On January 5, 2021 the Decree of the Government of the Russian Federation No. 3718-r dated December 31, 2020 (the Decree) was published. In accordance with the Decree, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use the inventions of the US companies Gilead Sciences Inc. and Gilead Pharmasset LLC protecting Remdesivir subject to a “fair compensation”¹.

A new procedure on medical devices import for their further registration in Russia¹ will enter into force from 1 January 2021.

18 September 2020 the Russian Federal Antimonopoly Service (the FAS) published the full decisions on cases No. 1-14-163/00-08-18 and 1-14-164\00-08-18. According to the decisions, Daimler AG and KYB Corporation breached art. 14.8 of the Russian Antitrust law by committing acts of unfair competition.

The new rules on the medicines interchangeability No. 1360 (hereinafter – the Rules) enacted by the Russian Government have entered into force on 9 September 2020.

Published on July 31, 2020 the Federal Law "On Experimental Legal Regimes in the Field of Digital Innovation" will enter into force in January 2021.

On 27 May 2020 WIPO launched new online business service, WIPO PROOF, that provides tamper-proof evidence of the existence at a point in time of any digital file, including data sets, in any format.

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 art. 38 of the Law on fundamental healthcare principles the software used for medical purposes has a legal status of medical device. Therefore, market turnover of such software in Russia is allowed only after software is registered before the Federal Service for Surveillance in Healthcare (Roszdravnadzor).