Drug Price Competition and Patent Term Restoration Act information

Drug Price Competition and Patent Term Restoration Act
Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.
Acronyms (colloquial)	Hatch-Waxman amendments
Enacted by	the 98th United States Congress
Effective	September 24, 1984
Citations
Public law	98-417
Statutes at Large	98 Stat. 1585
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301; 21 U.S.C. ch. 9, subch. V §§ 355 & 360cc;
Legislative history
	Introduced in the Senate as S. 1538 by Charles Mathias (R–MD) on June 23, 1983; Committee consideration by Judiciary; Passed the Senate on June 29, 1984 (voice vote agreed); Passed the House on September 6, 1984 (voice vote agreed, with amendments); Reported by the joint conference committee on September 6, 1984; agreed to by the Senate (agreeing to House amendments) on September 12, 1984 (voice vote) and by the Senate on September 19, 1984 (signed); Signed into law by President Ronald Reagan on September 24, 1984;

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.^[1]

Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.

^ The Future of Patent Protection for Post-FDA-Approved Generics: A Look at the Federal Circuit’s Incongruous Interpretations of the “Safe Harbor” Provision in 35 U.S.C. § 271(e)(1). 2014. Seton Hall Circuit Review. 10/2, 7. A. Robertson. https://scholarship.shu.edu/circuit_review/vol10/iss2/7/

[1] The Future of Patent Protection for Post-FDA-Approved Generics: A Look at the Federal Circuit’s Incongruous Interpretations of the “Safe Harbor” Provision in 35 U.S.C. § 271(e)(1). 2014. Seton Hall Circuit Review. 10/2, 7. A. Robertson. https://scholarship.shu.edu/circuit_review/vol10/iss2/7/

Drug Price Competition and Patent Term Restoration Act information

and 26 Related for: Drug Price Competition and Patent Term Restoration Act information

Drug Price Competition and Patent Term Restoration Act

Term of patent in the United States

Generic drug

United States patent law

Abbreviated New Drug Application

FDA citizen petition

Henry Waxman

History of the Food and Drug Administration

Copayment

Biologics Price Competition and Innovation Act of 2009

Orrin Hatch

Food and Drug Administration

Mylan

Biosimilar

Specialty drugs in the United States

Consumer health laws

William Haddad

Medical research

Innovation Act of the 114th Congress

Outline of patents

Drug coupon

Research exemption

Peter Rheinstein

2012 term United States Supreme Court opinions of Stephen Breyer

Innovation Act

2012 term United States Supreme Court opinions of John Roberts

Regulation of therapeutic goods in the United States

Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act CDAPCA Controlled Substances Act Prescription Drug Marketing Act Hatch-Waxman Act exemptions Marihuana Tax Act of 1937
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice DEA
Process Drug discovery Drug design Drug development New Drug Application Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination ICH Uppsala Monitoring Centre WHO CIOMS Single Convention on Narcotic Drugs
Non-governmental organizations National Academy of Medicine RADAR NORML
v t e

United States patent law
Legislation
American Inventors Protection Act Bayh–Dole Act Invention Secrecy Act Hatch-Waxman Act Leahy–Smith America Invents Act Title 35 of the United States Code
Types of patent claims
Article of manufacture Composition of matter Machine Method
Procedures
Inter partes review Markman hearing Reexamination
Other topics
United States Patent and Trademark Office Patent Trial and Appeal Board Exhaustion Infringement Misuse Term of patent Manual of Patent Examining Procedure (MPEP) History Biological patents Software patents List of patent law cases
v t e