Deborah Ku


The biotechnology sector is rapidly changing with the increase in technological advancements. 1 The laws governing patent protection, specifically the laws governing patent eligibility, have also changed to adapt to these innovations.2 This paper focuses on the CRISPR-Cas9 technology, a genome editing tool that is changing the field of genetic engineering.3 As of November 2016, the U.S. Patent and Trademark Office has issued 42 patents on the CRISPR-Cas9 technology.4 This paper addresses the issue of whether patents claiming the core CRISPR-Cas9 technology can survive a 35 U.S.C. §101 (“§101”) subject matter eligibility challenge. The paper concludes that the CRISPR-Cas9 technology is patentable subject matter under §101. In reaching this conclusion, the paper will do the following: explain the CRISPR-Cas9 technology, compare it to genome editing tools that utilize ZFNs and TALENs, examine relevant §101 Supreme Court and Federal Circuit decisions, introduce the current Alice framework, and apply it to a hypothetical §101 invalidity dispute.