New rules on registration of software as medical device in Russia

On March 3, 2020, the Russian Government introduced to the State Duma the Draft Law on amendments to the Russian Civil Code, namely, article 1360.1.

According to the explanatory note to the Draft Law, the purpose of this new regulation is to assist foreign states to combat epidemics.

New regulation will allow the Government to use of a patented invention in generic medicines for subsequent export without the patentholder’s consent, subject to prior notification and compensation of the patentholder.

Therefore, the Government will be entitled to issue an export license for any pharmaceutical invention for production and export of generic medicines. By doing so, 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 to prevent re-export.

The Government will 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.

The Draft Law aims to implement article 31-bis of the TRIPS Agreement (ratified by Russia in 2017), under which a WTO members with insufficient medicines production capacities may contact another WTO member to assist with medicines in case of emergency.

If the Draft Law is adopted, a new reason for a compulsory license will appear in the Russian legislation. We believe that this provision will reduce patent protection in Russia, which has been a tendency for a few recent years, and enrich generic producers in at the expense of originators.