Date: 12 April 2022
During the transition period and until 31 December 2020, the Withdrawal Agreement meant that SPC protection in the UK was governed by the EU SPC Regulation (Regulation (EC) No 469/2009). Since leaving the EU on 1 January 2021, the UK has transposed EU SPC law into UK law, as far as possible, via The Patents (Amendment) (EU Exit) Regulations 2019.
Prior to 1 January 2021, an application for an SPC required details of the first Marketing Authorisation issued within the EEA for the relevant product. An EEA Marketing Authorisation covers all EU member states. The date of this Marketing Authorisation determined the term of additional protection granted by the SPC.
From 1 January 2021, it is required that a UK SPC is to instead be based on a UK Marketing Authorisation. For SPC applications filed from this date, it will be necessary to:
a) obtain a separate UK Marketing Authorisation, and
b) provide details of the earliest EEA Marketing Authorisation, if this pre-dates the UK Marketing Authorisation.
It is possible to apply to the UK MHRA for marketing authorisations for different UK territories, i.e. either the UK as a whole, Northern Ireland only or Great Britain (i.e. England, Scotland and Wales) only. This is based on the continuing application of EU law in Northern Ireland under the Northern Ireland Protocol.
For UK SPC applications filed on 1 January 2021 and later, its term will begin from the date of the earliest Marketing Authorisation obtained in either the UK or EEA. EEA Marketing Authorisations which were granted before 1 January 2021 will be converted automatically to equivalent UK Marketing Authorisations.
For products that have been tested for paediatric use in accordance with a paediatric investigation plan (PIP), EU law provides for a six month SPC extension. From 1 January 2021, a paediatric extension is available based on equivalent provisions in the UK’s Human Medicines Regulation 2012. It will still be required to make the request for an SPC extension at the same time as filing the SPC application, or up until two years before expiry of the SPC.
Unlike under EU SPC law, evidence of EEA authorisations covering the product is no longer required under UK provisions. It is only necessary to show that the product is authorised in the UK. In line with the territorial protection provided by UK SPCs, a paediatric extension will only apply to UK territories where the Marketing Authorisation is associated with a PIP.
The SPC stockpiling and manufacturing waiver provides an exemption to infringement of an SPC in the final six months preceding its expiry. The waiver, which came into force on 1 July 2019 due to amendment of the EU SPC Regulation, permits third parties in Europe to manufacture biosimilar or generic versions of products under SPC protection for either export to countries where no equivalent or parallel SPC protection exits and/or stockpiling of the product in Europe in order to allow for quick entry into the market to improve access to medicines.
The waiver was originally proposed to be incorporated into UK statute. However, the proposal has been amended subsequent to a stakeholder consultation. A more restricted proposal is that UK-based companies will only be permitted to manufacture biosimilars or generics for export to countries outside of the EU. This proposal has not yet been passed by parliament.
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