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University of Michigan Law School

Intellectual Property Law

2015

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Full-Text Articles in Law

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 Oct 2015

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 …


Campbell At 21/Sony At 31, Jessica D. Litman Jan 2015

Campbell At 21/Sony At 31, Jessica D. Litman

Articles

When copyright lawyers gather to discuss fair use, the most common refrain is its alarming expansion. Their distress about fair use’s enlarged footprint seems completely untethered from any appreciation of the remarkable increase in exclusive copyright rights. In the nearly forty years since Congress enacted the 1976 copyright act, the rights of copyright owners have expanded markedly. Copyright owners’ demands for further expansion continue unabated. Meanwhile, they raise strident objections to proposals to add new privileges and exceptions to the statute to shelter non-infringing uses that might be implicated by their expanded rights. Copyright owners have used the resulting uncertainty …