As the European patent regime is not an instrument of the European Union ("EU"), it has remained largely unaffected by Brexit. The European Patent Convention 2000 and its various protocols are not part of the accumulated body of EU law. The current membership of the European Patent Office numbers 38 countries, which is a far greater number than the current 27 member states of the EU. The membership of the United Kingdom ("UK") to the Patent Cooperation Treaty also remains unaffected.
How does retained EU law impact patents?
All EU law (including EU regulations and implemented directives) that were in force on 31 December 2020 were converted into UK law by the Withdrawal Act. Such law continues to have effect in the UK unless and until it is amended or repealed.
The UK must treat any decisions by the Court of Justice of the EU ("CJEU") made before or on 31 December 2020 as retained law and its decisions continue to bind UK courts and be applicable in the UK, save that the UK Supreme Court may depart from the decisions of the CJEU.
Decisions of the CJEU from 1 January 2021 are not binding on the UK, but they may be persuasive on the UK courts.
The Patents (Amendment) (EU Exit) Regulations 2019 were introduced to address references to the EU and the European Economic Area ("EEA") in domestic UK patent and supplementary protection certificate ("SPC") legislation and provisions which would otherwise favour the EU/EEA over the UK, and to help maintain the systems and processes in place as at 31 December 2020.
How are Supplementary Protection Certificates affected?
The Withdrawal Agreement provided that any pending applications for SPCs filed at an authority in the UK before or on 31 December 2020 are governed by the existing EU regulations and shall be granted the same level of protection as provided for in the EU regulations.
Applications for UK SPCs from 1 January 2021 will only be granted by the UK Intellectual Property Office ("UKIPO") and must be based upon a national or European (UK) patent and a UK marketing authorisation.
Under the EU SPC regulations, SPCs take effect after the term of the basic patent for a term calculated with reference to the date of first marketing authorisation to place the product on the market in the EU. Any marketing authorisations that are required to be granted an SPC, which have been granted by the European Medical Agency, will be converted into equivalent UK authorisations.
Under the Northern Ireland Protocol, Northern Ireland is committed to aligning with certain EU regulations, including some relating to medicinal products and SPCs. The UK introduced the Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (SI 2020/1471) to amend the SPC regulations to accommodate the continuing application of the EU's marketing authorisation to Northern Ireland after 31 December 2020. This has introduced the concept of a UK marketing authorisation and a Northern Ireland marketing authorisation.
Are there changes to the fees or term of protection for SPCs?
SPCs filed on or after 1 January 2021 are granted the same term of protection as SPCs filed before or on 31 December 2020. The UK continues to have the power to charge fees for SPCs, and is free to extend the term of protection granted to SPCs moving forward.
What about Paediatric Extensions?
Under EU law, it is possible to extend by six months the duration of protection of a SPC which protects medicines for paediatric use. This is still possible in the UK but the availability is determined by the UK’s Human Medicines Regulations 2012. The application process and timings remain the same (application at the time of applying for a SPC or any time up to two years before the SPC expires). The application for the extension does not need to be accompanied by evidence of authorisation across the EEA.
If, before or on 31 December 2020, an application for a paediatric extension was filed at, or has been granted by, the UKIPO, the existing requirements continue to apply. Accordingly, it would be necessary to provide proof of marketing authorisation in all of the EEA member states and any existing paediatric extensions can be challenged on this basis.
What if my question is not answered here?
Please contact any member of our Intellectual Property team if you have any additional questions, such as:
- how do I enforce, or challenge, a SPC?
- does the 'manufacturing waiver' apply in the UK after 31 December 2020?
- has Brexit impacted plans for the Unified Patent, and Unified Patent Court, system?