The Supplementary Protection Certificate for medicinal products was established by Council Regulation (EEC) No 1768/92 in June 1992 and subsequently amended by Regulation (EC) No 469/2009 of the European Parliament and of the Council in May 2009. This mechanism aims to address gaps and disparities between national patent regimes in the field of pharmaceutical research. Its primary purpose is to ensure adequate protection for medicinal product development within the European Union (EU). Indeed, the time lag between filing a patent application for a new medicinal product and obtaining marketing authorization can lead to a reduction in the actual protection afforded by the patent, thus jeopardizing the profitability of research investments. Insufficient protection could also encourage research centers based in Member States to relocate to countries offering better protection. Furthermore, the supplementary protection certificate for medicinal products aims to prevent excessive disparities between national legislations, while facilitating the free movement of medicines.

This certificate is issued under certain conditions: the product must be protected by a valid patent, have obtained marketing authorization as a medicinal product, not have already been granted a certificate, and be authorized for the first time as a medicinal product. Moreover, the certificate applies to the product in the same way as the initial patent. The application and issuance procedures, as well as the conditions for the certificate’s expiry, invalidity, and publication, are specified in the regulation. Its duration may not exceed five years, and the combined total protection of the patent and the certificate for the first marketing authorization may not exceed 15 years for the holder.