Paragraph IV Disputes

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

Wednesday, April 30, 2008

About

With almost $85 billion in product sales currently subjected to Paragraph IV litigation, it is imperative that both brand and generic companies, and their counsel, have the offensive moves and defensive plays they respectively need in this high stakes arena of pharmaceutical patent endgame litigation.

Both branded and generic companies need to assess the risks and benefits of Paragraph IV challenges early on and make business decisions about potential litigation strategies accordingly. Evolving obviousness standards and new CAFC cases have only added to already strategically complex and costly litigation. In addition, the FTC’s stance on settlements in this area complicates matters even further as settlement options are limited and potentially subject to antitrust liability. Finally, convoluted statutory guidelines on forfeiture and other regulatory provisions may change the way companies approach the litigation overall.

ACI’s publication from Paragraph IV Disputes offers both brand name and generic companies practical knowledge and insights from top-notch faculty on every facet of Paragraph IV litigation, from pre-litigation concerns to the commencement of the suit to final adjudication – and every step in between.

Contents & Contributors

About

With almost $85 billion in product sales currently subjected to Paragraph IV litigation, it is imperative that both brand and generic companies, and their counsel, have the offensive moves and defensive plays they respectively need in this high stakes arena of pharmaceutical patent endgame litigation.

Both branded and generic companies need to assess the risks and benefits of Paragraph IV challenges early on and make business decisions about potential litigation strategies accordingly. Evolving obviousness standards and new CAFC cases have only added to already strategically complex and costly litigation. In addition, the FTC’s stance on settlements in this area complicates matters even further as settlement options are limited and potentially subject to antitrust liability. Finally, convoluted statutory guidelines on forfeiture and other regulatory provisions may change the way companies approach the litigation overall.

ACI’s publication from Paragraph IV Disputes offers both brand name and generic companies practical knowledge and insights from top-notch faculty on every facet of Paragraph IV litigation, from pre-litigation concerns to the commencement of the suit 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)

DUE DILIGENCE STRATEGIES FOR THE BRANDED SIDE
Thomas H. Beck, Sidley Austin LLP (New York, NY)

DUE DILIGENCE IN ANTICIPATION OF A PARAGRAPH IV CHALLENGE— REGULATORY CONSIDERATIONS
Donald O. Beers, Arnold & Porter LLP (Washington, DC)

ANDA PRE-FILING CONSIDERATIONS
Shashank Upadhye, Apotex, Inc. (Toronto, ON)

“PRE-LITIGATION” PATENT STRATEGY FOR GENERIC DRUG MANUFACTURERS
Richard J. Berman, Arent Fox LLP (Washington, DC)

KSR IN ANDA CASES
Mark Rachlin, GlaxoSmithKline (King of Prussia, PA)

KSR ONE YEAR LATER: RETHINKING PARAGRAPH IV CHALLENGES IN VIEW OF SHIFTING OBVIOUSNESS STANDARDS
Duane-David Hough, Fish & Richardson P.C. (New York, NY)

THROWING DOWN THE GAUNTLET: THE PARAGRAPH IV NOTICE LETTER – DELIVERY AND RECEIPT
Eric J. Marandett, Choate Hall & Stewart, LLP (Boston, MA)

THROWING DOWN THE GAUNTLET: THE PARAGRAPH IV NOTICE LETTER – DELIVERY AND RECEIPT
Steven H. Sklar, Leydig, Voit & Mayer, Ltd. (Chicago, IL)

PRE-TRIAL FILING CHALLENGES
Denise L. Loring, Ropes & Gray, LLP (New York, NY)

LITIGATING WITH MULTIPLE ANDA FILERS: BRAND NAME AND GENERIC PERSPECTIVES
Sandra A. Bresnick, Sidley Austin LLP (New York, NY) Christopher N. Sipes, Covington & Burling LLP (Washington, DC)

ANTITRUST CONCERNS WHEN SETTLING A PARAGRAPH IV ACTION
Markus H. Meier, Federal Trade Commission (Washington, DC)

MITIGATING ANTITRUST CONCERNS WHEN SETTLING A PARAGRAPH IV ACTION
Seth C. Silber, Wilson Sonsini Goodrich & Rosati (Washington, DC)

DOCUMENTS, EXPERTS AND PRIVILEGE: THE INNOVATOR PERSPECTIVE
Philip L. Hirschhorn, Morgan, Lewis & Bockius LLP (New York, NY)

DISCOVERY AND OTHER ISSUES IN PARAGRAPH IV DISPUTES
Glen P. Belvis, Brinks Hofer Gilson & Lione (Chicago, IL)

INEQUITABLE CONDUCT: THE PLAGUE CONTINUES!
Brian D. Coggio, Fish & Richardson P.C. (New York, NY)

IDENTIFYING AND ANALYZING HOW THE LATEST TRENDS IN CAFC DECISIONS, PTO RULES AND PATENT REFORM LEGISLATION IMPACT PARAGRAPH IV MOTION PRACTICE AND LITIGATION STRATEGIES
Madison Jellins, Townsend & Townsend & Crew LLP (Palo Alto, CA)

UPDATE ON PROPOSED PTO RULES AND THE PATENT REFORM ACT
Renee Kosslak, PhD, PDL BioPharma, Inc. (Redwood City, CA)

MASTERING THE INTERPLAY BETWEEN 180-DAY EXCLUSIVITY, FORFEITURE PROVISIONS AND PARAGRAPH IV LITIGATION
William D. Hare, Concentrx BioSciences, Inc. (Princeton, NJ)

MASTERING THE INTERPLAY BETWEEN 180-DAY EXCLUSIVITY, FORFEITURE PROVISIONS AND PARAGRAPH IV LITIGATION
Stephen R. Auten, Sandoz, Inc. (Princeton, NJ)

PRELIMINARY INJUNCTION MOTIONS: THE OPPORTUNITIES AND RISKS FACING GENERICS
James K. Stronski, Frommer Lawrence & Haug LLP (New York, NY)

MANAGING THE RISKS ASSOCIATED WITH INJUNCTIONS AND AT-RISK LAUNCHES DURING LITIGATION AND APPEAL
John Murnane, Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Joanna Garelick, Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Presented by: Lisa Barons Pensabene, Fitzpatrick, Cella, Harper & Scinto (New York, NY)

THE BRANDED PERSPECTIVE ON PARAGRAPH IV DISPUTES
Lisa A. Jakob, Schering-Plough Corp. (Kenilworth, NJ)

THE COMPANY PERSPECTIVE ON PARAGRAPH IV DISPUTES
Stuart A. Williams, Wilson Sonsini Goodrich & Rosati (New York, NY)



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