Hatch-Waxman Disputes in District Court and at the PTAB: Strategic Considerations and Recent Developments

This program will focus on Hatch-Waxman litigation, which is a special species of patent litigation involving generic pharmaceutical challenges to innovator patents. Hatch-Waxman litigation has been around for almost four decades and has generated a well-developed body of case law in federal courts. More recently, generic challengers have begun to use the IPR process at the PTAB as an additional means to challenge innovator patents. Managing these parallel proceedings at the PTAB and in district court presents a specific set of challenges, opportunities, and strategic options for both patent owners and challengers. This is especially true given the statutory timelines mandated for Hatch-Waxman litigation (a 30-month stay of generic drug approval) and IPRs (18-months from filing). This course, presented by Travis Bliss, Erin Dunston, Phil Hirschhorn, and Aaron Pereira of Panitch Schwarze Belisario & Nadel LLP, will examine the practice and strategy of such parallel proceedings, and also discuss recent developments, trends, settlement issues, and other considerations for companies and counsel.

Learning Objectives:

1. Explore recent trends in Hatch-Waxman litigation 

2. Identify noteworthy updates on IPR practice at the PTAB

3. Examine the interplay between PTAB and district court in Hatch-Waxman cases

4. Discuss the Strategic use of parallel proceedings

5. Gain updates on settlements and so-called pay-for-delay agreements