1. Pink Sheet
  2. >>Compliance

‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation

 
• By Brenda Sandburg

Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.

carve-out
Label-carve out case raises concerns about biosimilar litigation and marketing • Source: Alamy

The US Court of Appeals for the Federal Circuit’s ruling on Teva Pharmaceuticals USA Inc.’s use of a label carve-out is continuing to reverberate through the biopharmaceutical industry, as generic and biosimilar makers consider its impact on labeling, litigation and marketing.

Karin Hessler, deputy general counsel for the Association for Accessible Medicines, laid out their concerns about the decision at the Food and Drug Law Institute’s 13-15 October virtual conference on advertising and promotion for medical products. The case concerns Teva’s carveout of a patented indication from the labeling of its generic version of GlaxoSmithKline plc’s Coreg (carvedilol)

More from Marketing & Advertising

More from Compliance

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an audio interview.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.