Natera Wins Preliminary Injunction in Patent Infringement Lawsuit Against NeoGenomics’ RaDaR Test
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Insights
The preliminary injunction against NeoGenomics regarding its RaDaR assay represents a significant legal maneuver in the competitive landscape of cell-free DNA testing. From a legal standpoint, the injunction serves as a protective measure for Natera's intellectual property, specifically their '035 patent, which is evidently central to their business strategy. The ruling underscores the importance of robust patent portfolios in the biotech industry, where research and development investments are substantial and the ability to secure exclusive rights to technological advancements can be pivotal for a company's market position.
In the broader context, such legal actions often lead to a ripple effect, where competitors must navigate the complexities of patent law to avoid infringement. This can result in increased legal costs, potential delays in product development and challenges in obtaining regulatory approvals and reimbursements. For stakeholders, particularly investors, these developments can influence the perceived stability and growth potential of the involved companies, potentially affecting stock valuations.
The issuance of a preliminary injunction can have immediate financial implications for both Natera and NeoGenomics. For Natera, the injunction may reinforce investor confidence by demonstrating the company's ability to defend its intellectual property, which could translate into favorable stock market performance. On the other hand, NeoGenomics may face hurdles in its commercial activities and growth projections, as the injunction limits the company's ability to market and sell its RaDaR assay in the U.S. market.
Furthermore, the enforcement of such injunctions typically results in increased scrutiny from investors regarding a company's risk management practices and its preparedness for such legal challenges. The long-term financial impact will depend on NeoGenomics' ability to innovate beyond the patented technology or to successfully challenge the patent's validity, both of which carry inherent risks and uncertainties.
The cell-free DNA testing market is highly competitive and rapidly evolving, with molecular residual disease (MRD) assays playing a crucial role in personalized medicine, particularly in cancer treatment. The preliminary injunction against NeoGenomics may shift market dynamics, potentially benefiting Natera by reducing competition in the short term. However, it also highlights the aggressive nature of patent litigation in this sector.
From a market perspective, the ability to enforce patents can be seen as a competitive advantage, potentially attracting partnerships and collaborations. Conversely, companies facing such legal challenges may experience reputational damage and a loss of trust among potential partners and customers. The long-term market impact will hinge on the final outcome of the litigation and the ability of NeoGenomics to navigate around Natera's patents without infringing them.
Order enjoins NeoGenomics from making, using, selling or promoting its RaDaR molecular residual disease (MRD) assay in
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
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
Source: Natera, Inc.
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