Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?

61 Pages Posted: 29 Jun 2011 Last revised: 21 Feb 2014

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Date Written: June 28, 2011


On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.

Keywords: biologics, pharmaceuticals, patents, statutory exclusivities, market exclusivity, data exclusivity, generics, biologics price competition, hatch, waxman, BPCIA, PPACA, FDA

Suggested Citation

Heled, Yaniv, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both? (June 28, 2011). 18 Michigan Telecommunications and Technology Law Review 419; Georgia State University College of Law, Legal Studies Research Paper No. 2011-17. Available at SSRN: or

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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