Drug Price Competition and Patent Term Restoration Act

Drug Price Competition and Patent Term Restoration Act
Great Seal of the United States
Long titleAn 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 bythe 98th United States Congress
EffectiveSeptember 24, 1984
Citations
Public law98-417
Statutes at Large98 Stat. 1585
Codification
Acts amendedFederal Food, Drug, and Cosmetic Act
Titles amended21 U.S.C.: Food and Drugs
U.S.C. sections amended
Legislative history
  • Introduced in the Senate as S. 1538 by Charles Mathias (RMD) 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.

  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/