On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more
7/1/2025
/ Appeals ,
Food and Drug Administration (FDA) ,
Induced Infringement ,
Patent Infringement ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Solicitor General ,
Statutory Interpretation
Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more
6/25/2025
/ Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
5/2/2024
/ Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Teva Pharmaceuticals
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Background -
On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
9/21/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Induced Infringement ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals