Implementation of the SPC waiver by the INPI.
Since July 1, 2019, Regulation (EC) No. 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products has been amended to allow manufacturers of generics and biosimilars established in the European Union (EU) manufacture in the EU products, or medicines containing these products, for export to third countries outside of the EU, or for storage in the 6 months preceding SPC expiry.
If the making of the product (s) used in the composition of the medicinal product, or the manufacture of the medicinal product, is to take place in France, the maker must inform the INPI, in addition to the holder of the SPC, at the latest three months before the date from the start of making in France, or at the latest three months before the first related act prior to this making, which would otherwise be prohibited under the protection conferred by a SPC, the earliest date being retained.
The means to carry out this compulsory information of the INPI, which is a condition to benefit of the SPC waiver, are now in place.
The form required to inform the INPI can be downloaded from the following link.
This form, once completed, must be notified in electronic form to the INPI by means of a request for registration of an "act affecting the ownership or enjoyment of a title", made via the portal e-procedures of the INPI website, and must be accompanied by the payment of a fee amounting to € 27. The INPI will publish this registration as soon as possible at BOPI and will also make this form available in the INPI patent database.
Any update of the information contained in the form must be the subject of a new registration request, following this same procedure.