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. 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.
The bill establishes the right to conduct research and experiments necessary to obtain marketing approval for a drug. Such actions will not be considered a violation of the patent holder’s exclusive rights.
The provision mirrors the so-called Bolar exemption found in international practice. This rule allows the use of a patent-protected invention to prepare for the market launch of a generic drug after the patent expires.
Health Minister Mikhail Murashko 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, he said. 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.
