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Federal Court Hands Broad Institute Victory in CRISPR Patent Fight Against UC Berkeley

NEW YORK (GenomeWeb) – The United States Court of Appeals for the Federal Circuit today issued a ruling upholding a judgement from the Patent Trial and Appeal Board (PTAB) which gave the Broad Institute and its partners control of key CRISPR genome editing patents and left the University of California and its co-litigants in the cold.

In January 2017, the US Patent and Trademark Office declared an interference proceeding to settle certain claims related to the CRISPR patent battle between parties led by the Broad and UC. In the interference 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 PTAB hearing the interference case issued a judgement of no interference-in-fact, stopping UC'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 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's appeal, saying that it aimed to continue fighting, and further claiming that UC 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 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 claimed it ignored.

Now, the federal circuit court has found in the Broad's favor, writing in its brief today, "In 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."

The court further noted that UC spent a significant amount of time and effort to convince the judges that there exists substantial evidence to support its view that a person of ordinary skill would have had a reasonable expectation of success in implementing the CRISPR-Cas9 system in eukaryotes. But although there is "certainly evidence in the record that could support this position," the court wrote in its brief, "we are, however, an appellate body. We do not reweigh the evidence. It is not our role to ask whether substantial evidence supports fact-findings not made by the [PTAB], but instead whether such evidence supports the findings that were in fact made. Here, we conclude that it does."

The circuit court found no errors of law in the PTAB's rulings and didn't see any errors in its analyses nor in the ways it applied the relevant laws and statutes to the IP in question.

"For the foregoing reasons, we affirm the [PTAB's] judgment of no interference-in-fact. The [PTAB] performed a thorough analysis of the factual evidence and considered a variety of statements by experts for both parties and the inventors, past failures and successes in the field, evidence of simultaneous invention, and the extent to which the art provided instructions for applying the CRISPR-Cas9 technology in a new environment," the court's brief noted.

"In light of this exhaustive analysis and on this record, we conclude that substantial evidence supports the [PTAB's] finding that there was not a reasonable expectation of success, and the [PTAB] did not err in its determination that there is no interference-in-fact," the court also wrote. "We have considered UC's remaining arguments and find them unpersuasive."

In a statement, the Broad hailed the circuit court's decision as "correct" and noted that "the PTAB decision was clearly supported by sufficient evidence and followed applicable legal standards." The institute further said that it has worked for years with MIT and Harvard to ensure that CRISPR tools are widely available and called on all institutions to "move beyond litigation," and "work together to ensure wide, open access to this transformative technology."

This was an especially important victory for the Broad after it received a setback in Europe in January when the European Patent Office (EPO) decided to deny the institute's reliance on a US priority provisional application for a CRISPR-related patent in Europe based on a technicality. ERS Genomics noted at the time that the Broad's expectation that the EPO would harmonize procedures to be consistent with international treaties "would require a change in the law itself," and ERS CEO Eric Rhodes added that, "The vast majority of the Broad Institute's CRISPR patents in Europe are also affected by this same deficiency and we expect them to meet a similar fate."

The Broad also noted in its statement today that its patents are for genome editing in eukaryotic cells — including animals, humans, and plants — while the claims in UC's application were based on studies in cell-free systems. Therefore, these are about different subjects that don't interfere with each other, the institute said.

However, the type of IP that relates to genome editing in plant and animal cells equals big business for the entity or entities that hold it. In fact, the Broad has made several licensing deals for the CRISPR IP it holds over the course of the past year, including with Arcadia Biosciences to develop nutritional and agricultural productivity traits in its core crops, with Syngenta for use in multiple crops, and with Macrogen to build preclinical animal models, among others.

In October 2017, the Broad and DuPont Pioneer announced that they would jointly provide non-exclusive licenses to CRISPR-Cas9 IP under their respective control to any entities wanting to use the technology for commercial agricultural research and product development. And this past June, CRISPR-based therapeutics developer Editas Medicine agreed to provide up to $125 million in research funding to the Broad in exchange for the exclusive right to be the first to negotiate for licenses to genome-editing inventions that arise from the sponsored research.

Meanwhile, UC's General Counsel and Vice President of Legal Affairs Charles Robinson noted that the university and its partners are evaluating further legal options after today's ruling and are still looking to prove that Jennifer Doudna and Emmanuelle Charpentier were the first to invent usage of CRISPR in plant and animal cells.

Editas President and CEO Katrine Bosley released her own statement noting the company is "pleased with the Federal Circuit's decision," and adding that the affirmation of the PTAB's ruling is "highly favorable for Editas and for the Broad as it reaffirms the strength of our intellectual property foundation and has profound implications for making CRISPR medicines."

Editas' shares rose about 1 percent to $30.50 in afternoon trading on the Nasdaq.