Supplementary Protection certificates are intended to compensate a Patentee for the lengthy process of obtaining marketing authorisation for a medicinal or plant protection product. They are national rights and can provide up to a maximum of 5 years additional patent protection for the specific product which the marketing authorisation covers.
Historically, within six months of obtaining the first marketing authorisation in the European Economic Area (EEA) one applied for a SPC in those EU states where patents existed.
The UK Withdrawal Agreement incorporates the provisions of the EU SPC Regulation into UK law but with amendments to make them UK specific.
From 1 Jan 2021 a UK SPC will require a UK marketing authorisation. A centralised authorisation from the European Medicine Agency (EMA) for the EEA will no longer be able to serve as a relevant marketing authorisation for a UK SPC.
Moreover, under the Northern Ireland Protocol, it will be possible to apply to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorisations in different territories of the UK: a UK-wide marketing authorisation, a Northern Ireland only authorisation and/or a Great Britain only marketing authorisation. It is expected to be possible to apply for an SPC based on any of the different available marketing authorisations in the UK but the SPC will only apply to the territories that are covered by the marketing authorisation. As before, the deadline for applying for an SPC will be 6 months from the first marketing authorisation. If the marketing authorisation holder wishes to extend the SPC to additional UK territories based on a subsequent UK marketing authorisation, it will have to apply before the first SPC takes effect and before the expiry of the patent.
The SPC will lapse if the UK marketing authorisations(s) is/are withdrawn but the SPC will remain in those parts of the UK where any marketing authorisation remains.
In July 2019, the SPC stockpiling and manufacturing waiver came into force across the EU. The waiver applies to the last six months of an SPC term and it allows EU-based companies to manufacture a generic or biosimilar version of an SPC-protected product for the purpose of 1) stockpiling the product in the EU or 2) exporting the product to markets outside of the EU, including the UK, where there is no IP protection.
The UK government initially proposed to incorporate this same waiver into UK law with legislation that permitted someone to make the product in the UK and export the product to markets outside the UK in which there was no IP protection, including EU markets. However, the latest news is that the waiver in the UK will only allow stockpiling in the UK for export to countries outside both the UK and EU.
The UK provisions above are still subject to the outcome of the negotiations between the EU and UK.
Author: Dr Julie Myint