Petr Bely proposed to strengthen the protection of intellectual rights of Russian pharmaceutical manufacturers
Russian patent authorities should restructure its interaction with pharmaceutical companies. For the development of the domestic pharmaceutical industry and ensuring the national drug security, it is necessary to create a system that stimulates and supports the launch of Russian innovative drug products. This proposal was made by the Chairman of the Board of Directors of Promomed Group, Petr Bely, at a visiting meeting of the Intellectual Property Council of the Federation Council of the Russian Federation held in Saransk.
The event was held via videoconference by the head of the Federation Council Valentina Matvienko.
In his speech at the meeting, 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 the expert, some approaches to regulatory relations in this area need revision.
Petr Bely noted that broad patent protection is the basis for 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 expert, 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. Petr 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.
«Often, an excessively formal approach to assessing the state of the art narrows the scope of patent protection due to the requirement to detail the claims, in particular, to indicate specific point functional groups and radicals,» observed Petr Bely. «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.
The Chairman of the Federation Council Valentina Matvienko supported this position. She instructed senators to develop specific proposals to improve the work of the Russian Patent Office.
For reference
Promomed Group is one of the leaders of the Russian pharmaceutical industry, an active participant in the system of ensuring national pharmaceutical security. The company produces more than 180 names of drugs, 80 percent of them are included in the list of VED. Several company's products are listed in the guidelines «Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)» of the Russian Ministry of Health.
Source: rg.ru
