The Supplementary Protection Certificate (SPC) is a legal instrument aimed at extending the protection granted by patents for medicinal products and plant protection products, particularly agrochemical and biocidal products, to compensate for the time required to obtain marketing authorizations.
This extension offers manufacturers an additional period of protection to recover their investments in research and development.
The protection granted by an SPC is generally limited to five years, but it can be extended in certain specific cases, particularly when a pediatric marketing authorization is requested. To obtain an SPC, the patent holder must apply to the European Patent Office (EPO) or a national office and meet certain conditions, including holding a valid marketing authorization for the concerned product.
The SPC is a crucial instrument for the pharmaceutical and agrochemical industries as it allows for the protection of research and development investments and ensures a sufficient return on investment to encourage innovation in these highly regulated and costly sectors. However, the process of obtaining an SPC can be complex and requires a thorough understanding of European intellectual property regulations and product regulatory requirements.