Priority Win for Broad Institute upheld by PTAB in CRISPR Patent Case
Priority Win for Broad Institute upheld by PTAB in CRISPR Patent Case
On second review, the PTAB was again “not persuaded that CVC has met its burden as junior party of showing that its inventors conceived of an embodiment of Count 1 before the Broad inventors had reduced the invention to practice”
On remand from the U.S. Court of Appeals for the Federal Circuit (CAFC), the Patent Trial and Appeal Board (PTAB) reaffirmed its decision that The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (“Broad”) were the first inventors of the use of CRISPR-Cas9 gene editing in eukaryotic cells. Jennifer Doudna of the University of California, Berkeley and Emmanuelle Charpentier, a microbiologist from Umeå University in Sweden and the Max Planck Institute for Infection Biology in Berlin, were awarded the Nobel Prize in Chemistry in 2020 for their work on the CRISPR (clusters regularly interspaced palindromic repeats) gene editing technology, which has been the subject of a heated patent debate over alleged simultaneous inventorship with Broad for years.
In May 2025, the CAFC issued a precedential opinion relinquishing and remanding the PTAB’s determination awarding priority to Broad, finding the PTAB applied the wrong standard by requiring the Regents of the University of California, the University of Vienna and Charpentier (“CVA”) to show their invention was known to work. The CAFC explained that conception doesn’t require certainty of success and remanded for re-evaluation under the correct framework. While the court reversed the PTAB on conception, it upheld the finding that CVC’s 2012 provisional applications lacked adequate written description. The applications did not adequately show possession of an operable CRISPR-Cas9 system in eukaryotic cells, even though they described the core components of the technology, said the court. As a result, CVC could not rely on those early filings to establish a constructive reduction to practice. On second review, the PTAB was again “not persuaded that CVC has met its burden as junior party of showing that its inventors conceived of an embodiment of Count 1 before the Broad inventors had reduced the invention to practice.” The PTAB first addressed the CAFC’s ruling that its original decision conflated “‘the distinct legal standards for conception and reduction to practice’ by not considering routine methods and skill, focusing instead on the CVC scientists’ statements of uncertainty about whether their experiments had succeeded and suggestions for modifications to the system they were using.” While CVC posed three arguments to prove conception on remand, the Board said that nothing in the CAFC decision required them to consider only certain evidence this time around, rather than a “preponderance of the totality of evidence,” as in their original decision. The PTAB reportedly wrote, “The court stated that ‘[t]he Board erred in its analysis by failing to consider routine methods or skill, and, instead, focusing almost entirely on Regents’ scientists’ statements about perceived experimental difficulties and doubts about success,’ but the court did not say that the Board erred in considering the CVC inventors’ statements and the extent of their research or experimentation at all in the determination of the preponderance of the evidence of conception.”
