Natera Wins Preliminary Injunction in Patent Infringement Lawsuit Against NeoGenomics’ RaDaR Test
28 Dezembro 2023 - 1:48AM
Business Wire
Order enjoins NeoGenomics from making, using,
selling or promoting its RaDaR molecular residual disease (MRD)
assay in the United States with limited exceptions
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced that the federal District Court for the
Middle District of North Carolina has issued a preliminary
injunction, effective immediately, enjoining the RaDaR assay from
NeoGenomics Labs, Inc. (“NeoGenomics”).
The injunction bars NeoGenomics from “making, using, selling, or
offering for sale in the United States… the accused RaDaR assay,”
or “any assay or product not more than colorably different” from
the NeoGenomics RaDaR assay. In addition, the order prohibits
NeoGenomics from “promoting, advertising, marketing, servicing,
distributing or supplying” RaDaR to induce infringement by others.
NeoGenomics may continue to offer RaDaR for existing patients and
for clinical trials, studies or projects already in process.
Natera stated, “We are pleased with the Court’s decision to
issue a preliminary injunction. Any proposed workaround will need
to be more than ‘colorably different’ from the RaDaR assay and not
infringe our ‘035 patent. We believe this presents a significant
challenge for regulatory and reimbursement efforts that rely upon
NeoGenomics’ ongoing trials.”
Today’s news follows an order in a separate matter earlier this
month by the Delaware Federal District Court, which issued a
permanent injunction against Invitae Corporation (“Invitae”) and
its Personalized Cancer Monitoring (PCM) product. In issuing that
decision, the Court barred Invitae from using its infringing PCM
product and any product or service not more than colorably
different from PCM, with some limited exceptions.
"With a second injunction granted within two months, Natera’s IP
position in the tumor-informed, personalized molecular monitoring
and MRD market has been further validated,” the company continued.
“We will continue to vigorously protect and defend our extensive
portfolio of patents from unlawful infringement.”
For additional information, view the Court’s preliminary
injunction order and supporting memorandum.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated
to oncology, women’s health, and organ health. We aim to make
personalized genetic testing and diagnostics part of the standard
of care to protect health, and inform earlier, more targeted
interventions that help lead to longer, healthier lives. Natera’s
tests are validated by more than 180 peer-reviewed publications
that demonstrate high accuracy. Natera operates ISO 13485-certified
and CAP-accredited laboratories certified under the Clinical
Laboratory Improvement Amendments (CLIA) in Austin, Texas and San
Carlos, California. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts
contained in this press release are forward-looking statements and
are not a representation that Natera’s plans, estimates, or
expectations will be achieved. These forward-looking statements
represent Natera’s expectations as of the date of this press
release, and Natera disclaims any obligation to update the
forward-looking statements. These forward-looking statements are
subject to known and unknown risks and uncertainties that may cause
actual results to differ materially, including with respect to
developments in matters under dispute or litigation, the scope of
protection we establish and maintain for, and developments or
disputes concerning, our intellectual property or other proprietary
rights, expected regulatory and reimbursement outcomes, and our
expectations of the benefits of our tests and product offerings to
patients, providers and payers. Additional risks and uncertainties
are discussed in greater detail in “Risk Factors” in Natera’s
recent filings on Forms 10-K and 10-Q and in other filings Natera
makes with the SEC from time to time. These documents are available
at www.natera.com/investors and www.sec.gov.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231227389284/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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