UC Berkeley loses CRISPR gene editing patent case
UC Berkeley's Jennifer Doudna earned a Nobel Prize for her lab's work on Crispr-cas9, a revolutionary method to edit DNA.
But on Monday, UC lost its patent rights.
Ending — for now — a long, vitriolic and expensive fight over commercial application of a pioneering tool that is transforming biological research, a board of the U.S. Patent and Trademark Office ruled on Monday that use of the genome editing technology in humans belongs to the Broad Institute of Harvard and MIT, not UC Berkeley.
UC'S claims “are unpatentable,” according to the decision.
It's a major blow for UC, representing a potential loss of $100 million to $10 billion in licensing revenues, according to Jacob Sherkow, a professor at the University of Illinois College of Law who studies the intersection of scientific innovation and patent law, regulation, and bioethics. While UC can keep what it's earned so far, he said, it will be limited in the future.
“This 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,” said Sherkow. “Some of them are still valid. But arguably a large swath of the most important ones, from a financial perspective, are not.”
Vowing to challenge the decision, Doudna said that “today's USPTO ruling is surprising and contrary to what more that 30 countries and the Nobel Prize Committee have decided regarding the invention of CRISPR-CAS9 genome engineering technology for use in all cell types, including human cells.”
In a statement, UC said that it was disappointed by the decision and believes that the board made a number of errors. UC retains rights to more than 40 other Crispr-related patents that were not involved in this case, it said.
In 2020, Doudna and French scientist Emmanuelle Charpentier won the Nobel Prize in chemistry for their invention of the technique. The gene-editing tool gives scientists near godlike power, allowing them to rewrite the code of life by moving genes from one living creature to another.
Doudna and Charpentier have each continued to lead the worldwide development and application of CRISPR technology. Doctors are now testing it as a cure for genetic disorders such as sickle cell disease, cancer and hereditary blindness.
It's not the first time there's a disconnect between a Nobel Prize and a patented invention, said Sherkow.
The patents for at least three historic discoveries — recombinant DNA, Magnetic Resonance Imaging and human embryonic stem cells — all went to someone other than the original creator.
“The standards are different,” explained Sherkow.
“Patent law has this particularly wonky standard about `definite and permanent conception in the mind's eye of the inventor' and `reduced the invention to practice' — that kind of stuff,” he said. “The Nobel Prize is `who got most of the way there first' and `who first contributed to the theoretical understanding.”
Monday's ruling throws a monkey wrench into the business model of several up-and-coming biotech companies, such as Caribou Biosciences of Berkeley and Boston's Intellia Therapeutics and CRISPR Therapeutics, who aim to create treatments using CRISPR.