Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP

June 20, 2024 11:30am

James T. Evans, Ph.D.
Senior Director, Assistant General Counsel, Dispute Resolution
Regeneron Pharmaceuticals

Matthew A. Pearson
Partner
Akin Gump Strauss Hauer & Feld LLP

Mark A. Perry
Partner | Co-Head Appeals & Strategic Counselling
Weil, Gotshal & Mangers LLP

John Christopher Rozendaal
Partner | Director | Chair of Trial & Appellate Practice Group
Sterne Kessler Goldstein & Fox LLP

Alicia A. Russo
Partner
Venable LLP

  • Understanding how product launches are influenced by PTE and OTDP
  • Unpacking the In Re Cellect federal circuit arguments and decision
    • Reading the tea leaves on what this case will mean for the future of patent term adjustment strategy
  • Appreciating the interplay between obviousness type double patenting and In re Cellect
  • Emphasizing strategies in drafting claims for first filed and subsequent continuation applications to avoid OTDP concerns
    • Maintaining safe harbor of a divisional all the way through versus filing all at once and re-dividing down the line?
  • Unpacking the USPTO’s Guidance on obviousness rejections
  • Updating patent adjustment forecasts to biologic or biosimilar launch timelines