title: Patent term extension systems differentiate Japanese and US drug lifecycle management.
abstract: Drug lifecycle management (LCM) contributes to maximizing drug discovery investment returns. After initial drug approval, additional approvals can be sought for novel indications and formulations to extend product marketability. Patents provide additional barriers to entry and patent term extension systems facilitate extension of these. Several aspects of the US and Japanese patent term extension systems differ. Therefore, we compared both systems using a drug LCM case study to highlight the differences. Our findings indicate that the extension of multiple drug patents on multiple occasions in Japan produces a more complicated range of extended patent protections, compared with the US system.
authors.affiliation: Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, 5-1-5 Kashiwanoha, Kashiwa-shi, Chiba 277-8561, Japan. Electronic address: yamanaka-takayuki@k.u-tokyo.ac.jp.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamanaka
authors.affiliation: Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, 5-1-5 Kashiwanoha, Kashiwa-shi, Chiba 277-8561, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kano
mesh_terms: D017277:Drug Approval / Q000379:methods; D055808:Drug Discovery / Q000379:methods; D006801:Humans; D007564:Japan; D040541:Marketing; D010330:Patents as Topic; D004364:Pharmaceutical Preparations; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations