In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more
9/12/2017
/ Administrative Procedure Act ,
Appeals ,
Chevron Deference ,
Commercial Marketing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First-to-File ,
Food and Drug Administration (FDA) ,
Marketing Exclusivity Periods ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Exclusivity ,
Reaffirmation ,
Summary Judgment
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
7/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
CAFC ,
Commercial Marketing ,
Exclusivity ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health Service Act ,
Rulemaking Process