The new SPC Regulation - Manufacturing Waiver
SÉRVULO PUBLICATIONS 31 Jul 2019
The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred by the supplementary protection certificate (“SPC”) has the unintentional consequence of preventing the manufacture of generics and biosimilars established in the European Union (“EU”) from manufacturers established in the European Union, including for the purpose of export to third-country markets in which protection does not exist or has expired. EU. Manufacturers established in the EU were also prevented, as a result of this legislation, from manufacturing generics and biosimilars for the purpose of storing them for a limited period before the expiry of the certificate. Those circumstances make it more difficult for those manufacturers, in contrast to manufacturers located in third countries where protection does not exist or has elapsed, to enter the Union market immediately after the expiry of the certificate, putting them at a significant competitive disadvantage.
Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019, amended Regulation (EC) No 469/2009, concerning the supplementary protection certificate for medicinal products, and created an exception to the protection conferred by the SPC.
With the entry into force of this Regulation (1st July 2019), it became possible for manufacturers of generics and biosimilars established in the EU to manufacture products in the EU, or medicines containing those products, for export to third-country markets in which protection does not exist or has expired. Also, those manufacturers were now allowed to make and store products, or medicines containing those products, in a Member State for a defined period of 6 months until the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate. This amendment will help those manufacturers to enter in the market immediately after protection has expired (‘EU day-one entry’).
The manufacturer to which this exception is applicable has an obligation to provide certain information to the competent industrial property office (in Portugal, the INPI) and to the certificate holder.
This exception to the SPC protection is only applicable to certificates that are applied for on or after 1 July 2019. It is not applicable to certificates that are in force before 1 July 2019. Regarding the certificates that have been applied for before 1 July 2019 and that become effective on or after that date, the exception shall only apply from 2 July 2022.
Mariana Costa Pinto
mcp@servulo.com
