Intellectual property analysis for derivation and use of induced pluripotent stem cells


Kim Yong-ou, Koo Soo-kyung
Division of Intractable Disease, Center for Biomedical Science, KNIH, KCDC
Lee Hee-sung, Lee Dong-gun, Bae Sun-gu
Darae IP Strategy Consulting Group

Human induced pluripotent stem cells (iPSCs) are a promising tool with respect to their application in cell therapy, disease modeling, drug screening, and toxicity tests. The National Center for Stem Cell and Regenerative Medicine (NCSR), as a national stem cell bank and public infrastructure to facilitate clinical application of stem cells, is providing human iPSCs and a manufacturing service for clinical trials of cell therapy. For clinical application and commercialization, intellectual property (IP) surrounding iPSCs has been an important issue. Herein, we analyzed iPSC-related IPs in order to draft guidelines of the NCSR regarding the distribution of iPSCs and their application.
We searched the Worldwide Intellectual Property Service database using “induced,” “pluripotent,” “stem,” “cell,” “reprogramming,” and “etc.” as key words. We were able to extract a total of 2,665 patents in major nations. In Korea, 276 patents had been submitted until 2016. We analyzed each nation’s situation with respect to patent and applicant numbers. Analysis showed that the number of applicant had not increased in Korea since 2012, while it is still increasing in the United States, Japan, and China. Through in-depth analysis three major patents were recognized as barrier patents.
In this analysis, we identified barrier patents in the application of iPSC technology and realized that we need to develop new methods to overcome the barrier patents while making efforts to develop therapeutics for patients using current technology.

Keywords: Induced pluripotent stem cells, Cell therapy, Drug screening, Toxicity tests, Regenerative medicine