Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator's position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.

On 1 September 2024, a joint order of the Ministry of Industry and Trade No. 3554 and the Ministry of Health No. 406n dated 7 August 2024 (hereinafter referred to as the “Order”) entered into force, approving a new procedure for providing the Ministry of Industry and Trade with information on medicines necessary for the purposes of licensing their production and inspecting the subjects of their circulation for compliance the requirements of good manufacturing practice. The Order replaced the previously existing procedure for interdepartmental interaction between the Ministry of Health and the Ministry of Industry and Trade.

On 9 July 2024, the State Duma passed Bill No. 638771-8 “On Introduction of the Draft Federal Law ’On Amendments to Certain Legislative Acts of the Russian Federation’” (the “Bill”) in first reading, which focuses on changes in the regulatory regime for the circulation of dietary supplements in Russia.

The proposed amendments would introduce significant changes affecting the circulation of dietary supplements and, to a certain extent, bringing it closer to the regime established for pharmaceuticals and medical devices.

By its Ruling of 25.09.2023 in case No. A40-185112/2022, the Ninth Commercial Court of Appeal ordered the pharmaceutical company Vertex, the right holder of a series of patents for the drug Trikafta (INN: Ivacaftor+Tezacaftor+Elexacaftor, Ivacaftor), to grant a simple (non-exclusive) license to the Russian pharmaceutical company MIK under Article 1362(1) of the Russian Civil Code (insufficient use of patents).

Decree No. 529 of the Russian Government dated April 3, 2023 entered into force on April 18, 2023. It amends the Rules for Granting Subsidies for Research and Development in the Realization of Innovative Projects, approved by Decree No. 1649 of the Russian Government dated December 12, 2019.

On 22 February 2023 the Government has approved the rules for conducting an experiment on the remote sale of prescription medicines. The experiment is carried out in the territory of Moscow, Moscow and Belgorod regions from 1 March 2023 to 1 March 2026.

The State Duma has adopted in the first reading amendments to article 238.1 of Criminal Code, establishing liability for circulation of unregistered medicinal drugs and devices in Russia.

The bill proposes to exclude from note 3 to the article 238.1 a case of non–criminalization – the existence of a recommendation by the World Health Organization for the use of appropriate unregistered medicinal drugs and devices.

On 8 February 2023 Alexey Repik, the founder of R-Pharm – Russian pharmaceutical company, producing, among other things, drugs for COVID-19 (e.g. coronavir (favipiravir) and artlegia (olokizumab)) was listed in the UK Sanctions List.

Reasoning behind this decision is that he holds the position of the Chairman of the Board of R-Pharm, which receives financing from the Russian Direct Investment Fund – a Government of Russia-affiliated entity. Moreover, Alexey Repik is also designated as a person associated with Vladimir Putin, the Russian President.