Chapter 21 - CRISPR technology commercialization and biosafety

Abstract

Clustered regularly interspaced short palindromic repeats (CRISPR) represents the new face of genome editing and is one of the breakthrough discoveries of the 21st century. Since its first report as a genome editing tool in 2012, it has been most widely adopted in the life sciences, with a broad spectrum of applications in the agriculture, medical, and industrial sectors. CRISPR applications hold tremendous potential for mass production of low-cost products, sensitive diagnostics, the treatment of genetic diseases, and commercially important crops valuable for food security. As a result of this ubiquitous adaptation of CRISPR in all fields and its tremendous developments and benefits, Jennifer Doudna and Emmanuelle Charpentier were awarded the 2020 Nobel Prize for Chemistry. Similarly, many interrelated patents were also filed for intellectual property rights by universities and private companies for the commercialization of CRISPR-based products. Therefore to develop competing products through CRISPR technology, one must obtain a license from the appropriate owner for commercial developments. This chapter focuses on CRISPR-based innovations. We also discuss exclusive and surrogate licensing in CRISPR and the foundational patent dispute between UC Berkeley and the Broad Institute of MIT. In addition, we summarize the global landscape of CRISPR patents and IP rights and their distribution in the agricultural, medical, and industrial sectors. We also highlight how CRISPR patent distribution may impact food security in developing countries, as almost all patents are in developed countries. We also summarize biosafety and biosecurity concerns associated with CRISPR, such as off-targets, possible dual use, the availability of do-it-yourself kits for everyone, human germline editing, and rouge gene drives. Finally, we discuss prospects and future developments in CRISPR commercialization and its biosafety.