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
On January 9, 2023, the U.S. Court of Appeals for the Federal Circuit in In re Stingray IP Solutions, LLC, No. 23-102 granted a writ of mandamus, vacating a decision of the Eastern District Court of Texas which had...more
On October 5, 2022, U.S. Magistrate Judge Roy S. Payne of the Eastern District of Texas recommended denying-in-part a motion for summary judgment of no willful infringement, holding that requisite knowledge of the asserted...more
On March 16, 2022, U.S. District Judge William Alsup of the Northern District of California certified two of the hot button issues splitting district courts on the standard for pleading willful infringement (see order),...more
3/24/2022
/ Appeals ,
Bad Faith ,
CAFC ,
Cease and Desist ,
Declaratory Judgments ,
Federal Rules of Civil Procedure ,
Halo v Pulse ,
Interlocutory Appeals ,
Patent Infringement ,
Patent Litigation ,
Patent Ownership ,
Patents ,
SCOTUS ,
Willful Infringement
On January 26, 2022, in what appears to be a case of first impression, U.S. District Court Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant defendant’s...more
On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an...more
On January 18, 2022, U.S. District Judge R. Gary Klausner of the Central District of California sided with the majority of divided district courts, dismissing claims of willful and induced infringement that based the...more
On November 5, 2021, the U.S. Court of Appeals for the Federal Circuit in Celgene Corp. v. Mylan Pharmaceuticals Inc., Case No. 21-1154, affirmed a decision from the District Court of New Jersey dismissing a suit brought by...more
On September 28, 2021, in a precedential opinion, the United States Court of Appeals for the Federal Circuit, in SRI Int’l, Inc. v. Cisco Systems, Inc., Nos. 2020-1685, -1704, clarified its decision from a prior appeal in the...more
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 March 24, 2021, U.S. District Judge Colm F. Connolly of the District of Delaware, granted a defendant’s motion to dismiss claims for contributory and induced infringement and enhanced damages under 35 U.S.C. § 284 because...more
Recently in Nike, Inc. v. Skechers U.S.A., Inc., 2:17-cv-08509 (C.D. Cal.) (October 26, 2020), the U.S. District Court for the Central District of California granted-in-part and denied-in-part Defendant, Skechers U.S.A.,...more
11/16/2020
/ 35 U.S.C. § 284 ,
35 U.S.C. § 285 ,
Attorney's Fees ,
Bifurcation ,
Design Patent ,
Enhanced Damages ,
Judgment on the Pleadings ,
Motion to Dismiss ,
Nike ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pleading Standards ,
Skechers ,
Willful Infringement
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
11/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue
On July 30, 2020, the U.S. District Court for the District of Delaware, in APS Technology, Inc. v. Vertex Downhole, Inc. et al, No. 19-cv-01166, denied Vertex Downhole’s Rule 12(b)(6) motion to dismiss APS’s patent...more
8/18/2020
/ 35 U.S.C. § 284 ,
Enhanced Damages ,
Federal Rule 12(b)(6) ,
Jury Verdicts ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
Willful Infringement
On July 13, 2020, the U.S. District Court for the Eastern District of Michigan, in Mich. Motor Techs., v. Volkswagen Aktiengesellschaft, No. 19-10485, granted Volkswagen’s motion to dismiss Michigan Motor Technologies’...more
8/4/2020
/ 35 U.S.C. § 284 ,
Amended Complaints ,
Contributory Infringement ,
Enhanced Damages ,
Halo v Pulse ,
Induced Infringement ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Volkswagen ,
Willful Infringement
On June 26, 2020, the U.S. District Court for the District of Delaware, in VLSI Tech. LLC. v. Intel Corp, No. 18-0966-CFC, denied VLSI’s motion for leave to amend to add claims for willful infringement of U.S. Patent Nos....more
On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide)...more
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...more
8/24/2019
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Venue
On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan...more
6/27/2019
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Dismissals ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Improper Venue ,
Mylan Pharmaceuticals ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Principal Place of Business ,
TC Heartland LLC v Kraft Foods ,
Venue
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic...more
On February 7, 2019, the United States Court of Appeals for the Federal Circuit, in Momenta Pharmaceuticals v. Bristol-Myers Squibb, No. 2017-1694, dismissed Momenta’s appeal of a Final Written Decision in an Inter Partes...more
On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals...more
On May 14, 2018, the United States Court of Appeals for the Federal Circuit, In re: ZTE (USA) Inc., No. 2018-113, held that Federal circuit law governs the burden of proof for venue challenges under 28 U.S.C. § 1400(b) and...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