Manufacturing exception related to the supplementary protection certificates


1. European and Italian Patent and Trademark Attomey
2. Italian Trademark Attomey and IP documentation specialist

The Supplementary Protection Certificates – SPC in EU is a way to extend patents exclusive rights on a drug up to five years (1). 

SPC doesn’t exists all over the world, even if a similar kind of protection can be found in various countries, including Japan and USA.


In mid-2018 the European commission published the proposal of a SPC manufacturing waiver for the export activities.


The rationale of this proposal lays in the fact that, at the end of the standard (20 years) life of the patent on a drug, generics manufacturers chose to produce the active ingredient or the final formulation of a drug in the countries, where the SPC doesn’t exist . The consequence is that European companies are exposed to heavy competition from non-EU producers, not subject to similar restrictions on intellectual property, and forced to relocate the plants, entering into agreements tied with the host countries (2).


What happened to the UE proposal of 28 May 2018? A year later, a regulation has been issued by the European Parliament ...