The head of "Promomed";: In a few years, we'll treat cancer like a migraine.

Peter Bely, Founder and Chairman of the Board of Directors of Promomed PJSC, spoke about the role of intellectual property in the development of the Russian pharmaceutical industry in an interview with TASS at the St. Petersburg International Economic Forum (SPIEF).

© Stepan Pugachev/ Roscongress Foundation

— What is the role of intellectual property in the development of the pharmaceutical industry in the next 5-10 years?

— In general, intellectual property in the pharmaceutical industry is now the most nerve, the most vertebral column of the effective development of the innovative component of the pharmaceutical industry. What does it mean to be innovative? These are drugs that bring solutions to those medical problems that were previously considered unsolvable. If such a solution is not protected by a patent, no matter how brilliant the scientific development is, investments will not come into it. Investments will come only if the intellectual property is protected. And then we will win, as we are winning more and more different terrible diagnoses, and we will stop being afraid of them. We will soon be discussing this phrase on one of the upcoming forums: "Oh, does he have cancer? Well, it's just cancer." We will treat this as pneumonia, as a migraine, but not as something that can kill a person or significantly incapacitate them.

— What is the current situation with the development of intellectual property in Russia?

— The system works well, it is developed. Our main regulator, Rospatent, is extremely flexible in responding to the challenges that each period of historical development presents to us. Once upon a time, within the framework of the Intellectual Property Council, we discussed that the amount of patent protection given to Russian manufacturers does not correspond to the amount that our Western colleagues have. This situation has been leveled as a result of our dialogues. Fast track has been created for development, specifically for domestic innovative developments, where Rospatent acts as an intellectual and scientific partner, providing a very high level of patenting. I would like to emphasize that, despite all the political transformations and global polarization, patent law remains international. And the principles by which we work here remain international. And the applications that we patent here, they also apply to extraterritorial markets according to these international rules. And this is what we often do at Promomed.

But there are also problems. Currently, a large number of foreign companies that used to bring innovative drugs here are not conducting clinical trials in Russia. This means that the drugs of the next generation will not come. Who should do this job? Russian pharma. Do we need a solid patent system for such a story? More than necessary.

How is the Russian industry developing? Far in the past, we have a period when Russia was associated only with the production of cheap generics and reproduced drugs. Now, due to the threats that have arisen and the constant withdrawal of vital drugs from the market, the government has set the task for the entire industry so that we are ready to immediately replace any treatment that falls out, and this has been done.

Since the next generation of drugs will not arrive, we will have to provide the innovative solutions that need to be created here. And we create them. But we have some difficulties at the moment. For example, we see that there are many patent applications that actually monopolized the market. What is a patent? It's a monopoly. Dozens of cases of patent revocation in Russian courts. At the same time, the market was monopolized on the basis of invalid patents. And the huge money that the monopolistic exploitation of the market brought flowed somewhere abroad.

Now the question is: if we go out and violate such a patent, we have civil and criminal liability. And what responsibility is provided for those who monopolized the market unreasonably? It turns out that it doesn't exist. We do not see it in any of the legislative codes. These issues were raised today at our panel discussion led by Inna Svyatenko by representatives of all concerned ministries, in the presence of the head of Rospatent. We have agreed that these issues will be considered by the Intellectual Property Council of the Federation Council. And we will definitely find a solution.

The second is the phenomenon of challenging and verifying patents for durability. This is a recognized story in all countries, and it is very important for our work, because not all patents are equally useful. And if the monopolization of the market occurs illegally, on the basis of a patent that was made with errors or with an unreasonably wide scope of protection, someone should definitely take the initiative to conduct research, go public. Court, prove it. But then the invention will go into the public domain, and everyone will be the winner at once. But what about those who incurred the costs of this, who did it, spent time and resources?

Different countries have different practices. Somewhere, the first reproduced drug is given a monopoly right to sell its drug for a year or two, somewhere it is allowed: please come out with patent infringement and sue at the same time. If you lose, you will be punished, if you win, it means that you have done well - you are already on the market and commercializing the invention. And we still do not have a public agreement on what status we give for such an important and socially significant work. And we also agreed that we will come up with such rules.

This is important for all market participants, both for patent holders and for those who are working to verify these patents for durability. This is an initiative that creates even more conditions for the development of our patent system, so that our legislation becomes even more developed and provides for more situations for which we have standard and convenient solutions for all market participants. And now, when this issue will be considered by the Council on Intellectual Property in the Federation Council, we know for sure that there will be a solution.

— As for your company, how does Promomed plan to expand the geography of patenting its developments?

— We have a very large amount of development and clinical research that we are conducting. Over the past two years, we have received more than 55 patents for our inventions, ranging from new molecules to patents that provide a medical application process. The most important thing for us is to create medicines that treat what was incurable yesterday.

Yesterday, at a panel session, together with the Minister of Health of the Russian Federation Mikhail Murashko, we discussed a strange situation. The whole world is saying, "We have a new Chikungunya virus, 40 times more dangerous than covid." Many countries are already covered with local epidemics, but there is no cure. And in Russia it exists, in particular, in the Promomed company. And it is protected by a patent. The export potential for such a product is huge. Therefore, it is very important that Russia remains a party to international treaties on the dissemination and non-infringement of patents. And, of course, we are moving to different countries with our inventions. We have targets in Southeast Asia, North and South Africa, and the Caribbean. They are very interested in our experience, for example, in creating drugs for the treatment of diabetes. We have developed a therapy that meets the best international practices and is 10-20 times cheaper than foreign drugs. At the same time, the security profile is more favorable.

If we see from the documentation that an undesirable phenomenon in the form of nausea occurs in 5% of cases, then these are isolated phenomena in our country. And weight loss occurs in a few months, while maintaining a muscular silhouette.

We have invented a number of drugs that cure various oncological nosologies. We expect their release in 2028-2030. You know that we have almost won in hematology, different types of blood cancers are already treatable. Now the task is to learn how to cure tumors of various organs and systems. And these drugs are already in development, many of them have already passed the patenting stage. Now we are entering the phase of genetic research, and this is an interesting work that intellectually puts Russia in one of the leading powers in the world.

No one disputes that the Russian nuclear power industry is one of the strongest in the world. No one disputes that our mathematicians and programmers are one of the strongest intellectual forces in the world. In the coming years, we should see this transformation, as Russian pharma is one of the strongest in the world.

— How does Promomed contribute to ensuring Russia's drug sovereignty?

— We are constantly working on this. The state has set us the task of creating a dozen drugs. Clinical trials have been conducted, registration certificates have been received. We are in a state of readiness. As soon as the government gives us a signal, we will be able to deliver all these drugs to the Russian market.

Pharmacoeconomic studies are currently being conducted by the institutes of the Ministry of Health and the Ministry of Industry and Trade on when and how this very powerful weapon can be used precisely, which makes it possible for drugs to be released before the patent expires. An intergovernmental commission has been established, headed by Maxim Reshetnikov, Minister of Economic Development.

In other words, our regulatory system is being developed precisely in order not to violate the law and maintain a balance of interests. Foreign companies are not opponents of Russian ones. We are all busy ensuring that Russian patients are provided with the best and most advanced therapy. And the state is just building such a system so that in the future,There were no risks to the supply of healthcare facilities, a particular patient with drugs that treat vital diseases and are vital.

1. Tass.ru