The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies

June 28, 2022 11:45am

Jenny Johnson
Endo Pharmaceuticals

W. Blake Coblentz
Co-Chair Hatch-Waxman and Biologics Litigation Group
Cozen O’Connor

Nicholas Mitrokostas
Allen & Overy LLP


Vishal Gupta
Co-Chair, Healthcare & Life Sciences Practice

Steptoe & Johnson LLP

Subsequent to the Federal Circuit’s skinny label ruling in GSK v. Teva, the District of Delaware in Amarin v. Hikma (D. Del. 2022) embraced a narrower approach in dismissing an induced infringement claim based on an allegedly inadequate skinny label carve out. The Delaware court also examined the novel question of whether a health insurer’s formulary placement of the drug in question induced infringement of method-of-use patents. Further, confirming that without any bright line rules, and absent a decision from the U.S. Supreme Court or legislation, the fate of the skinny label remains in the balance.

  • Considering whether the language of press releases, web pages and other marketing materials require more scrutiny
  • Analyzing potential liability faced by insurers for placement of skinny label on formularies
    • Does liability exist for induced infringement by listing a skinny label on a formulary
    • Taking stock of the potential impact to patients
  • Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label