In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more
Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines....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
As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more
4/2/2015
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Biosimilars ,
BPCIA ,
Citizen Petitions ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular