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

45 Pages Posted: 16 Sep 2011  

Richard A. Epstein

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

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.

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: https://ssrn.com/abstract=1927940

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)

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