Both sides in the recently-rekindled legal wrangle over who invented CRISPR gene-editing technology—the Broad Institute of MIT and Harvard, the University of California (UC), and their respective partners—have filed lists of proposed motions this week in the latest interference proceeding.
The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) in June declared a patent interference between 10 separate U.S. patent applications owned by UC, the University of Vienna, and CRISPR pioneer Emmanuelle Charpentier, PhD, director and scientific member at the Max Planck Institute of Infection Biology, Berlin—collectively called CVC—and 13 of the 15 patents held by the Broad Institute, Harvard University, and MIT, plus one patent application.
In their motions list, the Broad Institute and partners have sought authorization to establish how the latest Interference on certain eukaryotic claims differs from the earlier interference, No. 106,048.
That proceeding resulted in a ruling by the U.S. Court of Appeals in September 2018 that upheld a PTAB judgment finding no interference-in-fact between UC claims and patents already issued to Broad, stating that the claims were not directed to the same subject matter.
However, the appeals court ruling made no specific determination regarding priority of invention of genome editing within eukaryotic cells. Since then, UC and partners filed their series of applications.
“There is no basis in law or logic to proceed with a second interference as to the same subject matter, or to aspects that could have been raised in the prior proceeding,” the Broad argued in its motions list.
“To the extent any second interference between Broad and CVC is determined to be proper (which it should not), the Count should be narrowly tailored and Broad’s claims that are not limited to the subject matter of the new Count should not be involved here, as the 048 Interference has successfully concluded,” the Broad added. “There should be no do-over of what was or could have been decided in the 048 Interference.”
In its Motions List, CVC has requested that USPTO reverse its designations so that CVC would become the senior party in the latest interference and the Broad, the junior party. The senior party is presumed to be the “first to invent,” with the junior party carrying the burden of proof to show otherwise.
CVC also filed motions seeking a judgment of unpatentability applying to all of the Broad’s involved patents and application due to obviousness based on prior art, as well as what the UC and partners argue is inequitable conduct by the Broad and its partners.
As an example of such conduct, CVC cited a declaration by Feng Zhang, PhD, of the Broad, an inventor listed in all of the Institute’s patents and application covered by the latest interference proceeding.
Zhang declared he had a complete conception and reduction to practice of the use of CRISPR-Cas9 to edit a eukaryotic cell before May 2012, a month before publication in Science of the seminal paper by Charpentier, Jennifer Doudna, PhD, of University of California, Berkeley, and colleagues detailing CRISPR’s potential for potential to exploit the system for RNA-programmable genome editing.
“Zhang knew that this statement was untrue,” CVC declared, since Zhang’s experiments failed to include tracrRNA, a required component of a functional CRISPR-Cas9 cleavage complex.
“Incomplete, cherry-picked data”
CVC cited “correspondence from other scientists in Zhang’s lab,” indicating that Zhang and co-inventors failed to conceive of a complete CRISPR-Cas9 DNA cleavage complex until after reading the seminal paper.
CVC also contended that Zhang “presented incomplete, cherry-picked data and intentionally omitted the context that shows his claims of successful DNA cleavage to be false,” adding that he showed reduced luciferase activity in an experimental group attributable to successful DNA cleavage by selectively omitting unfavorable data and context from his summary panel.
“Because the experimental failures are clear on their faces and the omission of the essential subject matter (tracrRNA) would have been readily evident to Zhang at the time he signed his declaration, the only reasonable inference one can draw is that Broad withheld or misrepresented material information with the intent to deceive the Office, in order to secure allowance of the involved application,” CVC alleged in its filing.
The Broad shot back in a statement: “UC casts baseless claims at the Broad patents and inventors in the hope of avoiding having to provide any actual evidence of UC’s work in eukaryotic cells. The Broad Institute stands behind the scientific claims and filings it has made to the Patent Office over many years.”
“It is deeply unfortunate, for the entire field, that the University of California, Berkeley, has chosen this strategy,” the Broad added.
The proposed motions will be reviewed by the PTAB’s administrative patent judges at the PTAB, and are set to be discussed with lawyers for both sides on August 5. The PTAB is expected to authorize at least some motions to proceed in the interference proceeding’s first phase, while deferring or denying others.