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

• IP and economic assessments on product selection and defense
• Factoring-in R&D considerations and market trends
• Analyzing available exclusivities, both regulatory and patent
• Assessing key litigation considerations and related costs
• Considering the likelihood of victory depending on patent type
• Budgeting, forecasting, and aligning litigation costs to business goals
• Exploring cost saving options in litigation
• Examining value of licensing deals and structures

Track 2 — Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity

• Reviewing FDA’s citizen petition processes and protocols
• Understanding the criteria FDA considers when evaluating a petition
• How does FDA determine the petition’s primary purpose was to delay?
• Analyzing market exclusivities to be addressed in the petition
• Detailing what should be included and what the process entails
• Taking stock of recent decisions involving Citizens Petitions
• Best practices for the reconsideration process and litigation