SPC manufacturing waivers: A blow to innovation?
The EU’s Big Pharma companies have sharply criticised the European Parliament’s Legal Committee JURI backing of an amended proposal of the European Commission (EC) to introduce a supplementary protection certificates (SPC) manufacturing waiver. Under the waiver, EU-based biosimilar and generics makers would be allowed to export copycat drugs during the SPC period that adds five years of additional IP protection to the 20 years of patent duration.