The new Federal law will enter into force on 18 October 2022. The amendments provide for the possibility to challenge extension of a patent related to a medicine, pesticide, or agrochemical (granting SPCs) by filing an opposition with Rospatent according to procedure set out in Article 1398 (2) of the Russian Civil Code if conditions for such patent extension, stipulated in Article 1363 (2) of the Russian Civil Code, have been violated.

On July 29, the Government introduced Bill No. 173061-8 "On Amendments to the Federal Law "On the Circulation of Medicines" in order to conduct an experiment on the retail sale of medicines for medical use, prescription medicines, remotely

Restriction Impossible to be Registered: Lidings Team Defends Interests of Major Russian Pharmaceutical Manufacturer in Patent Dispute Over Registration of Generic.

On 5 July 2022 the State Duma approved in the third reading a draft law No. 11662-8 “On amendments to art. 6 of the Federal Law “On trade secrets” and art. 45 of the Federal Law “On medicines circulation”, under which the Ministry of Industry and Trade will be granted access to trade secrets of medicines ьmanufacturing.

The Russian Government adopted Regulation No. 947 “On the use of an invention to produce of a medicine in the Russian Federation for its further export without the patentholder consent” on 25 May 2022. The Regulation establishes the procedure for issuing export licenses, as well as the methodology for calculation of the sum of compensation to patentholders.

The Draft Order of the Russian Ministry of Healthcare on multiagency commission on the detection of medicines shortage or a risk of shortage was published on the official website for draft regulatory acts.

On March 26, 2022, the Federal Law No. 64-FZ “On Amendments to Certain Legislative Acts of the Russian Federation” was adopted (“Law”). It provides for the establishment of certain features of the circulation of medical products (“MP”) and medical devices (“MD”) in Russia in connection with the current economic situation. Such features include the following.

Lidings takes high positions in the new rating of the leading legal advisors in Russia based on the analytical research held annually by the “Kommersant” newspaper.

On 8 March 2022, Federal Law No. 46 “On Amending Certain Legislative Acts of the Russian Federation” entered into full force and effect, suggesting considerable changes in regulations and intellectual property in the pharmaceutical sphere.

On March 04, 2022, the Council of Federation has approved and sent to the President the Federal Law “On Amending Certain Legislative Regulations of the Russian Federation” (the “Law”). This Law provides for a number of changes in the regulation of procurement and circulation of medical products (“MP”) and medical devices (“MD”), corporate and financial relations, and even social matters.