CRISPR Dispute Heats up With Recent Federal Court Decision

Written by:Jane Dai, Ph.D. and Geetha Durairaj, Ph.D.

On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California's (Regents) challenge to the Broad Institute's CRISPR-Cas9 patents, overturning a 2022 decision by the Patent Trial and Appeal Board (PTAB)[1]. The main issue centers on inventions related to the CRISPR-Cas9 editing in eukaryotic cells. The Patent Trial and Appeal Board (PTAB) had previously ruled in favor of Broad, finding that the Regents did not demonstrate whether CRISPR-Cas9 editing worked in eukaryotes prior to Broad's reduction to practice. The Court partially vacated and remanded PTAB’s ruling, finding that PTAB incorrectly applied the legal standard for conception in awarding priority to the Broad Institute for certain gene-editing patents.

The Court criticized the PTAB for conflating legal concepts of conception and reduction to practice. Emphasizing that conception is established when an inventor has “a definite and permanent idea of the complete and operative invention,” the Court criticized the PTAB for focusing almost exclusively on the Regents scientists’ statements expressing uncertainty about their experiments’ success[2]. The Court explained that such scientific uncertainty, common in complex research, does not negate conception unless it leads to substantive modifications of the original invention.

The Court also faulted the PTAB for failing to consider whether routine skills or methods known in the field could have reduced the invention to practice. The Court held that the PTAB erred in focusing solely on the inventors’ expressed doubts and experimental challenges, while failing to consider whether a person of ordinary skill in the art could have reduced the invention to practice through routine experimentation. The Court vacated the PTAB’s determination on Regents’ conception and remanded the case for reconsideration under the correct legal standard[3].

Separately, the Court affirmed the PTAB’s finding that certain Regents’ patent applications did not satisfy the written description requirement and dismissed Broad’s cross-appeal challenging the PTAB’s interpretation of “guide RNA” as moot[4].

The Court’s decision marks the latest development in the ongoing patent dispute between Regents and Broad over foundational CRISPR technology in the United States. The Federal Circuit’s decision injects renewed uncertainty into the CRISPR patent landscape, especially for companies and researchers relying on existing licenses. With foundational ownership between Regents and Broad still unresolved, biotech firms may face increased legal and commercial risk when developing or investing in CRISPR-based therapies and tools.

Editor: Brenden S. Gingrich, Ph.D.

 

[1] Regents of the University of California v. Broad Institute, Inc., Nos. 2022-1594, 2022-1653 (Fed. Cir. May 12, 2025)

[2] Id. at 17.

[3] Id. at 29.

[4] Id.