An Executive Discussion

The Present State of Paragraph IV Litigation and Its Impact on the Pharmaceutical Industry: Legal Analyses and Business Prognoses

April 29, 2019 8:15am

Charlotte Jacobsen
Partner
Ropes & Gray LLP (New York, NY)

Christina Schwarz
Partner
Venable LLP (New York, NY)

Lisa B. Pensabene
Partner
O’Melveny & Myers LLP (New York, NY)

Taras A. Gracey
Shareholder
Polsinelli PC (Chicago, IL)

  • Investigating the most popular districts, filing trends, settlements and timings
    • Examining how judicial shortages in key districts are impacting ANDA litigation and venue selection
    • Understanding how this is influencing PTAB filings
  • Analyzing the connection between recent Paragraph IV filings and the speed of ANDA approvals
  • Studying IPR outcomes of Orange Book patents and appreciating the correlation with District Court litigation
  • Exploring when settlement is considered as a favorable outcome in an IPR and its consequences for related District Court litigation
  • Understanding how ANDA litigation outcomes affect business forecasts in this next era of the patent cliff
  • Appreciating how Paragraph IV outcomes impact business decisions from, R&D to licensing, to M&A activity and beyond