Eisenberg, Rebecca S. --- "Data Secrecy in the Age of Regulatory Exclusivity" [2011] ELECD 559; in Dreyfuss, C. Rochelle; Strandburg, J. Katherine (eds), "The Law and Theory of Trade Secrecy" (Edward Elgar Publishing, 2011)

Book Title: The Law and Theory of Trade Secrecy

Editor(s): Dreyfuss, C. Rochelle; Strandburg, J. Katherine

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781847208996

Section: Chapter 18

Section Title: Data Secrecy in the Age of Regulatory Exclusivity

Author(s): Eisenberg, Rebecca S.

Number of pages: 26

Extract:

18 Data secrecy in the age of regulatory
exclusivity
Rebecca S. Eisenberg*


INTRODUCTION

Drug regulation works in tandem with the patent system to defer generic
entry in the market for pharmaceutical products, thereby preserving lucra-
tive market exclusivity more effectively than the patent system could do
without the regulatory assist.1 Firms need regulatory approval to sell their
products,2 and to get that approval they need data showing that their
products meet regulatory standards.3 Prior to passage of the Drug Price
Competition and Patent Term Restoration Act of 1984 (commonly known
as the Hatch-Waxman Act)4 drug developers relied upon confidential treat-
ment of the data they submitted to the Food and Drug Administration
(FDA) in support of a New Drug Application (NDA) to keep their data
out of the hands of generic competitors who might otherwise use it to get
competing versions of the same products approved. Although competitors
could conduct their own trials and submit their own data, the costs of such
trials were generally prohibitive for generic products that would be sold
at competitive prices rather than at the premium prices charged for drugs
available from only one source. As a result, the regulatory entry barrier
often continued to exclude competition even after relevant patents expired.5
The Hatch-Waxman Act changed the rules, striking a new balance
between the interests of innovators and generic competitors. To facilitate
generic entry, the Hatch-Waxman Act lowered the regulatory entry barrier
for generic versions of previously ...