PATENT LAW – SPC
SPC can be granted if less than five years have elapsed between the first market authorization and the date of the basic patent application
• that Article 13 of Regulation No 1768/92, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that me-dicinal products can be the object of the grant of an SPC where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the EU is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.
Purpose of SPC of negative or zero duration: paediatric extension