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Albany Law Journal of Science and Technology
Destroying a Pharmaceutical Patent for Saving Lives?: A Case Study of Sanofi-Synthelabo v. Apotex, Inc.
21.0000000000000 ALB. L.J. SCI. & TECH. 125 (2011)
Quincy (Ping-Hsun) Chen
The Abbreviated New Drug Application ("ANDA") is a short path to drug approval. It was designed to allow a generic drug company to introduce a "bioequivalent" version of a currently-approved, brand-name drug. Particularly, in the ANDA procedure, if a generic drug company challenges the validity of patents protecting a brand-name drug in its application, it could gain a privilege after its application is approved, where it could exclusively share the market of such brand-name drug with the pioneer drug company for 180 days. But, the privilege is mainly conditioned on whether the pioneer drug company will sue the generic drug company for patent infringement and on whether the generic drug company could succeed in such litigation.