Tilleggsbeskyttelse

Tilleggsbeskyttelse, often referred to as supplementary protection or SPC, is a form of intellectual property protection in the European Union. It aims to compensate for the loss of patent protection time that occurs during the lengthy and expensive process of obtaining regulatory approval for medicinal products and plant protection products. A patent for an invention, such as a new drug, is granted for a fixed term, typically 20 years from the filing date. However, significant time can elapse between the patent grant and the marketing authorization required to bring the product to market.

SPC extends the protection conferred by a patent for a specific product that is subject to an authorization procedure. It grants the holder an additional period of protection, up to a maximum of five years, after the expiry of the basic patent. This extension is intended to provide a reasonable period of market exclusivity once the product can actually be commercialized. To obtain an SPC, several conditions must be met, including the existence of a valid basic patent, the product being covered by a marketing authorization, and that the product not having already benefited from an SPC. The SPC system is harmonized across EU member states, ensuring consistent protection throughout the Union. It is a crucial mechanism for pharmaceutical and agrochemical companies to recoup their research and development investments.