Japanese biotechnology regulation and life science (gene) patenting

Abstract

AbstractJapanese patenting system on biotechnological inventions is unique. In 1979, before the US Supreme court's decision in the Chakrabarti case (1980), the Japanese Patent Office (JPO) had issued the “Implementing Guidelines for the Invention of Microorganisms,” and microorganism was considered as patentable. Japan lacks case laws. However, we can find cases like the Engineered Mice case. This study paper critically surveys and focuses on the Japanese life science (Gene/DNA) patenting system and its prevailing issues. This paper critically analyzes the current position and practices of the JPO on DNA patenting, including induced pluripotent stem cells as well as CRISPR gene‐editing technique, its challenges, and its potential future courses on this issue; the basis of granting a patent for DNA in Japan; Japanese outlook at ethical (living organisms) aspects of DNA patenting; depository system in Japan; the impacts of the tragedy of anticommons in Japan; “Creative Commons” movement; and others.