Pharmaceutical and agricultural companies in particular should consider the effect of Brexit on their European patent portfolios.
Supplementary Protection Certificates (SPCs) are governed by EU regulations and are thus only available to EU member states. SPCs allow for up to five years of additional product exclusivity beyond expiration of any patent issued by the European Patent Office and validated in a member state of the European Patent Convention. SPC protection must be applied for in each EU member state where a European patent is validated. Existing SPC holders in the United Kingdom will likely lose their exclusivity under their SPC in the United Kingdom following Brexit because EU laws that govern the SPC will no longer be enforceable in the United Kingdom.
The United Kingdom’s exit from the European Union will likely require amendments to the UK Patents Act or implementation of a new act to provide for SPC protection or its equivalent in the United Kingdom. A form of new SPC protection will likely also be established in the United Kingdom prior to it leaving the European Union. Furthermore, transitional provisions will need to be established for existing SPCs so that they do not lapse or suddenly cease to have effect in the United Kingdom. Clients with existing SPCs and clients that plan to file for a SPC in the United Kingdom for medicinal products in development should closely monitor this situation to prevent any loss of rights.
Read about our initial intellectual property (IP) considerations post-Brexit in our previous LawFlash: Brexit: IP Considerations in Light of the UK’s Vote to Leave the EU.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact Robert Smyth, Ph.D. in our Washington, DC, office or any member of our intellectual property life sciences practice:
Mark L. Hayman
Gregory T. Lowen