Before a drug can reach the market, years of costly clinical trials are required, often eroding the duration of effective patent protection for the new drug.
Supplementary protection certificates (SPCs) were introduced in European legislation to allow the holder of a patent relating to a new drug, a new method for its production or a new use to obtain sufficient protection to compensate for the economic efforts incurred in the development of a new medicine, also taking into account public health interests.
SPCs therefore allow the protection provided by a patent to a specific product with a marketing authorization to be extended by up to five years.
