Drug Price Competition and Patent Term Restoration Act
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| Acronym / colloquial name | Hatch-Waxman amendments |
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The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], 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)(5)(B)(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 standing 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, but pales in comparison to the immense volume of generic sales and profits. [1]
Law Celebrates 25th Anniversary
Washington, Sep 25,2009 - In honor of the 25th Anniversary of the Waxman-Hatch Act, which delivered generic drug competition to the American marketplace, Rep. Waxman gave a speech recognizing the law’s achievements. Through the Waxman-Hatch law, millions of Americans have gained access to affordable medicine while incentives for bio-tech innovation have simultaneously increased.
"Madam Speaker, twenty-five years ago, President Ronald Reagan signed the landmark Waxman-Hatch law, delivering generic drug competition to the American marketplace. Since that time, generic drugs have provided millions of American consumers with access to low-cost, yet safe and effective drugs. In the last decade alone, generics have saved consumers, businesses, and state and federal governments $734 billion. American consumers fill more than six of every ten prescriptions with safe and effective generic medicines. During these difficult economic times, generic pharmaceuticals are critical to assuring that patients continue to have access to lifesaving medicines. Making sure that Americans have access to, and can afford, life-saving medicines has been one of my chief goals as a Member of Congress, and I am proud of the success of generic competition in helping achieve that goal. Since passage of the Hatch-Waxman law, we have seen a shift in the pharmaceutical marketplace to permit greater competition and innovation--a win-win for purchasers and manufacturers alike. As a result, millions of Americans have access to safe and affordable generic medicines and our health care bill is much lower than it otherwise would have been. There is still much more we can do to increase savings from generic drugs. We should not only celebrate the 25th anniversary of Hatch-Waxman, but we should use it as motivation to ensure there is real generic competition for biotech medications. Let us show Americans that we understand that they deserve access to affordable medicine and give them a pathway that provides reasonable incentives for innovation, but does not pose unnecessary barriers to competition."[[1]]
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[edit] References
- ^ Schering-Plough v. FTC (11th Cir. 2005)
[edit] See also
[edit] External links
[edit] Papers
- "The ”Hatch-Waxman” Act: Selected Patent-Related Issues", United States Congressional Research Service, April 1, 2002
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