Réflexion sur l’extension du terme du brevet : Europe, États-Unis, Japon

Abstract

Pharmaceuticals products have the lowest “effective patent life” of any product. So the length of time during which firms can sell their product without copy is too short. Effective patent-life has been shrinking and to compensate patent holders for marketing time lost while developing the product, policymakers have adopted regulations. The supplementary protection certificate (EU 1992) or patent term restauration (US -FDA 1988) or patent term extension system (Japan 1988). This article explains what products are included, what are the criteria for determining whether a patent for a human drug product is eligible for a patent extension, what is the maximum of time allowed, how the patent term extent is calculated. The regulations for supplementary protection of patent are nearly identicals but incentives established are critical to continued innovation.