BRCA Patent Owners and Gene by Gene, Ltd. Resolve Patent Suit
February 07 2014 - 7:00AM
Gene by Gene, Ltd. and Myriad Genetics, Inc., the University of
Utah Research Foundation, HSC Research and Development Limited
Partnership, Endorecherche, Inc., and the Trustees of the
University of Pennsylvania (the "Patent Owners") have reached an
agreement to settle the patent infringement lawsuit between them
regarding BRCA testing.
Under the agreement and effective immediately, Gene by Gene will
cease selling or marketing clinical diagnostic tests within North
America that include analysis of the BRCA1 and/or BRCA2 genes as a
standalone test or in conjunction with gene panels, but Gene by
Gene will continue to offer such tests outside of North America.
The Parties have also agreed that Gene by Gene may continue to
offer its whole genome and exome products and services, which
include the BRCA genes, as well as Gene by Gene's custom array
products that test variants for inherited Mendelian disorders,
including variants for BRCA1 and BRCA2, worldwide.
The agreement will continue until the earlier of February 12,
2016 or the last-to-expire valid patent claim in any of the BRCA
patents involved in the case. In return, the Patent Owners have
agreed to dismiss the patent infringement case against Gene by Gene
without prejudice.
This settlement effectively ends the suit that was filed July
10, 2013, in which the Patent Owners alleged that the testing
process employed by Gene by Gene infringes certain claims in
patents owned by the Patent Owners covering synthetic DNA and
methods-of-use related to the BRCA1 and BRCA2 genes.
About Gene by Gene
Founded in 2000, Gene By Gene, Ltd. (www.genebygene.com)
provides reliable DNA testing to a wide range of consumer and
institutional customers through its four divisions focusing on
ancestry, health, research and paternity. Through its CAP Certified
clinical-health division it offers regulated clinical diagnostic
tests as well as Research Use Only (RUO) division serving both
direct-to-consumer and institutional clients worldwide.
Additionally, it provides DNA tests through its FamilyTreeDNA.com
division, which pioneered the concept of direct-to-consumer testing
in the field of genetic genealogy more than a decade ago and is the
leader in the field. The privately held company is headquartered in
Houston, which is also home to its state-of-the-art molecular CAP
accredited Genomics Research Center.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions and
assess risk of disease progression and recurrence. Myriad's
portfolio of molecular diagnostic tests are based on an
understanding of the role genes play in human disease and were
developed with a commitment to improving an individual's decision
making process for monitoring and treating disease. Myriad is
focused on strategic directives to introduce new products,
including companion diagnostics, as well as expanding
internationally. For more information on how Myriad is making a
difference, please visit the Company's website: www.myriad.com.
Myriad and the Myriad logo are trademarks or registered
trademarks of Myriad Genetics, Inc. in the United States and
foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the scope, effect and
duration of the settlement agreement entered into by Gene by Gene
and the Company; and the Company's strategic directives under the
caption "About Myriad Genetics". These "forward-looking statements"
are management's present 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
described in the forward-looking statements. These risks include,
but are not limited to: the risk that sales and profit margins of
our existing molecular diagnostic tests and companion diagnostic
services may decline or will not continue to increase at historical
rates; risks related to changes in the governmental or private
insurers reimbursement levels for our tests; the risk that we may
be unable to develop or achieve commercial success for additional
molecular diagnostic tests and companion diagnostic services in a
timely manner, or at all; the risk that we may not successfully
develop new markets for our molecular diagnostic tests and
companion diagnostic services, including our ability to
successfully generate revenue outside the United States; the risk
that licenses to the technology underlying our molecular diagnostic
tests and companion diagnostic services tests and any future tests
are terminated or cannot be maintained on satisfactory terms; risks
related to delays or other problems with operating our laboratory
testing facilities; risks related to public concern over our
genetic testing in general or our tests in particular; risks
related to regulatory requirements or enforcement in the United
States and foreign countries and changes in the structure of the
healthcare system or healthcare payment systems; risks related to
our ability to obtain new corporate collaborations or licenses and
acquire new technologies or businesses on satisfactory terms, if at
all; risks related to our ability to successfully integrate and
derive benefits from any technologies or businesses that we license
or acquire; the development of competing tests and services; the
risk that we or our licensors may be unable to protect the
proprietary technologies underlying our tests; the risk of
patent-infringement claims or challenges to the validity of our
patents; risks of new, changing and competitive technologies and
regulations in the United States and internationally; and other
factors discussed under the heading "Risk Factors" contained in
Item 1A in our most recent Annual Report on Form 10-K filed with
the Securities and Exchange Commission, as well as any updates to
those risk factors filed from time to time in our Quarterly Reports
on Form 10-Q or Current Reports on Form 8-K. All information in
this press release is as of the date of the release, and Myriad
undertakes no duty to update this information unless required by
law.
CONTACT: Media Contact (Myriad): Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
Media Contact (Gene by Gene):
media@genebygene.com
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