EARNING EXCLUSIVITY: GENERIC DRUG INCENTIVES AND THE HATCH-WAXMAN ACT

A quarter century ago, Congress fundamentally changed the way the Food and Drug Administration approves pharmaceuticals for the market. The Hatch-Waxman Act gave additional protection to the inventors of new drugs, both by lengthening patent terms and by providing guaranteed periods of data exclusiv...

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Bibliographic Details
Published in:Antitrust law journal 2011-06, Vol.77 (3), p.947-989
Main Authors: Hemphill, C. Scott, Lemley, Mark A.
Format: Article
Language:English
Subjects:
Antitrust
Asset forfeiture
Brand name drugs
Competition
Economic incentives
Exclusive agency selling
FDA approval
Federal legislation
Generic drugs
Incentives
Insurance settlements
Intellectual property
Laws, regulations and rules
Litigation
Patent infringement
Pharmaceutical preparations
Plaintiffs
Prescription drugs
SYMPOSIUM: ANTITRUST AND INNOVATION
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Summary:A quarter century ago, Congress fundamentally changed the way the Food and Drug Administration approves pharmaceuticals for the market. The Hatch-Waxman Act gave additional protection to the inventors of new drugs, both by lengthening patent terms and by providing guaranteed periods of data exclusivity. In exchange, Hatch-Waxman made it easier for generic drug manufacturers to enter the market with a copy of the drug, either by waiting until the patent expires or by challenging weak patents. To encourage generic manufacturers to identify and challenge weak patents, Hatch-Waxman offered a sort of quasi-exclusive right to the generic challenger. The first generic manufacturer to file for approval with the FDA, with caveats discussed below, is entitled to 180 days of "generic exclusivity" when it first enters the market. During that period, other generic drug makers are prohibited from entering the market.
ISSN:0003-6056
2326-9774