Counting the Days—How Regulatory Exclusivity, PTE, PTA, and ODP Coalesce to Influence Lifecycle

Sterne Kessler’s Deborah Sterling, John Covert, and Dennies Varughese hosted an engaging webinar tailored for in‑house counsel, patent strategists, and business leaders. This session moved beyond doctrine to explore how early prosecution decisions, mid-stage portfolio management, and late-stage regulatory choices work together to shape a product’s true exclusivity horizon.

Attendees gained practical guidance on:

• Determining when PTA meaningfully adds enforceable life—and when it may not
• Understanding how ODP reshapes patent families long before litigation begins
• Selecting PTE patents strategically in light of irreversible choices and ODP vulnerability
• Coordinating FDA-awarded exclusivities with patent strategy
• Avoiding common lifecycle planning mistakes that may undermine exclusivity late in the product timeline