Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Regents of the University of California v. Broad Institute, Inc., Nos. 2022-1594, 2022-1653 (May 12, 2025), addressing Regents’ appeal from a PTAB decision in a patent interference proceeding. The Federal Circuit vacated the PTAB’s primary decision and remanded.
Regents and Broad claimed ownership of the patent rights for systems using simplified CRISPR-Cas9 technology to edit DNA in eukaryotic cells. Regents’ scientists began research and claimed to have used their system to edit DNA in a cell-free in vitro environment in early 2012. Regents’ scientists then presented their system at a conference in June 2012. Thereafter, experiments by Regents’ scientists temporarily foundered; attempts to edit DNA in eukaryotic cells failed or led to inconclusive results. Regents’ scientists expressed concerns that their experiments may not achieve DNA editing in eukaryotic cells but still believed in the core concept of their system. In Regents’ team did ultimately experience experimental success in October 2012. While Regents’ experimental frustrations were ongoing, however, a scientist from Broad used the disclosures from Regents’ presentation with techniques he had previously developed and reported experimental success in July 2012.
Both Regents’ and Broad filed patent applications, each claiming to be the assignee of inventions covering the CRISPR technology. The PTAB declared an interference and found that Broad was entitled to priority. The PTAB determined that Regents’ experimental failures, combined with doubts expressed by Regents’ scientists regarding the achievability of experimental success, meant that Regents’ scientists did not conceive of the claimed invention until after Broad’s scientist had reduced the invention to practice.
The Federal Circuit vacated the priority determination, holding that the PTAB had applied the wrong legal standard for conception, essentially requiring that Regents’ scientists needed to know that their invention would work to prove conception. What was important, the Court held, was not the general uncertainty inherent in experimental sciences, but whether the inventors had a definite and permanent idea of the operative invention. The Court also found that the PTAB erred in failing to consider: (1) whether the record showed that a POSITA could have reduced the conceived invention to practice; (2) experimental success of others using Regents’ invention; (3) whether Regents’ scientists described routine methods or skill in their early disclosures and used such methods and skill in ultimately successful experiments. The Court thus remanded to the PTAB for reconsideration.
