In a decision announced today (March 26), the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (USPTO and PTAB, respectively) reaffirmed its original decision that the Broad Institute, the Massachusetts Institute of Technology and Harvard University - referred to collectively as the Broad - first invented the use of CRISPR-Cas9 gene editing in eukaryotic cells, the general term for plant, fungal and animal cells, including human cells.
CRISPR-Cas9 gene editing is a revolutionary technique for manipulating DNA invented by Jennifer Doudna of the University of California, Berkeley; Emmanuelle Charpentier, then of Umeå University in Sweden; and their colleagues, one of whom worked as a Ph.D. student at the University of Vienna in Austria (collectively referred to as CVC, for California-Vienna-Charpentier). Doudna and Charpentier are widely recognized within the scientific community as the inventors of CRIRPR-Cas9 gene editing, and the two were recognized for the breakthrough with the 2020 Nobel Prize in Chemistry.
In 2022, however, the PTAB decided that the Broad, not the Doudna/Charpentier team, invented the application of CRISPR-Cas9 gene editing to eukaryotic cells. Last year, the U.S. Court of Appeals for the Federal Circuit remanded the case to the PTAB to reconsider its 2022 decision, stating that the PTAB applied the wrong standard and failed to consider relevant evidence. Today's decision was reached after the parties briefed the case and the PTAB reviewed the evidence in light of the Federal Circuit's decision.
The PTAB concluded that, "After considering the Federal Circuit's remand and CVC's and Broad's briefing on priority, we determine that the preponderance of the evidence shows that the CVC inventors did not conceive of an embodiment of Count 1 before the Broad inventors' actual reduction to practice on 5 October 2012. Accordingly, we deny CVC's motion for priority."
The University of California is disappointed by the PTAB's decision, which prevents 14 CVC patent applications from moving to allowance at the USPTO.
Unaffected by this decision are more than 60 U.S. and more than 40 non-U.S. patents awarded to CVC claiming compositions and methods for the use of CRISPR-Cas9 gene editing in all cell types, including human cells.
