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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 19 May 2022

The “Follow-On” Challenge

The “Follow-On” Challenge

Statutory Exclusivities and Patent Dances

(p.402) Chapter Twenty-One The “Follow-On” Challenge
FDA in the Twenty-First Century

Arti Rai

Columbia University Press

This chapter addresses two controversial features of the regime for “follow-on” biologics set up by Biologics Price Competition and Innovation Act (“BPCIA”) -- statutory exclusivity and mechanisms for patent dispute resolution. The chapter's critique draws in part upon a contrast with the Hatch-Waxman's exclusivity regime for branded small molecules.

Keywords:   BPCIA, Hatch-Waxman, statutory exclusivity, patent dance, follow-on biologics, generic

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