The SPC Manufacturing Waiver (the “Waiver“) is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and biosimilar manufacturers on a level playing field with their competitors in third countries. The Waiver carves out of SPC protection the making of SPC protected material in the EU during the life of an SPC for export to third countries and the storing of SPC protected material made in the EU in the last 6 months of the SPC’s life ready for release onto the EU market when the SPC expires. The Waiver is not intended to interfere with the SPC holder’s exploitation of their SPC while it is in force or the other patents owned by the SPC holder which protect the same commercial product as the SPC.
What effect will the Waiver have on SPCs?