Open Access. Powered by Scholars. Published by Universities.®
- Publication Type
Articles 1 - 3 of 3
Full-Text Articles in Law
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Michigan Telecommunications & Technology Law Review
2011 was an eventful year for those interested in patent law. In March, the Federal Trade Commission ("FTC") released a report that urges the Patent and Trademark Office ("PTO") and courts to remedy perceived inadequacies underlying the U.S. patent system. The FTC observes that people of skill in the art routinely encounter difficulty in determining the meaning, and hence exclusive scope, of a patent's claims. Not only does this failure of notice stymie the efficient dispersion of technology throughout the economy, the FTC argues, but the judicial process can aggravate the problem by granting inappropriate remedies in patent-infringement cases. Then, …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …