The decade-long CRISPR patent battle between the University of California, Berkeley and the MIT and Harvard-backed Broad Institute wages on, even after multiple rulings in the last several years. The patent landscape and legal challenges within it have become more complicated since UC Berkeley and the Broad Institute filed their first patent applications related to the discovery of CRISPR-Cas9 in 2012. It’s easy to understand why this particular technology has ignited such a fierce legal battle. CRISPR, which can be broadly described as “molecular scissors,” is a foundational technology with applications in agriculture and medicine. It is both simple and versatile, especially when compared to other known gene-editing technologies. These valuable characteristics have forecasters predicting the global CRISPR market will be worth almost $6 billion by 2025.
CRISPR Patent Battle Timeline
The entities with granted patents for the most foundational aspects of CRISPR technology will likely profit from their IP rights. Licensing revenue is becoming more important for academic institutions, which may help explain why this particular patent battle is so heated. We will not cover the entire CRISPR patent battle timeline here; this overview contains additional resources for a deeper understanding of the scenario.
- June 2012: Scientists from UC Berkeley and other institutions publish their research on CRISPR-Cas9 in prokaryotes (single-celled organisms).
- January 2013: Researchers at the Broad Institute publish their work with CRISPR-Cas9 in eukaryotic cells, which have a nucleus and other organelles.
- April 2014: The USPTO granted the Broad Institute a patent (No. 8,697,359) for CRISPR-Cas Systems and Methods for Altering Expressions of Gene Products.
- April 2015: UB Berkeley requests interference proceedings to compare the Broad Institute’s granted patent to a pending application filed by the team at UC Berkeley.
- February 2017: The Patent Trial and Appeal Board (PTAB) rules there is not interference, as “eukaryotic CRISPR and other uses of the genome editor were separate inventions.”
- September 2018: After an appeal by UC Berkeley, the US Court of Appeals for the Federal Circuit confirms PTAB’s decision. The two institutions’ patents are not conflicting, giving the Broad Institute rights to the technology in eukaryotes, including plants and animals.
- June 2019: The USPTO declares interference between CRISPR-related patent applications filed by UC Berkeley in 2018 and the Broad Institute’s 2014 patent.
- September 2020: PTAB rules the Broad Institute has priority.
- February 2022: The USPTO names the Broad Institute as the first to invent the technology in question. While UC Berkeley was first to file in 2012, both patent applications were filed before the US implemented a first-inventor-to-file system in 2013.
- April 2022: UC Berkeley appealed the USPTO decision.
While this patent battle wages on in the United States, similar debates are happening in other regions between UC Berkeley and the Broad Institute as well as other entities working with CRISPR.
Implications of the Legal Dispute
1. Licensees will need to reexamine their rights.
Multiple companies using CRISPR technology license UC Berkeley’s patent portfolio to do so. If UC Berkeley does not hold the rights to CRISPR utilization in plant and animal cells, these companies—including Intellia Therapeutics, CRISPR Therapeutics, ERS Genomics, and Caribou Biosciences—will need to reexamine their ability to commercialize their innovations. Investors feel the same, as Intellia’s stock fell more than 20% the day of the USPTO’s most recent decision.
2. Industry will bypass Cas9 altogether.
The UC Berkeley and Broad Institute CRISPR patent battle only covers the Cas9 enzyme. Other academic and commercial entities are patenting and utilizing CRISPR technology with other enzymes (of which there are hundreds of variations), completely sidestepping the legal dispute altogether—at least for now. This approach could potentially (and ironically) reduce the value of the patents at the center of the decade-long controversy.
3. The details matter.
Technicalities around filing always matter, but they are unfortunately not always a focus, especially when rushing to patent a groundbreaking innovation. UC Berkeley believed that their first patent application would grant them the right to use CRISPR in any cell. Biochemist Jennifer Doudna of UC Berkeley uses tennis balls to describe the technology, stating, “They will have a patent on green tennis balls. We will get a patent on all tennis balls.” However, the USPTO granted the Broad Institute priority for the technology in eukaryotic cells. This, in turn, eliminates UC Berkeley’s ability to patent a broader version of CRISPR.
In the European Union, UC Berkeley is widely accepted as the victor in a very similar patent battle, simply because there are “differences in the names of inventors across [the Broad Institute’s] international applications.”
4. Nonobviousness is subjective.
For as long as inventors have been patenting, they have been asking themselves if their inventions are obvious, as compared to the prior art. UC Berkeley has argued that because their original patent application covers both in vitro and prokaryotic cells (“tennis balls”), the Broad Institute’s use of eukaryotic cells (“green tennis balls)” is obvious. However, ruling bodies have repeatedly disagreed with this notion.