Amneal Pharm. LLC v. Food & Drug Admin.’s Empirical Analysis
2018
Citation profile
Relationships
Applies 21 U.S.C. § 355 (Federal Food, Drug, and Cosmetic Act) · 35 U.S.C. § 271 · 5 U.S.C. § 701 · 5 U.S.C. § 706
Relies on Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc. · Citizens to Preserve Overton Park, Inc. v. Volpe · Motor Vehicle Manufacturers Association of United States Inc v. State Farm Mutual Automobile Insurance Company Consumer Alert · Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc. · Marsh v. Oregon Natural Resources Council
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 1 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“(I) that such patent information has not been filed [a "Paragraph I certification"], (II) that such patent has expired [a "Paragraph II certification"], (III) of the date on which such patent will expire [a "Paragraph III certification"], 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 [a "Paragraph IV certification"].”
1 later decision quote this exact passage“Id. § 355(b)(1). If the patent is issued after the NDA is filed, the applicant or holder of the approved NDA must notify the FDA of the patent number and expiration date. Id. § 355(c)(2). The FDA then lists this patent information in the”
1 later decision quote this exact passage“the patent number and the expiration date of any patent ... to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.”
1 later decision quote this exact passage
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.