The Patentability of the Crispr-Cas9 Genome Editing Tool

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. 1. Timeline of Medical Biology, AMGEN, http://www.biotechnology.amgen.com/timeline.html (last visited Jan. 20, 2017). 2. Arti K. Rai & Jacob S. Sherkow, The Changing Life Science Patent Landscape, 34 NATURE BIOTECH. 292, 292-94 (2016). 3. Ekaterina Pak, CRISPR: A Game-changing Genetic Engineering Technique, SITN BLOG (July 31, 2014), http://sitn.hms.harvard.edu/flash/2014/crispr-a-game-changing-genetic-engineeringtechnique. 4. Lee McGuire, For Journalists: Statements and Background on the CRISPR Patent Interference Process, BROAD INSTITUTE (Dec. 6, 2016), https://www.broadinstitute.org/crispr/journalists-statement-and-background-crispr-patent-interfer. 2017 THE PATENTABILITY OF THE CRISPR-CAS9 GENOME EDITING TOOL 409