Peter Bely at the meeting of the Council on Intellectual Property of the Federation Council of the Russian Federation

In his speech at the meeting chaired by the head of the Federation Council of the Federal Assembly of the Russian Federation Valentina Matvienko, Petr Bely touched upon the issues of intellectual property protection, in particular, he dwelled 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 Petr Bely, some approaches to regulatory relations in this area require revision.

Valentina Matvienko, Chairman of the Federation Council of the Federal Assembly of the Russian Federation, supported the proposal of Peter Bely, Chairman of the Board of Directors of Promomed Group of Companies, that Russian patent authorities should restructure their work with pharmaceutical companies and commented as follows: "advise and help, not limit ^[i]." The Chairman of the Federation Council instructed the senators to develop specific proposals to improve their work. of the Russian Patent Office.

In his speech, Peter 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 speaker, 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. According to Petr Bely, there are certain difficulties in protecting intellectual property when creating original domestic molecules. The examples he gave from domestic and foreign practice demonstrated in a number of 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. 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.

To develop the domestic pharmaceutical industry, increase 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 importance and economic feasibility," concluded Peter Bely.

[i] Quote from the Senate inform edition: senatinform.ru