Workshop B – Biosimilars 2.0 for the Paragraph IV Litigator

Apr 26, 2017 1:00pm - 4:30pm



Corey M. Casey
Polsinelli PC (Kansas City, MO)

Erin Ator Thomson
Vinson & Elkins LLP (Austin, TX )

What is it about?

Despite the fact that BPCIA litigation has been filed and that a few decisions have been rendered notably in one case, Amgen v. Sandoz, we are still only at the beginning of beginning.

In this hands-on session, we will walk you through the first of the biosimilars cases which have been filed and will also take a look at the approval process and other key points of regulation.

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:

  • Reviewing the BPCIA cases filed to date and analyzing the substantive arguments in the first cases
    • Sandoz v. Amgen
    • Celltrion v. Janssen
  • 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
  • Analyzing the use of PTO Proceedings in biosimilars litigation
  • Developing patent certainty: factoring the decisions in the BPCIA case into BLA versus biosimilar application analysis and into forum choice between District Courts, USPTO, and the ITC


* Luncheon will be served at 12:00 PM for delegates who are attending both Workshop A and Workshop B.