Intellectual Property in the Field of Regenerative Medicine in Japan

Abstract Purpose Although most pharmaceutical companies and bio-ventures have not yet created a practical business model or a credible exit thus far, most are expecting potential new business to be derived from regenerative medicine. This article discusses and proposes some ideas regarding a patent strategy for regenerative medicine. Methods PubMed literature searches were conducted to identify recent reports relevant to regenerative medicine. Information regarding patents and patent applications were obtained from the database service of the Japan Platform for Patent Information on the website of the National Center for Industrial Property Information and Training at https://www.j-platpat.inpit.go.jp/web/all/top/BTmTopEnglishPage and the Japan Patent Office at https://www.jpo.go.jp/index.htm . Findings The infrastructure of regenerative medicine in Japan is still maturing. Patent protection is important in regenerative medicine considering its special characteristics. Implications Based on the understanding of the special characteristics of regenerative medicine, this article discusses and proposes some ideas regarding a patent strategy for the field, which is different from that of a typical patent strategy as in the case of a small-molecule drug.