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
Clients and their litigation teams face short and long-term scheduling uncertainty during the COVID-19 crisis. District courts have postponed trials and granted motions for extensions that tack on three or more months to the...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