Supplementary Protection Certificates (SPCs) and Brexit

Roona Deb, a partner and European Patent Attorney in the life sciences team at Page White and Farrer, explains the implications of Brexit for SPCs.

 

SPCs granted or filed in the UK before exit

 

An SPC granted in the UK is a UK national IP right, which is currently governed by EU law. However, any SPCs granted by exit day on 31 January 2020 (or before the end of the transition period) will not be affected by the UK’s departure from the EU.

 

There will also be no change to SPC applications which are pending on exit day. These will continue to be assessed under current criteria during the transition period. Following the transition period, it is expected that the relevant EU provisions will be incorporated into UK national law.

 

After exit from the EU

 

Under the current EU regulations, when applying for an SPC, the details of the first marketing authorisation for the product in the relevant country must be provided along with the first marketing authorisation in the EU/EEA. In practice, there is usually no difference between these– a centralised EU/EEA marketing authorisation covers all member states. 

 

For SPC applications filed in the UK after exit day, it will be necessary to obtain a separate UK marketing authorisation.

 

EU/EEA marketing authorisations which have been granted before exit day will be converted to equivalent UK marketing authorisations.

 

Pending applications for EU/EEA marketing authorisations will need to be refiled at the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in order to acquire an equivalent UK authorisation.

 

An SPC filed after exit day will get the same term of protection as it would if it were filed before exit day. This will still be calculated based on the first authorisation to place the product on the market in either the UK or the EEA.

 

SPC manufacturing waivers

 

An SPC manufacturing waiver was brought into effect on 1 July 2019. This permits generic and biosimilar manufacturers in Europe to manufacture medicines protected by an SPC for export to countries where parallel protection does not exist.

 

The waiver also permits stockpiling during six months prior to SPC expiry, to enable launch in Europe immediately on SPC expiry. Currently, the waiver applies only to SPCs with application dates after 1 July 2019.

 

For SPC applications which were pending on 1 July 2019, the waiver applies as of 2 July 2022.

 

Following Brexit, the waiver will be implemented into UK national law, with appropriate modifications to function properly in the UK.

 

Contact our patent attorneys for advice

 

Page White and Farrer has extensive experience in supporting companies in the life sciences and healthcare sectors to build and protect a portfolio of valuable intellectual property assets.

 

For advice on SPCs or the SPC manufacturing waiver, please contact Roona Deb on 020 7831 7929 or email roona.deb@pagewhite.com.

 

This briefing is for general information purposes only and should not be used as a substitute for legal advice relating to your particular circumstances. We can discuss specific issues and facts on an individual basis. Please note that the law may have changed since the day this was first published in January 2020.