LEGISLATIVE CHANGES AS A COUNTER “EVERGREEN” PATENTS

Abstract

First of all, during the elaboration of the topic on the state of intellectual property rights in the pharmaceutical sphere, the report of the European Commission on the situation with the protection of intellectual property in third countries was analyzed, on the basis of which the most common problems were identified. The problem of “evergreen’ patents, which is typical for Ukraine, is taken into consideration and research. In the course of the work the definitions of the terms “original drug” and “generic” are given. The obligatory stages of launching original medicines on the pharmaceutical market were also studied and the reasons for the long duration and high cost of this procedure were noted. In the same context, the reasons for the policy of many countries to support the production of generic drugs were considered. The main attention is paid to finding out the reasons for the emergence of “evergreen” patents and the consequences of their distribution. To confirm the negative impact of the above problem on the state’s provision of a high level of public health, indicators of the cost of medicines and the degree of patient provision were presented. It was noted that the state has taken a step towards solving the problem of “evergreen” patents by adopting the Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine on the Reform of Patent Legislation”. However, in the course of the work, the effectiveness of some of the provisions of the Law was questioned and their assessment by the European Commission was given. In addition, the adopted Law of Ukraine “On Amendments to Certain Laws of Ukraine on Elimination of Artificial Bureaucratic Barriers and Corrupting Factors in Health Care”, which amended the Laws of Ukraine “On Medicinal Products” and “On Protection of Rights” on inventions and utility models”. Based on the analysis, the introduction of the “Bolar provision” into national legislation was noted, and both its advantages and possible risks were described. On the basis of the conducted researches the conclusions in which the priority direction of a policy of the state concerning regulation of the intellectual property rights in the field of pharmaceuticals is underlined are made.