Track 1: The Business of PIV Disputes — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge

• Conducting IP and economic due diligence assessments for brand name and generic manufacturers relative to such matters as NCE exclusivity, patent positions, screenings and alleged product hopping
• Factoring-in R&D considerations and market trends
• Analyzing available exclusivities, both regulatory and patent
• Assessing key litigation considerations and related costs for pharmaceutical patent challenges
• Considering the likelihood of victory at the District Court level and the PTAB on patent type and review of recent decisions
• Mastering the art of budgeting, forecasting, and aligning litigation costs to business goals
• Exploring cost saving options in litigation, including alternate billing, contingency clauses and outside funding
• Examining value of licensing deals and structures

Track 2: The Practice of PIV Disputes — Mastering the Use of Experts in Parallel Proceedings

• Developing strategies to use expert testimony to your advantage at both the District Court and the PTAB in a dual proceedings scenario
• Understanding the scope and limitations of expert testimony at the PTAB, and how this may impact the District Court proceeding
• Appreciating the nuances of expert depositions for PTAB and District Court proceedings
• Ensuring that your expert communicates properly for the requisite forum