07 Aug 2020

The European patent regime is not an instrument of the European Union ("EU"). 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 28 member states of the EU.

As a result, the European patent regime, of which the United Kingdom ("UK") is a part, will remain largely unaffected by Brexit. The UK's membership of the Patent Cooperation Treaty will also remain unaffected.

How will retained EU law impact patents?

The Withdrawal Act will convert all EU law, in force on Exit Day[1], into UK law which means that EU regulations and implemented directives in force at the time of the UK's withdrawal from the EU will continue to have effect in the UK, unless amended or repealed. Therefore the existing EU regulations and directives affecting patent law in the UK will continue to have effect post Brexit.

Further, under the Withdrawal Act, the UK will treat any decisions by the Court of Justice of the EU ("CJEU") made before or on Exit Day as retained law and its decisions shall continue to bind UK courts and be applicable in the UK (save that the Supreme Court may depart from the decisions of the CJEU). Any decisions of the CJEU after Exit Day will not be binding on the UK, but they may be persuasive and taken into account by the UK courts.

Otherwise, the Patents (Amendment) (EU Exit) Regulations 2019, made on 4 April 2019, introduced inter alia changes to address references to the EU and the European Economic Area ("EEA") in any domestic UK patent and supplementary protection certificate ("SPC") legislation, in order to deal with any provisions which would otherwise favour the EU/EEA over the UK and to help maintain the current systems and processes.

How does this affect Supplementary Protection Certificates?

The Withdrawal Agreement provides that any pending applications for SPCs filed at an authority in the UK before or on Exit Day, will be governed by the existing EU regulations and shall be granted the same level of protection as provided for in the EU regulations. After Exit Day, the EU regulations governing SPCs will not apply in the UK, save for as provided in the Withdrawal Agreement.

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. Immediately following Exit Day, any marketing authorisations that are required to be granted as SPC, which have been granted by the European Medical Agency, will be converted into equivalent UK authorisations. However, marketing authorisation granted in the UK will not be considered the first marketing authorisation for the EU.

Will the fees or term of protection for SPCs change?

SPCs filed after Exit Day will be granted the same term of protection as SPCs filed before or on Exit Day. The UK will continue to have the power to charge fees for SPCs but these are not expected to change on Exit Day.

What about Paediatric Extensions?

Under existing EU law, it is possible to extend by six months the duration of protection of a SPC which protects medicines for paediatric use. After Exit Day, this will still be possible in the UK but the availability will be dependent on UK’s Human Medicines Regulations 2012. The application process and timings will 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 Exit Day, an application for a paediatric extension has been filed at, or has been granted by, the UK Intellectual Property Office, the existing requirements will continue to apply. Accordingly, it will 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?
  • will the 'manufacturing waiver' apply in the UK after Exit Day?
  • what impact will Brexit have on the Unified Patent, and Unified Patent Court, system?

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[1] The day which marks the end of the period of time during which the UK will remain in both the EU customs union and the single market, currently 31 December 2020.