The CRISPR patent battle has, after more than a decade of proceedings, split ownership of the gene-editing tool between two research groups. In the United States, the Broad Institute of MIT and Harvard holds the patents covering CRISPR-Cas9 use inside the cells of humans, animals, and plants. The University of California at Berkeley, the University of Vienna, and researchers Jennifer Doudna and Emmanuelle Charpentier (together known as CVC) hold broader foundational patents on the CRISPR-Cas9 system itself and have the stronger position in Europe, where the Broad lost a key patent on a procedural ground. Any company developing a CRISPR-based therapy likely needs licenses from both sides.1Broad Institute. Statements and Background on the CRISPR Patent Process
Who Invented What
On June 28, 2012, the CVC team published a paper in Science showing that CRISPR-Cas9 could be programmed to cut specific DNA sequences in a test tube. CVC had already filed a provisional patent application on May 25, 2012.2United States Court of Appeals for the Federal Circuit. Regents of the University of California v. Broad Institute, Inc. Doudna and Charpentier later won the 2020 Nobel Prize in Chemistry for the work.3NobelPrize.org. Press Release – The Nobel Prize in Chemistry 2020
Later in 2012, a team at the Broad Institute led by Feng Zhang filed its own applications and paid for expedited USPTO review, which produced granted patents while CVC’s application was still pending.1Broad Institute. Statements and Background on the CRISPR Patent Process The Broad’s patents were specifically aimed at making CRISPR-Cas9 work inside eukaryotic cells, the complex cells found in humans, animals, and plants.
That distinction looks small and is actually the whole fight. Test-tube demonstrations are scientifically important, but virtually every medical and agricultural use of CRISPR requires editing genes inside living cells. Whoever controls the eukaryotic-cell patents controls the licensing pipeline for human therapies, crop traits, and animal genetics. The Broad argued that making the system function inside a cell nucleus (where DNA is wrapped in chromatin and surrounded by the cell’s own repair machinery) required real innovation beyond CVC’s in-vitro work. CVC countered that any competent scientist could have taken its results into living cells without much trouble. The central legal question became whether showing the tool works in a test tube entitles you to own its use inside cells.
Why This Was a “First-to-Invent” Fight
Both groups filed in 2012, which placed them under the older U.S. patent rules. The America Invents Act moved the United States from “first-to-invent” to “first-inventor-to-file,” but that change didn’t take effect until March 16, 2013.4United States Patent and Trademark Office. First Inventor to File (FITF) Resources Under the older Section 102(g), priority goes to whoever can prove they were first to conceive the invention and reduce it to practice, with some allowance for diligence between those two steps.5Office of the Law Revision Counsel. 35 U.S.C. 102 – Conditions for Patentability; Novelty and Loss of Right to Patent
“Conception” means having a definite and permanent idea of the complete invention. “Reduction to practice” means actually building and testing it. When two applications claim the same invention under the old rules, the USPTO can declare an “interference proceeding,” which forces each side to prove through notebooks, emails, and testimony when it hit each milestone.
How the U.S. Case Was Decided
CVC asked the USPTO to declare an interference in 2015. The Patent Trial and Appeal Board first had to decide whether the two sets of claims even covered the same invention. In February 2017, the PTAB ruled there was “no interference-in-fact,” concluding that CVC’s claims described CRISPR-Cas9 in general terms while Broad’s claims were specifically limited to eukaryotic cells. A skilled scientist reading CVC’s work, the board said, would not have had a reasonable expectation of success in moving the system into eukaryotic cells without further experimentation. The Federal Circuit affirmed in 2018.1Broad Institute. Statements and Background on the CRISPR Patent Process
CVC then obtained its own patent applications covering eukaryotic-cell use and triggered a second interference, No. 106,115, in June 2019.6United States Patent and Trademark Office. Notice Declaring Interference Now the question was priority: who invented the eukaryotic-cell version first? The PTAB found Broad had reduced the invention to practice by October 5, 2012, when Zhang submitted a manuscript to Science showing successful editing in human and mouse cells. CVC needed to prove it had conceived the eukaryotic-cell application before that date and could not.2United States Court of Appeals for the Federal Circuit. Regents of the University of California v. Broad Institute, Inc.
CVC appealed. On May 12, 2025, the Federal Circuit issued a mixed ruling. It found the PTAB had conflated conception with reduction to practice by effectively requiring CVC to have known its invention would work in eukaryotic cells, a higher bar than the law sets. It vacated that part of the decision and sent it back. But the court affirmed a separate finding that CVC’s 2012 applications lacked adequate “written description” to show the inventors actually possessed the eukaryotic-cell invention when they filed.2United States Court of Appeals for the Federal Circuit. Regents of the University of California v. Broad Institute, Inc.
