24 May 2018
The European Commission has recently published a notice on the consequences of Brexit on supplementary protection certificates (SPCs) for medicinal and plant protection products.
According to the law on SPCs, the date of the first authorisation to place a medicinal or plant protection product on the market in the European Economic Area is used to calculate the duration of supplementary protection that is available, as well as the deadline for filing an application for an SPC.
The notice confirms, perhaps unsurprisingly, that as of the date of withdrawal of the UK from the EU and subject to any transitional provisions, an authorisation to place a medicinal or plant protection product on the market granted by a UK authority will not be considered a first authorisation for SPC purposes in the EU. Any UK authorisations granted before the withdrawal date will, however, continue to be accepted.
The notice also confirms that, as of the withdrawal date, the EU SPC legislation will no longer apply to the UK. The EU and UK are in the process of agreeing how an application for an SPC in the UK that was submitted before, but is pending at, the withdrawal date should be treated. The EU’s position is that any such applications should, when granted, provide protection comparable to that provided for by EU law.
The UK is currently set to leave the EU on 30 March 2019, although the withdrawal date may be delayed on agreement between the EU and UK. Furthermore, transitional provisions will, quite likely, mean that EU law will continue to apply in the UK beyond the withdrawal date. Whilst the UK has yet to confirm the arrangements for any future domestic SPC regime, it seems likely that it will still be possible to apply for and obtain SPCs in the UK after Brexit.
For queries or advice about SPCs, please contact Mathys & Squire Partner, James Wilding via [email protected]
James’ practice is focused on EPO prosecution and opposition work in the life sciences sector. He also has extensive experience with SPCs and has prosecuted SPC applications covering a number of blockbuster drugs. James has a master’s degree in biochemistry and a doctorate on the biochemistry of heart disease, both from Oxford University.
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