The Second Paragraph IV Litigation Strategy Congress

Katten is pleased to sponsor The Second Paragraph IV Litigation Strategy Congress, which will address the unique litigation challenges presented by the Hatch-Waxman Paragraph IV dispute mechanism. In-house counsel representing both brand name and generic manufacturers will share firsthand insights and proven litigation strategies for Paragraph IV disputes.

Partner Brian Sodikoff will moderate the panel discussion "Key Takeaways for Brand and Generic Drug Manufacturers From Recent Case Law" at 9:00 a.m. on Wednesday, October 29. The session will explore key case law decisions from the past year at both the Federal Circuit and District Court levels involving Paragraph IV disputes.

Also on Wednesday, partner Craig Kuchii will participate in the panel discussion "Evaluating the Emerging Impact of Parallel PTO Proceedings on the Procedural Dynamics of Hatch-Waxman Litigation" at 1:30 p.m. The session will review the impact of newly established and updated USPTO procedures for re-evaluating and challenging patents that are leading to claims before the Patent Trial and Appeals Board in which brand name and generic drug manufacturers seek a second look at their most hotly contested IP rights. Panelists will also address how the interjection of these new PTO proceedings are adding yet another layer of complexity to the already complicated landscape of District Court and Federal Circuit litigation under Paragraph IV.

Partner Stephen Benson will present "Avoiding or Triggering Forfeiture Events in Hatch-Waxman Litigation Involving Multiple ANDA Filers" at 10:00 a.m. on Thursday, October 30. Stephen will address the following topics:

• strategies for preserving your position and obtaining the desired result when multiple ANDA filers are involved;
• dissecting triggering circumstances for the forfeiture provisions and the impact on litigation of later filers;
• addressing relinquishment and waiver; and
• patent delisting and forfeiture – where the two roads intersect.