Eli Lilly and Company v. Robert Kennedy, Jr. — 7th Cir. (Sep 24, 2026)
The Seventh Circuit hears Eli Lilly's challenge to the FDA's classification of retatrutide, an investigational medicine Lilly is studying for obesity and other conditions. Lilly sought a biological-product designation, but the FDA classified retatrutide as a drug. The agency counted at most 40 alpha amino acids, short of what it says the protein rule requires. A district judge accepted that reading of protein but rejected the agency's separate reason for excluding retatrutide as a product analogous to a protein, and sent that question back. Lilly appealed.
Eli Lilly and Company v. Robert Kennedy, Jr. (No. 26-1301) — U.S. Court of Appeals for the Seventh Circuit, argued September 24, 2026.
Sources
Argument audio — Seventh Circuit (public domain, 17 U.S.C. § 105):https://media.ca7.uscourts.gov/sound/external/ef.26-1301.26-1301_09_24_2026.mp3
Argument listing and date — Seventh Circuit:https://media.ca7.uscourts.gov/oralArguments/oar.jsp?amonth=09%2F2026&aMonth=List+case%28s%29
Amended district-court order:https://www.govinfo.gov/content/pkg/USCOURTS-insd-1_24-cv-01503/pdf/USCOURTS-insd-1_24-cv-01503-1.pdf
FDA protein-definition rule:https://www.govinfo.gov/content/pkg/FR-2020-02-21/pdf/2020-03505.pdf
Product-classification statute:https://uscode.house.gov/view.xhtml?edition=prelim&num=0&req=granuleid%3AUSC-prelim-title21-section360bbb-2
Retatrutide development — Eli Lilly:https://www.lilly.com/news/stories/what-to-know-about-retatrutide
- 0:00Introduction
- 0:57Advocate — Allon Kedem
- 12:15Advocate — Steven Hazel