LEGAL REGULATION OF PATENT LINKAGE IN PHARMACEUTICALS: ЕXPERIENCE FROM FOREIGN COUNTRIES

Abstract

The article is dedicated to exploring the nuances of legal regulation concerning "patent linkage" in pharmaceuticals in foreign countries, focusing on its impact on competition, access to medicines, and intellectual property rights infringement. The research methodology employed includes general scientific and specific approaches to scientific cognition: dialectical method, formal-logical method, systemic-structural method, and comparative legal method. These approaches facilitated the clarification of the legal aspects of regulating the "patent linkage" system. The mechanisms of legal regulation of patent linkage in various countries, including France, Germany, Hong Kong, and Japan, are examined. In France and Hong Kong, patent linkage is not legislatively enforced, allowing generics to market drugs even before the expiration of patent rights. However, this may lead to legal disputes and significant risks for generics in case of subsequent patent conflicts. In Germany, as in other EU member states, the establishment of the Unified Patent Court aims to facilitate effective resolution of patent disputes and reduce legal risks for all parties involved. It is noted that patent linkage, which permits generics to market drugs before patent expiry without infringement, is actively criticized due to the absence of legislative regulation, potentially leading to artificial extension of patent rights and fostering unfair competition. The article discusses judicial practices concerning patent disputes, which play a pivotal role in shaping the competitive environment in the pharmaceutical sector. Key issues related to unfair mechanisms, such as the creation of "patent thickets" aimed at avoiding competition and delaying the market entry of generics, are identified. The conclusion emphasizes the importance of refining the regulatory environment to promote access to innovative medical technologies and reduce legal uncertainties arising from patent linkage.