Natera, Inc. v. NeoGenomics Laboratories, Inc., Nos. 2024-1324, -1409 (Fed. Cir. (M.D.N.C.) July 12, 2024). Opinion by Moore, joined by Taranto and Chen.
Natera owns two patents directed to the early detection of cancer relapse involving detecting small amounts of DNA fragments shed by cancerous cells in the body. Natera uses the methods claimed in its patents in its Signatera product. Another company, NeoGenomics, offers a competing product under the brand name RaDaR. Both the Signatera product and RaDaR product are tumor-informed tests (the only two on the market), as opposed to tumor-naïve tests, because they are designed from a patient’s genetic information.
Natera sued NeoGenomics alleging infringement and subsequently moved for a preliminary injunction that would bar NeoGenomics from using, selling, or offering for sale its accused RaDaR product. The district court found that Natera proved that it was likely to succeed on the merits for one of its patents and so granted the preliminary injunction. In doing so, the district court limited the scope of the preliminary injunction to not apply to ongoing research contracts or testing of already-collected patient samples.
The Federal Circuit affirmed. First considering likelihood of infringement, the Federal Circuit rejected NeoGenomics’ argument that the district court failed to consider a key claim construction issue. The Federal Circuit explained that a district court has no obligation to definitively construe claims at the preliminary injunction stage, especially where the parties did not present any claim construction disputes. Regardless, the Federal Circuit determined that the district court’s implicit construction was correct, and thus there was no clear error in the district court’s finding that Natera proffered sufficient evidence of infringement.
As to the likelihood that the infringement claim would withstand challenges to validity, the Federal Circuit rejected NeoGenomics’ argument that it only had to prove “mere vulnerability,” explaining that the relevant inquiry is whether the patentee has shown it is more likely than not to prevail over an invalidity challenge. The Federal Circuit subsequently determined there was no clear error in the district court’s finding that there was no motivation to combine, and thus that Natera was likely to withstand a validity challenge. While NeoGenomics put forth only four paragraphs with little more than conclusory argument with no meaningful supporting documentation, Natera put forth significant evidence of obstacles that disfavored the proposed combination.
Second, the Federal Circuit agreed with the district court that Natera was likely to suffer irreparable harm because Natera and NeoGenomics directly compete in a two-player market for tumor-informed (as opposed to tumor-naïve) tests, and so any growth experienced by NeoGenomics would result in lost potential customers, profits, business relationships, and clinical opportunities for Natera. The Federal Circuit also rejected NeoGenomics’ argument that the district court erred in considering the tumor-informed testing market because tumor-informed testing was not claimed, stating that the district court properly weighed evidence that the allegedly infringing method is key to RaDaR’s tumor-informed testing.
Third, turning to public interest, the Federal Circuit rejected NeoGenomics’ argument that no cancer test can substitute for its product, RaDaR, including Natera’s product Signatera. Each piece of evidence relied on by NeoGenomics was controverted by Natera, and the district court drew reasonable conclusions from those facts. The Federal Circuit also agreed consumers could still purchase the early detection product for cancer relapse from Natera, and Natera has the capacity to take on more customers to satisfy increased demand for the testing. Because the district court also carefully crafted the scope of the preliminary injunction to exclude patients already using RaDaR and clinical trials and research projects already in progress (or that had already obtained approval), the district court did not legally err in the weight it afforded to the public interest.
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