There are two independent systems of legal protection of drugs: state registration ofdrugs and patent protection of drugs in most countries. Due to the common object ofprotection collisions, competition and inconsistency (issues of drug interchangeability,determining the point at which the generic drug manufacturer can begin to take actionsto introduce the drug into circulation, content of such actions, possibility of registering ageneric drug the term of patent for which has not expired, etc.) invariably arise betweenthese systems. One of the legal institutions ensuring the interaction of registration andpatent protection of drugs is the so-called patent linkage. The relevance of the study ofadditional mechanisms for the protection of exclusive rights of manufacturers of originaldrugs during registering of reproduced drugs in the form of patent linkage for Russia isassociated with international obligations. The integration legal regulation ensuring thefunctioning of the common markets of drugs and medical products in the EAEU providesfor establishing the patent status of the drug during registration. As a result of the analysisof the best foreign practices of regulating the registration of drugs from the point of view ofprotecting the exclusive rights of third parties to patents used in them, the main elementsof the patent linkage were identified, including: the additional obligations of applicantsapplying for state registration of drugs, protecting the rights to patents used in registereddrugs; legal mechanisms for preliminary verification of exclusive rights of third partiesfor patents used in registered drugs during applying for registration; state informationsystems containing information about patents used in reference drugs; registration ofdrugs with a deferred introduction into circulation due to the presence of third-partyrights to intellectual property items used in registered products; the applicant’s limitedrights to use the registered drug in the period from the moment of registration with adeferred introduction into circulation until the moment of complete introduction. Based onevaluation of the best foreign practices of regulating procedure for registering drugs andprotecting exclusive rights of third parties to inventions used, proposals were formulatedfor the domestic legal order.
For citation: Tsomartova F.V. (2019) On Correlation of Drug Registration and theirs Patent Protection. Pravo. Zhurnal Vysshey shkoly ekonomiki, no 1, pp. 133–157 (in Russian) DOI: 10.17-323/2072-8166.2019.1.133.157