A long legal dispute over the rights to CRISPR/Cas9 gene editing has climaxed. In a decision released on Sept. 10, a U.S. federal court ruled in favor of Broad Institute of MIT & Harvard, agreeing with a lower court that Broad’s patents for CRISPR/Cas9 gene editing didn’t interfere with a patent application from CRISPR’s other inventors at the University of California, Berkeley, and the University of Vienna.
That decision is a victory for Broad scientist Feng Zhang and Editas Medicine, a company he cofounded to develop CRISPR-based therapies. But it leaves two other major CRISPR companies without a foundational U.S. patent on the technology they are based on. One is Intellia Therapeutics, cofounded by UC Berkeley’s Jennifer Doudna; the other is Crispr Therapeutics, cofounded by Emmanuelle Charpentier, formerly at Vienna and now at the Max Planck Institute for Infection Biology.
UC Berkeley could request a rehearing or attempt to take the case to the Supreme Court. But Jacob Sherkow, a professor at New York Law School who has followed the case, says both scenarios are unlikely since no new legal issues have emerged. “This is almost certainly the end of this particular patent dispute,” Sherkow says.
The fight began in 2014, when the U.S. Patent & Trademark Office (USPTO) approved Broad’s patent applications for CRISPR/Cas9 even though UC Berkeley submitted its application first. UC Berkeley demanded a patent interference trial to determine, first, if the described inventions were the same and, second, who CRISPR/Cas9’s original inventor was. After the trial, the USPTO judges declared that Broad’s invention was separately patentable, since it detailed how to use CRISPR/Cas9 in eukaryotes, which include plants and animals, while UC Berkeley showed only how to use the tool in test tubes and bacteria. Having made that determination, USPTO did not hear arguments to determine CRISPR/Cas9’s original inventor, as UC Berkeley wanted.
UC Berkeley appealed the USPTO decision to the U.S. Court of Appeals for the Federal Circuit. That court heard the case in April and affirmed USPTO’s decision with the Sept. 10 ruling.
“It is time for all institutions to move beyond litigation,” Broad said after the ruling. But UC Berkeley’s retort cast doubt on whether that will happen: “We are evaluating further litigation options. We also look forward to proving that Drs. Doudna and Charpentier first invented usage in plant and animal cells.”
UC Berkeley’s patent application, which was in limbo until the patent dispute ended, could now undergo review. But Sherkow says it is unlikely that USPTO will approve the patent for using CRISPR/Cas9 in any organism, as UC Berkeley desires.
UC Berkeley has won foundational CRISPR/Cas9 patents outside the U.S., including in China and Europe. That means there is no global monopolist controlling all the rights to CRISPR, says Robert Cook-Deegan, a patent expert at Arizona State University. “So the parties have an incentive to get along and stop going to war.”
Kevin Noonan, a partner at the intellectual property law firm McDonnell Boehnen Hulbert & Berghoff, says the CRISPR patent interference fight was one of the fiercest and most expensive he’s ever seen. A cross-licensing agreement may be necessary for both sides. “I’m not sure the willingness is there yet,” he adds.
As for how CRISPR’s inventors will go down in history, “the scientific prizes say it all,” Sherkow says. Doudna and Charpentier won the prestigious Kavli Prize in Nanoscience “for the invention of CRISPR-Cas9.”
“The Kavli Prize gives you an idea of what the principal advance was that the scientific community thought was the most important,” Sherkow says. The patent dispute decision, he adds, “is only going to affirm in scientists’ minds that patent law is simply not aligned with the actual process of scientific discovery and invention.”