The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act", is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah.
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. Section 505(j)(2)(A)(vii)(IV), the so-called Paragraph IV, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.
Hatch-Waxman Amendments grant generic manufacturers the ability to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation: the exposure to liability amounts to litigation costs.
Read more about Drug Price Competition And Patent Term Restoration Act: Relevant Pharmaceutical Industry Background, Main Provisions of The Bill, Impact of The New Bill, Potential Revisions
Famous quotes containing the words drug, price, competition, patent, term, restoration and/or act:
“Most people aren’t appreciated enough, and the bravest things we do in our lives are usually known only to ourselves. No one throws ticker tape on the man who chose to be faithful to his wife, on the lawyer who didn’t take the drug money, or the daughter who held her tongue again and again. All this anonymous heroism.”
—Peggy Noonan (b. 1950)
“They give us a pair of cloth shorts twice a year for all our clothing. When we work in the sugar mills and catch our finger in the millstone, they cut off our hand; when we try to run away, they cut off our leg: both things have happened to me. It is at this price that you eat sugar in Europe.”
—Voltaire [François Marie Arouet] (1694–1778)
“Like many businessmen of genius he learned that free competition was wasteful, monopoly efficient. And so he simply set about achieving that efficient monopoly.”
—Mario Puzo (b. 1920)
“There is a patent office at the seat of government of the universe, whose managers are as much interested in the dispersion of seeds as anybody at Washington can be, and their operations are infinitely more extensive and regular.”
—Henry David Thoreau (1817–1862)
“... feminism is a political term and it must be recognized as such: it is political in women’s terms. What are these terms? Essentially it means making connections: between personal power and economic power, between domestic oppression and labor exploitation, between plants and chemicals, feelings and theories; it means making connections between our inside worlds and the outside world.”
—Anica Vesel Mander, U.S. author and feminist, and Anne Kent Rush (b. 1945)
“The 1990s, after the reign of terror of academic vandalism, will be a decade of restoration: restoration of meaning, value, beauty, pleasure, and emotion to art and restoration of art to its audience.”
—Camille Paglia (b. 1947)
“Presidents quickly realize that while a single act might destroy the world they live in, no one single decision can make life suddenly better or can turn history around for the good.”
—Lyndon Baines Johnson (1908–1973)