Certain Melanoma Predictive and Prognostic Tests and Components Thereof; Inv. No. 337-TA-3921 (Violation)

Castle Biosciences filed a non-patent Section 337 complaint against SkylineDx Holding B.V., SkylineDx USA, Qiagen GmbH, and Qiagen LLC alleging Lanham Act false advertising and unfair competition involving SkylineDx’s imported Merlin melanoma predictive/prognostic gene-expression test and Qiagen RNeasy FFPE components used with it. Castle contends respondents falsely market Merlin as superior to Castle’s DecisionDx-Melanoma test and make misleading claims about clinical utility, scientific uniqueness, and physician liability. The complaint targets competition in melanoma gene-expression profiling tests used to guide sentinel lymph node biopsy and other cancer-management decisions, where comparative performance claims can influence physicians, payors, and health systems. Castle seeks a limited exclusion order and cease-and-desist orders barring importation, sales, marketing, and distribution of the accused Merlin-related products tied to the alleged unfair acts. Castle alleges Section 337(a)(1)(A) violations based on false and misleading advertising actionable under Lanham Act Section 43(a), not patent infringement. The accused products are SkylineDx’s Merlin melanoma CP-GEP test and imported Qiagen RNeasy FFPE kits/components allegedly used in Merlin testing in the United States. Castle asserts a domestic industry based on its U.S. DecisionDx-Melanoma testing operations, laboratories, regulatory approvals, personnel, and investments, and claims threatened injury through lost sales, market share, goodwill, and market value.