Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar. ...more
In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more
Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines....more
Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
7/11/2017
/ Amgen ,
Biosimilars ,
Biotechnology ,
BPCIA ,
CGMP ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hospira ,
Johnson & Johnson ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents
In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen’s Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347...more
After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more
The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more
7/22/2015
/ aBLA ,
Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more
4/2/2015
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Biosimilars ,
BPCIA ,
Citizen Petitions ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
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