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
1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more