The Deputy Chairman of the Federation Council supported the proposal of the relevant associations and PROMOMED to create a legislative initiative on changes in the patent system.

06.10.2025

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Inna Svyatenko, Deputy Chairman of the Federation Council, at the International Forum "BIOPROM: Industry and Technologies for Humans" supported the creation of a new legislative initiative on changes to the patent system. The changes are intended to form general rules aimed at developing innovations and guaranteeing the competitiveness of the patent fight.

The volume of innovation activity of foreign companies related to the registration of new drugs in Russia tends to zero. According to open source data, the number of clinical trials conducted in our country has decreased by more than 15 times. If more than 300 such studies were conducted in 2021, then in 2024 the year is only 24. This makes it impossible to register the latest foreign drugs. Responsible decisions need to be made in such a sensitive area as preserving the health and increasing the life expectancy of citizens. It is necessary to break down any barriers that may stand in the way of providing patients with modern innovative therapies. One of the key conditions for achieving Russia's drug independence is the improvement of patent regulation.

The specific actions that need to be taken to address this issue were discussed at the session "Development of intellectual competition as a factor in the innovative development of the domestic pharmaceutical industry." Experts agreed that in order to ensure fair intellectual competition, mechanisms should be developed to ensure the liability of patent holders for abuse of exclusive rights. Thus, the legally defined liability for infringement of intellectual property rights should be balanced by the introduction of liability for illegal monopolization of the market associated with the use of unjustified and subsequently revoked patents, while encouraging competitive verification of patents by manufacturers of reproduced drugs. The experience of such law enforcement is vividly demonstrated in the world. For example, Teva was recently fined 462.6 million euros for abusing its monopoly position on the market of a drug against multiple sclerosis in seven European Union countries.

"Testing the strength of patents and supporting companies that seek to eliminate illegal monopolies is the best global practice. It encourages fair competition, lowers prices, and increases the availability of modern therapies for patients. In the United States, it has been estimated that unfair competition in the pharmaceutical industry leads to the fact that consumers and taxpayers annually href="https://www.ftc.gov/news-events/topics/competition-enforcement/pay-delay">переплачивают there are billions of dollars for medicines. We must recognize that it is very important for society that there are companies that take risks and spend resources testing patents and trying to revoke them. This is a very important social function, and it is necessary to encourage companies that assume it. But those whose patents were eventually revoked, who illegally monopolized the market, should be held accountable. We must provide for liability for illegal monopolization of the market as a mirror measure of liability for violations. And these rules should be defined at the legislative level."

Peter the White

Founder and Chairman of the Board of Directors of PJSC PROMOMED

Another step towards ensuring fair competition and intellectual struggle is to consolidate the dependence of the application of antimonopoly legislation on the results of patent disputes and decisions of competent authorities: Rospatent, the Intellectual Property Rights Court, the Arbitration Court, etc. The harmonization of patent and antimonopoly legislation will consolidate a systematic approach to protecting the interests of patients and the state.

Inna Svyatenko said that the time has come when we need to talk less and do more. Summing up the opinions of experts, she summed up that the issues of improving patent legislation had already been submitted for consideration by the Council on Intellectual Property under the Chairman of the Federation Council and that the general rules developed as soon as possible would be clearly described within the framework of the relevant legislative initiative. According to her, this is not only about the economy, but also about national security issues.

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