SPC waiver
Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the Supplementary Protection Certificate for medicinal products (SPC) entered into force on 1 July 2019 (published in the Official Journal of the European Union L 153 of 11 June 2019).
The related Regulation introduces the exception to the protection conferred by the supplementary protection certificate for medicinal products as laid down in Regulation (EC) No 469/2009 (SPC waiver). This exception allows EU makers of generics and/or biosimilars (G/Bs) to make a medicinal product protected by SPC for the purpose of export to third countries outside of the EU and for the purpose of storing with a view to EU day-one entry upon expiry of the SPC. The making for the purpose of export shall be allowed for the entire period of SPC term, whereas storing shall be allowed only during the last six months before the expiry of the SPC.
SPC waiver shall apply to all SPCs that have been applied for on 1 July 2019 or after that date; and as of 2 July 2022, the waiver shall apply also to SPCs that have been applied for before 1 July 2019, but only those ones that take effect on or after that date. Hence, SPC waiver shall not apply to SPCs that have started taking effect before 1 July 2019.
G/Bs makers who intend to use the exception to the exclusive rights of holders of SPCs need to fulfil certain requirements; among other things, they shall notify the SPC holder of their intention using standard form for notification, as well as the authority competent for granting the SPC in the EU Member State where the making and/or related acts are to take place (in the Republic of Croatia, this is the State Intellectual Property Office) within one of the periods: no later than three months before the start date of the making; or no later than three months before the first related act, that would otherwise be prohibited by the protection conferred by the SPC, whichever is the earlier. Furthermore, the maker shall notify the SPC holder and the competent authority of all the changes to the information before those changes take effect.
The fee for sending the notification in the Republic of Croatia has not been set as yet, and the makers are required to submit the hard-copy of the form filled in to the SIPO. The Regulation and the standard form in Croatian language in HTML and PDF format are available here.
DZIV shall publish, as soon as possible, the information received, as well as their changes, together with the date of notification of that information.