The disputed patents on the gene-editing tool CRISPR belong to the Broad Institute of MIT and Harvard, according to a ruling by judges at the United States Patent and Trademark Office (PTO) in Alexandria, Virginia. The ruling comes a little over two months after a high-profile court hearing, during which MIT and University of California, Berkeley heatedly argued about who should own CRISPR.
STAT News reported that the decision was one sentence long. The three judges decided that the Broad patents are different enough from the ones the University of California applied for that the Broad patents stand.
The patent ruling suggests that the work done by Jennifer Doudna of the University of California and her colleagues on CRISPR wasn’t so groundbreaking as to make any other advance obvious. But that legal opinion isn’t how the science world views her work, STAT points out: “Doudna and her chief collaborator, Emmanuelle Charpentier, won the $3 million Breakthrough Prize in the life sciences in 2015, the $500,000 Gruber Genetics Prize in 2015, and the $450,000 Japan Prize in 2017,” the outlet notes.
CRISPR-Cas9 is arguably this decade’s biggest biotech invention — a technique that allows scientists to cut DNA, inserting or reordering bits of genetic code with remarkable precision and remarkable results. The gene-editing tool has already been used to create malaria-blocking mosquitoes, muscular beagles, and miniature pet pigs. A clinical trial in China is using the technology to edit cancer patients’ immune cells so that they can fight lung cancer. And in the future, CRISPR could help treat debilitating genetic diseases like sickle cell anemia and cystic fibrosis.
Its potential is limitless, and so is the amount of money and fame that ownership of the technology would bring to its inventor. And that’s why the patent dispute over who owns the intellectual property of the CRISPR technology has been so heated. The two parties — the University of California, Berkeley and microbiologist Emmanuelle Charpentier on one side, and the Broad Institute and MIT on the other — have been involved in the dispute for years now, spending millions of dollars on the case.
It all began in 2012, when UC Berkeley biochemist Jennifer Doudna and others, including Charpentier, published a seminal Science paper on CRISPR. In this paper, Doudna showed that the gene-editing technology can be used to cut DNA in a test tube at targeted sites. Later, Doudna filed a patent application for CRISPR.
Then in 2013, in another Science paper, MIT bioengineer Feng Zhang and his team reported developing a CRISPR system that edited genomes in eukaryotic cells — the cells of animals and people. When Zhang filed his own patent application, he applied for the PTO to “fast track” its patent review process. The result was that although UC Berkeley filed first, the PTO actually awarded the patent to the Broad and MIT in April 2014. (The Broad and MIT were later awarded a bunch of other CRISPR patents.) So UC Berkeley asked for a so-called “interference proceeding” — an official reassessment to determine who was the first to invent the gene-editing tool CRISPR-Cas9.
At the hearing last December, UC Berkeley’s attorney argued that after the publication of Doudna’s 2012 CRISPR paper, anyone could have applied the technique to edit eukaryotic cells. In other words, Zhang’s use of CRISPR was an “obvious” development of the technology and his patents are without merit, UC Berkeley says. The Broad’s attorney fiercely opposed that argument, claiming that Zhang’s use of CRISPR to edit complex organisms like human cells was a huge inventive leap, so he deserves the patents.
The PTO judges at the hearing grilled UC Berkeley much more heavily than the Broad, and today’s decision reflects their apparent skepticism of the UC Berkeley argument. It seems likely that the university will appeal, since the technology will likely be worth billions.