U.S. Patent Office Upholds Validity of Natera's Early Priority Date '592 cfDNA Patent
Natera, Inc. (NASDAQ: NTRA) announced a significant win as the U.S. Patent Office upheld the validity of its U.S. Patent No. 8,682,592, denying a challenge from a multi-national sequencing company. This patent covers innovative methods for generating genetic data from limited DNA quantities, crucial in non-invasive prenatal testing and oncology. The Patent Office's decision highlights Natera's pioneering role in cfDNA testing, with only 20% of similar challenges resulting in a favorable outcome. Natera's early priority date of 2005 further solidifies its leadership in the field.
- U.S. Patent Office upheld the validity of Natera's U.S. Patent No. 8,682,592, confirming its patent claims against a competitor's challenge.
- The decision reinforces Natera's pioneering status in cell-free DNA testing and innovative genetic data generation methods.
- None.
SAN CARLOS, Calif., Dec. 18, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, is pleased that the United States Patent Office granted Natera a significant win when it denied a patentability challenge from a multi-national sequencing company against Natera's U.S. Patent No. 8,682,592 ('592 Patent) upholding all claims. Natera's '592 Patent claims early and significant innovations directed to generating genetic data from limited quantities of DNA, including cfDNA. Natera has shown the techniques to be useful in a variety of contexts such as non-invasive prenatal testing, ctDNA molecular residual disease testing in oncology, and donor-derived cfDNA assessment in organ transplant recipients.
In upholding the patentability of every one of the '592 Patent's claims against this Inter Partes Review ("IPR") petition, the Patent Office noted that the challenger had "not demonstrated by a preponderance of the evidence that [the claims] are unpatentable." According to Elizabeth Laughton of Smith Baluch LLP, IPR counsel for Natera, "The Board concluded that all challenged claims were patentable—a result that occurs in only 1 in 5 IPRs that reach a final written decision."
"The '592 Patent describes, amongst other things, core DNA quantitation methods and more sophisticated methods using genotyping, for analyzing tiny amounts of DNA for a variety of applications. We believe that the early priority date of 2005, along with the ideal IPR result, confirms the importance of this patent and Natera's pioneering leadership in non-invasive genetic testing," said Matthew Rabinowitz, Executive Chairman of Natera and an inventor of the patent.
About Natera
Natera is a pioneer and global leader in cell-free DNA testing. 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 an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in 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 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, 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 or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or 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.
Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com
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SOURCE Natera, Inc.
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