MIT and Harvard’s Broad Institute were the first to apply the CRISPR gene editing tool to human cells, the U.S. Patent and Trademark Office said Monday. The decision halted years of efforts by the University of California, Berkeley, to obtain lucrative technology patent rights. The University of California, Berkeley is home to Jennifer Dudna, who won the 2020 Nobel Prize with Emmanuel Charpentier for discovering the CRISPR-Cas9 gene editing technique.
This also complicates the work of some biotechnology companies to develop CRISPR-based gene editing therapies: many, including companies such as Caribou Biosciences (co-founder of Doudna) and Intellia Therapeutics, which licensed CRISPR technology from the UC Berkeley Group.
“This decision reaffirmed that Broad’s patents were properly granted,” the Broad Institute said in a statement. “Brod believes that all institutions must work together to ensure wide, open access to this transformative technology.
The UC Berkeley group, collectively called CVC, said in a statement that it intended to challenge the decision. The group holds dozens of other patents related to CRISPR.
The decision is likely to end a long struggle for ownership of the gene editing technique that has revolutionized genetic research and biotechnology. It allows scientists to easily and accurately cut and rearrange bits of DNA, changing the way it encodes different functions. Dudna and her colleagues published the first article on the CRISPR system in 2012, showing how it works in a test tube. Then, in 2013, researchers at the Broad Institute published an article on the use of CRISPR in cell types found in animals and humans.
Both institutions filed patent applications, and the U.S. Patent and Trademark Office (PTO) initially granted patents to the Broad Institute’s CRISPR in 2014. UC Berkeley challenged the decision, and the PTO ruled in 2017 that patents from both institutions were different enough that they could both stand – and that the Broad Institute has retained patents, potentially worth billions, for the use of CRISPR in complex human and animal cells. UC Berkeley appealed to the U.S. Court of Appeals in Washington, D.C., and lost that appeal.
Monday’s decision is the result of another challenge posed by UC Berkeley to the Patent Examination and Appeals Board in 2019, pitting various CVC patents against Broad Institute patents. Again, the PTO sided with the Broad Institute.
Biotech companies that originally licensed the technology from CVC will likely have to renegotiate with the Broad Institute. Companies licensed by the Broad Institute, such as the genome editing company Editas Medicine, are safer. “The decision reaffirms the strength of our fundamental intellectual property as we continue to develop life-changing drugs for people living with serious illnesses,” Editas CEO James Mullen said in a statement.