15th Summit on Biosimilars & Innovator Biologics

The firm was pleased to sponsor the 15th Summit on Biosimilars & Innovator Biologics, hosted by ACI at the New York Bar Association. Director JC Rozendaal was a speaker during the “Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP” panel on June 20, 2024.

Panel Overview

• 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