Where an alleged infringer administers a substance A to a subject, and the substance is subsequently transformed to a therapeutic agent X inside the subject’s body, does the administration of the substance A constitute an act...more
In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more
4/26/2024
/ Abbreviated New Drug Application (ANDA) ,
Applications ,
Carve Out Provisions ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Orange Book ,
Patent Applications ,
Patent Infringement ,
Patents ,
Prior Art
In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more
On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more
5/15/2020
/ Dedication-Disclosure Defense ,
Doctrine of Equivalents ,
Expert Testimony ,
Extrinsic Evidence ,
Judgment on the Pleadings ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Question of Law
On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more
On December 19, 2017, an expanded panel of the Patent Trial and Appeal Board (PTAB) ruled that the state of Minnesota waived its Eleventh Amendment immunity to challenges to patent validity by inter partes review (IPR) by...more
In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for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 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
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more
3/21/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Declaratory Relief ,
Dismissals ,
Genentech ,
Generic Drugs ,
Information Sharing ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more
7/23/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen