Open Access. Powered by Scholars. Published by Universities.®

Law Commons

Open Access. Powered by Scholars. Published by Universities.®

Food and Drug Law

PDF

University of Michigan Law School

Journal

Congress

Articles 1 - 4 of 4

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 …


Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook Jan 2011

Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook

Michigan Telecommunications & Technology Law Review

Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …


Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith Jan 2009

Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith

Michigan Journal of Race and Law

Many Americans-especially the poor-face severe hurdles in their attempts to secure the most basic of human needs-food. One reason for this struggle is the tendency of chain supermarkets to provide a limited selection of goods and a lower quality of goods to patrons in less affluent neighborhoods. Healthier items such as soy milks, fresh fish, and lean meats are not present in these stores, and the produce that is present is typically well past the peak of freshness. Yet, if the same patron were to go to another supermarket owned by the same chain--but located in a wealthier neighborhood-she would …


Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein Jun 1998

Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein

Michigan Law Review

A neon sign in the window of 7-Van Drugs reads "Food Stamps," but the contradictory truth is posted inside on a handwritten sign taped to a thick pane of bulletproof plastic. 7-Van Drugs sits at the intersection of Seven Mile Road and Van Dyke in northern Detroit, where it has "serv[ ed] the community since 1948 at the same corner." Inside 7-Van is an array of staple foods and basic household cleaning items, and there is a small pharmacy in the back. Customers must use a turnstile to pass their purchases through the bulletproof plastic to the cashier. There are …