National rights
Patents are national rights and are largely unaffected by Brexit. The European Patent Convention provides a streamlined route for applying for patents through the European Patent Office (EPO) in a wide range of countries, including the EU member states and the UK. However, the EPO is an independent institution outside the EU.
The Unified Patent Court (UPC)
The UK has now formally withdrawn from the proposed European Union UPC project, which aims to introduce a more streamlined and cost-effective framework for patent litigation in the EU. Despite recent constitutional challenges in Germany, there is still significant support for pushing ahead with the project in the EU27. All patent owners with patents in the EU27 and relevant licensees should therefore keep a watching brief in order to be ready to participate in the expected sunrise period if the court goes ahead. Please see our update here.
Supplementary Protection Certificates (SPCs)
SPCs extend 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). The SPC regime was established under EU law and applies across all EU Member States. However, the SPCs are applied for on a national basis. Following Brexit the UK has set up its own SPC scheme, which is broadly aligned with the EU regime. Applications will continue to be made to the UK Intellectual Property Office. However, there are some important procedural changes arising from Northern Ireland’s continuing regulatory alignment with the EU in particular.
Procedural changes
SPCs are based on MAs. In the post Brexit landscape MAs in the UK may cover the whole of the UK or they may be limited to Great Britain or to Northern Ireland (which will continue to participate in the European centralised procedure). The territory covered by the SPC will reflect the territory of the MA that has been obtained at the time the application for the SPC is filed (e.g. NI). It may then be extended later if an MA is obtained for another part of the UK (e.g. GB). The deadline for filing the SPC application is six months from the earliest authorisation anywhere in the UK. However, the term of the SPC will be based on the earliest authorisation in the UK or European Economic Area (EEA). This means that the potential term for GB may be cut short if authorisation anywhere in the EEA precedes authorisation in GB.
Paediatric extensions
The UK regime will continue to provide for six-month extensions to SPCs where there has been testing for paediatric use. An advantage is that it is no longer necessary to provide evidence of corresponding MAs right across the EEA in order to obtain the extension.
Manufacturing waiver
In order to encourage generic and biosimilar production within the EEA, the EU recently introduced a limitation allowing generics and biosimilars to manufacture products in the EEA during the term of an SPC for export to countries outside the EEA where there was no equivalent protection or where patent protection has expired. The waiver also allows manufacture of generics and biosimilars in the last six months of the SPC to prepare for launch immediately on expiration of the SPC. This waiver is replicated in the new UK system, allowing biosimilars and generics to be manufactured in the UK for export outside the UK or EU and for launch on expiry in the UK or EU.
Kate Hamson-Maguire