Navigating the intricacies of biosimilar settlements and launches pursuant to the BPCIA requires a consideration of the Federal Trade Commission and legal concepts such as reasonable damages. Even outside of the BPCIA, the FTC and, to a lesser extent, the ITC, are keeping a close eye on mergers within biopharma and alleged antitrust and anticompetitive practices. In this comprehensive session, topics of discussion will include:

• Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages
• Applying that judicial cadence to your litigation or settlement strategy
• Learning the newest strategies for negotiating launch triggers and volume limitations in compliance with the law, avoiding costly litigation and associated penalties
• Reviewing the FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay Examining recent listing and relisting of drugs in the Orange Book
• Understanding how this is influencing the dynamics of drug patenting and market exclusivity
• Analyzing recent antitrust lawsuits in the life sciences on pricing strategies, anticompetitive behavior, and life cycle management
• Reviewing recent life sciences M&As that have been challenged by the FTC and DOJ