Speakers

Co-Chairs

Stephanie Donahue

Principal Counsel, Patent Litigation
Sanofi- Aventis

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

Pearl T. L. Siew

Senior Vice President and Head, Intellectual Property
Eagle Pharmaceuticals, Inc.

Co-Chairs’ Opening Remarks

October 7, 2020 • 8:00 am

United States District Court

Honorable Christopher J. Burke

Magistrate Judge
District of Delaware

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Practical Strategies and Tactics for Effective Settlement Negotiation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Appreciating the Magistrate’s Role in Settlement Discussions

October 6, 2020 • 4:20 pm

Honorable Tonianne J. Bongiovanni

Magistrate Judge
District of New Jersey

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Understanding and Harnessing the Nuances of Local Rules

October 6, 2020 • 2:25 pm

Honorable Roy Payne

Magistrate Judge
Eastern District of Texas

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Effectively Managing Global Pharmaceutical Patent Litigation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Evaluating the Effectiveness of Summary Judgment in Different Venues

October 6, 2020 • 4:15 pm

Honorable Teresa Rea

Partner
Crowell & Moring LLP
Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation

October 7, 2020 • 11:25 am

Honorable Leonard P. Stark

Chief Judge
District of Delaware

And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge

October 6, 2020 • 10:25 am

Honorable Mary Pat Thynge

Chief Magistrate Judge
District of Delaware

And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge

October 6, 2020 • 10:25 am

U.S.P.T.O's Patent Trial and Appeal Board

Honorable Jacqueline Wright Bonilla

Vice Chief, Administrative Patent Judge

PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers

October 6, 2020 • 5:00 pm

Honorable Michelle N. Ankenbrand

Lead Administrative Patent Judge

PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers

October 6, 2020 • 5:00 pm

Honorable Kristi Rupert Sawert

Administrative Patent Judge

PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers

October 6, 2020 • 5:00 pm

Government

Markus H. Meier

Assistant Director, Health Care Division, Bureau of Competition
U.S. Federal Trade Commission

FTC KEYNOTE: Antitrust Developments Impacting Brands and Generics

October 7, 2020 • 11:55 am

Grail Sipes

Deputy Center Director for Regulatory Policy, CDER

FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities

October 7, 2020 • 1:30 pm

Maryll Toufanian

Director, Office of Generic Drug Policy, CDER
U.S. Food & Drug Administration

FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities

October 7, 2020 • 1:30 pm

In-House Counsel

Karen E. Brown

Senior Vice President, Intellectual Property and Legal Affairs
Obsidian Therapeutics, Inc.

Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry

October 6, 2020 • 1:10 pm

Neal Dahiya

Assistant General Counsel – Patents
Bristol-Myers Squibb

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Practical Strategies and Tactics for Effective Settlement Negotiation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Appreciating the Magistrate’s Role in Settlement Discussions

October 6, 2020 • 4:20 pm

Maureen Bresnahan

Assistant General Counsel, Legal Department
Eisai, Inc.

The Continuing §101 Saga: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies

October 6, 2020 • 9:00 am

Stephanie Donahue

Principal Counsel, Patent Litigation
Sanofi- Aventis

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

Henry Gu

Vice President, Chief IP Counsel
Akebia Therapeutics

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Effectively Managing Global Pharmaceutical Patent Litigation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Evaluating the Effectiveness of Summary Judgment in Different Venues

October 6, 2020 • 4:15 pm

Rekha Hanu, Ph.D, J.D

Executive Director, Chief IP Counsel
Akorn Pharmaceuticals

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation

October 7, 2020 • 11:25 am

Donna Meuth

Associate General Counsel, IP
Eisai

New Studies in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations

October 7, 2020 • 3:00 pm

Mary Morry

Counsel
Merck & Company

The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies

October 6, 2020 • 11:10 am

Brian Stone

Vice President Assistant Global General Counsel Regulatory
Mylan

FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities

October 7, 2020 • 1:30 pm

Lars Taavola

VP, Chief Intellectual Property Counsel
Mallinckrodt Pharmaceuticals

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Practical Strategies and Tactics for Effective Settlement Negotiation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Appreciating the Magistrate’s Role in Settlement Discussions

October 6, 2020 • 4:20 pm

Kevin Zive

Vice President – Global Intellectual Property and Legal Affairs
Apotex Inc.

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

TRACK D: Devising Strategies for Proving Infringement and Defending Validity
Devising Novel Strategies for Proving Infringement and Defending Validity

October 7, 2020 • 9:15 am

Law Firms

Takanori Abe

Founder
Abe & Partners

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Effectively Managing Global Pharmaceutical Patent Litigation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Evaluating the Effectiveness of Summary Judgment in Different Venues

October 6, 2020 • 4:15 pm

David B. Abramowitz

Partner
Locke Lord LLP

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Understanding and Harnessing the Nuances of Local Rules

October 6, 2020 • 2:25 pm

Andrew J. Allen

Senior Director, Legal Counsel – IP
Dr. Reddy’s

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

John Bennett

Partner
Goodwin Procter LLP

Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry

October 6, 2020 • 1:10 pm

Aziz Burgy

Axinn, Veltrop & Harkrider LLP

Jonathan S. Caplan

Partner, Co-Chair, Intellectual Property
Kramer Levin Naftalis & Frankel LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation

October 7, 2020 • 11:25 am

Kathleen B. Carr

Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

New Studies in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations

October 7, 2020 • 3:00 pm

Alan B. Clement

Partner
Locke Lord LLP

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Practical Strategies and Tactics for Effective Settlement Negotiation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Appreciating the Magistrate’s Role in Settlement Discussions

October 6, 2020 • 4:20 pm

David G. Conlin

Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

ETHICS DRILLS: Ethics and New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

October 7, 2020 • 3:45 pm

Evan Diamond

Partner
King & Spalding LLP

Paragraph IV State of the Union: Developing a New Game Plan for the New Normal: Assessing Legal, Regulatory, and Jurisprudential Developments in the Era of COVID-19

October 6, 2020 • 8:15 am

Gerald Flattmann

Partner
King & Spalding

Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry

October 6, 2020 • 1:10 pm

Jeffrey R. Gargano

Partner
Morgan, Lewis & Bockius LLP

The Continuing §101 Saga: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies

October 6, 2020 • 9:00 am

Vishal Gupta

Partner
Steptoe & Johnson LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation

October 7, 2020 • 11:25 am

Ryan Hagglund

Senior Counsel
Loeb & Loeb LLP

Paragraph IV State of the Union: Developing a New Game Plan for the New Normal: Assessing Legal, Regulatory, and Jurisprudential Developments in the Era of COVID-19

October 6, 2020 • 8:15 am

Staci Julie

SVP and Chief IP Counsel
Teva Pharmaceuticals

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Understanding and Harnessing the Nuances of Local Rules

October 6, 2020 • 2:25 pm

Kurt Karst

Director
Hyman, Phelps & McNamara PC

FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities

October 7, 2020 • 1:30 pm

Pilar G. Kraman

Partner
Young Conaway Stargatt & Taylor, LLP

Susan Krumplitsch

Partner
DLA Piper LLP

The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies

October 6, 2020 • 11:10 am

Chad Landmon

Partner
Axinn, Veltrop & Harkrider, LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

Noah M. Leibowitz

Partner
Dechert LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

TRACK D: Devising Strategies for Proving Infringement and Defending Validity
Devising Novel Strategies for Proving Infringement and Defending Validity

October 7, 2020 • 9:15 am

William Marsillo

Partner
Boies, Schiller & Flexner LLP

Steven Maslowski

Partner
Akin Gump Strauss Hauer & Feld LLP

The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies

October 6, 2020 • 11:10 am

John J. Molenda

Partner
Steptoe & Johnson LLP

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Understanding and Harnessing the Nuances of Local Rules

October 6, 2020 • 2:25 pm

Paul J. Molino

Managing Partner
Rakoczy Molino Mazzochi Siwik LLP

Gregory A. Morris

Partner
Honigman LLP

PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers

October 6, 2020 • 5:00 pm

Deepro R. Mukerjee

Partner & Member, Board of Directors; National Co- Chair, Patent Litigation
Katten Muchin Rosenman LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

TRACK D: Devising Strategies for Proving Infringement and Defending Validity
Devising Novel Strategies for Proving Infringement and Defending Validity

October 7, 2020 • 9:15 am

Sanjay K. Murthy

Partner
Morgan, Lewis & Bockius LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

TRACK D: Devising Strategies for Proving Infringement and Defending Validity
Devising Novel Strategies for Proving Infringement and Defending Validity

October 7, 2020 • 9:15 am

Huong Nguyen

General Counsel
Fosun Pharma USA Inc.

Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry

October 6, 2020 • 1:10 pm

Matthew Pearson

Partner
Akin Gump Strauss Hauer & Feld LLP

New Studies in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations

October 7, 2020 • 3:00 pm

Adam Perlman

Partner
Latham & Watkins LLP

The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies

October 6, 2020 • 11:10 am

Stephen S. Rabinowitz

Partner
Dechert LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

Colman Ragan

Vice President & General Counsel, North America IP
Teva Pharmaceuticals

Paragraph IV State of the Union: Developing a New Game Plan for the New Normal: Assessing Legal, Regulatory, and Jurisprudential Developments in the Era of COVID-19

October 6, 2020 • 8:15 am

Melanie R. Rupert

Partner and Co-Chair, Talent Development
Paul Hastings LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation

October 7, 2020 • 11:25 am

David Silverstein

Partner
Axinn, Veltrop & Harkrider LLP

TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel
How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication

TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial
Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely

October 7, 2020 • 10:35 am

Jeanna M. Wacker

Partner
Kirkland & Ellis LLP

The Continuing §101 Saga: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies

October 6, 2020 • 9:00 am

Bill Ward

Partner
Boies Schiller Flexner

TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members
Effectively Managing Global Pharmaceutical Patent Litigation

TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges
Evaluating the Effectiveness of Summary Judgment in Different Venues

October 6, 2020 • 4:15 pm

Bruce M. Wexler

Partner and Global Co-Chair of IP
Paul Hastings LLP

Fireside Chat with The Hon. Stanley R. Chesler

October 7, 2020 • 8:15 am