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Legal barriers to the withdrawal of new medicines discussed at SPIEF

05.06.2026

Corporate
For investors
The patent system of medicines came to Russia from abroad. Domestic manufacturers have successfully mastered it, and the legislation protects it according to all the rules. However, it is difficult to call it competitive now — some drugs are monopolized by the unique developments of foreign pharmaceutical companies, but they do not reach our shelves. And Russian manufacturers are running into the very legislation that they so honestly follow.

The correspondent 78.ru During SPIEF 2026, I listened to the discussion around the pharmaceutical industry and now I know how to return fair competition to the pharmaceutical market.


Regular omeprozole — many people have it in their medicine cabinet. When the patent protection period for such drugs comes to an end, manufacturers slightly change the formula and again receive protection for their development, which means that analogues will not appear. This phenomenon is called evergreen patents. The participants of the Economic Forum discussed how to deal with them.

The same patent system of medicines is used in Russia as abroad. Since 2021 alone, the number of international clinical trials has dropped by almost 18 times. The logic is simple — there is no research, there are no drugs. But foreign pharmaceutical companies continue to patent them, but they do not bring them to the market.

— This is just a direct brake, a direct obstacle for society on the way to receiving modern therapy on more affordable terms. How does it work? A patent has the right to a monopoly and, accordingly, the right to sell at a monopolistically high price," explains Peter Bely, Chairman of the Board of Directors of PJSC PROMOMED.

The Supreme Court stands guard over patent law. Foreign investors can be sure that they will be safe in our country. But such protection should not be abused either.

— The Constitutional Court said that access to therapy is an aspect of protecting the constitutional order. Therefore, if some kind of therapy is not enough, the state can and should intervene," Bely notes.

There is currently a compulsory licensing mechanism in Russia. If the company does not use the patent for four years, then everyone will be allowed to produce the drug. But when it comes to life-saving medicines, it's simply impossible to wait that long.

In order for the balance to always exist, this requires legislative adjustment. That is why all these issues are being discussed in the Federation Council and the Intellectual Property Council.

Yuri Zubov

Head of the Federal Service for Intellectual Property (Rospatent)


And after all, domestic pharmaceutical companies are able to create their own innovations to provide patients with effective therapy. In total, PROMOMED has more than 100 patents, only 30 of them in the last year. Moreover, the increase in exports of medicines in Russia over the past year was 30%. And this is largely due to domestic developments. They have already begun to be protected in Rospatent.
— At the stage of expertise, at the stage of assessing the novelty of the expertise level and industrial applicability, use all those novelties that were made several years ago, — says Zubov. — An environment, approach and practice are being formed that do not allow existing patents to be "greened" in this way.
In the meantime, the legislation is being adjusted to take into account the current situation, experts believe that the best way is to file public lawsuits and fight "evergreen" patents through expertise. Sources
  1. 78.ru

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