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An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
Conflicting Requirements Of Notice: The Incorporation Of Rule 9(B) Into The False Claims Act's First-To-File Bar, Brian D. Howe
Conflicting Requirements Of Notice: The Incorporation Of Rule 9(B) Into The False Claims Act's First-To-File Bar, Brian D. Howe
Michigan Law Review
Intended to prevent fraud against the government, the False Claims Act (“FCA”) contains a qui tam provision allowing private individuals, known as relators, to bring suits on behalf of the government and receive a portion of the damages. At the heart of the qui tam provision lies the first-to-file bar, which provides that, once a first relator has filed a complaint, subsequent relators are prohibited from coming forward with complaints based on the facts underlying the first relator’s pending action. A circuit split has recently emerged regarding the incorporation of Federal Rule of Civil Procedure 9(b)’s heightened pleading standard into …