Gap of intellectual property regulation in the field of generic registration

Abstract

The work is devoted to the analysis of problems related to intellectual property rights in the field of pharmaceuticals. In particular, the indicators of low effectiveness of Ukrainian legislation and the practice of its implementation were noted on the basis of the analysis of the annual report of the European Commission on the situation with protection of intellectual property in third countries, which was conducted in 2020. In the course of scientific work the problem of registration of generic drugs before the expiration of the patent for the original drug is covered and the ineffectiveness of the system of protection of the rights of persons-owners of original drugs is noted. In this context, the experience of the United States is considered, in particular in the functioning of the patent linkage system and the Orange Book, as well as their main features are analyzed and the feasibility of such experience for Ukraine is substantiated. The situation with the registration of generics before the expiration of the patent for the original drug, where the Law of Ukraine "On Protection of Inventions and Utility Models" noted the vagueness of legislation on the legality or, conversely, the illegality of patent for the original drug. For the practical value of the work and detailed coverage of the problem, the case law in disputes between manufacturers of originals and manufacturers of generics was reviewed and summarized, based on which the negative aspects that are characteristic of the practice of resolving such disputes were identified. In addition, it was noted what is the main economic interest of the parties to the dispute in resolving the case in their favor, including the possibility for the manufacturer of the original drug to hold a monopoly position in the market for some time, and for manufacturers of generic drugs - to accelerate market entry. and cover the costs of creating and distributing a generic drug. In conclusion, the main results of the study are described and the proposed measures necessary for reforming the system of intellectual property rights in the field of pharmaceuticals and achieving a result that does not differ from developed countries and would ensure a high level of protection of life and health countries.