As previously reported by Setterwalls on 9 April, 18 April och 15 May, amendments to the EU Regulation on the supplementary protection certificate (SPC) for medicinal products (no. 469/2009) were adopted by the European Parliament and the Council this spring. Yesterday (11 June 2019), the SPC Waiver legislation was published in the EU Official Journal and will consequently enter into force on 1 July 2019. The published legislation can be found here.
The SPC Waiver legislation introduces exemptions from the SPC-conferred exclusivity, essentially for manufacturing for export and for certain storage measures in the EU. The exemptions will apply to the following SPCs:
a) SPCs applied for on or after 1 July 2019;
b) SPCs applied for before 1 July 2019 and taking effect on or after that date. For these SPCs, the exemptions will apply only from 2 July 2019.
SPCs taking effect before 1 July 2019 are not subject to the exemptions.
Setterwalls has extensive experience with SPCs and we follow the developments closely. Welcome to contact us.