This educational guide is based on the linked primary sources. It is not a Court publication, is not affiliated with the Court, and is not legal advice.
In brief
Overview
According to Sandoz, Inc., according to Sandoz, Inc., the case concerns how the Biosimilars Act’s comprehensive scheme for early resolution of patent disputes should be applied to biosimilar applicants and reference‑product sponsors.
According to Amgen, the party argues that the Biosimilars Act implicitly entitles them to an injunction, contrary to Congress’s provision of only a reasonable‑royalty remedy if they choose not to sue.
Background and question before the Court
According to Sandoz, Inc., according to Sandoz, Inc., the Biosimilars Act created a comprehensive, self‑contained scheme for the early resolution of patent disputes, and courts are urged to apply it as written.
Justice Kennedy asked whether a biosimilar that receives FDA approval in the fourth year of a twelve‑year exclusivity period would be considered “licensed” at that time.
What each side argues
Sandoz, Inc.
According to Sandoz, Inc., sandoz argues that the Biosimilars Act provides a comprehensive, self‑contained scheme for early patent‑dispute resolution and that courts should apply the scheme exactly as written.
Amgen, Inc.
Amgen contends that the statute implicitly grants them an injunction, and that the remedies Congress provided are merely a backup.
Mr. Waxman (representing petitioners)
According to Mr. Waxman, the Biosimilars Act requires FDA approval to determine whether a biosimilar is licensed, unlike Hatch‑Waxman for small‑molecule drugs.
According to Mr. Waxman, mr. Waxman further states that a declaratory‑judgment action cannot be filed until the notice under (8)(A) is received.
Petitioner (general)
According to Petitioner, the petitioner emphasizes that the judgment sought is a federal judgment, noting that the Federal Circuit issued a federal injunction and dismissed state‑law claims.
What happened at oral argument
Justice Kennedy asked whether a biosimilar approved in the fourth year of a twelve‑year exclusivity period would be considered licensed at that time.
Justice Ginsburg asked for an explanation of the two rounds of patent infringement referenced in the case.
According to Justice Breyer, justice Breyer referenced the 180‑day notice provision (section 262(l)(8)(a)) during his questioning.
Justice Sotomayor asked whether notice under (8)(a) permits a sponsor to seek a preliminary injunction against commercial marketing.
Justice Gorsuch asked for clarification that “shall” in the statute is mandatory.
According to Chief Justice Roberts, chief Justice Roberts cautioned against prejudging the issues before hearing arguments.
- [1] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 5
- [2] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 21
- [3] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 40
- [4] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 41
- [5] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 43
- [6] 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdf, p. 50
What the Court decided
Why it matters
Terms to know
No glossary terms are available for this guide.
Primary sources
Read the source materials on the official site or open the immutable repository copy used for this guide.
- 8a2270cb0a4bc7090d7c-r1-5da794bcd5ea2f53.pdforal argument transcript
Guide generated September 25, 2026. Automated validation accepted this version.