On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for...more
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In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did...more
11/20/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Witness Statements
In a precedential opinion issued on October 11, 2017, the United States Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeals Board’s (“PTAB”) finding of non-obviousness where the prior art taught...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
7/26/2017
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
FDA Approval ,
Generic Drugs ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Sandoz
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
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price...more
3/30/2017
/ Biosimilars ,
BPCIA ,
Good Faith ,
Information Sharing ,
Lost Profits ,
Patent Dance ,
Patent Infringement ,
Patent Royalties ,
Patents ,
Pharmaceutical Patents ,
Remedies
On March 3, 2017, the United States Court of Appeals for the Federal Circuit reaffirmed, in a precedential opinion, that prosecution disclaimers may only limit the scope of a claim where the disclaimer is “both clear and...more