Drug Price Competition and Patent Term Restoration Act
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.
|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|
|Statutes at Large||98 Stat. 1585|
|Acts amended||Federal Food, Drug, and Cosmetic Act|
|Titles amended||21 U.S.C.: Food and Drugs|
|U.S.C. sections amended|
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.
The Act facilitates the filing of ANDAs by generic companies, by preventing the FDA from asking generic companies to provide anything other than information on how it is going to manufacture the drug and assure its quality and a study showing that the drug they manufacture acts the same in a human as the innovator drug – this is called "bioequivalence". This part of the Act is one of few pieces of legislation that restricts the powers and reach of a federal agency. The Act also provided generic companies with safe harbor from patent infringement lawsuits during the time when the generic company is preparing its ANDA – during that time the generic company needs to learn how to manufacture the drug, manufacture a test batch, and run bioequivalence studies with it, which are all activities that it could be sued for infringement for. This protection is called the "research exemption".
When a company is ready to file its ANDA, the Act requires it to declare how its activities when it begins to market the drug will relate to patents listed in the Orange Book; there are four options or "certifications": it can state that there never were patents listed, or that listed patents have expired, or that it will not market the drug until the all the patents listed in the Orange Book have expired, or that it believes the patents in the Orange Book are not relevant or are invalid. These four alternative statements are referred to as the Paragraph I, II, III, and IV certifications (named after Section 505(j)(2)(A)(vii)(IV)). The Act incentivized companies to file paragraph IV certifications by rewarding the first company to file an ANDA with such a certification with 180 days of administrative exclusivity if their ANDA is approved – during that period the FDA cannot approve another generic. Because the Act also made it clear that the act of filing an ANDA with a paragraph IV certification was an act of patent infringement, the law actually promotes litigation between private parties; the innovator is prompted to commence patent enforcement litigation against the generic infringer, and the generic company is incentivized to file a countersuit to have the patents listed in the Orange Book be declared invalid.
Passage of the law prompted a gold rush into the generic industry and a crush of applications, which the FDA was not prepared to handle. A series of scandals soon arose that shook public confidence in generic drugs; there were several instances in which companies obtained bioequivalence data fraudulently, by using the branded drug in their tests instead of their own product, and a congressional investigation found corruption at the FDA, where employees were accepting bribes to approve some generic companies' applications and delaying or denying others.
With time the law became successful in promoting the introduction of generics; in 1983 only 35% of top-selling branded drugs with expired patents had generic competition, and only 13% of prescriptions were for generics but in 2012, 84% of prescriptions in the US were filled with generic drugs.
There have been issues with litigation incentivized by the Act. Once the parties are in litigation, they can choose to fight the litigation to the end, or they may choose to settle the litigation. Some of these settlements have been found to be invalid reverse payment patent settlement agreements and have been struck down in court.
The FDA has been slow to adopt regulations for the introduction of generic versions of biopharmaceutical drugs (known as "biosimilars") because the manufacturing of biopharmaceuticals is so much more complicated than small molecule drugs. Innovator companies have emphasized those complications while generic companies, insurance companies, and consumers have advocated for the FDA to finalize their process.
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- Epstein, MS; Ehrenpreis, ED; Kulkarni, PM; FDA-Related Matters Committee of the American College of, Gastroenterology (December 2014). "Biosimilars: the need, the challenge, the future: the FDA perspective" (PDF). The American Journal of Gastroenterology. 109 (12): 1856–9. doi:10.1038/ajg.2014.151. PMID 24957160.