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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 …
The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon
The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon
Kentucky Law Journal
No abstract provided.