Hatch-Waxman

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 Forbes 2011

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 2010

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 Stephen Miller 2011

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

The 'Pay for Delay' Rap 2010

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 2010

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 2010

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 2010

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? Anup Malani 2010

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? Anup Malani 2010

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 2010