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Federal Circuit: Affirms Preliminary Injunction on Cancer Assays
On July 12, 2024, a Federal Circuit panel of Chief Judge Moore and Judges Taranto and Chen issued a unanimous opinion, authored by Chief Judge Moore, in Natera, Inc. v. NeoGenomics Labs, Inc., Case Nos. 2024-1324; 2024-1409. The panel affirmed the United States District Court for the Middle District of North Carolina's grant of a preliminary injunction barring NeoGenomics from making, using, selling, advertising or distributing its RaDaR assay. Slip Op. at 2.
Natera, Inc. is a "research-focused healthcare compan[y] operating in the oncology testing industry" that "manufacture[s] products used for early detection of cancer relapse." Id. Natera asserted two patents (U.S. Patent No. 11,519,035 (the '035 Patent) and U.S. Patent No. 11,530,454 (the '454 Patent)) related to methods of amplifying and detecting cell-free DNA and circulating tumor DNA against NeoGenomics Laboratories, Inc. (NeoGenomics) Id. at 2-3. While "Natera uses the methods claimed in the '035 and '454 patents in its Signatera product," "NeoGenomics offers a competing product under the brand name RaDaR." Id. at 3. Both Signatera and RaDaR are used to "identify ctDNA within the bloodstream to assess the efficacy of cancer treatment and the risk of cancer recurrence." Id.
"Natera sued NeoGenomics alleging RaDaR infringed the '035 and '454 patents and moved for a preliminary injunction." Id. at 4. The district court "granted the preliminary injunction because it determined Natera satisfied the requirements for injunctive relief, including likelihood of success on the merits of its '035 patent infringement claim." Id. The panel reviewed the district court's grant of a preliminary injunction for abuse of discretion and explained that to "obtain a preliminary injunction, a party must establish likelihood of success on the merits, likelihood it will suffer irreparable harm absent preliminary relief, the balance of equities tips in its favor, and an injunction is in the public interest." Id. at 5-6.
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