Regulatory Competitive Shelters as Incentives for Innovation in Agrobiotech
7 Pages Posted: 6 Nov 2015 Last revised: 16 Dec 2015
Date Written: 2015
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
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