Public Law 98-417
E643467
Public Law 98-417 is a landmark U.S. federal statute that created the modern generic drug approval pathway while balancing pharmaceutical innovation through patent term restoration.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Public Law 98-417 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7110968 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Public Law 98-417 Context triple: [Drug Price Competition and Patent Term Restoration Act of 1984, legalCitation, Public Law 98-417]
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A.
Public Law 99-410
Public Law 99-410 is the U.S. federal statute that established the Uniformed and Overseas Citizens Absentee Voting Act, guaranteeing absentee voting rights in federal elections for military personnel and citizens living abroad.
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B.
Public Law 97-414
Public Law 97-414 is the U.S. federal statute commonly known as the Orphan Drug Act of 1983, which incentivizes the development of treatments for rare diseases through benefits such as market exclusivity and tax credits.
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C.
Public Law 99-177
Public Law 99-177 is the 1985 U.S. federal statute, commonly known as the Gramm–Rudman–Hollings Act, that established automatic deficit-reduction measures aimed at achieving a balanced federal budget.
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D.
Public Law 95-341
Public Law 95-341 is the federal statute commonly known as the American Indian Religious Freedom Act of 1978, which protects and promotes the traditional religious rights and cultural practices of American Indians, Alaska Natives, and Native Hawaiians.
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E.
Public Law 99-198
Public Law 99-198 is a major U.S. federal statute, commonly known as the Food Security Act of 1985, that overhauled agricultural policy, including farm income support, conservation programs, and food assistance.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Public Law 98-417 Target entity description: Public Law 98-417 is a landmark U.S. federal statute that created the modern generic drug approval pathway while balancing pharmaceutical innovation through patent term restoration.
-
A.
Public Law 99-410
Public Law 99-410 is the U.S. federal statute that established the Uniformed and Overseas Citizens Absentee Voting Act, guaranteeing absentee voting rights in federal elections for military personnel and citizens living abroad.
-
B.
Public Law 97-414
Public Law 97-414 is the U.S. federal statute commonly known as the Orphan Drug Act of 1983, which incentivizes the development of treatments for rare diseases through benefits such as market exclusivity and tax credits.
-
C.
Public Law 99-177
Public Law 99-177 is the 1985 U.S. federal statute, commonly known as the Gramm–Rudman–Hollings Act, that established automatic deficit-reduction measures aimed at achieving a balanced federal budget.
-
D.
Public Law 95-341
Public Law 95-341 is the federal statute commonly known as the American Indian Religious Freedom Act of 1978, which protects and promotes the traditional religious rights and cultural practices of American Indians, Alaska Natives, and Native Hawaiians.
-
E.
Public Law 99-198
Public Law 99-198 is a major U.S. federal statute, commonly known as the Food Security Act of 1985, that overhauled agricultural policy, including farm income support, conservation programs, and food assistance.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
Act of Congress
ⓘ
United States federal statute ⓘ pharmaceutical law ⓘ |
| abbreviation | ANDA NERFINISHED ⓘ |
| aimsTo | balance pharmaceutical innovation and generic drug competition ⓘ |
| amends |
Federal Food, Drug, and Cosmetic Act
NERFINISHED
ⓘ
Title 35 of the United States Code NERFINISHED ⓘ |
| appliesTo |
certain veterinary and biological products through related provisions
ⓘ
human prescription drugs ⓘ |
| branchOfGovernment | legislative branch of the United States ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| creates |
mechanism for generic challenges to listed patents
ⓘ
modern generic drug approval pathway ⓘ paragraph I–IV certification framework for ANDAs ⓘ |
| dateSigned | 1984-09-24 ⓘ |
| effect |
facilitated widespread entry of lower-cost generic drugs
ⓘ
strengthened incentives for pharmaceutical research and development through patent term restoration ⓘ |
| enactedBy | 98th United States Congress NERFINISHED ⓘ |
| establishes |
Abbreviated New Drug Application process
ⓘ
Orange Book patent listing framework ⓘ |
| hasCommonName | Hatch–Waxman Act NERFINISHED ⓘ |
| hasLanguage | English ⓘ |
| hasShortTitle | Drug Price Competition and Patent Term Restoration Act of 1984 NERFINISHED ⓘ |
| jurisdiction | federal law of the United States ⓘ |
| legalCitationType | Public Law NERFINISHED ⓘ |
| namedAfter |
Henry Waxman
NERFINISHED
ⓘ
Orrin Hatch NERFINISHED ⓘ |
| policyArea |
health law
ⓘ
intellectual property law ⓘ pharmaceutical regulation ⓘ |
| primaryPurpose |
to create an abbreviated approval pathway for generic drugs
ⓘ
to restore a portion of patent term lost during regulatory review ⓘ |
| providesFor |
180-day exclusivity for first generic applicants making certain patent challenges
ⓘ
market exclusivity periods for certain drug products ⓘ patent term extensions for certain drug patents ⓘ |
| publicLawNumber | P.L. 98-417 NERFINISHED ⓘ |
| regulates | approval standards for bioequivalent generic drugs ⓘ |
| regulatoryAgencyInvolved | U.S. Food and Drug Administration NERFINISHED ⓘ |
| requires | listing of relevant drug patents with the FDA ⓘ |
| signedBy | Ronald Reagan ⓘ |
| sponsors |
Henry Waxman
NERFINISHED
ⓘ
Orrin Hatch NERFINISHED ⓘ |
| statutesAtLargeCitation | 98 Stat. 1585 ⓘ |
| subjectMatter |
drug price competition
ⓘ
generic drugs ⓘ patent term restoration ⓘ pharmaceutical patents ⓘ |
| yearEnacted | 1984 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Public Law 98-417 Description of subject: Public Law 98-417 is a landmark U.S. federal statute that created the modern generic drug approval pathway while balancing pharmaceutical innovation through patent term restoration.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
Drug Price Competition and Patent Term Restoration Act of 1984
→
legalCitation
→
Public Law 98-417
ⓘ