Journal of Legal, Ethical and Regulatory Issues (Print ISSN: 1544-0036; Online ISSN: 1544-0044)

Abstract

The Protection of Intellectual Property Rights in the Field of Biomedicine in Ukraine

Author(s): Vyacheslav Volik, Kateryna Yanishevska, Svitlana Pylypenko, Lesia Zolota, Hanna Nikitina-Dudikova

The article is devoted to the research of the protection of intellectual property rights in the field of biomedicine in Ukraine. The relevance of the research is justified by the fact that one of the functions of the country is the protection of public health, which includes both the search for new drugs and methods of treatment and minimizing the negative impact from the existing ones, including those that are patented. It has been identified that the patenting is one of the most common ways to protect intellectual property rights in the biomedical field, though it is not entirely perfect. It is determined that Ukraine has one of the first places for the number of patents issued in class A61 (medical or veterinary science; hygiene) for the total number of patents. That fact indicates that the shortcomings of the patent legislation in the country impact on the situation that the patents are registrated for the objects that poorly meet the criteria of the patentability. It has been found that one such drawback is the ability of patent entities to establish a monopoly on the patented objects. It is concluded that no perfect alternatives to patenting in the field of biomedicine have been proposed yet. It is noted, that the discussions on the issue of the creation of the state funding for biomedical researches and developments are underway, but the existence of such a mechanism in Ukraine is still in doubt. The particular attention is paid to the procedure of bringing the patenting mechanism in Ukraine into line with the requirements of Ukraine's accession to the Association Agreement with the EU, and the ratification of a number of international intellectual property acts. In this case, the innovations related to the strengthening of the patentability criteria, the updating the list of inventions for which a patent can be obtained, the introduction of the Bolar exemption, the possibility of appealing a patent’s application, similar to the existing positive practices of India, where there is a tendency to grant patents, which make the country competitive in various fields, including biomedicine.