Analysis of Global Patenting Trends in Radiopharmaceutical Industry: Diagnostics, Therapy, and Theranostics

INTRODUCTION. Radiopharmaceuticals play a crucial role in modern nuclear medicine, offering effective methods for cancer diagnostics, treatment, and theranostics. Despite the rapid growth, the field still lacks a comprehensive patent analysis that would identify key scientific and technological achievements, market leaders, and potential risks and opportunities. Systematising and analysing patent activity for radiopharmaceuticals will help both track the evolution of technology and identify promising areas for future research and commercialisation.

AIM. This study aimed to analyse patent activity comprehensively in order to assess its current state and prospects of radiopharmaceutical industry.

MATERIALS AND METHODS. The study was performed using Questel Orbit database. Patent and bibliometric analysis, segmentation of scientific and technical information was used to analyse 4,988 patent families over a period of 2000–2024. Eligibility criteria included indexes of International Patent Classification and keywords in the Russian and English languages.

RESULTS. There has been an increase in patent activity after 2018 related to approval of innovative drugs based on ¹⁷⁷Lu and ⁶⁸Ga. Three main patenting areas were identified: diagnostics (43%), treatment (23%), and theranostics (34%). The leaders in the number of patents are the USA, China and the EU countries that have well-developed science and technology base and strong market potential. Differences were found in patent strategies of Russian and foreign organisations. Foreign institutions prefer using broad claims: one patent consolidates a whole class of radionuclides, several molecular carriers and delivery mechanisms, providing wide legal protection and protecting innovations in case of minor formula changes. This strategy allows for a complex protection of technological solutions and provides stable market advantage. At the same time, Russian companies prefer narrowly focused patents that cover specific process solutions. This allows protecting separate innovations, but makes broader coverage impossible and gives the competitors a chance to circumvent the patent.

CONCLUSIONS. Patent analysis shows the focus of developmental studies shifted from traditional diagnostic radiopharmaceuticals towards complex theranostic radiopharmaceuticals (with combined diagnostic and therapeutic properties). Despite available practical designs in radiopharmacy, Russia is far behind the leading countries in patenting. Moreover, the differences detected in patent claims of Russian and foreign scientists as well as patenting as a whole emphasise the need to improve patenting strategy in Russia in order to enhance intellectual property protection and stimulate international development of radiopharmaceuticals.

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