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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.
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