SCOTUS rules biosimilar applicants can provide notice before FDA approval

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2026

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

SCOTUS rules biosimilar applicants can provide notice before FDA approval

sandoz20logo.jpg

The Supreme Court in the Sandoz v Amgen biosimilar case has ruled that an injunction is not available under federal law and an applicant may provide notice before obtaining a licence from the FDA. The ruling is a win for Sandoz, but the case was remanded for the Federal Circuit to rule on whether an injunction is still available under state law

Unlock this content.

The content you are trying to view is exclusive to our subscribers.

To unlock this content:

Take a Free Trial or Login
more from across site and SHARED ros bottom lb

More from across our site

While the firm lost several litigators this month, Winston & Strawn is betting that its transatlantic merger will strengthen its IP practice
In other news, Ericsson sought a declaratory judgment against Acer and Netflix filed a cease-and-desist letter against ByteDance over AI misuse
As trade secret filings rise due to AI development and economic espionage concerns, firms are relying on proactive counselling to help clients navigate disputes
IP firm leaders share why they remain positive in the face of falling patent applications from US filers, and how they are meeting a rising demand from China
The power of DEI to swing IP pitches is welcome, but why does it have to be left so late?
Mathew Lucas has joined Pearce IP after spending more than 25 years at Qantm IP-owned firm Davies Collison Cave
Exclusive survey data reveals a generally lax in-house attitude towards DEI, but pitches have been known to turn on a final diversity question
Managing IP will host a ceremony in London on May 1 to reveal the winners
Abigail Wise shares her unusual pathway into the profession, from failing A-levels to becoming Lewis Silkin’s first female IP partner
There are some impressive AI tools available for trademark lawyers, but law firm leaders say humans can still outthink the bots
Gift this article