Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals. In so doing, the label would closely reflect limitations in the asserted patent claims...more
In a March 31, 2019 opinion in Belcher Pharmaceuticals LLC v. International Mediation Systems, Limited, Judge Stark of the Delaware District Court held that complaints in Hatch-Waxman actions can satisfy the requirements...more
Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more
4/15/2019
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
Federal Rule 12(b)(6) ,
Food and Drug Administration (FDA) ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
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