No Deal Brexit Government advice: SPCs
The impact of a No Deal Brexit on supplementary protection certificates (SPCs) and regulatory-based protection – UK Government advice released on 24 September 2018.
As part of the UK Government’s preparations for a possible “hard Brexit”, it has published a set of guidance notes on how intellectual property rights would be affected if the UK leaves the EU in March 2019 with no deal. This is part of a series of technical notices being issued by the Government to assist businesses in their preparations, although it is widely anticipated that an agreement between the UK and EU will still be possible.
The UK Government proposes to retain the existing EU law relating to SPCs after March 2019. Therefore the SPC regime in the UK will continue to operate as before, even if the event of no deal.
The UK Government states that “… all other EU legislation relevant to patents and supplementary protection certificates will be kept in UK law..”
The UK Government also states that existing SPCs and licences in force in the UK will therefore remain in force automatically after March 2019, and the legal requirements and application process for new SPCs in the UK will remain essentially the same.
The UK Government has also indicated changes that may occur in the regulation of human and veterinary medicines and the various forms of regulatory-based protection available. For medicines, existing marketing authorisations (MAs) granted centrally by the European Medicines Agency (EMA) will automatically be converted into UK MAs after March 2019. Existing UK MAs based on the mutual recognition or decentralised procedures will be unaffected.
The UK Government also states that regulatory data and market exclusivity will remain available based on UK MAs after the UK exits the EU, and the period of “8+2+1” years for this form of regulatory protection will remain unchanged. After the UK’s exit from the EU, the start of this period will be the date of authorisation in the EU or UK, whichever is earlier.
The UK Government also states that paediatric medicines will be regulated by a UK system after the UK exits the EU, and incentives will remain to encourage such medicines onto the UK market. It can therefore be envisaged that the 6-month extension will remain available for SPCs for medicines on which agreed paediatric studies have been carried out, although the UK Government indicates that details will be subject to consultation.
The UK Government also states that consultation will take place on the proposed regulatory approach to orphan medicines (for the treatment of rare diseases) after the UK exits the EU. This will include incentives to encourage such medicines onto the UK market. It can therefore be envisaged that some form of market exclusivity for orphan medicines may remain, but details will be subject to consultation.
Finally, the UK Government has indicated that they will retain the existing “EU Bolar” law which exempts from patent infringement trials carried out on generic medicines in order to obtain regulatory approval, for marketing after the patent expires.