FTC TO CLARIFY PHARMA LITIGATION SETTLEMENTS. The Hatch-Waxman Act permits generic pharma to petition FDA that an innovator’s patents are either invalid or that there is no infringement. “Some of these patent infringement suits are resolved by settlements that include a payment by the pioneer manufacturer to the generic manufacturer, which agrees to refrain from producing its generic drug for a specified period…these settlement agreements )are) “reverse payment agreements” or “pay-to-delay” agreements.””
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