Pharma & Biotech Patent Litigation USA & Canada

Sterne Kessler’s Jackie W. Bonilla, Ph.D. will serve as a co-chair and speaker at the Pharma & Biotech Patent Litigation USA & Canada forum, hosted by ACI in New York, NY. The event brings together industry leaders in life sciences patent litigation from across the U.S. and Canada to discuss emerging challenges, recent developments, and effective litigation strategies.

Jackie’s session, “The Impact of Current US Regulatory Policy on Pharma Biotech Patent Litigation: Present Day Status and Future Forecasts,” will examine recent changes and emerging trends in the U.S. regulatory landscape governing biopharmaceutical products and their associated intellectual property protections. Ongoing agency turnover, legislative scrutiny of drug pricing and access, and evolving questions surrounding IP protections and enforcement have created an atmosphere of instability for long-time practitioners.

The session will explore the implications of these developments for patent litigation today and provide insights into potential regulatory and litigation trends in the year ahead.

Points for discussion will include:

• Examining how leadership changes at key agencies are impacting the biopharmaceutical industry
  • Assessing key agency activity and their related impact on pharma and biotech patents
• Preparing for challenges to life sciences patents following federal government activity
  • The continued threat of march in rights
  • FDA enforcement activity and notice letters
    • Clinical trials
  • USPTO/PTAB activity
    • Terminal disclaimers
    • PTEs and PTRs
  • Antitrust enforcement activity from the FTC
• Understanding how Executive Orders and other new activity by the federal government is “re-making” the biopharma industry, and the challenges that these changes present
  • Pricing vouchers
  • Most favored nation
  • Inflation Reduction Act
  • Drug value under TrumpRx
• Exploring the first patent cliff for both small and large molecules, and how litigation may change as a result
• Considering the effect of US regulatory policy on Canadian practice