The Draft Law № 912458-7 “On amendments to the part four of the Russian Civil Code” has passed through the third reading in the State Duma on 25 May 2021. The Draft Law implements article 1360.1 to part four of the Russian Civil Code.
According to the new article, under the conditions provided by an international treaty, the Government may allow to use a patented invention in generic medicines for production in the Russian territory for the purpose of subsequent export without the patentholder’s consent, with prior notification and compensation of the patentholder.
At the same time, the Government will have to disclose the volume of generic medicines to be produced and exported, depending on the needs of a foreign state.The packaging of such generic medicines shall contain a special designation.
The Government should further clarify the procedure of sending notifications to patentholders, the grounds, and procedure for issuing and terminating licenses, as well as the methodology for calculation of the sum of compensation to patentholders.
As stated in the explanatory note to the Draft Law, the amendments aim to implement article 31-bis of the TRIPS Agreement(TRIPS) introduced in 2005 and ratified by Russia in 2017.
As soon as the Draft Law is adopted, a new reason for a compulsory licensing will appear in the Russian legislation without the prior consent of the patentholder. Notably, at the beginning of May amendments related to compulsory licensing were already made to the Russian Civil Code (see our review).
We believe that this provision will additionally reduce originators patent monopoly in Russia and enrich generic producers.