Correlation between Legal Institutions of Patent Law and Regulation of Medicinal Products Circulation

Due to the specifics of the industry, pharmaceuticals belongs to one of the areas where patent protection of the results of intellectual activity is most in demand and has received the greatest development. However, patent law and legal regulation of the circulation of medicines are developing in fact in parallel, which raises many questions in practice. The paper examines the problems of incoordination of these areas of law, in particular on issues of terminology, specifies the points of intersection between the legal mechanisms established in them. The author elucidates the features of prolongation of patent protection of the invention relating to the drug as a product, as well as the relationship of this prolongation with the state registration of the drug under consideration. Particular attention is paid to discussion issues on the advisability of introducing into the Russian legal system the so-called patent linkage and the Bolar provisions in the legal regulation of the circulation of medicines commonly applied in foreign law. The author makes proposals on the basis of an analysis of judicial practice, foreign and domestic experience in finding a legal compromise between the interests of generic companies and patent holders — manufacturers of original drugs — to facilitate appropriate changes to Russian law.

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