UPDATED – Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decision ruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 8/1/2019
Unpatentable claims
In its newest brief, UC identified a list of motions it would like permission to file with the PTAB. Among these motions, UC has asked the PTAB to judge all the Broad’s claims involved in the interference unpatentable.
First, UC alleges that the Broad’s patents fall under the provisions of AIA’s “first to file” system. All of the Broad’s involved cases issued from applications with a filing date on or after March 16, 2013 when the AIA took effect, but claim priority benefit to one or more applications filed before that date, the motion said. However, the Broad’s involved cases and/or the applications involved in the cases “contains or contained at one time at least one claim that was not supported by Broad’s applications filed before March 16, 2013,” the university added. “Thus, Broad’s involved cases, the application from which each of Broad’s involved patents issued, and/or a parent application to which each of Broad’s involved cases claims benefit, contains or contained at one time at least one claim to subject matter having an effective filing date on or after March 16, 2013 — thereby subjecting each of Broad’s involved cases to AIA prior art provisions.”
In its filing, UC noted that this motion should be enough for the PTAB to decide the unpatentability of the Broad’s claims. However, the filing adds, if this argument isn’t enough, there are other provisions that would render the Broad’s claims unpatentable.
Misidentified inventors
In the next motion, UC claims that “Broad deliberately misidentified the inventors on its involved patents and application, as demonstrated by the fact that its own prosecuting attorney’s sworn declaration contradicts the inventive entities named during prosecution of the involved applications.”
The Broad’s patents name either Zhang as the sole inventor or Zhang in combination with Le Cong, Fei Ran, Randall Platt, Patrick Hsu, and/or Sanjana. However, UC claims, Broad attorney Thomas Kowalski identified “a substantially different set of inventors” in a declaration provided to the European Patent Office.” Specifically, Kowalski’s declaration attests that several individuals who weren’t listed on the official patents “had contributed in a not insubstantial manner” to various CRISPR inventions, including Cong, Ran, Shuailiang Lin, Platt, Ophir Shalem, Matthias Heidenreich, and Lukasz Swiech.
“As one example, Broad’s attorney determined that Dr. Cong contributed to the invention of ‘the CRISPR-Cas9 system adapted in for [sic] uses in eukaryotic cells,’ a critical feature of every involved claim in the Interference. But Dr. Cong is not named on 8 of the 14 patents/application involved,” UC’s motion notes. “If all inventors are not named, then a patent or application is unpatentable unless it is corrected.”
“Inequitable… untrue… materially false”
UC’s next motion, alleging the Broad engaged in “inequitable conduct” is the most explosive, however.
The university said that the Broad’s claims are unpatentable because it made “at least one affirmative material misstatement” in each of its applications. Specifically, UC alleges that Zhang made statements he knew to be “untrue” at the time he made them, and that Sanjana had made a “materially false declaration.”
Zhang alleged in his declaration that he had a complete conception and reduction to practice of the technology he’d claimed he’d invented, USC said. But the university alleges that the evidence shows Zhang’s experiments failed to include tracrRNA, which is a required component of a functional CRISPR-Cas9 cleavage complex.
“The evidence shows that Dr. Zhang did not include tracrRNA in his experiments to form a CRISPR-Cas9 complex at that time and therefore could not have had a complete conception, much less a reduction to practice, of a functional CRISPR-Cas9 system for cleaving DNA,” UC wrote.
The university also claimed that Zhang didn’t include tracrRNA in his CRISPR-Cas9 complex until after he’d read a 2012 Science paper co-authored by Doudna, Charpentier, and Martin Jinek, which showed that tracrRNA is essential for cleavage of target DNA.
“Dr. Zhang was aware of the Jinek paper, and cited it in his own publications before he signed his declaration and before his counsel submitted it to the [USPTO],” UC said.
UC also accused Zhang of omitting unfavorable data and context from a summary panel the Broad showed the patent office. The full data would have showed the experimental failure of not including tracrRNA, as well as Zhang’s “failure to understand the criticality of tracrRNA at the time he conducted the experiments,” UC said.
“The Broad’s affirmative mischaracterization of data… is part of a larger pattern of deception,” the university added. In filing a claim for one of the involved patents, the Broad submitted a declaration from Sanjana, stating that the researchers had achieved successful cleavage of target DNA in eukaryotic cells by a CRISPR-Cas9 system comprising a single-guide RNA. As evidence, the team included a copy of an experimental gel. But UC said that gel was misrepresented, and clearly shows that Zhang and Sanjana’s experiment was “a failure.”
By presenting the gel as proof of a successful experiment, UC added, “Sanjana materially misstated facts in an attempt to prove an even earlier date of invention. Those acts evidence Broad’s pattern of deceptive behavior in its dealings with the patent office.”
In its supporting documents, UC submitted a February 2015 email from Shuailiang Lin, a researcher who had worked in Zhang’s lab from 2011 to 2012 and who was listed as an inventor on the Broad’s provisional applications.
