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Examples

  • A 1984 law called the Hatch-Waxman Act created a streamlined approval pathway that uses blood tests to prove the generic is equivalent to the brand, rather than full clinical trials.

    Forbes.com: News

  • Teva was perfectly poised to take advantage of the U.S. Hatch-Waxman Act of 1984, which allowed the sale of a generic drug if its manufacturer could prove that it was chemically equivalent to the original drug and broke no patents.

    Former Test-Tube Washer Built Generic-Drug Maker Teva

  • Without the FTC's efforts to stop pay for delay, consumers would likely lose all the benefits from generic entry intended by the Hatch-Waxman Act. Michael A. Salinger

    'Pay for Delay' Can

  • But not all patents are equally strong or valid, and Hatch-Waxman encourages generic companies to sue to bust the patents before the 14-year window is opened.

    The 'Pay for Delay' Rap

  • Perhaps Congress could resolve this with tweaks to Hatch-Waxman, but Congress rarely tweaks.

    The 'Pay for Delay' Rap

  • But keep in mind that reverse settlements occur prior to a patent's expiration date under the terms of the 1984 Hatch-Waxman law.

    The 'Pay for Delay' Rap

  • Since the passage of the Hatch-Waxman Act in 1984, policymakers have given innovative drug manufacturers an extended period of time during which they are the sole manufacturer of a product, so they can earn back their investment and generate a return to spur further innovation.

    Pat Choate: Biologics: The Case for 13 or More Years of Data Exclusivity

  • In addition to patent protection, Hatch-Waxman allows a period of data exclusivity, during which a drug innovator maintains proprietary access to data that led to the approval of its drug, before that data has to be made available to generic imitators.

    Pat Choate: Biologics: The Case for 13 or More Years of Data Exclusivity

  • To understand how these settlements work, we need to review the Hatch-Waxman Act of 1984, which lowered the regulatory barriers preventing generic drug producers from entering pharmaceutical markets.

    Pay-For-Delay Or Pay-For-Innovation?

  • Initially, generic competitors used the Hatch-Waxman Act to enter drug markets only after an innovator's patent naturally expired, on average 12 years after Food and Drug Administration approval.

    Pay-For-Delay Or Pay-For-Innovation?

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  • For when you need your hatch professionally waxed.

    November 18, 2009