On remand, the PTAB reconsidered conception under the corrected standard and reached the same conclusion. In its March 26, 2026 decision, the board again found CVC’s inventors did not conceive the eukaryotic-cell invention before Broad’s October 5, 2012 reduction to practice. Broad’s U.S. patents for CRISPR-Cas9 in eukaryotic cells remain in force.1Broad Institute. Statements and Background on the CRISPR Patent Process
Why Europe Went the Other Way
The European Patent Office applies different rules, and the Broad Institute’s fortunes there have been considerably worse. Under the European Patent Convention, every applicant named on the original priority document must also appear on the European application claiming that priority. Luciano Marraffini, a Rockefeller University researcher named on the Broad’s U.S. provisionals, was not listed on its European filing for patent EP 2,771,468. The EPO’s Opposition Division held that the Broad could not claim the earlier U.S. priority date because the applicant lists didn’t match. Without that priority date, intervening publications disclosing CRISPR-Cas9 use in eukaryotic cells counted as prior art and destroyed the novelty of the Broad’s claims. The patent was revoked in January 2018, and the Board of Appeal made the revocation final in January 2020.7European Patent Office. T 0844/18 (CRISPR-Cas/BROAD INSTITUTE) of 16.01.2020
The Broad hasn’t been shut out of Europe entirely. It held 33 granted European CRISPR patents as of 2026, 29 of them related to CRISPR-Cas9, though many face active opposition proceedings.1Broad Institute. Statements and Background on the CRISPR Patent Process Still, the contrast with the U.S. outcome shows how a slip on an applicant list can cost years of legal advantage in a jurisdiction worth billions.
What It Means for Companies Using CRISPR
The patents dictate who can commercialize CRISPR therapies and what they pay. The Broad granted an exclusive joint license to Editas Medicine in 2014 covering CRISPR-Cas9 and TALE genome-editing patents for preventing and treating human disease.8Editas Medicine. Editas Medicine Licenses Genome Editing Technology from Broad Institute and Harvard University Intellia Therapeutics holds an exclusive license to the CVC patent estate for human therapeutics.9Intellia Therapeutics. Intellia Therapeutics Statement on Recent U.S. Patent and Trademark Office Decision Relating to CRISPR/Cas9 Genome Editing Technology in Eukaryotic Cells
The stakes became concrete in December 2023 when the FDA approved Casgevy, the first CRISPR-based therapy, for sickle cell disease in patients twelve and older. Developed by Vertex Pharmaceuticals, Casgevy uses CRISPR-Cas9 to edit a patient’s own blood stem cells.10U.S. Food and Drug Administration. FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease The approval also drew in a new player. South Korean biotech ToolGen holds patents on delivering CRISPR-Cas9 as a preassembled protein complex, with coverage in the U.S., Europe, South Korea, Japan, and Australia. It has filed a U.S. patent infringement lawsuit alleging Casgevy’s manufacturing process uses its technology.11ToolGen. ToolGen Completes U.S. Patent Registration for Core CRISPR Cas9 RNP Technology, Files U.S. Lawsuit Related to Casgevy
No unified CRISPR patent pool exists. An earlier attempt through VIA Licensing failed to gain consensus among the major holders, and as of 2026 licensing runs on individual bilateral agreements.1Broad Institute. Statements and Background on the CRISPR Patent Process A company bringing a CRISPR product to market may need separate licenses from CVC, the Broad Institute, ToolGen, and potentially others to avoid litigation across jurisdictions.
Where Things Stand
Neither side owns everything. The Broad Institute controls eukaryotic-cell applications in the United States and holds 31 granted U.S. CRISPR patents, 26 related to CRISPR-Cas9. CVC holds foundational U.S. patents on the CRISPR-Cas9 system and the stronger European position. Both have substantial European portfolios subject to ongoing opposition.1Broad Institute. Statements and Background on the CRISPR Patent Process Scientific credit and patent ownership have ended up in different places: Doudna and Charpentier received the Nobel; the Broad holds the U.S. patents on the most commercially valuable uses; a European filing error cost the Broad its priority on one of its highest-profile European patents; and a South Korean company is now suing the maker of the first approved CRISPR therapy. The technology keeps advancing. The question of who gets paid for it is still being litigated.