Law Commons^™

Are We Exclusive? Does It Matter?: An Antitrust-Inspired Framework For Understanding Anti-Exclusive Dealing Statutes And The Meaning Of Coercion, Christopher E. Ware, Alison A. Hill

Alison Hill

We both practice in the area of Product Distribution and Franchise law, where we first encountered client concerns regarding the anti-exclusive dealing statutes described in our Article. These laws prevent manufacturers from "coercing" their dealers into not selling products from a competing manufacturer. However, the laws are problematic because they never define what it means for a manufacturer to "coerce" a dealer into an exclusive deal.

Our subsequent research demonstrated four key factors which make our Article timely for publication:

(1) The number of states passing anti-exclusive dealing statutes is continually increasing. Between 2000 and 2007, ten states enacted anti-exclusive …

Broadcasting The 2006 World Cup: The Right Of Arab Fans Versus Art Exclusivity, Bashar H. Malkawi

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …

Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn

Faculty Publications

Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended it substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The core concept of this exclusivity as it has been applied by FDA and the courts is that the first generic drug applicant to challenge an innovator's patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. The 180-day exclusivity provision is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA, and it is intended …

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …