Part II: What Every PIV Litigator Needs to Know about the USPTO- FDA Collaboration and the Efforts to Promote Competition

April 20, 2023 9:00am

Christopher Pruitt
Deputy Director, Office of Generic Policy

Brian Stone
Associate General Counsel
Global Legal-Regulatory


Maryll W. Toufanian
Senior Vice President, Regulatory Strategy and Policy
Amneal Pharmaceuticals


Daniel G. Brown
Latham & Watkins LLP

President Biden and Congress have applied pressure on USPTO and FDA to change patent policies to keep drug prices down and promote competition. The two agencies are exploring initiatives, as the Order required USPTO and FDA to identify inter-agency goals for collaboration. Areas of collaboration to be discussed will include:

  • Reconciling how the two agencies can collaborate on PTE determinations
  • Policy considerations for method of use patents, use codes and skinny labeling
  • Considerations regarding risk evaluation and mitigation strategies (REMS)
    • Avadel CNS Pharmaceuticals v. Jazz Pharmaceuticals
  • Efforts to thwart the misuse of patents to delay completion