Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary Considerations

April 24, 2018 11:00am

Tony V. Pezzano
Hogan Lovells LLP (New York, NY)

John Snow
Polsinelli PC (Chicago, IL)

Stephen R. Smerek
Winston & Strawn LLP (Los Angeles, CA)

Bruce M. Wexler
Paul Hastings LLP (New York, NY)


Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai (Andover, MA)

  • Deciphering recent Federal Circuit opinions addressing inherency and anticipation in an ANDA setting
    • Millennium Pharm. v. Sandoz, Inc., Appeal no. 2015-2066 (Fed. Cir., July 17, 2017)
  • Dissecting the concept of inherent obviousness and establishing the correct standard
    • Honeywell International, Inc. v. Mexichem Amanco
    • Requirements for rejections based on inherency and burden of proof determinations
    • Understanding how ‘that which may be inherent is not necessarily known’ and that which is unknown cannot be obvious
  • Examining inherency rejections
  • Survey of recent cases at the District Courts highlighting the importance of secondary considerations in an obviousness determination
  • Examining trends at the District Court and PTAB indicating a receptiveness to the use of secondary considerations
  • Applying these findings to ANDA litigation
    • Analyzing factors of commercial success, unmet need, licensing
    • Exploring the ongoing debate on copying and its relevance or irrelevance to Hatch-Waxman litigation