Drug Price Competition and Patent Term Restoration Act

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 McC. Mathias, Jr. (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 which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.

Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market. Congress studied the issue and realized that under patent and regulatory law, it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs and that the regulatory pathway to get ANDAs approved was irregular and uncertain. In response, the Hatch-Waxman Act was negotiated and enacted.

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA).

The Act provides some protection for drug innovators while facilitating and providing incentives for companies to file ANDAs.

Drug innovators were provided protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug. This provides market exclusivity for the drug innovator outside of any patent rights. Second, the Act allowed the life of patents covering a drug to be extended by a portion of the time the drug is under regulatory review by the FDA, ensuring innovator companies that regulatory review will not unduly consume patent life. The Act also requires the drug innovator to provide the FDA with the numbers of patents it believes cover its drug; the FDA does not evaluate whether the patents cover the drug or not, but it publicly lists those patents in the Orange Book, and these are the patents, the life of which gets extended if there are regulatory delays.

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