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CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics
Announce Appellate Brief Seeking Reversal of U.S. Patent Board Decision on
CRISPR/Cas9 Gene Editing
ZUG, Switzerland; CAMBRIDGE, Massachusetts; BERKELEY, California; DUBLIN,
Ireland; July 25, 2017 (GLOBE NEWSWIRE) 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:
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 Therapeutics
CRISPR 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 Therapeutics
Intellia 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
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.
ERS 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 Statement
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 Statement
This 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.
Westwicke Partners for CRISPR
Jennifer Mound Smoter
Senior Vice President, External
Affairs & Communications
Executive Vice President, Chief Financial Officer
Feinstein Kean Healthcare
ERS GENOMICS CONTACTS
MacDougall Biomedical Communications
or Dr. Stephanie May
+49 89 2420 9345 or +48 89 2420 9344