Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more
8/27/2025
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patient Access ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Stays
On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more
6/26/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims