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Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator

Kevin E. Noonan, Ph.D.October 1, 20189:00 am - 12:00 pm

MBHB partner Kevin Noonan, Ph.D. is a featured presenter at the American Conference Institute’s Paragraph IV Disputes Master Symposium for a workshop entitled “Biosimilar Litigation Boot Camp for the Hatch- Waxman Litigator,” which is set for 9:00 a.m. to 12:00 p.m. on Oct. 1, 2018 in Chicago.

About the Workshop

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

View details here