Speakers

American Conference Institute’s Hatch-Waxman Series Advisory board was created as a part of ACI’s ongoing effort to provide industry leading content and a world renowned speaker faculty. The board is composed of a selection of all-in-house advisers, including Chief IP and very senior IP/Patent counsel from the leading brand name and generic pharmaceutical companies in the country and in some cases the world. This ‘inner circle’ counsels ACI on the impact of litigation trends and emerging topics.

Co-Chairs

Rekha Hanu

Vice President, Associate General Counsel Chief IP Counsel
Akorn, Inc.

Main Conference Resumes | Opening Remarks from Co-Chairs and Recap of Day One

April 27, 2021 • 9:50 am

Andrea Hutchison

Senior Associate General Counsel, IP Litigation
Gilead Sciences

Main Conference Resumes | Opening Remarks from Co-Chairs and Recap of Day One

April 27, 2021 • 9:50 am

Members of the Judiciary

Honorable Leonard P. Stark

Chief Judge
United States District Court, District of Delaware

Spotlight on Delaware: Fireside Chat with Chief Judge Stark and Judge Noreika

April 26, 2021 • 11:35 am

Honorable Maryellen Noreika

Chief Judge
United States District Court, District of Delaware

Spotlight on Delaware: Fireside Chat with Chief Judge Stark and Judge Noreika

April 26, 2021 • 11:35 am

The Honorable Alan D. Albright

District Judge
United States District Court​, Western District of Texas​

All Rise! District Court Judges Address Brand and Generic Concerns

April 27, 2021 • 12:00 pm

Honorable Tonianne J. Bongiovanni

Magistrate Judge
United States District Court, District of New Jersey

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Honorable Christopher J. Burke

Magistrate Judge
District of Delaware

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Honorable Mitchell S. Goldberg

District Judge
United States District Court
Eastern District of Pennsylvania
(Visiting Judge, District of Delaware)

All Rise! District Court Judges Address Brand and Generic Concerns

April 27, 2021 • 12:00 pm

USPTO’s Patent Trial and Appeal Board (PTAB)

Honorable Jacqueline Wright Bonilla

Vice Chief, Administrative Patent Judge
USPTO Patent Trial and Appeal Board

A Study in Stats, Status, Standing, and Sustainability: The PTAB Year in Review

April 27, 2021 • 1:45 pm

Government

Beckey Egeland

Attorney, Health Care Division
Federal Trade Commission

Challenges and Opportunities in an Evolving Landscape Featuring USPTO, FDA and FTC

April 27, 2021 • 10:00 am

Maryll Toufanian

Director, Office of Generic Drug Policy
United States Food and Drug Administration

Challenges and Opportunities in an Evolving Landscape Featuring USPTO, FDA and FTC

April 27, 2021 • 10:00 am

In-House Counsel

Karen E. Brown

SVP, IP and Legal Affairs
Obsidian Therapeutics, Inc.

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

April 27, 2021 • 11:00 am

Ryan M. Daniel

Chief Patent Counsel Region North America
Fresenius Kabi USA, LLC

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

April 26, 2021 • 9:00 am

Guy Donatiello

SVP Intellectual Property
Endo Pharmaceuticals

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

April 27, 2021 • 11:00 am

Henry Gu

Vice President, Head of Intellectual Property
Morphic Therapeutics

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Colin Heitzmann

Senior Corporate Attorney Senior Director, IP Group Leader
Otsuka Pharmaceutical Companies

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Derek Johnson

Associate General Counsel, IP
Baxter International Inc.

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

April 26, 2021 • 2:15 pm

James P. Leeds

Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)

GSK v. Teva: What’s the Skinny on Carve Outs?

April 26, 2021 • 10:00 am

Donna Meuth

Associate General Counsel, IP
Eisai

GSK v. Teva: What’s the Skinny on Carve Outs?

April 26, 2021 • 10:00 am

Mary J. Morry

Counsel, IP Litigation Merck Office of the General Counsel
Merck Sharp & Dohme Corp

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Huong T. Nguyen

General Counsel
Fosun Pharma USA Inc.

Diversity, Inclusion, Incorporation: How to Manage and Maintain a Diverse Pharmaceutical IP Team

April 26, 2021 • 1:15 pm

Lars Taavola

VP, Chief Intellectual Property Counsel
Mallinckrodt Pharmaceuticals

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Kevin Zive

Vice President – Global Intellectual Property and Legal Affairs
Apotex Inc. (Toronto, CA)

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Law Firms

David B. Abramowitz

Partner
Locke Lord LLP

Challenges and Opportunities in an Evolving Landscape Featuring USPTO, FDA and FTC

April 27, 2021 • 10:00 am

Dominic Adair

Partner
Bristows LLP

Pharmaceutical Patent Litigation in the EU: A New Look at Bolar Exemptions and Recent Critical Developments Impacting Pharmaceutical Patent Litigation

April 27, 2021 • 9:00 am

Hong Ai

Partner
ZY Partners

China Strategy Session: An Inside Look at the Reformations to the Patent Law of the People’s Republic of China Relative for the Hatch-Waxman Practitioner

April 26, 2021 • 8:00 am

David L. Anstaett

Partner
Perkins Coie LLP

GSK v. Teva: What’s the Skinny on Carve Outs?

April 26, 2021 • 10:00 am

Aaron F. Barkoff

Shareholder
McAndrews, Held & Malloy, Ltd.

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

April 27, 2021 • 4:00 pm

Matt Becker

Partner
Axinn, Veltrop & Harkrider LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Sara Burghart

Lead IP Litigation Counsel
Global Litigation & Launch – Global IP
Sandoz International GmbH

Pharmaceutical Patent Litigation in the EU: A New Look at Bolar Exemptions and Recent Critical Developments Impacting Pharmaceutical Patent Litigation

April 27, 2021 • 9:00 am

Aziz Burgy

Partner
Axinn, Veltrop & Harkrider LLP

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

April 26, 2021 • 2:15 pm

Kathleen B. Carr

Partner
McCarter & English, LLP

A Study in Stats, Status, Standing, and Sustainability: The PTAB Year in Review

April 27, 2021 • 1:45 pm

Arlene Lee Chow

Partner
Latham & Watkins LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Alan B. Clement

Partner
Locke Lord LLP

Debating the Applicability of the Doctrine of Assignor Estoppel: What Every Hatch-Waxman Practitioner Needs to Know About the Anticipated SCOTUS Decision in Hologic v. Minerva

April 27, 2021 • 2:45 pm

David G. Conlin

Partner
McCarter & English, LLP

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

April 27, 2021 • 4:00 pm

Steven M. Coyle

Partner, Pharmaceutical Patent Practice Co-Chair, Litigation Co-Chair
Cantor Colburn LLP

Diversity, Inclusion, Incorporation: How to Manage and Maintain a Diverse Pharmaceutical IP Team

April 26, 2021 • 1:15 pm

Evan Diamond

Partner
King & Spalding LLP

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

April 26, 2021 • 9:00 am

Eric W. Dittmann

Partner and Global Vice-Chair, Intellectual Property
Paul Hastings LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Meg Fasulo

Partner
Bartlit Beck LLP

Spotlight on Delaware: Fireside Chat with Chief Judge Stark and Judge Noreika

April 26, 2021 • 11:35 am

Amy Feng

Managing and Founding Partner
Wu, Feng & Zhang

China Strategy Session: An Inside Look at the Reformations to the Patent Law of the People’s Republic of China Relative for the Hatch-Waxman Practitioner

April 26, 2021 • 8:00 am

Gerald Flattmann

Partner
King & Spalding LLP

All Rise! District Court Judges Address Brand and Generic Concerns

April 27, 2021 • 12:00 pm

Wanda D. French-Brown

Partner
Loeb & Loeb LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Jeffrey R. Gargano

Partner
Morgan, Lewis & Bockius LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Anne Shea Gaza

Partner
Young Conaway Stargatt & Taylor, LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

April 26, 2021 • 4:15 pm

Vishal Gupta

Partner
Steptoe & Johnson LLP

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

April 27, 2021 • 4:00 pm

Omar Jabri

Senior Director, Global Intellectual Property
Apotex Inc.

