Brexit and supplementary protection certificates (SPCs) for medicaments in UK
The transition period following Brexit ended on 30th December 2020.
“The Patents (Amendment) (EU Exit) Regulations 2019” which brings the EU legislation (Regulation No 469/2009) into the UK – with some adjustments to make the legislation UK-specific - and “The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020” have now entered into force.
The following focuses on the impact of Brexit on SPCs in the UK, as from 1st January 2021 :
■ For SPCs and paediatric extensions granted by 30th December 2020:
They remain in effect after 31st December 2020, or will come into force normally.
■ For SPCs and paediatric extensions filed on or before 30th December 2020, and still under examination at the end of the transition period:
Examination will continue to progress without the need to re-file the application.
If the Marketing Authorization (MA), relied on in the SPC application, was granted by the EMA (European Medicines Agency), the UK IPO may request to be provided with the information on the conversion of the MA of the EMA into a UK MA.
■ For SPC applications filed on or after 1st January 2021
The MA relied on will have to be a UK MA, i.e. with respect to Great Britain (GB) and/or Northern Ireland (NI), as follows:
|→||A UK-wide marketing authorization, i.e. a centralized MA granted by the EMA before 1st January 2021 converted into a GB + NI MA; or|
|→||A GB only marketing authorization granted by the HMRA ( Medicines and Healthcare products Regulatory Agency), or|
|→||A Northern Ireland (NI) only marketing authorization, e. a centralized MA granted by the EMA as on 1st January 2021, having effect in NI by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement.|
The time-limit for filing the UK SPC application is the later of 6 months from:
the grant of a basic patent valid in UK, and
the grant of the 1st MA for the product in the UK (a UK-wide, GB only or NI only MA).
The UK SPC will have a territorial scope which depends on the MA relied on, provided that the scope of the SPC can be extended to the additional territory by notifying the UK IPO with the subsequent MA within 6 months of its grant and before the expiry of the SPC.
The term of the SPC will be calculated based on the earliest MA of the product in the UK or the European Economic Area (EEA).
■ For paediatric extension applications filed on or after 1st January 2021
The process for applying for a paediatric extension will remain the same, except that it is no longer required to provide evidence of a MA covering the product across the EEA.
■ Manufacturing waiver
The EU law providing for the SPC manufacturing waiver was introduced into the UK Law by “The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020”.
It provides that third parties will be allowed to:
Manufacture in the UK in order to export to countries outside both the UK andEU;
Do stockpiling in the UK in the last 6 months before the SPC expiry, in order to sell the product in the UK or in the EU market when the SPC expires.