The UKIPO has issued further clear guidance on changes to the application process for Supplementary Protection Certificates (SPCs) in the UK from 1 January 2021.
Reassuringly, for the most part, the application process remains the same as at present under the European Union law. After 1 January 2021, the UK will maintain the same law but with some important changes in the processing of new applications.
As the reader will know, the UK is a union of Great Britain and Northern Ireland. From 1 January 2021, SPC Applicants will need to check if the marketing authorisation for a medicine or agrochemical product is valid for the UK as a whole, or only Northern Ireland or only Great Britain.
From 1 January 2021, an SPC application can be filed on the basis of any marketing authorisation which allows the patented product to be placed on the market in any part of the UK.
However, the SPC granted will only extend protection to that part of the UK covered by the marketing authorisation. If a subsequent marketing authorisation is granted for another part of the UK before the SPC takes effect then the SPC can be extended to cover the additional territory, on request by the Applicant to the UK IPO. It should be noted that the Applicant must action this subsequent step themselves. The Applicant must notify the UK IPO within six months of any (in this case subsequent) marketing authorisation (with the necessary documentation of the further authorisation) and before the SPC takes effect, in order for the protection to be extended to the additional territory.
It is important to be aware that marketing authorisations for medicines granted by the European Medicines Agency (EMA) will continue to be effective for Northern Ireland. Thus, SPC Applicants for the UK must remember that a marketing authorisation granted by either the EMA or the relevant GB authority will be considered as the first marketing authorisation in the UK. If you have been granted more than one authorisation covering different parts of the UK when you come to file your application, you must file the application within six months of the earliest of those authorisations being granted. Otherwise, your application may be refused.
Paediatric extensions of UK SPCs will similarly be determined to extend only to the territory for which the paediatric investigation plan (PIP) has been agreed. Thus, separate paediatric extension applications may be needed for Northern Ireland and for the rest of Great Britain, based on the relevant agreed PIP. The amended application process for paediatric extensions of SPCs requires that the Applicant indicate which territory the authorised PIP relates. The timing for a paediatric extension application remains unchanged (at least 2 years before expiry of the SPC).
We strongly recommend that you consult your SPC advisor as soon as the earliest marketing authorisation covering any part of the UK, is allowed. Do not delay. Include details of any further marketing authorisations that are being sought to cover other parts of the UK. Your advisor will confirm the deadlines to meet and will ensure that the terms of the new application process are met.
Existing pending SPC applications will be examined under the terms of the current law in force up to 31 December 2020.