September 29, 2021
Court Rules in Natera's Favor Invalidating All of CareDx's Asserted Patents

AUSTIN, Texas, Sept. 29, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), is pleased that the Delaware Federal District Court ruled today that all three patents CareDx has asserted against Natera "are invalid as a matter of law under §101 for claiming patent-ineligible subject matter."1 Natera expects this ruling will be upheld on appeal and continues to forcefully pursue its own claims that CareDx infringes Natera's '658 and '724 patents.

The '658 and '724 patents are two of nearly 100 issued and pending assets in Natera's organ health IP portfolio. This robust portfolio reflects Natera's trailblazing contribution to cfDNA-based diagnostic methods.

About the Prospera test
The Prospera test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers, our ability to obtain favorable coverage and reimbursement determinations from third-party payers, 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. 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

References

  1. Memorandum Opinion, CareDx, Inc. et al. v. Natera, Inc. et al, 1:19-cv-00567-CFC-CJB, Dkt. No. 183 at 35 (D.Del. September 28, 2021)

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/court-rules-in-nateras-favor-invalidating-all-of-caredxs-asserted-patents-301387457.html

SOURCE Natera, Inc.

AUSTIN, Texas, Sept. 29, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), is pleased that the Delaware Federal District Court ruled today that all three patents CareDx has asserted against Natera "are invalid as a matter of law under §101 for claiming patent-ineligible subject matter."1 Natera expects this ruling will be upheld on appeal and continues to forcefully pursue its own claims that CareDx infringes Natera's '658 and '724 patents.

The '658 and '724 patents are two of nearly 100 issued and pending assets in Natera's organ health IP portfolio. This robust portfolio reflects Natera's trailblazing contribution to cfDNA-based diagnostic methods.

About the Prospera test
The Prospera test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers, our ability to obtain favorable coverage and reimbursement determinations from third-party payers, 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. 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

References

  1. Memorandum Opinion, CareDx, Inc. et al. v. Natera, Inc. et al, 1:19-cv-00567-CFC-CJB, Dkt. No. 183 at 35 (D.Del. September 28, 2021)

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/court-rules-in-nateras-favor-invalidating-all-of-caredxs-asserted-patents-301387457.html

SOURCE Natera, Inc.