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Full-Text Articles in Intellectual Property Law
The Significance Of The Data Exclusivity And Its Impact On Generic Drugs, Srividhya Ragavan
The Significance Of The Data Exclusivity And Its Impact On Generic Drugs, Srividhya Ragavan
Srividhya Ragavan
The following is a law review interview with Professor Srividhya Ragavan on the issues in interpretation of data exclusivity provisions under the TRIPS Agreement, and the impact of data exclusivity on generic drugs.
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
Yaniv Heled
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 …