Peter Bely proposed to strengthen the protection of the intellectual rights of Russian pharmaceutical manufacturers

Russian patent authorities should restructure their work with pharmaceutical companies. For the development of the domestic pharmaceutical industry and ensuring the country's drug safety, it is necessary to create a system that stimulates and supports the launch of domestic innovative medicines on the market. This proposal was made by Peter Bely, Chairman of the Board of Directors of Promomed Group of Companies, at an off-site meeting of the Council on Intellectual Property of the Federation Council of the Russian Federation in Saransk.

The event was held by the Head of the Federation Council of Russia, Valentina Matvienko, via videoconference.

In his speech, Peter Bely touched upon the issues of intellectual property protection, in particular, he focused on the advantages and risks of compulsory licensing, the specifics of the current system of registration of medicines in Russia and the protection of intellectual property in the pharmaceutical industry. According to the expert, some approaches to regulatory relations in this area require revision.

Petr Bely noted that broad patent protection is at the heart of the successful and innovative development of the pharmaceutical industry. Compulsory licensing is a regulatory tool that is currently necessary for an operational and short—term solution to the issue of import substitution. However, it carries the risk of an outflow of innovations and modern international therapies. Therefore, it is extremely important to stimulate Russia's own development of original drugs with a similar therapeutic effect — next in class, confirmed by clinical studies that will replace foreign medicines and nullify compulsory patents for it.

According to the expert, the most reliable and long—term tool that ensures true drug independence and security of the country is to stimulate the creation of a large-scale legal protection system for domestic original drugs. Peter Bely pointed out certain difficulties in protecting intellectual property when creating domestic original molecules and gave examples from domestic and foreign practice, which demonstrated in some cases a fundamentally different approach to the possible scope of patent protection.

"An overly formal approach to assessing the state of the art often leads to a narrowing of the scope of patent protection due to the requirement to specify claims, in particular, specifying specific point functional groups and radicals," stated Peter Bely. — Adopted, for example, in the USA and Europe, the practice of a much broader scope of protection gives the inventor guarantees of a return on investment, and, most importantly, the opportunity to choose the most successful drug for market launch, both from a clinical and economic point of view.

For the development of the domestic pharmaceutical industry, increasing the country's export potential, and most importantly, the drug safety of citizens, it is necessary to create a system that stimulates and supports the withdrawal of Russian innovative medicines by revising the approach to the examination of applications for inventions in the direction of expanding the scope of protection from the specified Markush formula to variability within functional groups and combinations, based on clinical significance and economic feasibility.

Chairman of the Federation Council of the Federal Assembly of the Russian Federation Valentina Matvienko supported this position. The head of the Federation Council instructed the senators to develop specific proposals to improve the work of the Russian patent office.

Reference

Promomed Group is one of the leaders of the Russian pharmaceutical industry, an active participant in the national drug safety system. More than 180 types of drugs are produced here, 80 percent of them are included in the list of VED. A number of the company's drugs are included in the list of methodological recommendations for the Prevention, diagnosis and treatment of new coronavirus infection (COVID-19) by the Russian Ministry of Health.

Source: rg.ru

1. https://rg.ru/2022/04/18/reg-pfo/petr-belyj-predlozhil-usilit-zashchitu-intellektualnyh-prav-rossijskih-farmproizvoditelej.html