In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more
7/7/2016
/ Amgen ,
Apotex ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
7/24/2015
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Opt-Outs ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Preliminary Injunctions ,
Prescription Drugs