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Supplementary protection for medicinal products in the UK

As in many territories, there is provision in the UK for supplementary protection for a medicinal product which is protected by a patent with effect in the UK and for which a marketing authorisation (MA) is required to place the product on the market in the UK. The supplementary protection comes in the form of a supplementary protection certificate (SPC), which comes into force when the patent expires. While the SPC does not extend the term of the patent itself, it protects the authorised product and any use of the active ingredient in an authorised product.

An SPC can last for up to five years. The exact term of an SPC is equal to the time elapsed from the date of application of the patent on which the SPC application is based and the date of the first MA to place the product on the market anywhere in the UK, minus 5 years, and is up to a maximum of 5 years. For medicinal products that have been tested for paediatric use, an additional 6 months’ protection may be available.

It is necessary for the product that is the subject of the SPC application to be protected by a basic patent in force in the UK; this may be a patent granted by the UK Intellectual Property Office, or it may be a European Patent with effect in the UK. A basic patent is one that protects the active ingredient itself, a process to obtain the active ingredient, or an application of the active ingredient; when multiple patents exist, any of those patents may be used as the basic patent in applying for an SPC.

The MA should be the first authorisation granted to place the product on the market anywhere in the UK. From 1st January 2021, following the end of the transition period in the UK’s exit from the European Union (EU), MAs issued by the European Commission, following evaluation by the European Medicines Agency (EMA), will no longer extend to most of the UK. MAs for Great Britain (England, Scotland and Wales) will now by granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA); however, special provisions in relation to Northern Ireland mean that Northern Ireland continues to have custom and regulatory alignment with the EU, and MAs issued by the European Commission will have effect in Northern Ireland.  Thus, the first MA may be one that covers only Northern Ireland, or one that covers only England, Scotland and Wales. Where only one of these MAs has been granted at the time of filing of the SPC application, the SPC will extend only to the parts of the UK with the MA, and an additional application, to extend the territorial scope of the SPC to the remainder of the UK, will be necessary.

The deadline for an SPC application is the later of six months from the date of the first MA and six months from the date of the grant of the basic patent. For further details, or to discuss applying for an SPC in the UK, please contact us.

Author: Jenny Vaughan

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