Amgen v. Sanofi: Understanding How the Supreme Court May Re-Shape §112

April 19, 2023 9:15am

Matthew A. Pearson
Akin Gump Strauss Hauer & Feld LLP

Emily J. Greb
Perkins Coie LLP

Eric Stone
Groombridge, Wu, Baughman & Stone LLP

Richard C. Pettus
Greenberg Traurig LLP


Vishal C. Gupta
Steptoe & Johnson LLP

In November of 2022, The U.S. Supreme Court granted cert. in Amgen v. Sanofi, but strangely denied cert. in Juno v. Kite, a case with remarkably similar questions presented. At the time of press, Juno petitioned the Court for rehearing, arguing that the grant of cert. in Amgen warrants reconsideration. The fate of §112 hangs in the balance leaving Hatch-Waxman practitioners wondering how this will impact litigation strategies. Topics of discussion will include:

  • Analyzing why SCOTUS granted cert only in Amgen v. Sanofi despite the presentation of the same single issue of the proper interpretation of §112 in Juno v. Kite
  • Assessing the current state of 112 jurisprudence and predicting how the law may evolve in the future
  • Preparing for the impact to existing patents with functional claims
  • Evaluating the impact on patent prosecution practice in the future
  • Best practices for strengthening or invalidating patent claims
    • What is the true test for enablement?
    • What is the relevant inquiry for written description post-Biogen v. Mylan?