Regents of the Univ. of Cal. v. Broad. Inst., Inc

Authored by: Jeremy J. Gustrowsky

The long-running patent dispute over who first invented the CRISPR-Cas9 gene-editing technology for use in eukaryotic cells—those found in plants, animals, and humans—took another turn with a recent Federal Circuit decision. The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, “Regents”) challenged a Patent Trial and Appeal Board (PTAB) ruling that gave priority to the Broad Institute, Massachusetts Institute of Technology, and Harvard College (“Broad”) for key CRISPR patents. The core issue was who first conceived of and reduced to practice the use of CRISPR-Cas9 with a single-guide RNA (sgRNA) in eukaryotic cells.

The Federal Circuit found that the PTAB made several legal errors in its analysis of “conception”—the moment when an inventor has a definite and permanent idea of the invention. The court clarified that inventors do not need to know for certain that their invention will work in order to have conceived it; actual proof that it works is only needed for “reduction to practice.” The PTAB had focused too much on the Regents’ scientists’ doubts and ongoing experiments, without properly considering whether their original idea was clear enough that only routine skill would be needed to make it work. The court also said the PTAB should have looked at whether others in the field, using standard techniques, were able to successfully use the Regents’ CRISPR system in eukaryotic cells.

On the other hand, the Federal Circuit agreed with the PTAB’s decision that the Regents’ earliest patent applications (including U.S. Patent Application No. 61/652,086) did not meet the “written description” requirement. Because CRISPR-Cas9 in eukaryotic cells was such a complex and unpredictable technology at the time, the applications needed to show more detail to prove the inventors actually possessed the claimed invention. The court also dismissed Broad’s cross-appeal about claim construction as moot, since it would not have changed the outcome.

In summary, the Federal Circuit sent the case back to the PTAB to reconsider who first conceived of the invention, using the correct legal standards. The outcome could have a major impact on who holds the foundational patents for CRISPR gene editing in eukaryotic cells—a technology with enormous potential for medicine and agriculture.