Biosimilar Applicants Must Provide Notice of Commercial Launch:
What You Need To Know -
Case Background -
In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more
7/7/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
On February 5, the Federal Circuit issued its first decision on an appeal of a final written decision of an Inter Partes Review (“IPR”). The decision addressed two outstanding questions of interest to IPR proceedings. First,...more