- A federal appeals court on Monday gave the Broad Institute of MIT and Harvard a victory in the twisting legal fight over inventorship of CRISPR gene-editing technology, upholding an earlier decision by U.S. patent board that favored the Broad over a challenge from the University of California.
- In a unanimous opinion from a three-judge panel, the U.S. Court of Appeals for the Federal Circuit affirmed a 2017 ruling by the Patent Trial and Appeal Board. That verdict found key CRISPR patents granted to the Broad did not "interfere" with competing patents applied for by UC.
- Market reaction to news of the ruling, which had been expected to go the Broad's way, was relatively muted. Editas Medicine stock traded higher by nearly 3% — reflecting the biotech's ties to the Broad — while shares in CRISPR Therapeutics and Intellia, both of which are aligned with UC, dipped slightly.
Over the past two years, the legal back-and-forth between the Broad and UC has served as an ever-present backdrop to CRISPR's rapid emergence as a foundational scientific advance.
Monday's ruling could mark an end, unless UC moves for a rehearing or appeals to the Supreme Court — options with no certainty of a different outcome.
Jacob Sherkow, a law professor at New York Law School and close follower of the case, noted on Twitter that both are unlikely to succeed.
Well, UC could petition for either rehearing to the CAFC or cert to the Supreme Court. Because I don't think this case presents any novel *legal* issues, I don't think either is going to happen. /12— Jacob S. Sherkow (@jsherkow) September 10, 2018
The case centers on whether using CRISPR to edit human DNA would be an "obvious" next step from what was described in a landmark 2012 paper published by UC researchers, including Jennifer Doudna.
In 2014, researchers from the Broad, led by Feng Zhang, were awarded the first of a series of patents covering use of CRISPR in so-called eukaryotic cells, such as those of animals or humans.
When it came to deciding the UC's patent application for CRISPR, the patent office instituted "interference proceedings" to determine whether each sides' claims were separately patentable. For that to be the case, the work of Zhang and others at the Broad had to be judged non-obvious or, in other words, different enough that someone skilled in the field would not have had a "reasonable expectation of success."
That's what the Patent Trial and Appeal Board ruled in 2017, spurring UC to appeal in hopes of invalidating the Broad's patents. Monday's ruling shuts the door — at least for now — on those efforts.
It's worth noting, though, that the appeals court was not tasked with making new judgments about each side's competing claims.
"We do not reweigh the evidence. It is not our role to ask whether substantial evidence supports fact findings not made by the Board, but instead whether such evidence supports the findings that were in fact made," Circuit Judge Kimberly Moore wrote in the decision. "Here, we conclude that it does."
That's a nuance that the UC side sought to play up, highlighting other pending patent applications involving CRISPR and hinting at further litigation options.
"The Federal Circuit opinion also does not preclude other proceedings, either at the USPTO or in the courts, to determine which research group is the actual inventor and, thus, the proper owner of the technology," CRISPR Therapeutics, Intellia and Caribou Biosciences, another biotech that's licensed IP from UC, said in a statement.
Perhaps unsurprisingly, the Broad called for Monday's ruling to bring litigation to a close and to instead focus on working together to "enable the broadest possible sharing and licensing of foundational CRISPR IP" — a nod to potential license agreements in the future.
While the case has broken the Broad's way, it's not necessarily a crippling blow for the biotechs that licensed CRISPR technology from UC. Analysts expect cross-licensing agreements to be ironed out, allowing the companies to move forward with clinical development of their gene therapy candidates.
And the U.S. is not the only jurisdiction of consequence, nor are the patent claims in question the only ones being considered. The UC team last fall scored a patent win in Europe for its CRISPR IP and, in June, secured a U.S. patent covering the use of guide RNAs involved in CRISPR gene-editing.