What is a supplementary protection certificate (SPC)?

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A supplementary protection certificate extends the period of effective protection for patents on new medical products for which an authorisation to be placed on the market is required.

A supplementary protection certificate serves as a compensation for the investments put into research for the period that elapses between the filing of a patent application for a new medicinal product and the obtention of an authorisation to place such a product on the market.

In the European Union, a supplementary protection certificate can be granted under the following conditions:

·         at the date of the application for supplementary protection, a product is protected by a basic patent in force;

·         the product has not already been the subject of a certificate;

·         a valid and first administrative authorisation to place the product on the market as a medicinal product has been granted.

Supplementary protection certificates are applied for and granted at national level by the competent industrial property office of the Member State where the basic patent has been issued and in which the authorisation to place the medical product on the market was obtained.  At national level, each European Union Member State can designate another specific authority for this purpose.  

Once granted, the certificate takes effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the European Union, reduced by a period of five years.

However, the duration of the certificate may not exceed five years from the date on which it takes effect.

This means that the holder of both a patent and a certificate benefits from an overall maximum of 15 years of protection from the moment the medicinal product in question first obtains the authorisationto be placed on the market in the European Union.