On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S....more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
9/26/2017
/ 35 U.S.C. § 271(e)(1) ,
Amgen ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Damages ,
Food and Drug Administration (FDA) ,
Hospira ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Expiration ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Safe Harbors
When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more
5/17/2017
/ Biologics ,
Build America Investment Initiative ,
Food and Drug Administration (FDA) ,
On-Sale Bar ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals ,
USPTO
The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more
7/22/2015
/ aBLA ,
Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition