Russian lawmakers propose Bolar-style amendment on patented drugs
Russian lawmakers submitted a bill allowing use of patented drugs in research before patent expiry to prepare generic registration. The measure mirrors a Bolar exemption as patent disputes over early generic launches rise.
A bill has been submitted to the State Duma allowing the use of patented drugs for scientific research and experiments before the patent expires. The purpose of such activities is to prepare for state registration of a generic version of the original drug, and such actions will not be considered a violation of the patent holder’s exclusive rights.
The bill establishes the right to conduct research and experiments necessary to obtain marketing approval for a drug. The provision mirrors the so-called Bolar exemption found in international practice, which allows the use of a patent-protected invention to prepare for the market launch of a generic drug after the patent expires.
The bill’s authors believe that its adoption will have a positive impact on the development of Russia’s pharmaceutical industry and improve drug availability for the population.
In recent years, the number of patent disputes between pharmaceutical companies in Russian courts has nearly tripled, according to a study by the Association of International Pharmaceutical Manufacturers. While courts considered just over 30 such cases between 2017 and 2021, the number has already reached over 80 between 2022 and 2026. Previously, the main subject of litigation was challenging patents per se, but now the focus has shifted to the early launch of generics and attempts to obtain compulsory licenses. Of the 35 international non-proprietary names for which disputes have been recorded, more than half are related to the early launch of generics.
The Federal Antimonopoly Service classifies sale of such drugs as unfair competition and requires the transfer of illegally obtained income to the budget, but defendant companies often succeed in challenging these orders in court.
The health minister said earlier that around 6 billion drug packs enter civilian circulation in Russia each year, nearly 72% of which are domestically produced. About 80% of drugs on the list of vital and essential medicines are also manufactured in the country. Over the past decade, more than 80 new production facilities have opened in the pharmaceutical industry, and over 520 companies hold licences to manufacture drugs.