Workshop B – Biosimilars 2.0 for the Paragraph IV Litigator
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
- 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.