Reviewing Cases and Distilling Trends: The Key Federal and District Court Lawsuits Shaping the BPCIA Landscape

June 21, 2024 8:15am

Larry Coury
Vice-President, Associate General Counsel
Regeneron Pharmaceuticals

Aziz Burgy
Partner
Axinn, Veltron & Harkrider LLP

Hassen A. Sayeed
Partner
O’Melveny & Myers LLP

Alison Hanstead
Partner
White & Case LLP

  • Diving deep into Regeneron’s BPCIA litigation against Celltrion, Samsung Bioepis, Formycon, and Mylan for each of their proposed biosimilars of EYLEA
    • Exploring Regeneron’s motion to establish multi-district litigation encompassing the aflibercept BPCIA cases
  • Learning the latest biologic patent litigation strategies:
    • Timing the lawsuit and seeking preliminary injunctions to block accused infringer’s at risk launch
  • Learning the latest biosimilar patent litigation strategies:
    • Appreciating when and how courts find permanent injunctions appropriate before receiving FDA approval
    • Analyzing the decision to argue against a PI versus not launching at the end of the market exclusivity period