Violation of intellectual property rights or restriction of access to therapy?

Experts on symmetrical responsibility in matters of intellectual property protection.

A balanced and economically-oriented approach to the protection of intellectual property in the pharmaceutical industry was the subject of discussion on the sidelines of the St. Petersburg International Economic Forum. At the session "Patent issues in the pharmaceutical industry: challenges and opportunities" raised the issue of monopolizing the market when using patents, which are subsequently revoked as illegal. In such a sensitive area as maintaining the health and increasing the life expectancy of our country's citizens, a responsible decision needs to be made, and this was discussed by the participants of the session.

In order to synchronize views and outline a way to solve the problems identified in the field of intellectual property, representatives of the involved authorities and major pharmaceutical companies gathered at the same venue: Maxim Kolesnikov, First Deputy Minister of Economic Development of the Russian Federation; Vasily Osmakov, First Deputy Minister of Industry and Trade of the Russian Federation; Sergey Glagolev, Deputy Minister of Health of the Russian Federation; Alexey Lavrov, Deputy Minister of Finance of the Russian Federation; Yuri Zubov, Head of Rospatent, Irina Filatova, member of the State Duma Committee for the Protection of Competition, Artem Zdunov, Head of the Republic of Mordovia, Dmitry Zaitsev, CEO of Pharmstandard JSC, and Peter Bely, founder and Chairman of the Board of Directors of PROMOMED. The session was moderated by Inna Svyatenko, Deputy Chairman of the Federation Council of the Federal Assembly of the Russian Federation.

Experts almost in unison stated the urgent need to fine-tune the patent system and destroy any barriers that may stand in the way of providing patients with modern innovative therapies.

They discussed both the success of the first year of work of the government sub-commission, which issues so-called "compulsory licenses", and the need to change legislation. Currently, there is only liability for infringement of intellectual property rights. The experts discussed the need to impose liability for illegal monopolization of the market related to the use of unjustified and subsequently revoked patents, while encouraging competitive testing of patents by manufacturers of reproduced drugs.

The panelists noted the successes of Russian pharma, the accelerated pace of implementation of the Pharma 2030 strategy, the strengthening of fair patent and intellectual competition, and the need to fine-tune the existing system. It should consist in introducing symmetrical liability measures for unfair actions, such as unprovoked withdrawal from the market and/or revocation of registration certificates by pharmaceutical manufacturing companies, unjustified "greening" of patents, illegal monopolization or violation of well-founded, sustainable patents.

Maxim Kolesnikov, First Deputy Minister of Economic Development of the Russian Federation, noted during his speech that it is impossible to suspend the purchase of drugs and receiving therapy for patients due to patent disputes, and also recalled that there is an article in the Civil Code that allows the state to issue so-called "compulsory licenses", or rather, permits to use certain patents without consent. the patent holder in an emergency. This measure is applicable in emergency cases if the patent holder has stopped producing or supplying the necessary medicines.

"How to use this rule, how to get this solution, was not completely clear. That is why we have organized a sub-commission in the government under the leadership of Maxim Reshetnikov, Minister of Economic Development of the Russian Federation. This subcommittee must include colleagues from the Ministry of Industry and Trade, the Federal Antimonopoly Service, the Ministry of Health and Rospatent. We involve industry departments in case we have any narrow industry issues. At this sub—commission, we are considering the possibility of issuing a so—called "compulsory license" - permission to use patents without the consent of the copyright holder through a separate act of the government," explained Maxim Kolesnikov.

Peter Bely, Chairman of the Board of Directors of PROMOMED, added that even a small number of such permits has a crucial effect for the state. "Let's look at the economy and the benefits to society that have occurred. For example, several companies were granted permission to manufacture a drug for the treatment of diabetes and use the relevant patents without the consent of the copyright holder. What was the result? The drug has become 20 times more affordable, and now several million people receive it," he said.

First Deputy Minister of Industry and Trade of the Russian Federation Vasily Osmakov stressed that Russia needs a full cycle of production of vital drugs. "The responsibility for the risks that are always present in the innovation race lies with the developer, but we are now trying to find a support mechanism that will work correctly in the innovation segment, such as pharma," he added. Regarding patent issues, the expert explained that "at the moment, you can get a sharp reduction in the costs of the healthcare system, but too frivolous an attitude to the protection of intellectual property rights is another "nuclear weapon"." When developing new rules, agencies should act on the principle of "do no harm," since "everything again rests on the fact that foreigners either raise prices godlessly, or have really stopped supplying [drugs]."

The protection of innovative medicines is a driver for the development of the pharmaceutical industry, but at the same time it is necessary to address increasingly acute intellectual property issues and protect the rights of Russian manufacturers for the further development of the domestic industry. This opinion was expressed by Deputy Minister of Health of the Russian Federation Sergey Glagolev during the SPIEF.

The topic of the growing number of patent disputes and the reasons why this is inevitable was revealed by Peter Bely, Chairman of the Board of Directors of PROMOMED. According to the expert, after 2022, the number of clinical trials conducted by foreign pharmaceutical companies has decreased by 20 times. This makes it impossible for the latest foreign medicines to appear in the country in the foreseeable future. "Now a special responsibility falls on the domestic industry. 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. Another thing is that this should happen according to some rules that need to be agreed upon. We must provide for liability for illegal monopolization of the market as a mirror measure of responsibility for violations," Petr Bely emphasized.

"The intellectual property system should not be destroyed for the sake of short-term interests. It needs to be adjusted. As part of the implementation of the Pharma 2030 action plan, we have already introduced a number of legislative changes aimed at combating the "evergreen" patents that we still have. At the same time, we are conducting important and necessary consulting work with businesses within the framework of the Center for Assistance to Advanced Technologies, and we are helping to create comprehensive protection for domestic innovations. Intellectual property largely creates an investment climate and the very "rules of the game" that have been talked about so much, the very balance that needs to be achieved today in changing conditions so that it is profitable and comfortable for honest manufacturers, both domestic and foreign, to work and develop," explained Yuri Zubov, head of Rospatent.

The head of the Republic of Mordovia, Artyom Zdunov, noted that intellectual property issues directly affect the region's economy: "It is very important for us how much medicines cost. Especially if these are hospital medications, vital medications. Why should we overpay when we see that similar domestic medicines are several times cheaper? Why should we tear up our budgets because someone overprotected their products and turned out to be wrong after that?" Artyom Zdunov stressed that responsibility should lie with all market participants, and expressed readiness to bring the issues under discussion to the state level on behalf of the heads of regions: "Companies that enter the market have a powerful scientific and production base, they have passed many supervisory and competitive procedures. They need to be given equal rights. Work on resolving this issue is currently proceeding very slowly. These rules need to be adopted and approved at the legislative level."

Deputy Chairman of the Federation Council of the Federal Assembly of the Russian Federation Inna Svyatenko, summing up the opinions of experts, summed up that it is necessary to submit issues of improving patent legislation to the Council on Intellectual Property under the Chairman of the Federation Council and as soon as possible to develop general rules aimed at developing innovations and guaranteeing the competitiveness of patent warfare.

1. Tass.ru