Paragraph IV Disputes

Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics

Monday, April 23, 2007

About

The Complete Hatch-Waxman Litigation Playbook for Brand Names and Generics

A Paragraph IV challenge is the ultimate Hatch-Waxman face-off in which a brand name and generic drug maker battle it out to preserve or shrink patent life and market share. These are strange lawsuits in which the roles and behaviors of plaintiff and defendant often seem reversed due to requisite maneuvering in a complex statutory rubric.

The Hatch-Waxman reforms of the MMA and the tough stance of the FTC with respect to the settlement of Paragraph IV cases have made this litigation more strategically complex and more costly. The threat of proposed legislation, which may make settlement of these matters near impossible – let alone illegal – not only adds to this complexity, but also raises the monetary stakes of this litigation to unprecedented heights.

It is imperative that brand name or generic pharmaceutical companies, and their counsel, have the offensive moves and defensive plays that they respectively need in this high stakes arena of pharmaceutical patent endgame litigation. ACI’s Paragraph IV Disputes publication has been designed to give counsel for both brand name and generic companies the critical up-to-the minute information that they need to plan their Hatch-Waxman litigation strategies.

Just as ACI’s publication on Maximizing Pharmaceutical Patent Life Cycles has become the industry’s most trusted source of information for the legal issues surrounding patent life cycle management, this new ACI event will become the source for the ins and outs of Paragraph IV litigation. An experienced faculty comprised of respected and renowned counsel for both brand name and generic pharmaceutical companies will provide insights on every facet of Paragraph IV litigation from pre-litigation concerns to the commencement of suit through to final adjudication – and every step in between.

Contents & Contributors

About

The Complete Hatch-Waxman Litigation Playbook for Brand Names and Generics

A Paragraph IV challenge is the ultimate Hatch-Waxman face-off in which a brand name and generic drug maker battle it out to preserve or shrink patent life and market share. These are strange lawsuits in which the roles and behaviors of plaintiff and defendant often seem reversed due to requisite maneuvering in a complex statutory rubric.

The Hatch-Waxman reforms of the MMA and the tough stance of the FTC with respect to the settlement of Paragraph IV cases have made this litigation more strategically complex and more costly. The threat of proposed legislation, which may make settlement of these matters near impossible – let alone illegal – not only adds to this complexity, but also raises the monetary stakes of this litigation to unprecedented heights.

It is imperative that brand name or generic pharmaceutical companies, and their counsel, have the offensive moves and defensive plays that they respectively need in this high stakes arena of pharmaceutical patent endgame litigation. ACI’s Paragraph IV Disputes publication has been designed to give counsel for both brand name and generic companies the critical up-to-the minute information that they need to plan their Hatch-Waxman litigation strategies.

Just as ACI’s publication on Maximizing Pharmaceutical Patent Life Cycles has become the industry’s most trusted source of information for the legal issues surrounding patent life cycle management, this new ACI event will become the source for the ins and outs of Paragraph IV litigation. An experienced faculty comprised of respected and renowned counsel for both brand name and generic pharmaceutical companies will provide insights on every facet of Paragraph IV litigation from pre-litigation concerns to the commencement of suit through to final adjudication – and every step in between.

Contents & Contributors

Co–Chairs’ Opening Remarks
Brian P. Murphy, Morgan Lewis & Bockius LLP (New York, NY)
Barry S. White, Frommer, Lawrence & Haug LLP (New York, NY)

Pre-Suit Due Diligence: Anticipating the Paragraph IV Challenge
Thomas H. Beck, Sidley Austin LLP (New York, NY)
Denise Loring, The Fish & Neave IP Group of Ropes & Gray LLP (New York, NY)

Throwing Down the Gauntlet: The Paragraph IV Notice Letter—Delivery and Receipt
Bartholomew Verdirame, Morgan & Finnegan, LLP (New York, NY)

The Start of a Paragraph IV Law Suit
Brian D. Coggio, Greenberg Traurig, LLP (New York, NY)

Litigating With Multiple ANDA Filers: Brand Name and Generic Perspectives
Sandra A. Bresnick, Sidley Austin LLP (New York, NY)

Litigating With Multiple ANDA Filers: Brand Name and Generic Perspectives
Sandra Kuzmich Ph.D., Frommer, Lawrence & Haug LLP (New York, NY)

Discovery in Paragraph IV Matters: Documents, Experts And Privilege - The Generic Perspective
Janine A. Carlan, Arent Fox LLP, (Washington, DC)

Paragraph IV Discovery: Documents, Experts and Privilege – The Innovator Perspective
Philip L. Hirschhorn, Morgan, Lewis & Bockius LLP (New York, NY)



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