SPC waiver enters into force 1 July 2019

From 1 July 2019, the new “SPC Waiver” Regulation (EU) 2019/933 allows makers of generics and biosimilars established in the European Union (EU) to:

  • manufacture in the EU an SPC protected product for the purpose of export to third countries in which protection does not exists or has expired, and/or
  • manufacture an SPC protected product during the final six months before expiry of the SPC for the purpose of storing it in the Member State of manufacture, in order to place that product on the UE market upon expiry of the corresponding SPC (“EU day-one entry”).

The Regulation requires a generics or biosimilar producer intending to benefit from the manufacturing waiver to notify not only the national patent office that granted the SPC in question, using a standardized form, but must also directly inform the SPC holder and all those involved in the commercialisation of the product, no later than three months before the intended start of manufacture (or the first related act).   More information on the provisions of the  SPC Waiver Regulation is available here

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009

Introduction and background to the SPC Manufacturing and Stockpiling Waiver

Standard Form of Notification (to be sent to regadmin@ipoi.gov.ie)