On July 15, 2025, Judge Evelyn Padin of the District of New Jersey denied Novartis’s motion for preliminary injunction, which would have blocked MSN Laboratories Pvt. Ltd. from selling a generic version of Novartis’s Entresto...more
8/4/2025
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Injunctive Relief ,
Likelihood of Confusion ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs ,
Trade Dress ,
Trademark Infringement ,
Trademark Litigation
A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more
4/17/2025
/ Corporate Taxes ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Income Taxes ,
Internal Revenue Code (IRC) ,
IRS ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Tax Appeals ,
Tax Deductions
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
6/14/2024
/ Abbreviated New Drug Application (ANDA) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Life Sciences ,
Medicare Modernization Act ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO