U.S. Court of Appeals for the D.C. Circuit
Servier Pharmaceuticals LLC v. Robert F. Kennedy, Jr.
August 18, 2026
Summary
The court affirmed summary judgment for the government, holding that Servier did not qualify as a specified small manufacturer because it did not produce, prepare, propagate, compound, convert, or process any Tibsovo tablets that were dispensed to Part D patients in 2021. The court rejected Servier's ownership-based interpretation, held that several factual arguments were forfeited, and concluded that CMS's use of labeler codes and attribution of contract manufacturing to Agios were not arbitrary or capricious.