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Brexit & SPCs

Here we answer some frequently asked questions regarding supplementary protection certificates following the UK vote to leave the EU.

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Supplementary Protection Certificates (SPCs)

In the European Union (EU), supplementary protection certificates (SPCs) are granted to patented medicinal and plant protection products which have required marketing authorisation (regulatory approval) prior to being placed on the market. SPCs extend the lifetime of the patent (for the approved product) for up to five years, extended by an additional six months for medicinal products if paediatric studies are carried out on the product – their value to the pharmaceutical and agricultural industries is therefore of great significance, as the term of the SPC is typically when the product achieves its peak sales.

What has changed for SPCs?

There is no change to the EU SPC regulations. In particular, the scope, effectiveness and enforceability of SPCs in the UK remain the same, and will continue to be the case until such time as the UK actually leaves the EU. The negotiations could take many years and suitable transitional provisions will be implemented at an appropriate time - we will keep you informed.

In respect of existing SPCs, although the position is unclear at present, we anticipate that appropriate UK legislation will be implemented to ensure that UK SPCs pending or granted under existing EU legislation will continue to have effect in the UK after the UK leaves the EU.

Will D Young & Co be able to continue representing clients in relation to SPCs?

Again, yes we will. SPCs will remain valid and enforceable in the UK, and new SPCs can be obtained, until Brexit takes effect. Moreover, Brexit should have no effect on the existing SPC system in other EU countries, therefore our advice is to continue filing in the usual way for SPC protection in the UK and in other EU countries.

Will UK SPCs continue to be available after the UK leaves the EU?

It is difficult to be certain exactly how SPCs will be impacted – this will depend somewhat on the terms of the UK's exit, and in particular whether the UK remains in the EEA (along with Norway and Iceland - to which the EU SPC regulation applies).

However, the purpose of SPCs (to compensate the patent holder for the patent term lost caused by the need to obtain regulatory approval), and their value to the pharmaceutical and plant protection industries, remains unchanged by the UK leaving the EU.

A number of non-EU countries, such as Switzerland, already allow SPCs based on their national law, under provisions that essentially parallel those of the EU Regulations. Accordingly, the UK Government is likely to follow a similar model and enact new legislation to allow for UK national SPCs under provisions similar to those currently provided under the EU SPC Regulations.

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