The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more
7/14/2020
/ Biosimilars ,
BPCIA ,
Corporate Branding ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Protection ,
Litigation Strategies ,
Patent Prosecution ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more
7/8/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more
3/23/2015
/ Amgen ,
Biologics ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more