3rd Annual Paragraph IV Disputes

Monday, April 27, 2009

About

With 549 ANDA’s containing Paragraph IV Certifications currently pending before the Office of Generic Drugs, patent litigators on both sides, must be acutely attuned to what their opponent’s next move maybe in order to achieve success at trial. Several changes have taken place in the past few months that will have an impact on Paragraph IV litigation in 2009. With a new administration taking office, bringing with it different priorities for patent reform legislation and market exclusivity for brand name products, this event is the one forum both brand name and generic litigation counsel can attend to obtain the latest updates on issues affecting the outcome of Paragraph IV disputes.

Litigating in an environment where a conflicting standard continuesto persist on the issue of reverse payment settlements and aconvoluted MMA structure provides the last say on forfeiture,Paragraph IV challenges have become more costly and complex in recent years.

ACI’s Paragraph IV Disputes conference has gained a reputation as THE event for Hatch-Waxman litigators representing both brand name and generic companies to gain insights into the most current issues affecting Paragraph IV litigation, discussing everything from pre-litigation due diligence strategies to at risk launches – and every step in between.Also, to gain in-depth insights into the unique issues presented by settlement agreements and the antitrust issues they raise, add value to your attendance by joining us at the Advanced Master Class on Obtaining Optimal Terms and Mitigating Antitrust Concerns When Settling Paragraph IV Disputes: Brand Name and Generic Perspectives.In this high-stakes, high-risk litigation, you cannot afford to make the wrong move. Learn what strategies you can implore to ensure your success at trial!

Contents & Contributors

About

With 549 ANDA’s containing Paragraph IV Certifications currently pending before the Office of Generic Drugs, patent litigators on both sides, must be acutely attuned to what their opponent’s next move maybe in order to achieve success at trial. Several changes have taken place in the past few months that will have an impact on Paragraph IV litigation in 2009. With a new administration taking office, bringing with it different priorities for patent reform legislation and market exclusivity for brand name products, this event is the one forum both brand name and generic litigation counsel can attend to obtain the latest updates on issues affecting the outcome of Paragraph IV disputes.

Litigating in an environment where a conflicting standard continuesto persist on the issue of reverse payment settlements and aconvoluted MMA structure provides the last say on forfeiture,Paragraph IV challenges have become more costly and complex in recent years.

ACI’s Paragraph IV Disputes conference has gained a reputation as THE event for Hatch-Waxman litigators representing both brand name and generic companies to gain insights into the most current issues affecting Paragraph IV litigation, discussing everything from pre-litigation due diligence strategies to at risk launches – and every step in between.Also, to gain in-depth insights into the unique issues presented by settlement agreements and the antitrust issues they raise, add value to your attendance by joining us at the Advanced Master Class on Obtaining Optimal Terms and Mitigating Antitrust Concerns When Settling Paragraph IV Disputes: Brand Name and Generic Perspectives.In this high-stakes, high-risk litigation, you cannot afford to make the wrong move. Learn what strategies you can implore to ensure your success at trial!

Contents & Contributors

Co-Chairs’ Opening Remarks
Brian P. Murphy, Partner & Deputy Practice Group Leader, Patent Litigation Group, Morgan Lewis & Bockius LLP (New York, NY)
Barry S. White, Partner, Frommer, Lawrence & Haug LLP (New York, NY)

FOCUS ON PRE-SUIT DUE DILIGENCE
Pre-Litigation Tactics for Evaluating Patent Strength, Orange Book Listing and Assertion Strategies Brand Name Considerations – Anticipating and Preparing for a Paragraph IV Challenge
Reem Jishi, Vice President & Deputy Chief Patent Counsel Wyeth (Madison, NJ)
Basil (Bill) J. Lewris, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)

Generic Considerations – Making the Decision to Certify Paragraph IV

Steven H. Sklar, Member, Leydig, Voit & Mayer, Ltd. (Chicago, IL)

Issuing the Challenge and Coordinating a Response: The Paragraph IV Notice Letter
For Brand Name
Dianne B. Elderkin, Chair, Litigation Services Practice Group Woodcock Washburn LLP (Philadelphia, PA)
For Generic
Shashank Upadhye, Global Head of I.P. Apotex, Inc. (Toronto, ON)

Factoring Recent Local Patent Rule Changes, Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
Lisa A. Jakob, Legal Director, Patents, Schering-Plough Corporation (Kenilworth, NJ)
Steven J. Moore, Partner, Kelley Drye & Warren LLP (Stamford, CT)

Positioning Your Patent/Product for Success at Trial: Crafting the Initial Pleadings, Seeking Declaratory Judgment and Managing the Markman Hearing

James H. Wallace, Jr., Chair, Intellectual Property Patent Group, Wiley Rein LLP (Washington, DC)
Eric J. Marandett, Chair, Intellectual Property Litigation Group, Choate Hall & Stewart LLP (Boston, MA)

Litigating with Multiple ANDA Filers: Considerations for Managing Multiple Parties During Paragraph IV Disputes
For Brand Name
Lisa M. Ferri, Partner, McDermott Will & Emery (New York, NY)
For Generic
Meg Snowden, VP, Intellectual Property, Impax Laboratories, Inc.(Hayward, CA)

FTC Address: The Law of Hatch-Waxman Patent Infringement Settlements and Where It Is Going
Markus H. Meier, Assistant Director of the Healthcare Services and Products Division, Bureau of Competition, Federal Trade Commission (Washington, DC)

Overseeing Discovery and Expert Witness Selection Before and During Paragraph IV Litigation: Reducing Costs While Maintaining Control Over the Process
William R. Golden, Jr., Chair, Intellectual Property & Technology Litigation Practice Group, Kelley Drye & Warren LLP (New York, NY)
Brian D. Coggio, Senior Counsel, Fish & Richardson, P.C. (New York, NY)

Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizens Petitions and Paragraph IV Litigation
Stephen R. Auten, Vice President, Intellectual Property, Sandoz, Inc. (Princeton, NJ)
Moderator:
Chad A. Landmon, Partner, Axinn Veltrop Harkrider LLP (Hartford, CT)

Ethical Dilemmas, Confidentiality and Privilege to Avoid When Overseeing and Litigating a Paragraph IV Dispute
Glen P. Belvis, Chair, Interference Practice Group, Brinks Hofer Gilson & Lione (Chicago, IL)

Minimizing Downstream Risk and Calculating Damages Associated with Preliminary Injunctions and At Risk Launches
Nicholas Groombridge, Chair, Patent Litigation Group, Weil, Gotshal & Manges LLP (New York, NY)


DOCUMENT TYPES: PPT PDF PRESENTATIONS AVAILABLE: 20

7:30
Registration and Continental Breakfast
8:00
Co-Chairs' Opening Remarks
Brian Murphy, Esq.
Partner
Edwards Angell Palmer and Dodge LLP
1 file
Paragraph IV
6.9 MB 11 pages Presentation
PPT - Paragraph IV
-Mr. Barry S. S. White
Partner
Frommer Lawrence & Haug LLP
1 file
Paragraph IV
8.8 MB 20 pages Presentation
PPT - Paragraph IV
8:15
Brand Name Considerations - Anticipating and Preparing for a Paragraph IV Challenge
Ms. Reem Jishi
Vice President & Deputy Chief Patent Counsel
Wyeth
1 file
Anticipating and Preparing for a Paragraph IV Challenge
214.9 KB 22 pages Presentation
PDF - Anticipating and Preparing for a Paragraph IV Challenge
Mr. Basil (Bill) J. J. Lewris
Partner
Finnegan‚ Henderson‚ Farabow‚ Garrett & Dunner‚ LLP
1 file
Anticipating and Preparing for a Paragraph IV Challenge
214.9 KB 22 pages Presentation
PDF - Anticipating and Preparing for a Paragraph IV Challenge
9:00
Generic Considerations - Making the Decision to Certify Paragraph IV
Mr. Steven H. Sklar
Member
Leydig‚ Voit & Mayer‚ Ltd.
1 file
PARAGRAPH IV DISPUTES
1.4 MB 25 pages Presentation
PPT - PARAGRAPH IV DISPUTES
9:45
Morning Refreshment Break
10:00
Issuing the Challenge and Coordinating a Response: The Paragraph IV Notice Letter
Ms. Dianne B. B. Elderkin
Partner
Woodcock Washburn LLP
1 file
Responding to the Paragraph IV Notice Letter
254 KB 18 pages Presentation
PPT - Responding to the Paragraph IV Notice Letter
Mr. Shashank Upadhye
Lawyer & Pharma Executive
1 file
Paragraph IV Notice Letter – The Generic View of the Notice Letter
714.9 KB 43 pages Presentation
PDF - Paragraph IV Notice Letter – The Generic View of the Notice Letter
11:30
Factoring Recent Local Patent Rule Changes‚ Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company
1 file
Factoring Recent Local Patent Rule Changes, Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
538.5 KB 30 pages Presentation
PPT - Factoring Recent Local Patent Rule Changes, Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
Steven J. Moore
Partner
Kelley Drye & Warren LLP
2 files
FACTORING RECENT LOCAL PATENT RULE CHANGES, JURISDICTIONAL CONSIDERATIONS AND PATENT REFORM LEGISLATION
73.1 KB 10 pages Presentation
PDF - FACTORING RECENT LOCAL PATENT RULE CHANGES, JURISDICTIONAL CONSIDERATIONS AND PATENT REFORM LEGISLATION
Factoring Recent Local Patent Rule Changes, Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
538.5 KB 30 pages Presentation
PPT - Factoring Recent Local Patent Rule Changes, Jurisdictional Considerations and Patent Reform Legislation into Your Litigation Strategy
12:30
Networking Lunch Hosted by White and Case LLP
13:30
Positioning Your Patent/Product for Success at Trial: Crafting the Initial Pleadings‚ Seeking Declaratory Judgment and Managing the Markman Hearing
Mr. -James Wallace
Partner
Wiley Rein LLP
1 file
Positioning Your Patent/Product for Success at Trial -- The Generic Prospective
553.3 KB 25 pages Presentation
PDF - Positioning Your Patent/Product for Success at Trial -- The Generic Prospective
Mr. Eric J. J. Marandett
Practice Group Leader
Choate Hall & Stewart‚ LLP
1 file
Positioning Your Patent/Product for Success at Trial: Crafting Initial Pleadings, Seeking Declaratory Judgment and Managing the Markman Hearing
197.5 KB 13 pages Presentation
PPT - Positioning Your Patent/Product for Success at Trial:Crafting Initial Pleadings, Seeking Declaratory Judgment and Managing the Markman Hearing
-Teresa Stanek Rea, Esq.
Partner
Crowell & Moring LLP
14:30
Afternoon Coffee Break
14:45
Litigating with Multiple ANDA Filers: Considerations for Managing Multiple Parties During Paragraph IV Disputes
- Lisa M. Ferri, Esq.
Partner
Mayer Brown LLP
1 file
Litigating with Multiple ANDA Filers: The Brand Name Perspective
1.5 MB 26 pages Presentation
PPT - Litigating with Multiple ANDA Filers: The Brand Name Perspective
-Ms. Margaret (Meg) Snowden
VP, Intellectual Property
Impax Laboratories, Inc.
1 file
Paragraph IV Disputes Litigating with Multiple ANDA Filers: Generic Perspective
231.5 KB 20 pages Presentation
PPT - Paragraph IV DisputesLitigating with Multiple ANDA Filers:Generic Perspective
16:15
View from the Bench: Judge's Roundtable on Paragraph IV Litigation
Hon. John C. C. Lifland
U.S. District Judge (Ret.)
JAMS‚ The Resolution Experts
The Honorable Tonianne J. Bongiovanni
Magistrate Judge
United States Federal District Court, District of New Jersey
Brian Murphy, Esq.
Partner
Edwards Angell Palmer and Dodge LLP
-Mr. Barry S. S. White
Partner
Frommer Lawrence & Haug LLP
17:30
Cocktail Reception Hosted by: FROMMER LAWRENCE & HAUG LLP
8:00
Continental Breakfast
8:30
Co-Chairs' Recap of Day One
8:45
FTC Address: The Law of Hatch-Waxman Patent Infringement Settlements and Where It Is Going
Markus H. Meier
Assistant Director of the Health Care Division
Bureau of Competition, Federal Trade Commission
1 file
FTC Briefing on Pharmaceutical “Pay-for-Delay” Settlements
462 KB 25 pages Presentation
PPT - FTC Briefing on Pharmaceutical “Pay-for-Delay” Settlements
9:45
Overseeing Discovery and Expert Witness Selection Before and During Paragraph IV Litigation: Reducing Costs While Maintaining Control Over the Process
Mr. William Golden, Jr.
Partner
Kelley Drye & Warren LLP
1 file
THE USE AND ABUSE OF EXPERTS IN “ORANGE BOOK” LITIGATION
251.5 KB 35 pages Presentation
PPT - THE USE AND ABUSE OF EXPERTS IN “ORANGE BOOK” LITIGATION
-Brian Coggio
Senior Principal
Fish & Richardson‚ P.C.
1 file
Overseeing Discovery Before And During Paragraph IV Litigation: Reducing Costs While Maintaining Control Over The Process
559.5 KB 28 pages Presentation
PPT - Overseeing Discovery Before And During Paragraph IV Litigation:   Reducing Costs While Maintaining Control Over The Process
11:00
Morning Refreshment Break
11:15
Mastering the Interplay Between 180-Day Exclusivity‚ Forfeiture Provisions‚ Citizens Petitions and Paragraph IV Litigation
- Timothy X. Witkowski, Esq.
Executive Director & Executive Counsel‚ Intellectual Property‚ Legal Department
Boehringer Ingelheim Pharmaceuticals‚ Inc.
1 file
Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizen Petitions and Paragraph IV Litigation
774.5 KB 12 pages Presentation
PPT - Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizen Petitions and Paragraph IV Litigation
Mr. Stephen R. Auten
Patent Attorney
Formerly VP, IP Sandoz, INC.
1 file
Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizens Petitions and Paragraph IV Litigation
538.5 KB 26 pages Presentation
PPT - Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizens Petitions and Paragraph IV Litigation
Chad A. Landmon
Partner
Axinn Veltrop & Harkrider LLP
2 files
Bioequivalence - What Patent Lawyers Need To Know
1.5 MB 33 pages Presentation
PPT - Bioequivalence -  What Patent Lawyers Need To Know
Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizen Petitions and Paragraph IV Litigation
774.5 KB 12 pages Presentation
PPT - Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, Citizen Petitions and Paragraph IV Litigation
12:45
Networking Lunch
13:45
Ethical Dilemmas‚ Confidentiality and Privilege to Avoid When Overseeing and Litigating a Paragraph IV Dispute
Mr. Glen P. P. Belvis
Shareholder
Brinks Hofer Gilson & Lione
1 file
Attorney-Client Privilege in General
1 MB 51 pages Presentation
PPT - Attorney-Client Privilege in General
14:45
Afternoon Coffee Break
15:00
Minimizing Downstream Risk and Calculating Damages Associated with Preliminary Injunctions and At Risk Launches
Mr. Nicholas Groombridge
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP
1 file
Preliminary Injunctions, At-Risk Launches and the Emerging Doctrine of Damages in ANDA Litigation
618 KB 20 pages Presentation
PPT - Preliminary Injunctions, At-Risk Launches and the Emerging Doctrine of Damages in ANDA Litigation
Mr. Stuart A. A. Williams
Partner
Wilson Sonsini Goodrich & Rosati
16:00
Conference Concludes