CRISPR Therapeutics (NASDAQ:CRSP), Intellia Therapeutics, Inc.
(NASDAQ:NTLA), Caribou Biosciences, Inc., and ERS Genomics Limited
provide 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 (“CRISPR/Cas9 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 United Kingdom’s Intellectual Property Office
(UK 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.
U.S. Interference Proceeding
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.)
U.K. Patent Grants
Outside the United States, 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
United Kingdom’s Intellectual Property Office and, despite multiple
evidentiary “observations” filed by third parties including the
Broad, was granted as UK Patent No. 2518764. A second UK 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 (UK 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.
About CRISPR TherapeuticsCRISPR Therapeutics is
a leading gene-editing company focused on developing transformative
gene-based medicines for serious diseases using its proprietary
CRISPR/Cas9 gene-editing platform. CRISPR/Cas9 is a revolutionary
technology that allows for precise, directed changes to genomic
DNA. The Company’s multi-disciplinary team of world-class
researchers and drug developers is working to translate this
technology into breakthrough human therapeutics in a number of
serious diseases. Additionally, CRISPR Therapeutics has established
strategic collaborations with Bayer AG and Vertex Pharmaceuticals
to develop CRISPR-based therapeutics in diseases with high unmet
need. The foundational CRISPR/Cas9 patent estate for human
therapeutic use was licensed from the Company’s scientific founder
Emmanuelle Charpentier, Ph.D. CRISPR Therapeutics is headquartered
in Basel, Switzerland with its R&D operations based in
Cambridge, Massachusetts. For more information, please visit
www.crisprtx.com.
About Intellia TherapeuticsIntellia
Therapeutics is a leading genome editing company, focused on the
development of proprietary, potentially curative therapeutics using
the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9
technology has the potential to transform medicine by permanently
editing disease-associated genes in the human body with a single
treatment course. Intellia’s combination of deep scientific,
technical and clinical development experience, along with its
leading intellectual property portfolio, puts it in a unique
position to unlock broad therapeutic applications of the
CRISPR/Cas9 technology and create a new class of therapeutic
products. Learn more about Intellia Therapeutics and CRISPR/Cas9
at intelliatx.com; Follow us on Twitter @intelliatweets.
About Caribou Biosciences, Inc.Caribou is a
developer of cellular engineering and analysis solutions based on
CRISPR technologies. The Company was founded by pioneers of
CRISPR/Cas9 biology based on research carried out in the Doudna
Laboratory at the University of California, Berkeley. Caribou’s
tools and technologies provide transformative capabilities to
therapeutic development, agricultural biotechnology, industrial
biotechnology, and basic and applied biological research. For more
information, visit www.cariboubio.com and follow the
Company @CaribouBio. “Caribou Biosciences” and the Caribou
logo are registered trademarks of Caribou Biosciences, Inc.
About ERS GenomicsERS
Genomics was formed to provide broad access
to the foundational CRISPR/Cas9 intellectual property held by Dr.
Emmanuelle Charpentier. Non-exclusive licenses are available for
research and sale of products and services across multiple fields
including: research tools, kits, reagents; discovery of novel
targets for therapeutic intervention; cell lines for discovery and
screening of novel drug candidates; GMP production of healthcare
products; production of industrial materials such as enzymes,
biofuels and chemicals; and synthetic biology. For additional
information please visit www.ersgenomics.com.
CRISPR Forward-Looking StatementsCertain
statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the therapeutic value,
development, and commercial potential of CRISPR/Cas-9 gene editing
technologies and therapies and the intellectual property protection
of our technology and therapies. You are cautioned that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: uncertainties regarding the
intellectual property protection for our technology and
intellectual property belonging to third parties; uncertainties
inherent in the initiation and completion of preclinical studies
for the Company’s product candidates; availability and timing of
results from preclinical studies; whether results from a
preclinical trial will be predictive of future results of the
future trials; expectations for regulatory approvals to conduct
trials or to market products; and those risks and uncertainties
described in Item 1A under the heading “Risk Factors” in the
company’s most recent quarterly report on Form 10-Q, and in any
other subsequent filings made by the company with the U.S.
Securities and Exchange Commission (SEC), which are available on
the SEC’s website at www.sec.gov. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. The information contained in this press release is
provided by the company as of the date hereof, and, except as
required by law, the company disclaims any intention or
responsibility for updating or revising any forward-looking
information contained in this press release.
Intellia’s Forward-Looking StatementsThis press
release contains “forward-looking statements” of Intellia within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward looking statements include, but are not limited
to, statements regarding Intellia’s ability to advance CRISPR/Cas9
into therapeutic products for severe and life-threatening diseases
and its CRISPR/Cas9 intellectual property portfolio, and statements
regarding the intellectual property position and strategy of
Intellia’s licensors. Any forward-looking statements in this press
release are based on management’s current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to,
risks related to Intellia’s ability to protect and maintain its
intellectual property position, risks related to the ability of
Intellia’s licensors to protect and maintain their intellectual
property position, the risk that any one or more of Intellia’s
product candidates will not be successfully developed and
commercialized, the risk of cessation or delay of any of the
ongoing or planned clinical trials and/or development of Intellia’s
product candidates, the risk that the results of previously
conducted studies involving similar product candidates will not be
repeated or observed in ongoing or future studies involving current
product candidates, and the risk that Intellia’s collaborations
with Novartis or Regeneron will not continue or will not be
successful. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause Intellia’s actual
results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in Intellia’s
most recent quarterly report on Form 10-Q filed with the Securities
and Exchange Commission, as well as discussions of potential risks,
uncertainties, and other important factors in Intellia’s subsequent
filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release,
and Intellia Therapeutics undertakes no duty to update this
information unless required by law.
Disclaimer Regarding Third Party WebsitesThe
announcing companies are providing the above reference to the
USPTO’s website as a third-party source of additional factual
information relating to U.S. patent interference 106,048, and none
of the announcing companies adopt any information contained or
found in such reference. Any information in this press release
accessible through such reference is as of the date of the release,
and the announcing companies undertake no duty to update this
information unless required by law.
CRISPR CONTACTS
Media Contact:
Jennifer Paganelli
W2O Group for CRISPR
+1 347-658-8290
jpaganelli@w2ogroup.com
Investor Contact:
Chris Brinzey
Westwicke Partners for CRISPR
+1 339-970-2843
chris.brinzey@westwicke.com
INTELLIA CONTACTS
Media Contact:
Jennifer Mound Smoter
SVP, External Affairs & Communications
+1 857-706-1071
jenn.smoter@intelliatx.com
Investor Contact:
Graeme Bell
Chief Financial Officer
+1 857-706-1081
graeme.bell@intelliatx.com
CARIBOU CONTACTS
Greg Kelley
Feinstein Kean Healthcare
+1 404-836-2302
gregory.kelley@fkhealth.com
ERS GENOMICS CONTACTS
MacDougall Communications
Mario Brkulj or Dr. Stephanie May
Direct: +49 89 2420 9345 or
+48 89 2420 9344
E-Mail: mbrkulj@macbiocom.com
or smay@macbiocom.com
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