On Correlation of Drugs Registration and theirs Patent Protection
Abstract
There are two independent systems of legal protection of drugs: state registration of drugs and patent protection of drugs in most countries. Due to the common object of protection collisions, competition and inconsistency (issues of drug interchangeability, determining the point at which the generic drug manufacturer can begin to take actions to introduce the drug into circulation, content of such actions, possibility of registering a generic drug the term of patent for which has not expired, etc.) invariably arise between these systems. One of the legal institutions ensuring the interaction of registration and patent protection of drugs is the so-called patent linkage. The relevance of the study of additional mechanisms for the protection of exclusive rights of manufacturers of original drugs during registering of reproduced drugs in the form of patent linkage for Russia is associated with international obligations. The integration legal regulation ensuring the functioning of the common markets of drugs and medical products in the EAEU provides for establishing the patent status of the drug during registration. As a result of the analysis of the best foreign practices of regulating the registration of drugs from the point of view of protecting the exclusive rights of third parties to patents used in them, the main elements of the patent linkage were identified, including: the additional obligations of applicants applying for state registration of drugs, protecting the rights to patents used in registered drugs; legal mechanisms for preliminary verification of exclusive rights of third parties for patents used in registered drugs during applying for registration; state information systems containing information about patents used in reference drugs; registration of drugs with a deferred introduction into circulation due to the presence of third-party rights to intellectual property items used in registered products; the applicant's limited rights to use the registered drug in the period from the moment of registration with a deferred introduction into circulation until the moment of complete introduction. Based on evaluation of the best foreign practices of regulating procedure for registering drugs and protecting exclusive rights of third parties to inventions used, proposals were formulated for the domestic legal order.
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