The Failure to Preserve CRISPR-Cas9’s Patentability post Myriad and Alice

The Failure to Preserve CRISPR-Cas9’s Patentability post Myriad and Alice

Benjamin C. Tuttle

The CRISPR-Cas9 system is a highly versatile genome-editing technology that is derived from bacteria. Heralded as one of the most influential biotechnology discoveries in history, CRISPR-Cas9 is unlike any previous geneediting technology because it utilizes a simple RNA template and a relatively small universal enzyme to accurately, efficiently, and cheaply make genetic modifications in any organism. Developed independently by two leading research groups out of the University of California, Berkeley (“Berkeley”) and the Massachusetts Institute of Technology (“MIT”), the ownership of CRISPR-Cas9 technology has lead to a patent dispute, culminating in the recent allowance of an “interference proceeding” by the United States Patent and Trademark Office (“USPTO”). The USPTO’s pending decision on this interference proceeding leaves uncertain the propriety of a technology projected to be worth billions. 

This new genetic modification technique presents many scientific, ethical, medical, and legal concerns that affect humanity and the global environment, beyond the realm of biotechnology and scientific innovation. This paper focuses on the patentability of CRISPR-Cas9 and concludes that given recent landmark U.S. Supreme Court decisions, such as Ass’n for Molecular Pathology v. Myriad Genetics, Inc. and Alice Corp. v. CLS Bank Int’l, CRISPR-Cas9 will no longer be eligible for patent protection in America. In order to reach this conclusion, first it is necessary to describe the progression of genetic modification technology leading to the discovery of CRISPR-Cas9; and second, to analyze both historical perspectives and recent trends in case law relating to the patentability of products derived from nature.

98 J. Pat. & Trademark Off. Soc’y 391(2016)

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