Abstract

http://ssrn.com/abstract=1927940
 
 

Footnotes (196)



 


 



The Constitutional Protection of Trade Secrets and Patents Under the Biologics Price Competition and Innovation Act of 2009


Richard A. Epstein


New York University School of Law; Stanford University - Hoover Institution on War, Revolution and Peace; University of Chicago - Law School


Food and Drug Law Journal, Vol. 66, No. 3, 2011
NYU Law and Economics Research Paper No. 11-30

Abstract:     
The Biologics Price Competition and Innovation Act of 2009 (“Biosimilars Act”) 1 is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”),2 on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Service Act (PHSA) to create a pathway for FDA approval of “biosimilar” biological products. Each biosimilar applicant is required to cite in its application a “reference product” that was approved on the basis of a full application containing testing data and manufacturing information, which is owned and was submitted by another company and much of which constitutes trade secret information subject to constitutional protection. Because the Biosimilars Act authorizes biosimilar applicants to cite these previously approved applications, the implementation of the new legislative scheme raises critical issues under the Fifth Amendment of the Constitution, pursuant to which private property - trade secrets included - may not be taken for public use, without “just compensation.” FDA must confront those issues as it implements the scheme set out in the Biosimilars Act. This article will discuss these issues, after providing a brief overview of the Biosimilars Act and a more detailed examination of the law of trade secrets.

Number of Pages in PDF File: 45

Accepted Paper Series





Download This Paper

Date posted: September 16, 2011  

Suggested Citation

Epstein, Richard A., The Constitutional Protection of Trade Secrets and Patents Under the Biologics Price Competition and Innovation Act of 2009. Food and Drug Law Journal, Vol. 66, No. 3, 2011 ; NYU Law and Economics Research Paper No. 11-30. Available at SSRN: http://ssrn.com/abstract=1927940

Contact Information

Richard A. Epstein
New York University School of Law ( email )
40 Washington Square South
New York, NY 10012
United States
(212) 992-8858 (Phone)
(212) 995-4894 (Fax)
Stanford University - Hoover Institution on War, Revolution and Peace
Stanford, CA 94305-6010
United States
University of Chicago - Law School ( email )
1111 E. 60th St.
Chicago, IL 60637
United States
773-702-9563 (Phone)
773-702-0730 (Fax)
Feedback to SSRN


Paper statistics
Abstract Views: 944
Downloads: 151
Download Rank: 118,226
Footnotes:  196

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo2 in 0.328 seconds