Jump to ContentJump to Main Navigation
FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 29 July 2021

The “Follow-On” Challenge

The “Follow-On” Challenge

Statutory Exclusivities and Patent Dances

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

Arti Rai

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0028

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

Columbia Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs, and if you can't find the answer there, please contact us .