Post Brexit: SPCs and regulatory protection
The UK Government essentially proposes to retain the existing EU law relating to supplementary protection certificates (SPCs) after exit day. The SPC regime in the UK will continue to operate as before, regardless of whether the UK exits the EU with an agreement or if there is no deal.
D Young and Co will continue to be able to represent clients in relation to SPCs. Although SPCs are based on EU legislation they are national rights, so the filing of SPCs will remain unchanged. There will be no change in our ability to file UK SPCs, nor in other EU countries on which we continue to instruct our trusted network of SPC agents as now.
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 after the UK leaves the EU. However, after exit day a UK national marketing authorisation (MA) will 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) after exit day will no longer apply to the UK and will not be available to support UK SPCs filed after exit day. However, as indicated below, all existing granted EMA MAs will be “cloned” into UK MAs after exit day, so any UK SPCs based on EMA MAs will be unaffected.
Under the draft legislation 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 five 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 exit day, 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 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 exit day. 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 marketing 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 two 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.