References
- Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov. 2009;8:959–968.
- Howard L. Use of patents in drug lifecycle management. J Generic Med. 2007;4:230–236.
- Kakkar AK. Patent cliff mitigation strategies: giving new life to blockbusters. Expert Opin Ther Pat. 2015;25:1–4.
- Sandner P, Ziegelbauer K. Product-related research: how research can contribute to successful life-cycle management. Drug Discov Today. 2008;13:457–463.
- Dunn MK. Timing of patent filing and market exclusivity. Nat Rev Drug Discov. 2011;10:487–488.
- Pharmaceutical Administration and Regulation in Japan [Internet]. English Regulatory Information Task Force. [cited 2015 Nov 17]. Available from: http://www.jpma.or.jp/english/parj/pdf/2014.pdf
- Examination Guidelines for Patent and Utility Model in Japan [Internet]. Japan Patent Office. [cited 2016 Jan 18]. Available from: https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/1312-002_e.htm
- Christiansen WT. Patent term extension of pharmaceuticals in japan: so you say you want to rush that generic drug to market in Japan. Good Luck. Pac Rim L Pol’y J. 1997;6:613.
- Yamanaka T, Kano S. Patent term extension systems differentiate Japanese and US drug lifecycle management. Drug Discov Today. 2015;21:111–117. doi:10.1016/j.drudis.2015.09.005.
- Smith RB. Repositioned drugs: integrating intellectual property and regulatory strategies. Drug Discov Today Ther Strateg. 2011;8:131–137.
- Kobayashi H. Macro analysis of drug lifecycle strategies. Annu Conf Japan Advanced Inst Sci Technol. 2011;26:749–52. ( Japanese only).
- Daidoji K, Yasukawa S, Kano S. Effects of new formulation strategy on life cycle management in the US pharmaceutical industry. J Generic Med. 2013;10:172–179.
- Tanaka K. Evaluation of drug lifecycle management by the product-generation patent-portfolio map [Internet]. 2007. [cited 2015 Nov 17]. Available from: http://mba.kobe-u.ac.jp/life/thesis/workingpaper/2007/WP2007-16.pdf ( Japanese only).
- Yamanaka T, Kano S. Mapping LCM activities for blockbuster drugs in Japan based on approvals and patent term extensions. Drug Discov Today;2015. doi:10.1016/j.drudis.2015.11.002.
- Mittra J. Life science innovation and the restructuring of the pharmaceutical industry. Technol Anal Strateg. 2007;19:279–301.
- Henderson R, Cockburn I. Scale, scope and spillover: the determinants of research productivity in drug discovery. Rand J Econ. 1996;27:32–59.
- Okada Y, Kawara A The research productivity of Japanese drug industry. Research Paper Series of Office of Pharmaceutical Industry Research 9, 2002. [cited 2015 Nov 17]. Available from: http://www.jpma.or.jp/opir/research/rs_009/paper_09.pdf ( Japanese only).
- Clift C. The value of patent term extensions to the pharmaceutical industry in the USA. J Generic Med. 2008;5:201–208.
- Genda K, Ono S. Clinical development and examination period of new drugs. OPIR Views and Actions. 2014;42:8–14. [cited 2015 Nov 17]. Available from: http://www.jpma.or.jp/opir/news/news-42.pdf ( Japanese only).
- Genda K, Ono S Clinical development and drug approval in Japan–new drugs between 2000 and 2013–Research Paper Series of Office of Pharmaceutical Industry Research 63, 2014. [cited 2015 Nov 17]. Available from: http://www.jpma.or.jp/opir/research/rs_063/paper_63.pdf( Japanese only).
- French H. Maximizing exclusivity for drug products. Nat Rev Drug Discov. 2005;4:709.
- Takahashi M. New pharma marketing strategy. Tokyo: Iyakukeizaisya Co. Ltd; 2011.