Natera, Inc. v. NeoGenomics Labs., Inc
Authored by: Jeremy J. Gustrowsky
A recent decision from the Federal Circuit highlights the importance of patent rights in the competitive world of cancer diagnostics. Natera, Inc., a company specializing in oncology testing, secured a preliminary injunction against NeoGenomics Laboratories, Inc., preventing them from selling their RaDaR assay—a product used for early detection of cancer relapse. The court found that Natera would likely suffer irreparable harm if NeoGenomics continued to sell the allegedly infringing product, especially since patients who start with one test are unlikely to switch to another, leading to lost repeat business for Natera.
At the heart of the dispute were two patents owned by Natera: U.S. Patent No. 11,519,035, which covers methods for amplifying targeted genetic material like cell-free DNA (cfDNA), and U.S. Patent No. 11,530,454, which relates to detecting genetic variations indicative of disease recurrence. Both Natera’s Signatera test and NeoGenomics’ RaDaR test use personalized, “tumor-informed” approaches to detect circulating tumor DNA (ctDNA) in the bloodstream. The court found that NeoGenomics’ RaDaR likely infringed at least one of these patents and that NeoGenomics had not raised a substantial question about the patent’s validity.
NeoGenomics argued that the injunction would harm cancer patients by limiting their choices, claiming RaDaR was more sensitive for certain cancers. However, the court found that Natera’s Signatera test was approved for the same cancer types and could meet patient needs. The injunction was carefully crafted to allow ongoing use of RaDaR for existing patients and clinical trials, minimizing disruption to ongoing care and research.
This case underscores how patent rights can shape competition and patient access in the fast-evolving field of medical diagnostics. The court’s decision sought to balance the interests of innovation, business competition, and public health, affirming that patent holders can protect their inventions even in critical healthcare markets.