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Innovation for the 21st CenturyHarnessing the Power of Intellectual Property and Antitrust Law$
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Michael A. Carrier

Print publication date: 2009

Print ISBN-13: 9780195342581

Published to Oxford Scholarship Online: May 2009

DOI: 10.1093/acprof:oso/9780195342581.001.0001

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Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality

Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality

Chapter:
(p.345) 15 UNSETTLING DRUG PATENT SETTLEMENTS: A FRAMEWORK FOR PRESUMPTIVE ILLEGALITY
Source:
Innovation for the 21st Century
Author(s):

Michael A. Carrier

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195342581.003.0015

This chapter explains why agreements by which brand-name pharmaceutical companies pay generic firms to settle patent infringement litigation and agree to delay entering the market should be presumptively illegal. It begins by introducing the Hatch-Waxman Act, exploring its purpose, text, and mixed success. It then discusses three representative cases illustrating courts' increased leniency toward reverse payment agreements. In justifying a framework for presumptive illegality, the chapter explains the importance of the relevant regulatory framework. It demonstrates the ineffectiveness of the Act's competition mechanisms. It focuses on reverse payments, describing their uniquely concerning aspects and potentially severe anticompetitive harm. Finally, it shows how the settling parties can rebut the presumption of illegality.

Keywords:   antitrust, Hatch-Waxman Act, settlement, reverse payments, pharmaceutical industry, Food, Drug, and Cosmetic Act, 2003 Medicare amendments, Schering-Plough, Tamoxifen, market division

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