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Janssen Pharmaceuticals, Inc. v. Robert F. Kennedy, Secretary of Health and Human Services, et al.

Paid petition · United States Court of Appeals for the Third Circuit, No. 24-1821 · judgment September 4, 2025


Certiorari denied · May 18, 2026
Pre-decision estimate: 3% cert probability

Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.

Questions presented

The “Medicare Drug Price Negotiation Program,” enacted in 2022, imposes new requirements for certain widely prescribed drugs. Under the Program, manufacturers must provide Medicare beneficiaries “access” to covered drugs at below-market prices set by the Centers for Medicare and Medicaid Services (“CMS”) and sign “agreement[s]” describing those prices as “negotiate[d]” “maximum fair price[s]” for their drugs. 42 U.S.C. § 1320f-2(a). Manufacturers that do not comply with these requirements are subject to tens of billions in annual excise taxes or exclusion from Medicare and Medicaid, which together account for nearly half the U.S. drug market. Petitioner Janssen Pharmaceuticals Inc. markets Xarelto®, a drug selected by CMS for the Program. Janssen alleged that the Program unlawfully compels the company’s speech and effects a per se taking of the company’s property. The Third Circuit rejected those claims, holding that the Program is lawful because participation is “voluntary.” Judge Hardiman dissented, concluding that the Program’s “enterprisecrippling” penalties unconstitutionally “force” Janssen “to turn over” its products on terms “set by CMS” and “misrepresent” that it “negotiated” a “fair” price for Xarelto®. The questions presented are:

  1. Does the Program violate the First Amendment by compelling Janssen to express the Government’s disputed messages regarding drug pricing?

  2. Does the Program effect a Fifth Amendment taking by forcing Janssen to transfer its Xarelto®

Counsel of record

For petitioner
Kevin Franz King
Covington & Burling LLP

For respondent
D. John Sauer
Solicitor General

Case

Conference history
Distributed for 1 conference

Amicus briefs
10 cert-stage

Related
Vide, 25-751

Linked docket
25A514

Proceedings

  1. May 18 2026
    Petition DENIED.
  2. Apr 22 2026
    DISTRIBUTED for Conference of 5/14/2026.
  3. Apr 08 2026
    Reply of petitioner Janssen Pharmaceuticals, Inc. filed.
  4. Mar 25 2026
    Brief of respondents Robert F. Kennedy, Secretary of Health and Human Services, et al. in opposition filed. VIDED.
  5. Feb 17 2026
    Motion to extend the time to file a response is granted and the time is further extended to and including March 25, 2026.
  6. Feb 13 2026
    Motion to extend the time to file a response from February 23, 2026 to March 25, 2026, submitted to The Clerk.
  7. Jan 22 2026
    Brief amicus curiae of Washington Legal Foundation filed. VIDED.
  8. Jan 22 2026
    Brief amicus curiae of Chamber of Commerce of the United States of America filed. VIDED.
  9. Jan 22 2026
    Brief amicus curiae of Manhattan Institute filed. VIDED.
  10. Jan 22 2026
    Brief amicus curiae of The National Association of Manufacturers filed. VIDED.
  11. Jan 22 2026
    Brief amicus curiae of Daniel E. Troy filed. VIDED.
  12. Jan 22 2026
    Brief amicus curiae of Biotechnology Innovation Organization filed. VIDED.
  13. Jan 22 2026
    Brief amici curiae of Advancing American Freedom, et al. filed. VIDED.
  14. Jan 22 2026
    Brief amicus curiae of Teva Pharmaceuticals USA, Inc. filed. VIDED.
  15. Jan 21 2026
    Brief amicus curiae of Atlantic Legal Foundation filed. VIDED.
  16. Jan 16 2026
    Motion to extend the time to file a response is granted and the time is extended to and including February 23, 2026.
  17. Jan 16 2026
    Brief amicus curiae of Pacific Research Institute filed. VIDED.
  18. Jan 15 2026
    Motion to extend the time to file a response from January 22, 2026 to February 23, 2026, submitted to The Clerk.
  19. Dec 19 2025
    Petition for a writ of certiorari filed. (Response due January 22, 2026)
  20. Nov 05 2025
    Application (25A514) granted by Justice Sotomayor extending the time to file until December 19, 2025.
  21. Oct 31 2025
    Application (25A514) to extend the time to file a petition for a writ of certiorari from December 3, 2025 to December 19, 2025, submitted to Justice Sotomayor. (Justice Alito is recused)