Lidings’ Intellectual Property practice team succeeded in obtaining cancellation of registration of a drug in a dispute against the holder of the marketing authorisation (MA) due to the fact that during the process of registration of a generic drug product the Ministry of Health of Russia received false information from the holder of the MA.

Senior associate of the Lidings’ Intellectual Property practice Vladislav Ryabov will take part in the International Conference entitled Intellectual Property Right: Challenges of 21st Century. The conference will take place on 14-16 November 2024 at the campus of the National Research Tomsk State University.

On November 7, 2024, Lidings held a round table discussion " Launch of Medicines and Pharmaceutical Substances in Russian and Indian Markets" as part of the business program of the Forum "Under One Sun: Russia-India. Business and Culture ", which took place in Delhi, November 6 - 8, 2024.

Highlights of the event in our overview.

On 6-8 November 2024 the international forum “Under One Sun: Russia-India. Business and Cultur” will take place in Delhi, India withing the 100th anniversary of the Russian Association for International Cooperation. The event is organized on the initiative of the Ministry of Foreign Affairs of the Russian Federation and the Trade Mission in India with the support of Lidings as a co-organizer of the business discussion.

During the forum on November 7 Lidings will hold a special round table “Launch of Medicines and Pharmaceutical Substances in Russian and Indian Markets” moderated by Lidings’ partner Boris Malakhov and counsel Natalya Thotahewage.

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 15 October, Lidings hosted a webinar for its clients to break down the legal aspects of critical information infrastructure (CII) security, focusing on the regulation applicable to the pharmaceutical and chemical (Pharma and FMCG) and healthcare industries.

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.

The new review of the most notable patents disputes in Life Sciences in Russian and the CIS.

• pdf, 2.52 Mb

We are delighted to announce that Lidings has updated The Pharma Legal Handbook: Russia - practical directory focused on the key aspects of legislative regulation of pharmaceutical industry in Russia.