The extended deadline for Brexit of 31 October 2019 has now passed, with a new exit date set for 31 January 2020. With a general election scheduled in the interim, there is still much uncertainty surrounding Brexit, from the timing, to what it might look like (or not). In the meantime, readers might be interested in current developments surrounding Supplementary Protection Certificates, or SPCs.
Government guidance on these issues is available here.
SPC manufacturing waiver
The EU’s SPC manufacturing waiver came into force on 1 July 2019.
To provide a brief re-cap, the waiver provides for some exceptions to the protections afforded to SPC holders, subject to certain safeguards. Generics and biosimilar manufacturers will now be able to:
- manufacture medicines, which are protected by an SPC, for export to markets outside the European Economic Area (EEA) where protection does not exist or has expired; and
- manufacture and stockpile medicines that are protected by an SPC in an EEA member state during the six months before expiry of the SPC,
for any SPCs applied for on or after 1 July 2019. From 2 July 2022, the waiver will also apply to SPCs applied for before 1 July 2019, but only if they came into effect on or after 1 July 2019.
SPC holders will need to be notified by manufacturers intending to rely on the waiver, giving an opportunity for the SPC holder to assess whether its rights are being “respected”.
This system has already been introduced into UK law, although some tweaks will be needed to ensure that it works properly post-Brexit.
Brexit impact for UK SPCs
The new withdrawal agreement reached between the UK and the EU has not changed the transitional period or the way in which SPCs would be dealt with.
The UK has separately issued the Patents (Amendment) (EU Exit) Regulations 2019, which effectively implement EU SPC legislation into UK law with some alterations. Timing depends on the politics. If a withdrawal agreement is not ratified, leading to a no-deal Brexit, this would kick in immediately. The alternative of a ratified withdrawal agreement would bring in a transition period that would suspend the new UK system temporarily – to December 2020 or later if there is an extension.
Under the new system, centrally granted marketing authorisations would no longer count as a basis for a UK SPC application. A UK MA would be needed, either through application to the Medicines and Healthcare Regulatory Agency (MHRA) or by the proposed “grandfathering” route. The MHRA has been liaising with MA holders directly regarding the “grandfathering” of their centrally-granted authorisations into UK MAs. Preparations include no-deal Brexit planning and guidance on how the MHRA will handle centralised applications that are still pending on exit day.
Duration of market exclusivity
For the purposes of calculating the duration of protection of an SPC, the date of the first MA in the UK or the EEA will be taken into account under the new UK system, as it is now. The intention is that the overall duration of the protection does not change.
In a no-deal scenario, however, this could mean that the total duration of market exclusivity in the UK is shortened. For centralised procedures which are still in the first phase of assessment (before Day 120) on exit day, an independent assessment by the MHRA will need to be made through a submission through one of the assessment routes. A resulting delay in the grant of a UK MA would cut into the period of market exclusivity in the UK. This effect is likely to be temporary, although the future position will depend on how effective the MHRA proves to be in processing MA applications.
Changes to the Human Medicines Regulations 2012 set out in the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 include a six month extension to the duration of SPCs for paediatric medicinal products. Again, this will come into effect on exit day, or at the end of any transition period.
The SPC regime will continue largely unaffected after Brexit. EU guidance on how it will operate indicates that calculation of the duration of SPCs will be influenced by UK MA grant dates only up to the date of the UK’s withdrawal. This would not be extended by a transition period, so MAs granted in the UK during that time would not be taken into account as a “first authorisation.