In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more
6/14/2017
/ 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
On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No....more
7/6/2016
/ Amgen ,
Apotex ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Sandoz ,
Sandoz v Amgen
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more
7/23/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more