Trends in the abuse of patent rights for medicinal products in the United States (review)

Аннотация

The article provides a systematic analysis of scholarly publications addressing contemporary trends in the abuse of patent rights in the pharmaceutical sector of the United States, with particular emphasis on the mechanisms for implementing “evergreen” patent strategies and their economic and legal consequences. The purpose of the study was to conduct a systematic review of the scientific literature on trends in the abuse of patent rights in the U.S. pharmaceutical sector, focusing on the mechanisms of “evergreen” patent strategies, their economic and legal implications, and possible directions for improving regulatory policy. To achieve this objective, a systematic literature review methodology was applied in accordance with the PRISMA guidelines, in combination with general scientific and special research methods, including the systemic-structural, dialectical, formal-logical, and comparative legal approaches, as well as methods of analysis and synthesis. The use of these methods made it possible to assess the current state of patent regulation in the United States, identify legal instruments for extending patent monopolies, and analyze their impact on the availability of generic and/or biosimilar medicines. The empirical basis of the study consisted of scientific publications, analytical and statistical reports indexed in PubMed, JAMA, Scopus, Springer, BMC, and Oxford Academic, reports and forecasts of international organizations (DrugPatentWatch, ProClinical, PhRMA, Statista), as well as official documents of the United States Patent and Trademark Office (USPTO), the TRIPS Agreement, and U.S. patent legislation (the U.S. Patent Act and the Hatch–Waxman Act). Out of 286 identified publications, 40 sources published between 2008 and 2025 were included in the qualitative analysis. Inclusion criteria comprised sources containing data on pharmaceutical patent protection, “evergreen” patent strategies, economic consequences, and access to medical technologies. Sources lacking a direct connection to the subject of the study or failing to meet scientific reliability standards were excluded. The results of the study demonstrate that U.S. pharmaceutical companies systematically employ multi-layered patent strategies aimed at prolonging market exclusivity beyond the expiration of the basic patent term, increasing drug prices, and restricting access to therapy for consumers. At the same time, empirical evidence confirms that patent expiration creates conditions for intensified market competition and a reduction in generic drug prices by 30–50% within the first years following market entry. The study emphasizes the need to improve regulatory mechanisms within U.S. patent law, including limiting “evergreen” practices and ensuring greater transparency of market processes. A forecast of structural changes in the U.S. pharmaceutical market for the period 2025-2029 is provided, associated with the expiration of key patents for original medicines, and approaches are proposed to achieve a balance between the interests of innovative development and societal needs for affordable medicines.