Supplementary Protection Certificate (SPC)

A Supplementary Protection Certificate (SPC) is a legal mechanism provided by the European Union (EU) that allows for the extension of patent exclusivity for a new medicine. It is designed to compensate for the time it takes to obtain marketing authorization for a pharmaceutical product, considering the lengthy development and regulatory processes involved.

The purpose of an SPC is to provide additional protection and exclusivity to innovative pharmaceutical products after the expiration of their basic patent. Once a medicine receives marketing authorization in an EU Member State, an SPC can be granted to extend the patent protection for a fixed period. This extension is intended to encourage innovation in the pharmaceutical industry by allowing companies to recoup their investment in research and development.

The duration of an SPC is typically determined by specific regulations and can vary depending on factors such as the type of medicine and the date of filing for the patent. Currently, the maximum duration of an SPC is five years, although certain circumstances may allow for an additional six-month extension.

During the period of SPC protection, the medicine enjoys exclusivity, meaning that generic or biosimilar versions cannot be introduced to the market, allowing the original manufacturer to maintain a monopoly and recover the costs associated with research, development, and regulatory approval. This exclusivity period facilitates the generation of revenue necessary for further innovation and investment in the pharmaceutical sector.

It is worth noting that SPCs are subject to specific requirements and limitations. For example, an SPC can only be granted for authorized medicinal products that have been subject to regulatory approval in an EU Member State. Furthermore, the SPC system is governed by EU regulations and operates within the framework of the European Patent Convention.