Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements

June 29, 2022 10:30am

Sarah Abraham
Manager
Cornerstone Research

Orion Armon
Partner
Cooley LLP

Evan Diamond
Partner
King & Spalding LLP

Steven R. Trybus
Partner
Locke Lord LLP

Antitrust enforcement is routinely triggered via the approval of a biosimilar. Many believe that anti-competitive behavior exhibited by reference products represents the most formidable barrier to entry. In response, FDA and FTC recently issued a joint statement regarding a collaboration to advance competition in the biologic marketplace. Complicating matters further, several states have enacted laws meant to curb reverse-payment patent settlements – with no comparable statute at the federal level. This session will consider the economic implications of biosimilar reverse payment litigation, the competitive effects, and economic damages. Topics of discussion will include:

  • Assessing whether developing a patent thicket is an antitrust violation
    • UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020)
      • Reviewing what is deemed “anti-competitive activities”
  • Do you need to prove that all the patents in the ‘thicket’ around a drug are invalid?
  • Reviewing the proper standards of antitrust review and the rising call for a legislative response
    • Analyzing the current legislative and regulatory framework
    • Mergers, acquisitions and exclusive licenses
    • Anticompetitive agreements
    • Abuse of dominance
    • Life cycle management and contracting
    • Pricing strategies
  • Avoiding costly litigation and associated penalties by effectively complying with the law