' Ian Sterlin | MTTLR

The CRISPR War Drags On: How the Fight to Patent CRISPR-Cas9 Creates Uncertainty in the Biotechnology Sphere

On September 10, 2018, the Federal Circuit Court of Appeals (“Federal Circuit”) affirmed the ruling of the United States Patent Trial and Appeals Board (“the Board”) in Regents of the University of California v. Broad Institute, finding that there was no interference-in-fact between competing patents that claimed methods of using CRISPR-Cas9 to modify cellular DNA. Rather than settling the patentability issue, however, exhaustive litigation has continued, as both parties seek to protect the results obtained from costly research. Such protracted litigation has created significant uncertainty among members of the scientific, legal, and biotechnology communities as to the exact demarcation of patent ownership and may ultimately reduce the amount of innovation in CRISPR-based technologies and stifle developing industries. Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) are a family of DNA sequences found naturally in bacteria that, when paired with guiding RNA sequences and CRISPR-associated proteins (Cas), can selectively modify an organism’s genetic material (genome) more effectively and cheaply than comparable gene-editing systems. Since the discovery of CRISPR’s gene-editing capacity by researchers at the University of California, the University of Vienna, and Emmanuelle Charpentier, innovators have applied CRISPR technology in diverse industries, including the medical, industrial, and agricultural sectors. Several thousand CRISPR-related patent applications have already been filed worldwide, with the majority being filed in the United States, China, and Europe. Researchers at the University of California were the first to (“UC”) demonstrate that isolated CRISPR-Cas9 components could effectively function in an in vitro environment. UC subsequently filed a patent application in May 2012 broadly claiming a method to using CRISPR-Cas9 without referencing specific cellular environments. In December 2012, a research...