The UK Intellectual Property Office has posted a guidance notice on its website on 8 March 2019 relating to the situation for Supplementary Protection Certificates (SPCs) if the UK leaves the European Union (EU) without a deal.
SPCs are a form of patent term extension for medicines and agrochemicals that have to obtain a marketing authorisation before being placed on the market. The SPC extends the term of patent protection to compensate for the regulatory delay in the approval process. SPCs are applied for at each national patent office where there is a basic patent in force which protects the relevant product and where there is a relevant granted marketing authorisation.
The law governing SPCs is derived from an EU Regulation. Consequently, the departure of the UK from the EU means that changes will be required to UK domestic laws in order to keep the system running. The UK government has signalled its intention to maintain existing SPC rights already granted and to ensure a smooth transition.
The guidance notice makes reference to the transitional provisions and confirms how the system will be continued. In essence, the system will function as now but it will be necessary to base the UK SPC application on an authorisation granted by the relevant UK authorities to place the product on the market.
The note links to an earlier guidance notice on how existing authorisations for medicines granted by the European Medicines Agency (EMA) can be converted into corresponding authorisations effective in the UK. See below:
The note indicates that if a current EMA authorisation is relied on for an SPC then it may be necessary to supply information on the equivalent UK authorisation so that it can be recorded in the UK Register of Patents. The note therefore seems to be indicating that the UKIPO will potentially retrospectively ask for this information for granted cases.
If you have any questions in relation to this update please contact Nick Bassil (email@example.com) or your usual advisor at Kilburn & Strode.