Key Litigations and Decisions at the Federal Circuit, the District Courts and the PTAB That Are Transforming the BPCIA Landscape

June 27, 2023 2:45pm

Lisa Cameron
The Brattle Group

Rachel J. Elsby

Rachel Elsby
Akin Gump Strauss Hauer & Feld LLP

Christopher Loh
Venable LLP


Elizabeth S. Weiswasser
Weil, Gotshal & Manges LLP

Innovator Biologic Patent Litigation Strategies

  • Reviewing the timing for bringing lawsuits and seeking preliminary injunctions
  • Filing for a preliminary injunction to block the accused infringers’ at risk launch
    • Considering public interest issues when seeking preliminary or permanent injunction
    • Delineating economic harm through factors other than price
  • Considering the different standards of proof in BPCIA, the PTAB, and district courts

Biosimilar Patent Litigation Strategies

  • Weighing the benefits of launching at risk
  • Analyzing the decision to argue against a preliminary injunction versus not launching at the end of the market exclusivity period
    • Considering whether, how, and under what circumstances courts will find a permanent injunction appropriate before FDA approval is obtained
    • Dealing with the potential for FDA approval before trial of the patent claims in a BPCIA
  • Coordinating BPCIA litigation with corresponding IPR/PGR petitions
    • Understanding when it makes sense to challenge patents in IPR or PGR proceedings in advance of BPCIA litigation