A U.S. appeals court has reopened the contentious battle over CRISPR gene-editing patent rights, potentially shifting ownership of the revolutionary technology and redefining legal standards for invention.
The U.S. Court of Appeals for the Federal Circuit ruled Monday in favor of the University of California and University of Vienna, vacating a 2022 decision that had awarded key patent rights to the Broad Institute of MIT and Harvard. The court determined that the Patent Trial and Appeal Board (PTAB) applied incorrect legal standards when evaluating who first conceived using CRISPR in human cells.
"This goes to who was the first to invent, who has priority, and who is entitled to the broadest patents," said Jacob Sherkow, a law professor at the University of Illinois, who noted that Nobel laureates Jennifer Doudna and Emmanuelle Charpentier "could walk away as the clear winner."
The Scientific Achievement and Patent Dispute
Doudna and Charpentier shared the 2020 Nobel Prize for developing CRISPR-Cas9, a versatile gene-editing system already being used to treat genetic disorders including sickle cell disease. Their groundbreaking 2012 paper first demonstrated CRISPR's ability to precisely cut DNA in a test tube.
However, the patent dispute centers specifically on CRISPR's application in animal and human cells. The Broad Institute's Feng Zhang received U.S. patent rights in 2014 after publishing research showing CRISPR editing in human cells in 2013, setting off what has become one of the most complex patent battles in history.
The PTAB previously ruled that Doudna and Charpentier hadn't fully conceived the invention because they initially encountered difficulties getting their editor to work in fish and other species. The appeals court rejected this reasoning, stating that inventors don't need to "know their invention would work" to get credit for conceiving it. What matters more, according to the court, is that the invention actually worked in the end.
Billions in Licensing Revenue at Stake
The financial implications of this patent dispute are enormous. CRISPR technology has applications across medicine, agriculture, and biotechnology, with potential licensing revenues worth billions of dollars. Multiple companies have already been formed to commercialize the technology, with their business models dependent on the outcome of this legal battle.
"Today's decision creates an opportunity for the PTAB to reevaluate the evidence under the correct legal standard and confirm what the rest of the world has recognized: that the Doudna and Charpentier team were the first to develop this groundbreaking technology for the world to share," said Jeff Lamken, one of Berkeley's attorneys, in a statement.
The Broad Institute remains confident in its position, stating that the "underlying facts have not changed" and expressing belief that the appeals board will again confirm their patents.
Redefining Invention in Patent Law
Beyond the immediate implications for CRISPR technology, this case could reshape how patent law defines the moment of invention. The concept of "conception" in patent law—the moment when an inventor has a definite and workable plan for an invention—is central to this dispute.
The appeals court's emphasis that inventors don't need to know their invention will work to get credit for conceiving it represents a potentially significant shift in legal interpretation. This standard could impact future patent disputes across various technological fields.
What Happens Next
The case now returns to the patent board for reconsideration under the corrected legal standard. This will likely involve a detailed examination of 13-year-old laboratory notebooks and whether Zhang's research was influenced by Doudna and Charpentier's publications.
Sherkow notes that the court finding can also be appealed directly to the U.S. Supreme Court, suggesting this already 13-year saga may continue for some time.
The CRISPR patent battle now joins other historically contested inventions like the steam engine, telephone, lightbulb, and laser—technologies whose ownership disputes shaped both industrial development and patent law itself.
As CRISPR continues to revolutionize genetic medicine, with treatments already approved for conditions like sickle cell disease, the question of who controls the underlying intellectual property remains as unsettled as ever.
