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