The maximum duration of a patent is 20 years. However, companies which develop and sell medicinal products or plant protection products requiring an authorization are often prevented from using their patent protection for a long period of time because of the lengthy process involved in obtaining an authorization. As a consequence, special legislation has been drawn up for these industries in the form of two corresponding Regulations on supplementar protection certificates. These Regulations provide for the extension of patent protection by up to five years for a product for which a authorization has been obtained.
In the following, an overview on supplementary protection certificates for medicinal products is provided.
Generally, a patent owner can even obtain a supplementary protection certificate based on an authorization of a third party. In the case of available data for a paediatric use, up to further six months may be granted, subject to certain conditions.
Supplementary protection certificates can be obtained in almost every country in Europe, the USA, Japan, and in numerous other countries worldwide. The respective regulations vary con- siderably from country to country.
Since many medicinal products only start to bring significant financial reward towards the end of the patent’s duration, supplementary protection certificates represent an important means of protecting pharmaceutical innovations against imitation.