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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 …
Aaron's Law: Reactionary Legislation In The Guise Of Justice, Matthew Aaron Viana
Aaron's Law: Reactionary Legislation In The Guise Of Justice, Matthew Aaron Viana
University of Massachusetts Law Review
This Note argues that the proposed amendment to the Computer Fraud and Abuse Act dubbed “Aaron’s Law,” created in the wake of the prosecution and subsequent suicide of hacktivist Aaron Swartz, should not be enacted as it is overly reactionary legislation which would have unfortunate and unjust repercussions in the realm of civil litigation. This Note first describes the circumstances under which Mr. Swartz found himself prosecuted under the Computer Fraud and Abuse Act, namely his intrusion into, and downloading massive amounts of data from, large internet databases like PACER and JSTOR. This Note also explores the disputed interpretation of …
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 …