Regulatory Competitive Shelters

58 Pages Posted: 26 Apr 2015 Last revised: 11 Jun 2015

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Date Written: April 23, 2015


This Article identifies an array of seemingly disparate federal exclusivity regimes as belonging to an increasingly prevalent and relatively new class of highly valuable government benefits, which it names “regulatory competitive shelters” (RCSs). It characterizes RCSs and distinguishes them from other, more traditional kinds of government-instituted properties. The Article then proceeds to describe a particular brand of RCSs established in federal statutory frameworks whose aim — much like patents — is to create incentives for technological innovation. Identifying several common motifs of such RCS regimes, the Article offers a taxonomy of these RCSs and describes the mechanisms by which RCSs instituted under such regimes achieve their goals. Part III of this Article surveys — for the first time under a single title — all of the RCS regimes instituted to date in federal law which are aimed at promoting technological innovation. The Article concludes with a discussion of several aspects of RCSs that require further inquiry and will be further discussed in later articles.

Keywords: Regulatory Competitive Shelters; regulatory exclusivity; data exclusivity; market exclusivity; generic exclusivity; Food and Drug Administration; Environmental Protection Agency; generic; follow-on; patents; innovation

Suggested Citation

Heled, Yaniv, Regulatory Competitive Shelters (April 23, 2015). 76 Ohio St. L.J. 299 (2015), Georgia State University College of Law, Legal Studies Research Paper No. 2015-15, Available at SSRN:

Yaniv Heled (Contact Author)

Georgia State University College of Law ( email )

85 Park Pl NE
Atlanta, GA 30303
United States
404-413-9092 (Phone)

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