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
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit.
The Result: The court found that the commercial...more
11/29/2017
/ aBLA ,
Amgen ,
Amgen v Apotex ,
Appeals ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Claim Construction ,
Hatch-Waxman ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Witness Statements