Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts

April 23, 2018 8:15am

Owen Byrd
Chief Evangelist and General Counsel
Lex Machina (Menlo Park, CA)

Benjamin A. Katzenellenbogen
Knobbe Martens (Irvine, CA)

John J. Molenda, Ph.D.
Steptoe & Johnson LLP (New York, NY)

Irena Royzman Ph.D.
Patterson Belknap Webb & Tyler LLP (New York, NY)

Paul Simboli
Depomed, Inc. (Newark, CA)

Jane M. Love
Gibson, Dunn & Crutcher LLP (New York, NY)


Mark E. Waddell
Co-Chair, Life Sciences; Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)

For the first time in three years, ANDA filings are on the decline. However, industry watchers believe that this trend will soon reverse itself. ANDA litigation is a unique beast and is unlike anything else that the patent bar deals with. This panel will consider the drivers behind this decrease in filings, as well as provide insights on why stakeholders believe that this decline will only be a short-lived phenomenon. Our speakers will also discuss current developments in and future forecasts for this distinct category of litigation. Points of discussion will include:

  • Analyzing the developments leading to the Paragraph IV litigation decline over the past 12 months
  • Understanding the correlation between Paragraph IV filings and the speed of ANDA approvals
  • Exploring the relationship between PDUFA, GDUFA and Paragraph IV filings
  • Examining ANDA filings in light of the patent cliff
  • Probing how changes in judiciary and Judges shortages in key jurisdictions have impacted trends in Paragraph IV litigation