On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more
12/18/2019
/ Biologics ,
Biotechnology ,
BPCIA ,
Copyright ,
Exclusivity ,
Exclusivity Rule ,
Foreign Entities ,
Intellectual Property Protection ,
NAFTA ,
Patent Term Extensions ,
Pharmaceutical Industry ,
Safe Harbors ,
Trade Associations ,
Trade Relations ,
United States-Mexico-Canada Agreement (USMCA)
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more
12/19/2017
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more
6/14/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more
5/18/2017
/ aBLA ,
Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Civil Conspiracy ,
Food and Drug Administration (FDA) ,
Misappropriation ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Trade Secrets
Yesterday, a Federal Circuit panel comprising Judges Newman, Lourie, and Chen heard oral argument in Amgen Inc. v. Sandoz Inc. (Fed. Cir. No. 2015-1499), the first ever case requiring the Appeals Court to address the meaning...more