Supplementary Protection Certificate (SPC)
The Supplementary Protection Certificate (SPC) is a sui generis form of legal protection that extends protection conferred by a patent (called "basic patent") in respect of a medicinal or plant protection product.
To eliminate the penalization of these sectors, of the European Communities has adopted Council Regulation (EEC) No 1768/92 (now codified under Regulation (EC) No 469/2009 ) creating a Supplementary Protection Certificate for medicinal products, and the European Parliament and the Council have adopted Regulation (EC) No 1610/96 creating a Supplementary Protection Certificate for plant protection products with the aim of compensating the patentees for the loss of effective protection.the number and date of the first
A certificate extends the protection conferred by the basic patent only to the product covered by the authorization to place the corresponding medicinal or plant protection product on the market, and to any use of the product as a medicinal product that has been authorized before the expiry of the certificate. The certificate confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations.
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 authorization to place the product on the market in the Community, reduced by a period of five years. The duration of the certificate may, however, not exceed five years from the date on which it takes effect.
However, the maximum period of five years above may be extended once by six months for medicinal products in the case where Article 36 of Regulation (EC) No 1901/2006 applies.
This special calculation method ensures that the product covered by the basic patent enjoys an overall maximum of fifteen years of adequate and effective protection and furthermore a uniform solution at Community level is provided.
