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.
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.
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 in 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.”
Proposed legislation has now been laid before the UK Parliament, which will essentially retain the existing EU SPC Regulations in force after the UK leaves the EU. However, a UK national marketing authorisation (MA) will now be required for both medicinal products and plant protection products in order for the product to be entitled to a UK national SPC. The EU-wide MAs granted for medicines by the European Medicines Agency (EMA) will no longer apply to the UK and will not be available to support UK SPCs filed after the UK leaves the EU. However, the duration of SPCs will be calculated based on 15 years from the first marketing authorisation in an EEA member state, if this precedes that of the UK national authorisation. The term of the SPC, as now, will be capped at 5 years from the expiry of the basic patent).
The UK Government also states that existing SPCs and licences in force in the UK will 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. This is essentially confirmed in the proposed legislation.
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 MAs granted centrally by the 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. Under the proposed legislation, the 6-month extension will remain available for SPCs for medicines on which agreed paediatric studies have been carried out, provided that the product is authorised in all EU member states as well as the UK. As now, this period will not be available for orphan medicines, which will instead retain the additional 2 years’ market exclusivity as set out below.
The UK Government also states that a dedicated regulatory system for orphan medicines (for the treatment of rare diseases) will continue after the UK exits the EU, and a specific UK orphan MA will be granted for such medicines. This will include incentives to encourage such medicines onto the UK market. The UK Government has now confirmed that the 10 year market exclusivity for orphan medicines will remain after the UK exits the EU. This will also begin on the date of authorisation in the EU or UK, whichever is earlier. Orphan medicines for which agreed paediatric studies have been carried out will, as now, be entitled to an additional 2 years’ market exclusivity.
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.