Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral arguments in The Regents of the University of California v. Broad Institute, Inc., No. 22-1653, were more than a year ago, and the decision just came down on Monday, May 12, 2025. But the decision was not the final word. The Federal Circuit vacated and remanded, sending the case back the U.S. Patent Office to try again at resolving which party was the first to invent a single guide CRISPR-Cas system for eukaryotic gene editing. This interference is one of several ongoing disputes related to the technology.

Background

This case is part of a long-running dispute between the University of California and the Broad Institute over who first invented certain IP covering the use of CRISPR-Cas9 in eukaryotic cells. Jennifer Doudna at the University of California was awarded a Nobel Prize for her contributions to the field, but the U.S. Patent Office’s Patent Trial and Appeal Board (PTAB) awarded priority of invention to Feng Zhang at the Broad Institute. In its decision, the PTAB found that the University of California inventors did not know whether their work would be transferrable from prokaryotes to eukaryotes.

Federal Circuit Decision

The Federal Circuit held that the PTAB “legally erred by conflating the distinct legal standard for conception and reduction to practice” in deciding priority because it required the University of California to “know their invention would work to prove conception.” The Regents of the University of California v. Broad Institute, Inc., No. 22-1653, slip op. at [16] (Fed. Cir. May 12, 2025).

According to the Federal Circuit “the Board erred by failing to consider routine methods or skill, focusing almost entirely on Regents’ scientists’ perceived experimental difficulties and related statements of doubt.” Id. at 22. Rather, the PTAB should have considered whether routine methods and skill would have allowed one to arrive at a CRISPR-Cas9 system that functions in eukaryotic cells based on the disclosures the University of California inventors provided. In addition, “the Board erred in failing to consider purported experimental success by other[s] presented on the record.” Id. at 20.

Separately, the Federal Circuit affirmed the PTAB’s decision that the first provisional application relied on by the University of California lacked written description. It also dismissed the Broad Institute’s cross-appeal on claim construction issues as moot.

What’s next

• The case will be sent back down to PTAB for further findings on priority, and that decision will be eligible for a further appeal to the Federal Circuit.
• Other parties claiming interests in early CRISPR IP—such as Sigma-Aldrich and ToolGen—are waiting in the wings. Both have actions that are on hold pending the outcome of the dispute between the University of California and the Broad Institute.