title: Strategic balance of drug lifecycle management options differs between domestic and foreign companies in Japan.
abstract: BACKGROUND
  Drug approvals and patent protections are critical in drug lifecycle management (LCM) in order to maximize drug discovery investment returns.
  
  
  METHODS
  We analyzed drug LCM activities implemented by 10 top companies in Japan, focusing on drug approvals and patent term extensions.
  
  
  CONCLUSIONS
  Foreign companies acquired numerous drug approvals primarily for new molecular entities (NMEs), while Japanese companies mainly obtained approvals for improved drugs including new indications, and intensively extended patent terms. Furthermore, we discovered three factors likely responsible for differences in drug LCM strategies of Japanese and foreign companies: research and development capacities for drugs, drug lags of foreign-origin NMEs, and cooperation between Research and Development Departments and Intellectual Property Departments.
authors.affiliation: a Innovation Policy Research Unit, Department of Computational Biology, and Medical Sciences, Graduate School of Frontier Sciences , The University of Tokyo , Kashiwa-shi , Chiba , Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamanaka
authors.affiliation: a Innovation Policy Research Unit, Department of Computational Biology, and Medical Sciences, Graduate School of Frontier Sciences , The University of Tokyo , Kashiwa-shi , Chiba , Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kano
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000706:statistics & numerical data*; D015195:Drug Design; D055808:Drug Discovery / Q000191:economics / Q000706:statistics & numerical data; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration / Q000706:statistics & numerical data*; D006801:Humans; D007564:Japan; D010330:Patents as Topic / Q000706:statistics & numerical data*; D012106:Research / Q000191:economics / Q000458:organization & administration / Q000706:statistics & numerical data
keywords: Japan; Lifecycle management; drug approval; market exclusivity; patent; patent term extensions