Workshops B | Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator

Apr 25, 2018 1:00pm – 4:00pm

Patricia A. Carson
Partner
Kirkland & Ellis LLP(New York, NY)

Robert V. Cerwinski
Partner
Goodwin Procter LLP

(Registration begins at 12:30 PM) In the landmark Amgen v. Sandoz decision, the Supreme Court granted more flexibility to biosimilar companies and filers of abbreviated biologics license applications.This intimate and interactive working group will examine the core components of the Court’s decision and provide an essential analysis of biosimilar litigation as well as the approval process and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:

LEGAL AND REGULATORY BACKGROUND:

  • Comparing and contrasting the biosimilar pathway to 505(b)(2) and BLA pathways
    • Determining whether research and development resources are best spent pursuing a biosimilar pathway or going the traditional BLA route
    • Breakdown of relevant considerations with each route including timing, costs, and IP litigation considerations, and exclusivity
  • Overview of the 2010 Biologics Price Competition and Innovation Act (BPCIA)
    • Exclusivity provisions
    • Criteria for biosimilarity and interchangeability
    • Clinical trials and safety studies
    • Patent litigation and exchange provisions: Understanding the major differences between
  • Hatch-Waxman and biosimilars litigation as outlined in the statute

LITIGATION UPDATE:

  • Review of Amgen v. Sandoz and its impact on other biosimilar cases currently being litigated
  • Exploring new strategies to engage in the patent dance in wake of the Supreme Court’s decision
  • Timing of patent filings: making the decision to file pre-suit, waiting out the lengthy legal process, or launching without the benefit of having discovery of the other party’s patents and legal positions
  • Evaluating the use of IPRs with biosimilars
  • Developing patent certainty
    • Factoring decisions in recent BPCIA cases into your overall patent validity analysis
    • BLA versus biosimilar application
    • Choosing between District Court, PTAB, and the ITC