The Patent Linkage Program of the U.S Drug Market Review

• Main Authors: Chiu-jung Huang, 黃秋蓉
• Other Authors: Chin-Chieh Yang
• Format: Others
• Language: zh-TW
• Published: 2013
• Online Access: http://ndltd.ncl.edu.tw/handle/98198773946196491541

碩士 === 國立雲林科技大學 === 科技法律研究所碩士班 === 101 === The patent linkage program of the United States, means that the marketing approval of generic drugs are 「linked」to the judgment of whether the generics infringe a valid patent held by a brand-name pharmaceutical company on the same type of drugs or not. In the drug for market, most high-profit drugs protected by patents, inexpensive generic drugs have the opportunity to enter the U.S. market in the patent expires. In 1984 through the 「Drug Price Competition and Patent Compensation Act」, Also known as the Hatch Waxman Act, jurisdiction by the U.S. Federal Food, Drug, and Cosmetic Act , provide a simplified application procedures for generics enter the market and for generics after the patent expires quickly enter the market. Focusing on this issue, discuss about the U.S. patent system linked and discuss biological generic products applications listing regime.Further research of the patent litigation arising by the Hatch Waxman Act, the litigation about reverse payment settlement issues and counterclaim .Focusing on this issue, Taiwan has no patent linkage program differents from United States,comparison between the two countries and discuss the problems arising from different systems.