Defendant

U.S. Department of Health and Human Services

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2022
Top venue
D. Columbia
1 case

Company profile

U.S. Department of Health and Human Services (HHS) is a cabinet-level department of the U.S. federal government, headquartered at the Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, D.C. It was established April 11, 1953 as the Department of Health, Education, and Welfare and renamed HHS on May 4, 1980. It is not a company: there is no ticker, no private ownership, and no parent — it is an executive-branch agency funded by congressional appropriation. Public sources put full-time staffing around 62,000 (2025, after federal workforce reductions) versus roughly 80,000 in earlier years, with an annual budget on the order of $1.7 trillion (FY2024), the largest of any federal agency. HHS is headed by the Secretary of Health and Human Services.

Its operations are regulatory, research, and benefit-administration functions rather than commercial products. Principal components include the Centers for Medicare & Medicaid Services (Medicare/Medicaid), the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Indian Health Service, SAMHSA, the Administration for Children and Families, and AHRQ. HHS is the largest federal grant-making agency.

Patent-litigation posture: HHS is neither an NPE nor a commercial operating company. The database shows 1 tracked case, 0 as plaintiff and 1 as defendant, in the U.S. District Court for the District of Columbia — consistent with APA challenges to federal agency action, which are brought in D.D.C., not with patent-assertion patterns or plaintiff-friendly venues such as the Eastern District of Texas.

Notable case: Avadel CNS Pharmaceuticals, LLC v. Xavier Becerra et al. (D.D.C., filed July 21, 2022) named the HHS Secretary, HHS, FDA, and the FDA Commissioner. Avadel challenged FDA's decision requiring a patent certification to Jazz Pharmaceuticals' U.S. Patent 8,731,963, a REMS distribution-system patent, which triggered a 30-month stay on final approval of Lumryz. The court granted summary judgment to the federal defendants, holding Avadel had adequate alternative relief in the parallel Delaware Hatch-Waxman proceedings. The dispute concerned FDA Orange Book listing practice, not any patent asserted by HHS.

Avadel CNS Pharmaceuticals, LLC v. Xavier Becerra et al.

denied Avadel's requested relief
Docket:
1:22-cv-02159
Filed:
2022-07-21
Patents:8731963

APA challenge to FDA's requirement that Avadel certify against U.S. 8,731,963 (REMS patent). Jazz Pharmaceuticals intervened on July 28, 2022, to defend the FDA decision. The D.D.C. denied Avadel's requested relief, holding Avadel had an adequate remedy at law via its delisting counterclaim in the Delaware action.