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
Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
3/27/2025
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks ,
Weight-Loss Products
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
2/17/2025
/ Drug Compounding ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more
Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more
As Benjamin Franklin famously remarked, “nothing is certain except death and taxes.” Recently, the U.S. Court of Appeals for the Third Circuit provided more certainty about the latter by holding that legal expenses incurred...more