Contributed By Linklaters
It is possible to extend the term of a Belgian or European patent for medical and plant protection products through an SPC, if a marketing authorisation has been granted under certain conditions described below. This has been introduced to (at least partially) remedy the loss of effective protection during the time needed to obtain market authorisation for such products.
The SPC legislative framework is harmonised at the EU level. An SPC is a national title granted by the local IP office of the EU Member State that granted the basic patent as well as a market authorisation. The requirements for granting an SPC are as follows: at the date of application of an SPC, the product must be covered by a basic patent, a valid market authorisation (ie, the first authorisation to put the product on the market as a medicinal or plant protection product) must have been granted, and it must be the first time that the product is subject to an SPC.
An SPC has a term of protection starting at the date of expiry of the patent and equal to the time that elapsed between the filing of the basic patent application and the date of the first market authorisation (ie, according to currently prevailing Court of Justice of the European Union (CJEU) case law, the date that the decision has been communicated to the applicant) reduced by five years and with a maximum of five years. In certain cases, another six-month extension is available for medicinal products for paediatric use.