Topic
Orange Book
7 published works
IP Finance
Teva Pharmaceuticals will remove over 200 improper patent listings from the Orange Book
By IP Finance
On December 10, 2025, the FTC announced that Teva Pharmaceuticals will “[r]emove. . . Over 200 Improper Patent Listings” to improve generic competition. The Press Release states: FTC investigation prompts…
ANDVA Advisor Blog
Federal Circuit Upholds Decision to Delist System Patent from the Orange Book
Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS…
Big Molecule Watch
President Signs the Orange Book Transparency Act
On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act of 2020 clarifies information related to patent listing and…
Global IP & Technology Law Blog
At 40 Years Old, the Orange Book Gets a Fresh Look as FDA Seeks Comments on Patent Listability
Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent…
Patents Post-Grant
PTAB to Discuss Orange Book Patents Thursday
By Scott McKeown, Scott McKeown Wolf Greenfield
Boardside Chat to Review Orange Book/Biologics The USPTO is hosting a Boardside Chat webinar on Thursday, July 18, from noon to 1 p.m. ET, to discuss its previous PTAB Orange Book patent/biologic patent…
Patents Post-Grant
PTAB Releases Orange Book Stats
By Scott McKeown, Scott McKeown Wolf Greenfield
PTAB Explains Orange Book Trial Experiences In today's Boardside Chat, the Patent Trial & Appeal Board (PTAB) explained expanded panel practice, and provided some useful insight into its work on Orange…
Focus on Regulation
FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision in Novartis AG v. Lee alters patent term adjustment
By David Fox, Gary Veron, George O'Brien, Sari Bourne
Two recent developments will affect the listing of patent information with pharmaceutical products approved by the U.S. Food and Drug Administration (FDA). First, the FDA has revised the forms on…