The huge patent fight over the powerful gene-editing technique CRISPR may have a winner—the Broad Institute of Cambridge, Massachusetts.
On Wednesday, a U.S. Patent Office appeal board ruled in the ongoing dispute over control of patents on CRISPR. The battle was brought by the University of California, Berkeley, when it challenged a dozen patents held by the Broad Institute, which is affiliated with Harvard and MIT.
In a brief order, the patent court ruled there is “no interference in fact.” Translating the legalese: the two schools’ discoveries don’t actually overlap and the fight is off. For now.
(Read the full decision here.)
The ruling is a win for the Broad Institute, which had asked for the finding of no interference. It will be able to retain its valuable patents, which cover the use of CRISPR in human and animal cells.
In a statement, Berkeley said it “respects” the decision but still maintains that Berkeley biochemist Jennifer Doudna and European collaborator Emmanuel Charpentier were the first to invent the CRISPR system.
It was mid-2012 when Doudna and colleagues published, for the first time, a description of a simple gene-editing system able to precisely cut DNA in a test tube.
But it was Feng Zhang of the Broad Institute who published, in January of 2013, a paper that showed how to adapt the same elegant approach to work inside of plant, animal, and human cells.
That sequence of events framed the question at the center of the patent dispute: who should hold the patent rights to CRISPR’s use in plants and animals? Was it Doudna, who first created the basic gene-editing system? Or Zhang, who tweaked it to make it work in more interesting organisms and opened the door to valuable applications in human gene therapy, GM crops, and novel animals?
Back in 2014, MIT Technology Review was first to break the story of the high-stakes patent fight over CRISPR, which we dubbed “the biggest biotech discovery of the century.”
According to the text of today's decision, the judges concluded that no researcher could have been absolutely sure that Doudna's discovery would also work in "eukaryotes" or cells with a nucleus, like human ones. Therefore, they ruled, Zhang gets to keep his patents.
UC Berkeley says it will still seek approval for its own patent, currently pending, which covers the basic use of CRISPR to alter the DNA molecule.
The legal wrangling is not likely to be over any time soon. UC Berkeley is nearly certain to appeal the finding to the U.S. Court of Appeals for the Federal Circuit, a process that could take a year, says Jacob Sherkow, a professor at New York Law School. "That will probably be the conclusive statement on the case," says Sherkow. "For now, Berkeley is the loser."
The Broad's patents are likely to face continued challenges from several others, including the Rockefeller University, which claims it helped invent CRISPR but was cut out of the patents. Inventors in Korea from the company ToolGen could also end up bidding to control CRISPR based on their own early patent applications.
The Patent Office’s decision could have big implications for industry, especially for three startup companies seeking to develop treatments using CRISPR for rare diseases.
On Wednesday, the stock price of Editas Medicine shot up by more 20 percent. That is because Editas has an exclusive license from the Broad Institute to develop multiple treatments using CRISPR and had been financing the legal fight, spending more than $11 million last year to defend Broad's patents against UC Berkeley’s legal challenge.
Editas hopes to begin testing its first CRISPR treatment, for a rare eye disease, this year.
The patent decision, however, casts a shadow over Intellia Therapeutic and CRISPR Therapeutics. Each company has raised hundreds of millions partly on a bet that Berkeley would prevail before the patent office judges. Both companies had purchased licenses to use UC Berkeley's patent applications, which have not yet been approved.
Rodger Novak, CEO of CRISPR Therapeutics, says the effort to strip Broad of its patents is not finished. "We are very confident about our position," says Novak, who released a statement outlining further legal steps. "It's disappointing that the Broad PR machine has put a lot of smoke out there."
All told, the U.S. Patent Office has issued about 50 patents connected to the CRISPR system. Of these, 14 are owned by Broad, MIT, or affiliated groups. "We believe CRISPR should continue to be available to the global scientific community to advance our understanding of the biology and treatment of human disease," the Broad Institute said in a statement.
The non-profit institution, one of the world's largest devoted to genome research, said the technology would remain free to use by academics worldwide. Companies, however, are being asked to pay for the right to employ the breakthrough gene-editing technique.
If UC Berkeley eventually wins its more basic CRISPR patent as well companies could be forced to pay fees to both institutions.