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CRISPR, Intellia, Caribou and ERS Genomics provide update on CRISPR/Cas9 U.S. patent

Friday, February 17, 2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics provided an update on the Patent Trial & Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) decision on the motions filed by the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively, UC), on one hand, and the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad), on the other, in the interference proceeding relating to CRISPR/Cas9 genome editing technology.

The PTAB discontinued the current interference finding that the claim sets presented by the two parties were considered “patentably distinct” from each other because UC’s current claims are broader in scope in that they are not restricted to use in eukaryotic cells, whereas Broad’s claims are all limited to use in eukaryotic cells. As a result of the decision, UC’s broader case, which was previously considered allowable but for the interference, is now released from the interference and may be prosecuted to potential issuance by UC, while a new interference can be sought with respect to eukaryote claims, currently pending in a separate UC patent application once they are deemed allowable. Alternatively, UC could appeal the current decision, which is currently under consideration. In parallel cases, the U.K.’s Intellectual Property Office (U.K. IPO) granted patents to foundational CRISPR/Cas9 genome editing technology in any non-cellular or cellular setting (including in human cells) to UC.

The prosecution and enforcement of UC’s foundational intellectual property covering CRISPR/Cas9 Technology, such as this patent application, is governed by a global cross-consent and invention management agreement between the co-owners of the intellectual property—the Regents of the University of California, Emmanuelle Charpentier and the University of Vienna—as well as their key licensees and sublicensees—CRISPR Therapeutics, ERS Genomics, Caribou Biosciences and Intellia Therapeutics.

The written decisions and associated documents relating to U.S. patent interference 106,048 are publicly available at https://acts.uspto.gov/ifiling/PublicView.jsp.

UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology was filed on May 25, 2012, and Broad’s earliest patent application was filed on December 12, 2012.

The interference was based on (i) UC’s claims directed to the use of the CRISPR/Cas9 Technology with the widely used single-guide RNA format (in which the two key RNA molecules, tracrRNA and crRNA, are fused into a single molecule) in any setting – including but not limited to eukaryotic cells, and (ii) Broad’s claims covering the use of the CRISPR/Cas9 Technology in eukaryotic cells only. UC’s claims, which USPTO examiners previously deemed in condition for allowance subject to the interference, are now released from the interference, and UC may pursue them to potential issuance.

The current proceeding was terminated as a “threshold” matter based on uses in eukaryotic cells being considered separately patentable from the use of the CRISPR/Cas9 Technology in all cellular and non-cellular settings (i.e. prokaryotes, eukaryotes and in vitro). Although UC’s and Broad’s claims both encompass uses in eukaryotic cells, the PTAB decided that the interference should not proceed with the current claim sets because UC’s claims are broader in scope in that they are not limited to use in the eukaryotic setting, whereas Broad’s claims are all limited to uses in eukaryotes. Under patent interference rules, the PTAB applies a “2-way” test requiring that the parties’ claims define the “same patentable invention.” In its decision, the PTAB concluded that, although they overlap, the respective scope of UC and Broad’s claims did not define the same patentable invention.

The PTAB’s holding ends the current proceeding based on the patent claims before it, and the PTAB’s decision is not intended to nor does it establish which party actually invented first with respect to use of the CRISPR-Cas9 Technology in eukaryotic cells. UC is free to seek a new interference with Broad’s patents based on existing applications UC already has before the PTO that include claims limited to use of the CRISPR-Cas9 Technology in eukaryotes. If a new interference is sought and declared, it would then begin with a motions phase related to the newly-designated claims.

The PTAB did not rule on substantive motions, including whether the parties are entitled to rely on their earliest patent applications for priority benefit. UC’s earliest application was filed on May 25, 2012, and Broad’s was filed on December 12, 2012. However, determinations on certain substantive matters have recently been made in parallel prosecution before the USPTO. The USPTO has rejected a series of patent applications filed by Broad that are directed to uses of CRISPR/Cas9 Technology in eukaryotic cells (as in the claims involved in the interference) as being “non-novel” in view of the UC’s prior-filed patent application (which the USPTO examiners considered to have provided an enabling disclosure that effectively taught use of the CRISPR/Cas9 Technology in eukaryotic cells).

These Broad cases include USSN 14/105,031, USSN 14/105,035, USSN 14/523,799, and USSN 14/703,511, all of which stand rejected by the USPTO. In rejecting Broad’s applications, the USPTO concluded that the UC’s priority application “discloses methods of, and compositions and CRISPR-Cas systems for interfering with a target DNA sequence in both prokaryotic and eukaryotic cells using CRISPR RNA (crRNA) and a CRISPR-associated (cas) protein/nucleic acid.” The USPTO also determined that Broad’s attempt to antedate or “swear behind” the earlier-filed UC patent applications using inventor declarations (as was done in obtaining many of the issued Broad patents) is improper because the UC case “clearly discloses each of the claimed limitations in the earliest two priority applications.” (See Final Rejection of Broad application USSN 14/523,799, August 29, 2016, and similar rejections made against all of the other above-referenced Broad cases.)

Regarding Staphylococcus aureus Cas9, the PTAB did not decide Broad’s substantive motion to “de-designate” (i.e. remove from the interference) claims directed to use of S. aureus Cas9 (essentially based on Broad’s arguments that use of the S. aureus Cas9 orthologue was non-obvious in view of the S. pyogenes Cas9 and therefore separately patentable). However, in substantive examination of an UC patent application, the USPTO recently determined as follows: “It would have been obvious to one of ordinary skill in the art to have modified the method of Jinek [a June 2012 publication co-authored by UC scientists] by replacing the S. pyogenes Cas9 protein with the Staphylococcus aureus Cas9 protein because it would have merely amounted to a simple substitution of one known Cas9 protein for another to yield predictable results.” (See USPTO Official Action in USSN 14/942,782, January 4, 2017)

Outside the U.S., a UC application directed broadly to the single-guide CRISPR/Cas9 genome editing system (i.e. not limited by cellular or non-cellular setting) was examined by the U.K.’s Intellectual Property Office and, despite multiple evidentiary “observations” filed by third parties including the Broad, was granted as U.K. Patent No. 2518764. A second U.K. patent application, which is directed to chimeric CRISPR/Cas9 systems, was also the subject of third-party observations, and was granted as a patent on February 7, 2017 (U.K. Patent No. 2537000). Corresponding applications are being prosecuted in the European Patent Office and in other regional and national offices covering approximately 80 jurisdictions worldwide. Granted patents can be subject to proceedings challenging their grant, validity or scope.

Almost all jurisdictions worldwide are “first-to-file” systems, which recognize the first patent applicant(s) as the legal inventor(s) and do not permit the filer of a later patent application to antedate the earlier filings of others. In the case of the CRISPR-Cas9 Technology, UC filed its first priority application on May 25, 2012, and Broad filed more than six months later on December 12, 2012. In the United States, with respect to patent applications filed prior to March 2013, a subsequent filer could claim to have invented before an earlier filer by filing a declaration in the USPTO, which is what the Broad did and led to the interference proceeding discussed herein.

Broad’s related European patents have been opposed by numerous parties on procedural as well as substantive grounds, and are now the subject of proceedings challenging their validity and issuance at the Opposition Division of the European Patent Office.

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