Regulatory Competitive Shelters as Incentives for Innovation in Agrobiotech

7 Pages Posted: 6 Nov 2015 Last revised: 16 Dec 2015

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Date Written: 2015

Abstract

This short paper is a summary of my presentation at the Michigan State Law Review 2014 Fall Symposium on “Public Domain(s): Law, Generating Knowledge, and Furthering Innovation in the Information Economy” held on October 3, 2014. The paper reviews the current role played by regulatory competitive shelters (RCSs; a.k.a. regulatory exclusivities) in the area of agrobiotech. The article also suggests that the Food and Drug Administration's move to treat genetically modified animals as "animal drugs" under the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) may result in the application of GADPTRA's RCS regime to genetically modified animals and in a "Hatch-Waxmanizing" of the regulation of that agrobiotechnology.

Keywords: Regulatory competitive shelters, RCS, regulatory exclusivities, agrobiotech, FIFRA, Generic Animal Drug and Patent Term Restoration Act, GADPTRA, genetically modified organisms, genetically modified animals, Federal Insecticide, Fungicide and Rodenticide Act, FDA, EPA, exclusivity

Suggested Citation

Heled, Yaniv, Regulatory Competitive Shelters as Incentives for Innovation in Agrobiotech (2015). 2015 Michigan State Law Review 553 ; Georgia State University College of Law, Legal Studies Research Paper No. 2015-34. Available at SSRN: https://ssrn.com/abstract=2686217

Yaniv Heled (Contact Author)

Georgia State University College of Law ( email )

140 Decatur St.
Atlanta, GA 30303
United States
404-413-9092 (Phone)

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