ACI’s 22nd Annual Paragraph IV Disputes: Elevate Your 2026 Hatch-Waxman Strategy

Key Takeaways

• Event dates: April 21‑22, 2026, NYC
• Focus on Paragraph IV patent challenges under Hatch‑Waxman
• Speakers include FDA‑focused experts Kurt Karst, Maarika Kimbrell
• Offers 10% discount with code D10‑999‑FDA26
• Attendees gain insights on PTAB trends and case law

Pulse Analysis

Paragraph IV certifications remain a pivotal lever in the Hatch‑Waxman framework, allowing generic manufacturers to challenge brand‑name patents and accelerate market entry. Recent Supreme Court rulings and PTAB procedural shifts have heightened uncertainty around patent validity assessments, prompting both innovators and generics to refine litigation tactics. Understanding these dynamics is essential for firms aiming to protect exclusivity periods or capture early generic market share, especially as the FDA tightens its review standards for ANDA submissions.

The upcoming ACI conference offers a rare convergence of top litigators, in‑house counsel, and regulators. Sessions led by Kurt R. Karst and Maarika Kimbrell will dissect the latest FDA guidance, PTAB appeal trends, and emerging case law that could reshape Paragraph IV strategies. Beyond technical briefings, the event facilitates networking with decision‑makers who influence policy and adjudication, providing participants a platform to benchmark approaches against industry best practices and to anticipate regulatory pivots before they crystallize.

For pharmaceutical companies, the strategic takeaways from this forum can translate into measurable financial outcomes. Early insight into PTAB rulings enables more accurate forecasting of 180‑day exclusivity windows, while refined litigation strategies can reduce settlement costs and preserve market share. Moreover, aligning generic launch plans with evolving FDA expectations helps mitigate approval delays. By leveraging the conference’s expertise, firms can craft proactive Hatch‑Waxman roadmaps that balance risk, speed, and profitability in a competitive landscape.