Three patent portfolio structures for lifecycle management of cell therapy products

Lifecycle management (LCM) in the pharmaceutical industry uses patent protection and regulatory strategies to maximize the lifetime value of approved products. Although product-level patent analyses have examined small molecules and biologics, product-patent linkage information remains limited for cell therapy products (CTPs). A previous study suggested that the drug LCM framework could be applied to approved chimeric antigen receptor T-cell (CAR-T) products. The present study assessed whether the drug LCM framework evaluated in the previous CAR-T study could be generalized to CTPs beyond CAR-T by analyzing five non-CAR-T products approved in Japan. Product–patent linkages were identified using Japanese patent term extension (J-PTE) data, and additional product-related patents were identified using product-specific search queries. Claims were classified into composition of cells, clinical application (use), manufacturing, formulation, and device categories. Applicability of the drug LCM framework was evaluated using the patent and regulatory requirements established in the previous CAR-T study. Primary patents were identified for two products, and no additional approvals relevant to the regulatory requirement were identified during the observation period. Therefore, none met both requirements at the time of observation under the operational criteria applied in the present study. Compared with CAR-T products, non-CAR-T products showed more heterogeneous patent structures. Based on these findings, we propose three exploratory patent portfolio structures for CTPs: substance type, use-oriented type, and manufacturing-oriented type. These results suggest that drug LCM applicability may vary among CTP modalities.