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