The role of medical equipment and other medical devices in modern healthcare is constantly increasing. At the same time, the legal regulation of this area significantly lags behind similar processes in relation to medicines. The legal regulation of the exercise of exclusive rights is no exception. First of all, the article highlights a number of key differences between the field of medical devices and pharmaceuticals that affect the specifics of the legal protection of related intellectual property results, in particular, which led to the absence of a number of preferences in legislation for them, for example, the possibility of prolongation of the exclusive right to an invention and the provision of exclusive protection of information on the results of clinical trials of medical devices. The purpose of the study is to analyze the specifics of the sphere of circulation of medical devices and the exercise of exclusive rights of related intellectual property results in order to further develop proposals for the modernization of relevant legal mechanisms. A wide range of general scientific and special methods of cognition were used in the research process. Thus, the analysis of regulatory sources and methodological documents in the field under study was carried out, followed by the specification and systematization of the necessary legal tools. Based on the results of the analytical studies, conclusions were drawn, in particular, about the expediency of using a “soft” version of patent binding in the field under consideration, as well as extending the provisions of the Bolar concept to the field of medical devices. As a characteristic feature of the area under consideration, the obligation of medical organizations, enshrined in the legislation on the basics of health protection, to comply with the standards for equipping medical devices provided for in the procedures for providing medical care, is highlighted. According to the author, this responsibility of medical organizations should correspond to the responsibilities of ensuring the availability of medical products, including innovative ones. A special legal regime is needed to ensure the availability of healthcare products, including, in particular, legal mechanisms for limiting the exclusive rights of ineffective and unscrupulous copyright holders.
Aleksander Latyntsev (Thu,) studied this question.