This article has been updated to add a comment from ERS Genomics CEO Eric Rhodes.
NEW YORK – The United States Patent and Trademark Office yesterday initiated a new patent interference in the CRISPR patent battle between the Broad Institute and the University of California, Berkeley.
The proceeding — which was started by the USPTO rather than one of the parties — involves one patent application filed by and 13 patents issued to the Broad in 2014, 2015, and 2017, and 10 patent applications filed by UC Berkeley in 2018, all on the use of CRISPR-Cas9 to edit eukaryotic genomes.
This argument is likely to be similar to the previous patent interference between UC Berkeley and the Broad. In January 2017, the USPTO declared an interference at Berkeley's request to settle certain claims related to the CRISPR patent battle. In the proceedings, the USPTO said it would collect, consider, and compare historical documentary evidence to establish invention dates. Because the applications were filed before the US moved to a "first to file" patent system in 2013, the patent rights would be granted under the old "first to invent" system.
In February, however, the three-judge panel from the Patent Trial and Appeal Board (PTAB) hearing the interference case issued a judgement of no interference-in-fact, stopping UC Berkeley's bid for the IP, and leaving the Broad to control the key IP estate for companies pursuing targeted genome editing applications in several areas, especially gene therapy, drug discovery and development, and ag-bio, which rely on editing in eukaryotic cells.
UC Berkeley filed an appeal in April, asserting that the PTAB's decision that the use of CRISPR-Cas9 in eukaryotes is separately patentable, as alleged by the Broad, was based on several errors; that the decision went against US Supreme Court precedent; that the PTAB applied "a narrow and restrictive approach that ignored certain key evidence;" and that correctly applying legal standards to the case would require a reversal of the PTAB's decision.
The Broad filed its own brief in October in response to UC Berkeley's appeal, saying that it aimed to continue fighting, and further claiming that UC Berkeley didn't provide "substantial evidence" to support its findings that the PTAB had made a material legal error, or that the PTAB failed to consider certain evidence when it closed the interference case. The Broad's brief also claimed that UC Berkeley was incorrect in claiming that the PTAB had made three legal errors in its decision, and that in fact the PTAB had reviewed all evidence that UC Berkeley claimed it ignored.
Almost a year later, in September 2018, the United States Court of Appeals for the Federal Circuit ruled in favor of the Broad, writing in its brief that "[i]n light of the record evidence, which includes expert testimony, contemporaneous statements made by skilled artisans, statements by the UC inventors themselves, and prior art failures, we conclude that the [PTAB's] fact-finding as to a lack of reasonable expectation of success is supported by substantial evidence."
In a statement, a spokesman for the Broad said the institute "welcomes" the PTAB's latest interference declaration.
"Importantly, in this interference, the USPTO designated Broad, MIT, and Harvard as the senior parties and UCB as the junior party. The senior party is presumed to be the 'first to invent,' and the junior party carries the burden of proof. This further underscores the significance of Broad's prior claims. Broad Institute looks forward to participating in the interference process," the Broad added.
UC Berkeley believes the interference proceeding could resolve the patent fight in its own favor. "The initiation of this interference proceeding highlights that previous decisions involving the Broad did not determine who was the first to invent this technology, and it lays out a pathway for resolving this important issue," Eldora Ellison, lead patent strategist on CRISPR matters for UC Berkeley and a director at Sterne, Kessler, Goldstein & Fox, said in an email. "We are confident that the USPTO will ultimately recognize that the Doudna and Charpentier team hold the priority of invention specific to eukaryotic cells, as well as other settings covered by previous patents."
ERS Genomics, which was formed to provide broad access to the CRISPR-Cas9 intellectual property held by Emmanuelle Charpentier, also believes that the new interference will resolve issues left open by the previous proceeding.
Because the first interference proceeding was terminated, the USPTO did not examine the question of who was first to invent the use of CRISPR-Cas9 in eukaryotes, according to ERS.
“This is precisely what we expected after the initial proceeding failed to examine the question of who first invented the use of CRISPR in eukaryotes," ERS CEO Eric Rhodes said in a statement. "The outcome of the first proceeding left open this question. We feel strongly that once the evidence is examined, the patent office will find that it was the collaborative efforts of Dr. Charpentier and Dr. Doudna and their colleagues that first provided this important application of CRISPR, including in a single-guide format."