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← 566 U.S. 399 - Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s’s Empirical Analysis

566 U.S. 399 · 2012

Citation profile

45
cited by 45 later decisions
2
cited 2 times by the Supreme Court
June 2026
most recently cited

9 federal appellate · 3 district ·

Appellate journey

reviewedthe decision below (from Federal Circuit Court of Appeals)

Relationships

Applies 21 U.S.C. § 355 (Federal Food, Drug, and Cosmetic Act) · 28 U.S.C. § 1338 · 35 U.S.C. § 271 · 5 U.S.C. § 504 (Equal Access to Justice Act)

Relies on United States v. Ron Pair Enterprises, Inc. · Robinson v. Shell Oil Co. · Trw Inc v. Adelaide Andrews · Ardestani v. Immigration & Naturalization Service · Solid Waste Agency of Northern Cook County v. United States Army Corps of Engineers

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 45 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

  1. “[t]he mere possibility of clearer phrasing cannot defeat the most natural reading of a statute.”
    2 later decisions quote this exact passage · from the majority
  2. “[O]nce the FDA has approved a brand-name drug ... a manufacturer of a generic drug can obtain similar marketing approval through the use of abbreviated procedures. The [Act] permits a generic manufacturer to file an Abbreviated New Drug Application [ (ANDA) ] specifying that the generic has the “same active ingredients as,” and is “biologically equivalent” to, the already-approved brand-name drug.... [B]y allowing the generic to piggy-back on the pioneer’s approval efforts, [the Act] “speed[s] the introduction of low-cost generic drugs to market,” thereby furthering drug competition.”
    1 later decision quote this exact passage · from the majority
  3. “(I) that such patent information has not been filed, (II) that such patent has expired, (III) ... the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.”
    1 later decision quote this exact passage · from the majority

How this case has been treated — in progress

Whether each later court followed, distinguished, criticized, or overruled this decision. The treatment classification (task #35) runs highest-cited cases first and lights up here as it reaches this one.