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
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
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