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

Promomed 18 April 2022

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 on the issues of intellectual property protection, in particular, dwelt on the advantages and risks of compulsory licensing, the peculiarities of the current system of approval of medicines in Russia and the protection of intellectual property in pharmaceutical industry. According to Petr Bely, some approaches to regulatory relations in this area need revision.

The Chairman of the Federation Council Valentina Matvienko supported the proposal of the Chairman of the Board of Directors of Promomed Group Petr Bely that the Russian patent authorities should restructure their interaction with pharmaceutical companies. Valentina Matvienko also made the following comment: «They shall advise and help, not limit[i].» The Chairman of the Federation Council instructed senators to develop specific proposals to improve the work of the Russian Patent Office.

In his speech, Petr Bely noted that broad patent protection underlies the successful and innovative development of the pharmaceutical industry. Compulsory licensing is a regulatory tool that is currently necessary for prompt and short-term solution to the issue of import substitution. However, it is associated with the risk of 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, which will replace foreign drug products and nullify relevant compulsory patents.

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

«Often, an excessively formal approach to assessing the state of the art narrows the scope of patent protection due to the requirement to detail claims, in particular, to indicate specific point functional groups and radicals. On the contrary, the practice adopted in the USA and Europe of a much broader scope of protection gives the inventor a guarantee of return on investment, and, most importantly, makes it possible to choose the most successful drug to launch to the market, both from a clinical and economic points of view.

For the development of the domestic pharmaceutical industry, increasing the export potential of the country, and most importantly, the drug security for Russian citizens, it is necessary to create a system that stimulates and supports the launch of Russian innovative drug products by revising the approach to the examination of patent applications in the direction of expanding the scope of protection from the detailed Markush formula to variability within functional groups and combinations, based on clinical significance and economic feasibility,» concluded Petr Bely.