180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction -
Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) -
A year after analyzing the patent dance and notice...more
7/19/2016
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Amgen ,
Assignments ,
Attorney-Client Privilege ,
Biosimilars ,
BPCIA ,
Federal Rule 12(b)(6) ,
Food and Drug Administration (FDA) ,
Hospira ,
Litigation Privilege ,
Merck ,
Method Claims ,
Motion to Dismiss ,
Obviousness ,
Patent Dance ,
Patent Infringement ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Product Exclusivity ,
Reverse Payment Settlement Agreements ,
Sandoz v Amgen ,
Summary Judgment ,
Unclean Hands ,
Work-Product Doctrine