to five years to compensate the patent holder for delays in bringing the drug to market resulting from the need to obtain marketing authorisation (MA).
What will change after Brexit?
The SPC regime was established under EU law and applies across all Member States. However, SPCs are applied for on a national basis. Following the end of the Brexit transition period on 31 December 2020, the UK intends to set up its own SPC scheme, which will be broadly aligned with the EU regime. This means that in practice relatively little will change for applicants. Applications for SPCs will continue to be made to the UK Intellectual Property Office. However, there will be some changes effective from 1 January 2021. In particular:
- A UK SPC holder relying on an authorisation from the European Medicines Agency as the basis for the SPC may have to provide information about the converted UK authorisation, so that this can be recorded on the register. This this will not affect the validity of the SPC.
- The EU SPC regime currently provides for a 6-month extension to SPCs where there has been testing for paediatric use. Similar extensions will be available under the UK’s Human Medicines Regulations 2012, with the advantage that it will no longer be necessary to provide evidence of corresponding MAs across the European Economic Area (EEA).
- When applying for a new UK SPC, it will be necessary to provide details of the first corresponding UK MA and in addition any earlier EEA MA. The SPC term will then be calculated on the basis of the earlier EEA MA. Controversially, this will lead to the term of protection being shorter than if it had been based on the UK MA.
Our multi-disciplinary life sciences team would be delighted to assist your business in preparing for the upcoming changes to intellectual property law as we approach the end of the transition period.
Further details about the other legal implications of Brexit in the UK are available in our guide here.