CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics Announce Appellate Brief Seeking Reversal of...
July 25 2017 - 5:00PM
CRISPR Therapeutics (NASDAQ:CRSP), Intellia Therapeutics, Inc.
(NASDAQ:NTLA), Caribou Biosciences, Inc. and ERS Genomics, Ltd.
announced 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, today submitted an appellate brief
to the U.S. Court of Appeals for the Federal Circuit (the “Federal
Circuit”) seeking reversal of a decision by the U.S. Patent and
Trademark Office’s Patent Trial and Appeal Board (“PTAB”) in an
interference proceeding relating to CRISPR/Cas9 gene editing
technology. In the appeal, UC requests reversal of the PTAB’s
decision terminating the interference between certain CRISPR/Cas9
patent claims owned by UC and claims of the Broad Institute,
Harvard University and the Massachusetts Institute of Technology
(collectively, “Broad”).
In its brief to the
Federal Circuit (Case No. 17-1907), UC asserts that the PTAB’s
February 15, 2017 determination that the UC patent claims did not
make the Broad’s patent claims obvious is based on a misapplication
of controlling legal standards established by U.S. Supreme Court
and Federal Circuit precedent. In its decision, the PTAB had
concluded that UC’s claims covering CRISPR/Cas9 single guide gene
editing technology and its application in any cellular or
non-cellular setting did not make obvious Broad’s claims covering
application of the same technology limited to use in eukaryotic
cellular settings. In its
brief, UC sets forth multiple errors in the PTAB’s holding that the
use of CRISPR/Cas9 in eukaryotes is separately patentable as
alleged by Broad, including the following:
- With respect to the obviousness of applying the technology to
eukaryotic cells, U.S. Supreme Court and Federal Circuit precedents
clearly mandate that obviousness determinations be based on an
“expansive and flexible approach” including consideration of “the
inferences and creative steps that a person of ordinary skill in
the art would employ.” In contrast, the PTAB applied a narrow and
restrictive approach that ignored certain key evidence, including
the steps actually employed by those of skill in the art at the
time, and also effectively required a “guarantee” that UC’s
CRISPR/Cas9 invention would work in eukaryotic cells, when
well-established case law requires only a “reasonable expectation
of success.”
- With respect to the reasonable expectation of success standard
that establishes obviousness, the PTAB effectively ignored U.S.
Supreme Court and Federal Circuit case law, which emphasize that an
invention can be obvious if it is “obvious to try,” even if
success is not guaranteed, “[w]hen there is a design need or market
pressure to solve a problem,” “there are a finite number of
identified, predictable solutions,” and experimentation leads to
“the anticipated success.”
- The PTAB ignored U.S. Supreme Court and Federal Circuit
precedent highlighting that the occurrence of what appear to be
simultaneous “inventions” arising close together in time is itself
strong evidence of their obviousness, and accordingly requiring
that such evidence be considered in any obviousness analysis. In
contrast, in terminating the interference, the PTAB essentially
dismissed as “irrelevant” the evidence that six different
laboratories successfully applied UC’s claimed CRISPR/Cas9
invention in eukaryotic cells using conventional techniques within
months after UC publicly disclosed the invention - some of them
prior to Broad’s first filing.
- The PTAB effectively ignored that Broad’s own eukaryotic
application of UC’s CRISPR/Cas9 invention had simply utilized
conventional prior art techniques. As a consequence, it
failed to consider that Broad’s alleged invention did not reflect
any significant innovation on Broad’s part, an important issue
under applicable precedent.
- The PTAB failed to hold Broad to its burden of proving, among
other things, the effective priority date for its patent claims, as
required by the PTAB’s own rules and Federal Circuit
precedent. By not requiring the Broad to meet its burden of
proof, and by merely assuming that all of the Broad’s claims were
entitled to their earliest possible filing date despite Broad’s
failure of proof, the PTAB improperly ignored relevant intervening
art that made the Broad’s claims obvious.
