Russia’s life sciences industry is growing rapidly, say Vadim Chagin and Maria Nilova.
In Russia, IP rights are regulated by the Civil Code of the Russian Federation (CCRF), and also subject to other legal provisions, such as the Law on Protection of Competition, Customs Code, Criminal Code, and others that form the legislative basis for the enforcement of IP rights. The Federal Law on Drug Circulation is often cited in pharmaceutical court cases when establishing the presence or absence of patent and trademark infringement.
Although the patent legislation in Russia is, in general, pro-patentee, in view of 80 percent of the commercial pharmacy market consisting of generics, the important question for many manufacturers would be the adoption of a ‘Bolar provision’, enabling them to start a lengthy market authorisation procedure before expiration of a patent. Changes to the Federal Law on Drug Circulation in 2010 have made such a provision possible.
According to CCRF, a patent for a product such as drug is infringed if the patented drug is manufactured, sold, offered for sale, imported or otherwise introduced into civil circulation. While scientific research in respect of a patented drug is excluded from infringing actions, it is not defined whether a registration of a patented drug is considered infringement.
CCRF, pharmaceuticals, patent licensing