Showing posts with label Orange Book. Show all posts
Showing posts with label Orange Book. Show all posts

Wednesday, May 1, 2024

FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic; CNBC, April 30, 2024

Annika Kim Constantino, CNBC; FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic

"Most top-selling medications are protected by dozens of patents covering various ingredients, manufacturing processes, and intellectual property. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

The FTC also notified the Food and Drug Administration about the challenges. The FDA manages patent listings for approved drugs on a document called the Orange Book.

The FTC first challenged dozens of branded drug patents last fall, leading three drugmakers to comply and delist their patents with the FDA. Five other companies did not. 

The Tuesday announcement expands the Biden administration’s effort to crack down on alleged patent abuses by the pharmaceutical industry. The FTC has argued that drugmakers are needlessly listing dozens of extra patents for branded medications to keep their drug prices high and stall generic competitors from entering the U.S. market."