Medicare Act Reforms Hatch-Waxman Procedures

Law360, New York (January 2, 2004, 12:00 AM EST) -- The Medicare Prescription Drug, Improvement, and Modernization Act signed into law by President George W. Bush last month modifies the approval process for generic drugs in several important ways, intellectual property attorneys say.

In addition, the new act codifies many of the current regulatory practices at the Food and Drug Administration, they say.

“Only six of 680 pages directly affect intellectual property issues, but the changes are likely to affect litigation arising out of ANDA filings as well as the marketing of new generics under the...
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