What is a Supplementary Protection Certificate (SPC) ?
The duration of the protection by a patent is maximally 20 years. An exception is made for medicinal products or phytopharmaceutical products , since their development phase often takes so long, that the remaining period for recovering the development is too short which discourages the development of new medicinal and phytopharmaceutical products.
For a medicinal or phytopharmaceutical product that is protected by a basic patent, it is therefore possible to demand an extension of the protection duration with maximally 5 years, for which a Supplementary Protection Certificate or SPC can be granted, that stipulates the granted extension of the protection duration.
After the protection duration of a Supplementary Protection Certificate has lapsed, the duration of the protection can still be extended further with 6 months if a demand for a Pediatric Extension is filed.
The purpose of this Pediatric Extension is to make the medicinal product accessible to children, by stimulating further research into the application of it for children.
A Pedriatic Extension of an SPC can be granted after submission of :
- an accomplished and approved pediatric plan for the medicinal product;
- a copy of the European Marketing Authorisation (EMA) of the medicinal product, approved for pediatric use.