“The University of California group and the Broad Institute group have been facing off in a series of legal battles regarding which side can properly claim to be the rightful inventor of perhaps the world’s most widely applicable gene editing technology useful for treating diseases, improving life science research and increasing the rate of biotechnology innovations.”
On Tuesday, June 24, the Patent Trial and Appeal Board (PTAB) declared an interference proceeding between a collection of entities that are on opposing sides in the race to commercialize CRISPR-Cas9 genomic editing technologies. The patent interference will decide if inventors from the Regents of the University of California, the University of Vienna and the Umea University of Sweden were the first to invent certain methods for gene editing in eukaryotic cells, or plant and animal cells, that are covered by patent claims which have been issued to the Broad Institute, the Massachusetts Institute of Technology (MIT) and Harvard College.
The Latest Chapter in a Long-Running Legal Battle
The patent interference involves 10 patent applications that have been filed by the University of California group and 13 patents that have been filed by the Broad Institute group. These two groups have been facing off in a series of legal battles regarding which side can properly claim to be the rightful inventor of perhaps the world’s most widely applicable gene editing technology useful for treating diseases, improving life science research and increasing the rate of biotechnology innovations. The first University of California patent applications for CRISPR-Cas9 technologies were filed in May 2012, seven months before the Broad Institute patent applications were filed. However, Broad Institute requested accelerated examination for its patent applications, leading to the grant of its first patent in April 2014.
The current interference proceedings are taking place about a year after the resolution of previous interference proceedings between the two groups. In September 2018, the Court of Appeals for the Federal Circuit issued a decision affirming the PTAB’s earlier finding that there was no interference-in-fact between a University of California patent application and claims from 12 patents and one patent application owned by Broad Institute. The Federal Circuit found that the PTAB’s factual findings were supported by substantial evidence and that it didn’t err in concluding that Broad Institute’s claims wouldn’t have been obvious over the University of California’s claims.
“CRISPR” stands for clustered regularly interspaced short palindromic repeats and was first identified in bacteria which created the CRISPR arrays in their DNA as an immune response mechanism to protect against viruses. Scientific researchers have since discovered how to create RNA sequences that bind to specific DNA sequences in plants and animals. The CRISPR arrays are then removed from the DNA with the use of an enzyme known as Cas9. This enzyme snips the DNA at either end of the binding RNA sequence, allowing for the removal of unwanted genetic sequences and promising a revolutionary new way to treat disease in humans, animals and plants.
Wait—Didn’t the America Invents Act Get Rid of Patent Interferences?
Patent interference proceedings are used to determine which party was the first to invent a particular technology claimed by different applicants. Such proceedings are no longer a fixture of U.S. patent law since the passage of the America Invents Act (AIA) of 2011. Under that law, the U.S. patent system was converted from a first-to-invent system to a first-to-file system in an attempt to harmonize with other major patent systems outside the United States. However, the interference proceeding between the University of California and the Broad Institute involves patents and patent applications that were filed before the AIA took effect, according to Eldora Ellison, Director at Sterne, Kessler, Goldstein & Fox and lead patent strategist on CRISPR matters for the University of California.
“All of the involved patent claims and patent application claims relate to CRISPR in eukaryotes, in contrast to the claims involved in the previous case, which led to a determination that the claims did not interfere with each other,” Ellison said. As Ellison notes, claims of six issued patents owned by the University of California relating to CRISPR in any setting are not at issue in the recently declared interference proceeding. Ellison added that seven University of California patent applications are expected to issue as patents in the coming weeks, bringing the university’s total CRISPR-Cas9 portfolio to 13 patents.
IPWatchdog contacted the Broad Institute for a comment on the recent patent interference and they referred us to this page providing background on the situation for journalists. It indicates that the Broad Institute has reached out to the University of California through multiple avenues in an attempt to resolve the situation. The Broad Institute notes that the previous interference proceedings at the PTAB upheld the validity of Broad’s claims because they were limited to the use of CRISPR-Cas9 systems in eukaryotic environments, whereas the University of California’s claims didn’t have the same restriction.
The Broad Institute and University of California aren’t the only entities that have filed patent applications or have even obtained patents covering CRISPR-Cas9 systems. The Broad Institute’s background page states that the U.S. Patent and Trademark Office has issued more than 80 patents with claims related to CRISPR and/or Cas9 naming more than 300 inventors and developed by close to 60 applicant organizations. Around the world, more than 1,500 patent applications claiming CRISPR-Cas9 technologies have been filed.
University of California Patent Applications
All University of California patent applications are titled Methods and Compositions for RNA-Directed Target DNA Modification and for RNA-Modulation of Transcription
Broad Institute Patents and Patent Application
U.S. Patent No. 8697359, CRISPR-Cas Systems and Methods for Altering Expression of Gene Products
U.S. Patent No. 8771945, same title as ‘359 patent
U.S. Patent No. 8795965, CRISPR-Cas Component Systems, Methods and Compositions for Sequence Manipulation
U.S. Patent No. 8865406, Engineering and Optimization of Improved Systems, Methods and Enzyme Compositions for Sequence Manipulations
U.S. Patent No. 8871445, same title as ‘965 patent
U.S. Patent No. 8889356, CRISPR-Cas Nickase Systems, Methods and Compositions for Sequence Manipulation in Eukaryotes
U.S. Patent No. 8895308, same title as ‘406 patent
U.S. Patent No. 8906616, Engineering of Systems, Methods and Optimized Guide Compositions for Sequence Manipulation
U.S. Patent No. 8932814, same title as ‘356 patent
U.S. Patent No. 8945839, same title of ‘359 patent
U.S. Patent No. 8993233, Engineering and Optimization of Systems, Methods and Compositions for Sequence Manipulation with Functional Domains
U.S. Patent No. 8999641, same title as ‘233 patent
U.S. Patent No. 9840713, same title as ‘965 patent
U.S. Patent Application No. 20150247150, same title as ‘616 patent