For every new drug application, the Hatch-Waxman Act requires pharmaceutical companies to identify each patent that claims the drug, its formulation, or a method of using it....more
The Biologics Price Competition and Innovation Act (“BPCIA”) contemplates the exchange of highly sensitive information from the pre-suit “patent dance” (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout litigation, bringing...more
1/5/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen