UC Berkeley Loses CRISPR Gene-Editing Patent Appeal

The US Patent and Trademark Office (PTAB) recently ruled that CRISPR gene-editing technology belongs to the Broad Institute of Harvard and MIT, according to multiple news sources.

After an eight-year-long legal battle over the commercial application of CRISPR, the recent decision rocked the University of California, Berkeley and biotech companies that originally licensed the technology to develop treatments.

In 2011, Emmanuelle Charpentier, French microbiologist at the Max Planck Institute for Infection Biology, published her first CRISPR paper. Just months later, Charpentier met Jennifer Doudna, an American biochemist at UC Berkeley.

In 2012, Charpentier and Doudna published a study that found that bacterial enzyme Cas9 could cut purified DNA floating outside of cells into test tubes. According to study findings, Cas9 can be paired with custom-designed molecules, CRISPR-related RNAs, that would lead the enzyme to any site on a DNA molecule.

Doudma and Charpentier won a Novel Prize in chemistry for their 2012 discovery of CRISPR gene editing in October 2020. Since then, both women have battled against Feng Zhang of MIT, who published a paper in October 2012 reporting the first successful programmable genome editing and the first successful use in mammalian cells of CRISPR-Cas9.

Now, UC faces a potential loss of $100 million to $10 billion in licensing revenues and these companies are forced to negotiate with Harvard and MIT for the right to use CRISPR for human therapies.

Notably, top CRISPR-based companies, including Caribou Biosciences, Intellia Therapeutics, and CRISPR Therapeutics, are the farthest in clinical trials and hold licenses from UC Berkeley, not MIT.

“This decision means that a number of UC Berkeley’s patents that are directed to the canonical CRISPR system — when used in the cells of higher organisms, like humans — are not valid,” Jacob Sherkow, a law professor at the University of Illinois studying the intersection of scientific innovation and patent law, regulation, and bioethics, said in a recent statement.

“Some of them are still valid. But arguably a large swath of the most important ones, from a financial perspective, are not,” Sherkow continued.

Doudna stated that the ruling is “surprising” and “contrary” to what over 30 countries and the Nobel Prize Committee decided regarding the invention of CRISPR-Cas9 genome engineering technology for use in all cell types, including human cells.

In an official statement, UC said it is disappointed by the PTAB’s decision and believes the PTAB made several errors. “CVC is considering various options to challenge this decision.

In addition to the 40+ US patents not involved in this interference; CVC also has issued patents to its foundational CRISPR-Cas9 systems in over 30 countries worldwide that are not affected by any US interference proceedings.”