Supplementary Protection Certificates

The duration of patents in the pharmaceutical and plant protection fields may be expanded by filing a Supplementary Protection Certificate (SPC).

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a) Medicinals products and processes

The owner of a basic patent on a medicinal product for human beings or animals, or on a process to obtain such a product, is entitled to a supplementary protection certificate (SPC) in each European State where such a product is subject, prior to its marketing, to an administrative authorization (or Marketing Authorization, MA).

The SPC takes effect at the term of the basic patent, and further protects the product for a period of five years after the term of the patent, or fifteen years after the date of the first MA in the European Community (whichever comes the first).

The SPC is governed by the provisions of the Council Regulation EC N°469/2009 of 6 may 2009. A SPC may be granted in each Member State in which the basic patent was granted and the MA was obtained, and the SPC application should be filed at the national industrial property office.

In France, the SPC application must be filed at the French National Patent Office (INPI) within six months of the date on which the first MA was delivered in France or, if such a MA is delivered before the basic patent is granted, within six months of the grant date of the patent.

Furthermore, a prolongation of six months of the SPC can be obtained when a pediatric MA is delivered.

b) Plant protection products and processes

In the same way, the owner of a basic patent on a plant protection product or a process to obtain such a product is entitled to a supplementary protection certificate in each European State where the marketing of such a product is subject to a Marketing Authorization.

The corresponding SPC is governed by the provisions of the Council Regulation EC N°1610/96 of 23 July 1996. Such provisions are quite similar to those relative to SPC for medicinal products as detailed above.