Drug Price Competition and Patent Term Restoration Act of 1984
E165704
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Drug Price Competition and Patent Term Restoration Act of 1984 canonical | 1 |
| Hatch-Waxman Act | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1445198 — 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.
Target entity: Drug Price Competition and Patent Term Restoration Act of 1984 Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Drug Price Competition and Patent Term Restoration Act of 1984]
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A.
False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
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B.
Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
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C.
Anti-Drug Abuse Act of 1986
The Anti-Drug Abuse Act of 1986 is a major U.S. federal law that significantly escalated the War on Drugs by establishing mandatory minimum sentences and harsher penalties for drug offenses, particularly involving crack cocaine.
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D.
Patent and Trademark Law Amendments Act
The Patent and Trademark Law Amendments Act, commonly known as the Bayh–Dole Act, is a U.S. federal law that allows universities, small businesses, and non-profits to retain ownership of inventions developed with federal funding, thereby promoting commercialization of research.
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E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Target entity: Drug Price Competition and Patent Term Restoration Act of 1984 Target entity description: The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
-
A.
False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
-
B.
Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
-
C.
Anti-Drug Abuse Act of 1986
The Anti-Drug Abuse Act of 1986 is a major U.S. federal law that significantly escalated the War on Drugs by establishing mandatory minimum sentences and harsher penalties for drug offenses, particularly involving crack cocaine.
-
D.
Patent and Trademark Law Amendments Act
The Patent and Trademark Law Amendments Act, commonly known as the Bayh–Dole Act, is a U.S. federal law that allows universities, small businesses, and non-profits to retain ownership of inventions developed with federal funding, thereby promoting commercialization of research.
-
E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal statute
ⓘ
pharmaceutical law ⓘ |
| abbreviation | ANDA ⓘ |
| administeredBy |
Food and Drug Administration
ⓘ
surface form:
U.S. Food and Drug Administration
United States Patent and Trademark Office ⓘ |
| affects |
pharmaceutical patent litigation
ⓘ
timing of generic drug market entry ⓘ |
| aimsTo | balance pharmaceutical innovation and generic competition ⓘ |
| allows | generic applicants to rely on safety and efficacy data of reference drugs ⓘ |
| amends |
Federal Food, Drug, and Cosmetic Act
ⓘ
Patent Act of 1952 ⓘ |
| componentOf | United States drug approval framework ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| creates |
mechanism for extending patent life of certain drugs
ⓘ
patent term restoration for time lost during FDA regulatory review ⓘ |
| criticizedFor | encouraging certain patent evergreening strategies ⓘ |
| effect |
facilitated growth of U.S. generic drug industry
ⓘ
increased availability of lower-cost generic medicines ⓘ |
| enactedInYear | 1984 ⓘ |
| establishes |
Abbreviated New Drug Application process
ⓘ
Paragraph I certification ⓘ Paragraph II certification ⓘ Paragraph III certification ⓘ Paragraph IV certification ⓘ |
| hasAlias |
Drug Price Competition and Patent Term Restoration Act of 1984
self-linksurface differs
ⓘ
surface form:
Hatch-Waxman Act
|
| influenced | subsequent U.S. generic drug legislation ⓘ |
| introduces | Orange Book patent listing requirements ⓘ |
| jurisdiction | federal law of the United States ⓘ |
| legalCitation | Public Law 98-417 ⓘ |
| objective |
maintain incentives for new drug research and development
ⓘ
reduce drug prices through generic competition ⓘ |
| policyArea |
health care
ⓘ
intellectual property ⓘ pharmaceutical regulation ⓘ |
| primaryGoal |
provide patent term restoration for certain brand-name drugs
ⓘ
streamline approval of generic drugs ⓘ |
| provides | 180-day market exclusivity for first generic filer with Paragraph IV certification ⓘ |
| regulates |
approval process for generic drugs
ⓘ
patent term extensions for pharmaceuticals ⓘ |
| relatedTo | Biologics Price Competition and Innovation Act ⓘ |
| requires |
brand-name drug manufacturers to list patents in the FDA Orange Book
ⓘ
generic drugs to demonstrate bioequivalence to reference listed drugs ⓘ |
| sector | pharmaceutical industry ⓘ |
| signedIntoLawBy | Ronald Reagan ⓘ |
| sponsors |
Henry Waxman
ⓘ
Orrin Hatch ⓘ |
How these facts were elicited
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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.
Subject: Drug Price Competition and Patent Term Restoration Act of 1984 Description of subject: The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.