Expanding the concept of drug lifecycle management to chimeric antigen receptor T-cell products through product-patent linkage analysis

Chimeric antigen receptor T (CAR-T) cell therapies have been actively developed, and five CAR-T products have been commercialized in Japan. Due to the ongoing development of CAR-T cell therapies, including next-generation variants, the patent landscape is expected to become increasingly complex. Therefore, understanding patent strategies for each CAR-T product is essential. In the pharmaceutical industry, lifecycle management (LCM) centered on regulatory and patent protection has been implemented to maximize product value. While studies have reported CAR-T patents through patent landscape analysis to gain insights into the overall CAR-T technology, there is a lack of research on product-related patents for CAR-T products. As a result, the foundational knowledge regarding the LCM of CAR-T products remains unclear. Therefore, we identified product-patent linkages for CAR-T products in the Japanese market by combining patent term extension (PTE) data with publicly available data and assessed the applicability of drug LCM to CAR-T products. Our identification of precise product-patent linkages revealed that all CAR-T products met the criteria for drug LCM. This study suggests that LCM activities can be implemented for CAR-T products and that the concept of drug LCM can be expanded to CAR-T products. • The drug LCM applicability was examined from both patent and regulatory perspectives. • The concept of drug LCM can be expanded to CAR-T products. • Future CAR-T patent strategies should consider LCM to maximize value and protection. • Japanese PTE data covers multiple patents and helps identify patent portfolios.