“The 15-page declaration of [Feng Zhang] and Le Cong’s luciferase data is mis- and overstated to change the examiner’s decision, which seems to be a joke. After seeing your in virto [sic, in vitro] paper, Feng Zhang and Le Cong quickly jumped to the project without letting me know. My lab notebooks, emails and other files like dropbox or gel pictures recorded every step of the lab’s failure process. I am willing to give more details and records if you are interested or whoever is interested to clear the truth. We did not work it out before seeing your paper, it’s really a pity,” the e-mail said, according to UC’s filing.
The bottom line, UC concluded, is that the Broad’s patents should be canceled.
SOURCE
https://www.statnews.com/2019/07/31/latest-crispr-patent-fight-mudslinging/
UPDATED on 3/2/2019
U.S. patent office indicates it will issue third CRISPR patent to UC
Patent involved in interference proceedings will add to university’s gene-editing portfolio
The U.S. Patent and Trademark Office has issued a notice of allowance for a University of California patent application covering systems and methods for using single molecule guide RNAs that, when combined with the Cas9 protein, create more efficient and effective ways for scientists to target and edit genes. U.S. patent application number 13/842,859, which had notably been examined in advance of a prior interference proceeding involving the Broad Institute, specifically focuses on methods and systems for modifying a target DNA molecule in any setting, both in vitro and within live cells, using one or multiple single guide RNAs, across every cell type. The associated patent is expected to issue in the next 6-9 weeks.
This CRISPR-Cas9 DNA-targeting technology, invented by Jennifer Doudna and Martin Jinek of the University of California, Berkeley, along with Emmanuelle Charpentier at Umea University and Krzystof Chylinski at the University of Vienna, is a fundamental molecular tool for editing genes. Together, this patent application and prior U.S. Patent Numbers 10,000,772 and 10,113,167, cover CRISPR-Cas9 methods and compositions useful as gene-editing scissors in any setting, including in vitro, as well as within live plant, animal and human cells.
“We are pleased the patent application is now allowed and that the issued patent will encompass the use of CRISPR-Cas9 technology in any cellular or non-cellular environment. We expect to see continued momentum in the expansion of UC’s CRISPR patent portfolio in the coming months,” said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR matters for the University of California and a director at Sterne, Kessler, Goldstein & Fox. “The steadfast protection of the CRISPR intellectual property pioneered by the Doudna-Charpentier team is wholly focused on the improvement of human welfare.”
UPDATED on 11/22/2017
John Leonard to helm Intellia
SOURCE
See Background:
UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century
- Appeal to the U.S. Court of Appeals for the Federal Circuit seeks review and reversal of the Patent Trial and Appeals Board’s (PTAB) decision to terminate CRISPR/Cas9 interference
- In parallel, the companies and their licensors plan to pursue additional patents in the U.S. and worldwide covering the CRISPR/Cas9 technology and its use in cellular and non-cellular settings, including eukaryotic cells
BASEL, Switzerland;
CAMBRIDGE, Massachusetts;
BERKELEY, California;
DUBLIN, Ireland,
April 13, 2017
(GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP), Intellia Therapeutics (NASDAQ:NTLA), Caribou Biosciences and ERS Genomics announced today that The Regents of the University of California, the University of Vienna, and Dr. Emmanuelle Charpentier (collectively “UC”), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, have appealed to the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”) the decision by the Patent Trial and Appeal Board (“PTAB”) to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, “Broad”).
In the appeal, UC is seeking review and reversal of the PTAB’s February 15, 2017 decision, which terminated the interference without determining which inventors actually invented the use of the CRISPR/Cas9 genome editing technology in eukaryotic cells. In its decision, the PTAB concluded that, although the claims overlap, the respective scope of UC and Broad’s claim sets as presented did not define the same patentable invention and, accordingly, terminated the interference without deciding which party first invented the use of the CRISPR/Cas9 technology in eukaryotic cells. UC is asking the Federal Circuit to review and reverse the PTAB’s decision.
In parallel with the appeal, UC is pursuing applications in the U.S. and other jurisdictions worldwide to obtain patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted in the United Kingdom, and the European Patent Office is also granting a patent to UC, which will issue on May 10, 2017. UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed more than six months later, on December 12, 2012.
The law firm of Munger, Tolles & Olson LLP will be handling the appeal, with Don Verrilli, former Solicitor General of the United States, as lead counsel.
SOURCE
Editas’ rivals appeal a recent setback on patent fight, mapping a global war for CRISPR supremacy
They say they are “pursuing applications in the U.S. and other jurisdictions worldwide to obtain patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted in the United Kingdom, and the European Patent Office is also granting a patent to UC, which will issue on May 10, 2017. UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed more than six months later, on December 12, 2012.”
The group said today it is also waging a global patent battle for CRISPR/Cas9 supremacy over Editas and its scientific founder, Feng Zhang, who patented the rival technology at The Broad.
SOURCE
REFERENCES
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