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 December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more