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

April 26, 2021 • 9:00 am

Michael P. Kahn

Partner
Akin Gump Strauss Hauer & Feld LLP

A Study in Stats, Status, Standing, and Sustainability: The PTAB Year in Review

April 27, 2021 • 1:45 pm

Noah M. Leibowitz

Partner
Dechert LLP

Debating the Applicability of the Doctrine of Assignor Estoppel: What Every Hatch-Waxman Practitioner Needs to Know About the Anticipated SCOTUS Decision in Hologic v. Minerva

April 27, 2021 • 2:45 pm

Dr. D.J. Jonathan Loeb, Ph.D.

Partner
Dechert LLP

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

April 27, 2021 • 11:00 am

Jeffrey A. Marx

Partner
Rakoczy Molino Mazzochi Siwik LLP

GSK v. Teva: What’s the Skinny on Carve Outs?

April 26, 2021 • 10:00 am

John J. Molenda

Partner
Steptoe & Johnson LLP

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

April 26, 2021 • 9:00 am

Paul J. Molino

Managing Partner
Rakoczy Molino Mazzochi Siwik LLP

All Rise! District Court Judges Address Brand and Generic Concerns

April 27, 2021 • 12:00 pm

Gregory A. Morris, Ph.D.

Partner
Honigman LLP

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

April 26, 2021 • 2:15 pm

Deepro R. Mukerjee

Partner and Co-Chair, Patent Litigation
Katten Muchin Rosenman LLP

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

April 26, 2021 • 3:30 pm

Bert Oosting

Partner
Hogan Lovells

Pharmaceutical Patent Litigation in the EU: A New Look at Bolar Exemptions and Recent Critical Developments Impacting Pharmaceutical Patent Litigation

April 27, 2021 • 9:00 am

Matthew A. Pearson

Partner
Akin Gump Strauss Hauer & Feld LLP

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

April 27, 2021 • 11:00 am

Liane M. Peterson

Partner
Foley & Lardner LLP

A Study in Stats, Status, Standing, and Sustainability: The PTAB Year in Review

April 27, 2021 • 1:45 pm

Irena Royzman

Partner
Kramer Levin Naftalis & Frankel LLP

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

April 26, 2021 • 2:15 pm

Kaveh V. Saba

Partner
Maddox Edwards, PLLC

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

April 27, 2021 • 11:00 am

Shashank Upadhye

Partner
Upadhye Tang LLP

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

April 26, 2021 • 9:00 am

Jeanna M. Wacker

Partner
Kirkland & Ellis LLP

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

April 26, 2021 • 2:15 pm

Mark E. Waddell

Partner
Loeb & Loeb LLP

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

April 27, 2021 • 4:00 pm

Bill Ward

Partner
Boies, Schiller & Flexner LLP

Debating the Applicability of the Doctrine of Assignor Estoppel: What Every Hatch-Waxman Practitioner Needs to Know About the Anticipated SCOTUS Decision in Hologic v. Minerva

April 27, 2021 • 2:45 pm

Elizabeth S. Weiswasser

Partner
Weil, Gotshal & Manges LLP

Diversity, Inclusion, Incorporation: How to Manage and Maintain a Diverse Pharmaceutical IP Team

April 26, 2021 • 1:15 pm

Bruce M. Wexler

Partner and Global Co-Chair, Intellectual Property
Paul Hastings LLP

GSK v. Teva: What’s the Skinny on Carve Outs?

April 26, 2021 • 10:00 am

Vanessa Yen

Partner
King & Spalding LLP

Diversity, Inclusion, Incorporation: How to Manage and Maintain a Diverse Pharmaceutical IP Team

April 26, 2021 • 1:15 pm