As explained in UC’s
brief, application of the correct legal standards to the case is
believed to require reversal of the PTAB’s decision. For these
reasons, UC requests that the Federal Circuit instruct the PTAB to
reinstate the interference proceeding so that it can properly
determine priority of inventorship, as previously requested by UC.
The PTAB’s failures to consider pertinent evidence and apply
appropriate legal standards should at the very least require the
matter to be remanded so that the PTAB can properly consider the
evidence related to obviousness and Broad’s no-interference-in-fact
motion using appropriate legal
standards. In the PTAB’s
February decision terminating the interference proceeding
prematurely, it had not yet considered the teachings of UC’s own
prior-filed patent application with respect to using CRISPR/Cas9 in
eukaryotic cells. Instead, the PTAB only addressed the threshold
question of whether use in eukaryotic cells can be separately
patentable from use in all settings as covered by UC’s claims.
However, determinations on the underlying substantive matters have
recently been made in parallel prosecution before the U.S. Patent
& Trademark Office (“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 being non-novel in
view of UC’s prior-filed patent application, which the USPTO
examiners considered to have effectively taught use of the
CRISPR/Cas9 technology in eukaryotic cells. In addition, patent
applications filed by Sigma-Aldrich and Toolgen that similarly
claim use of CRISPR/Cas9 in eukaryotic cells (both of which filed
applications before Broad’s application) have likewise recently
been rejected as being either non-novel or obvious in view of the
prior-filed UC patent application with specific respect to its
teachings regarding application of the invention to use in
eukaryotic
cells. Consistent with the
substantive determinations reached by the USPTO regarding the broad
teachings of the UC patent application, UC’s corresponding cases
covering use of CRISPR/Cas9 in all settings, including in
eukaryotic cells, have been advanced to grant or decisions to grant
in numerous jurisdictions worldwide, including in the United
Kingdom, the nearly 40 other countries that are members of the
European Patent Convention, and more recently in other
jurisdictions such as Australia, New Zealand, Singapore and
China. 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
Dr. Emmanuelle Charpentier. CRISPR Therapeutics is headquartered in
Zug, Switzerland, with business offices in London, United Kingdom,
and 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 leading company in
CRISPR genome engineering 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,
including information about obtaining research and commercial
licenses as well as collaborations,
visit www.cariboubio.com and follow the
Company @CaribouBio. “Caribou Biosciences” and the Caribou
logo are 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’s Forward-Looking StatementCertain
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 intellectual
property protection of our technology and therapies, the
intellectual property positions of third parties, and the
therapeutic value, development, and commercial potential of
CRISPR/Cas-9 gene editing technologies 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 under the heading “Risk Factors” in the company’s most
recent annual report on Form 10-K, 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 StatementThis 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, express or
implied statements regarding the intellectual property position and
strategy of Intellia’s licensors; and Intellia’s ability to advance
CRISPR/Cas9 into therapeutic products for severe and
life-threatening diseases and its CRISPR/Cas9 intellectual property
portfolio. 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 annual report on Form 10-K 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.
CRISPR CONTACTS
Media:
Jennifer Paganelli
WCG for CRISPR
+1 347-658-8290
jpaganelli@wcgworld.com
Investors:
Chris Brinzey
Westwicke Partners for CRISPR
+ 1 339-970-2843
chris.brinzey@westwicke.com
INTELLIA CONTACTS
Media:
Jennifer Mound Smoter
Senior Vice President, External Affairs & Communications
+ 1 857-706-1071
jenn.smoter@intelliatx.com
Investors:
Graeme Bell
Executive Vice President, Chief Financial Officer
+ 1 857-706-1081
graeme.bell@intelliatx.com
CARIBOU CONTACT
Greg Kelley
Feinstein Kean Healthcare
+ 1 404-836-2302
gregory.kelley@fkhealth.com
ERS GENOMICS CONTACTS
MacDougall Biomedical Communications
Mario Brkulj or Dr. Stephanie May
+49 89 2420 9345 or +48 89 2420 9344
mbrkulj@macbiocom.com or smay@macbiocom.com
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