The U.S. Patent and Trademark Office has made a decision in the patent fight over ownership of the landmark CRISPR-Cas9 gene editing technology. The ruling is in favor of the Broad Institute of MIT and Harvard, whose 2014 patents were challenged by a group led by the University of California, Berkeley (UC). But the ruling leaves room for Berkeley to make future gains.
The Broad Institute received patents for the work of Feng Zhang and colleagues in 2014. The Berkeley group challenged those patents, and the case was transferred into a rare process called an interference, in which a panel of PTO judges compares the two parties’ arguments side by side.
The PTO said today that the Broad patents can stand and that the two sides are not trying to patent the same thing. “The [PTO] determined that Broad and UC have different inventions,” said Muna Abu-Shaar of Biospark Intellectual Property Law in Cambridge, MA. “There is no unifying invention to fight over.”
It’s a victory for Broad and its allies, because in essence the ruling says Broad deserves patents it already owns that cover the use of CRISPR-Cas9 to make changes in eukaryotic cells—from humans on down to yeast—and that could give Broad domain over a vast range of applications, including the development of human medicines.
But the PTO also said the UC work, which was led by UC researcher Jennifer Doudna and her European colleague Emmanuelle Charpentier, could still lead to a patent from a PTO examiner.
“This outcome seems to preserve the real possibility that both sides’ portfolios could persist instead of one knocking out the other,” said Richard Blaylock, a patent attorney at the law firm Pillsbury in San Diego. “Both of them could eventually have intellectual property that’s pertinent and perhaps necessary to folks working with CRISPR. It’s a win for Broad, but not necessarily a loss for UC.”
UC released a statement that expressed optimism about eventually receiving a patent. “The Doudna/Charpentier patent application will be returned to the patent examiner, who previously determined that their patent application is allowable,” the statement read. “We are pleased that UC’s application, covering the invention and use of CRISPR gene editing in all cells, can move toward issuance as a U.S. patent.”
Blaylock said the PTO only agreed to the interference process because the examiner believed that Berkeley’s claims were “allowable”—worthy of a patent—which lends support to the UC side’s optimism.
One scenario is that Broad keeps hold of the rights to CRISPR-Cas9 when used in eukaryotic cells, and Berkeley gains rights to the underpinnings of the CRISPR-Cas9 machinery that Doudna and Charpentier described in their seminal 2012 paper.
UC said it would explore all of its options, including a possible appeal.
CRISPR-Cas9 is based on a bacterial defense system that researchers have known about for decades. But Doudna and Charpentier described in 2012 how to re-engineer the system’s parts into a molecular scissors and a programmable guide that points the scissors to cut specific places in a cell’s DNA. The crux of the fight is whether their description of using CRISPR-Cas9 in cells was enough to cancel out the Broad’s description of using CRISPR-Cas9 in a subset (a very, very large subset) of cells. The PTO judges said no, the Broad’s work was different, not an obvious extension.
In a lengthy discussion of the decision, the judges wrote: “The evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR/Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR/Cas9 system to be successful in an eukaryotic environment.”
The division between cell types noted by the judges might influence what kind of patent UC is eventually granted, said Abu-Shaar. “There is a possibility that the examiner might ask UC to narrow its claims to in vitro or prokaryotic systems,” she said. “However, if UC’s claims are allowed without amendment they would in principle encompass the use of CRISPR in any system.”
The two academic camps in the patent fight also have their allies in the biotech industry. Broad has licensed its work exclusively to Editas Medicine (NASDAQ: EDIT), which is working on human medicines and could have its first treatment, for a rare genetic form of blindness, in clinical trials by next year. “This important decision affirms the inventiveness of the Broad’s work in translating the biology of the natural world into fundamental building blocks to create unprecedented medicines,” said Editas president and CEO Katrine Bosley in a statement.
One of UC’s main biotech benefactors is Intellia Therapeutics (NASDAQ: NTLA), also of Cambridge, which has exclusive license to the Berkeley work for human therapeutics. Spokeswoman Jennifer Smoter sent this statement: “While this interference proceeding will not move forward, the [judges have] determined only that the parties’ claims do not meet legal standards for an interference. Importantly, it did not decide which party was the first to invent the use of CRISPR/Cas9 genome editing technology in eukaryote cells. We will work with UC and the other owners/licensees on the legal strategy moving forward, but for now it is too early to comment.”
Emmanuelle Charpentier’s share of the UC-related work has been licensed to Crispr Therapeutics (NASDAQ: CRSP). Its shares were down more than 13 percent to $14.90. Jeffries analyst Gena Wang wrote in a research note that the most likely outcome is that Editas, in one camp, and Intellia/Crispr, in the other camp, will end up cross-licensing work to each other.
The news sent the companies’ stock prices in opposite directions. As of 2 p.m. Eastern, Editas shares were up more than 25 percent to $23.76. Intellia shares were down more than 18 percent to $11.27.