CRISPR Gene Editing Patent Dispute May Not Be Over Soon

CRISPR Gene Editing Patent Dispute May Not Be Over Soon

Scientists have been fighting in the legal system over who owns the patents for a lucrative gene editing technology. The stakes here are huge. The patents are potentially worth billions of dollars.

CRISPR gene editing is a technique discovered a little more than a decade ago. It provides a precise and relatively inexpensive way to alter specific genes on a DNA strand. The applications are enormous. CRISPR is likely to revolutionize the way we prevent and cure diseases, grow food, and produce energy.

On one side of the dispute is the University of California, Berkeley. On the other side are MIT and the Broad Institute (a biomedical research institute drawing on scientists from MIT and Harvard). The dispute hinges on who holds the patent for CRISPR technology.

UC Berkeley scientist Jennifer Doudna and French scientist Emmanuelle Charpentier were the first to publish about CRISPR gene editing in June 2012. Their paper, published in Science, described how CRISPR could be used to cut DNA in a test tube. Seven months later, MIT scientist Feng Zhang published a paper, also in Science, on how CRISPR editing could be used in animal and human cells.

The scientific world generally recognizes Doudna and Charpentier as the inventors of CRISPR technology. The two scientists won the Nobel Prize in Chemistry in 2020 for their CRISPR work – their discovery of how a process naturally occurring in bacteria could be transformed into a gene editing tool. But Zhang and the Broad Institute are winning the patent fight.

UC Berkeley (representing Doudna, Charpentier, and their collaborators) was the first to file a patent application for CRISPR gene editing in May 2012. The Broad Institute and MIT (representing Zhang and his team) filed their first patent application a few months later, requesting that their application be fast-tracked.

The U.S. Patent and Trademark Office (PTO) awarded the patent to the Broad Institute and MIT. The PTO’s policy, at the time, was to award patents on the basis of who was first to invent a technology, not who was first to file the patent application.

Since that first patent award, the UC Berkeley group and the Broad/MIT group have continued arguing about who first discovered CRISPR. Millions of dollars have been spent in the years of court battles.

Over the years, the PTO made many rulings in favor of the Broad Institute. Then in February 2022, the PTO ruled on the major question of who first used CRISPR technology specifically in eukaryotes, a biological group that includes humans, animals, and plants.

The PTO awarded the patent to the Broad Institute, deciding that the institute had achieved this application before UC Berkeley, perhaps by only a matter of weeks.

This was a major victory for the Broad group. However, this ruling is unlikely to end the dispute, which will probably continue for years.

UC Berkeley announced it was considering its options. The University has the right to appeal the PTO’s ruling to the federal U.S. Court of Appeals, although it already lost a related case there in 2018.

Meanwhile, the UC Berkeley group owns more than 40 CRISPR patents. Similar patent cases between Berkeley and the Broad Institute have been proceeding in the European Union, and in those, the Broad has not fared well. Also, waiting in the wings are challenges from a company in South Korea and another in Germany.

There are also CRISPR technologies that may not be subject to the currently disputed patents because they are CRISPR systems that don’t use the original enzyme, called “Cas-9.”

It looks like it will be a long time before the dust finally settles on the CRISPR disputes.