June 12, 2019
EU SPC Manufacturing Waiver Regulation To Come Into Force on July 1st, 2019
A waiver which allows EU generic and biosimilar manufacturers to export and stockpile SPC-protected medicines will apply where the SPCs come into force after July 1st, 2019.
A transitional period means that, for certain SPCs, the waiver will not apply until July 2nd, 2022. Those looking to file SPC applications which could benefit from the transitional period should consider filing them before the end of June 2019.
In a recent article for Managing Intellectual Property, Mathys & Squire Partner Stephen Garner has commented on the news, explaining that ‘the main advice he would offer his patent-holder clients is to ensure that they are in a position to file for an SPC before the end of the month.’ Click here to read Stephen’s further comments and the MIP article in full.
Further details can be found via our SPC ‘Manufacturing Waiver’ for Export and Stockpiling download – click here to read more.