17th Annual Paragraph IV Disputes - DS

ACI’s

HatchWaxman SERIES

April 26–27, 2022 | Intercontinental New York Times Square | New York City

2022 Co-Chairs

17th Annual

PARAGRAPH IV DISPUTES

Stephanie Donahue

Senior Director, Patent Litigation Sanofi-Aventis

Expert Strategies for Brand Names and Generics Lars Taavola

VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals

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Extraordinary legal and regulatory changes are set to alter Hatch-Waxman and impact pharmaceutical patents this year. Prepare now to navigate and capitalize on this new and complex environment.

American Conference Institute invites you to attend the 17th Annual Paragraph IV Disputes Conference. With attendees expected from the United States — and across the world, we hope that you will join us this April to meet and reconnect with peers, acquire firsthand insights from industry thought leaders. Attend and acquire invaluable “take aways” for legal strategies and cost-analysis for every facet of this complex litigation, from pre-suit considerations to case filings through final adjudication.

Pharmaceutical patent law is constantly evolving, and the speed of that evolution has only hastened during the global pandemic. In the past twelve months we have witnessed debates over tribunal rule at the PTAB, new leadership at the helm of the helm of the FDA, FTC and USPTO, the Western District of Texas emerging as a major hub for patent litigation, and the use of the Safe Harbor exception during the COVID-19 pandemic. We will analyze the perceptions and approaches of both patent owners and patent challengers to these developments, highlighting these trends and more, as they inform Hatch-Waxman litigation.

Hear directly from Stephanie Donahue and Lars Taavola about what they are looking forward to at this year’s conference.

Now is the time to prepare for the implications of these critical events.

This conference provides Hatch-Waxman stakeholders with practical information on developments that affect both substantive and procedural matters of import for brand named and generics.

Join us in New York City this spring to discuss, debate, and analyze the latest trends, decisions, legislative and regulatory advancements affecting Hatch-Waxman litigation.

We look forward to seeing you and your contemporaries for another successful conference!

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ACI’s Hatch-Waxman Series Advisory Board

ACI’s

HatchWaxman SERIES

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.

EMERITUS MEMBERS Ryan M. Daniel

James Kellerman

Pearl T. L. Siew

Stephen R. Auten

Stephanie Donahue

James P. Leeds

Brian Stone

George W. Johnston

Guy Donatiello

Josephine Liu, Ph.D., J.D.

Lars Taavola

Global Head of IP Litigation Sandoz Inc. (Princeton, NJ)

VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals (Bedminster, NJ)

David H. Silverstein, M.S., J.D.

Rekha Hanu, Ph.D, J.D

Mary Morry

Peter Waibel

Meg Snowden

Andrea Hutchison

Jeffrey N. Myers, Ph.D.

Kevin Zive

Shashank Upadhye

Chief Patent Counsel Fresenius Kabi USA, LLC (Lake Zurich, IL)

Senior Director, Patent Litigation Sanofi (Bridgewater, NJ)

Senior Vice President, Intellectual Property Endo Pharmaceuticals (Malvern, PA)

Executive Director, Chief IP Counsel Akorn Pharmaceuticals (Lake Forest, IL)

Vice President, Intellectual Property Litigation Gilead Sciences (Foster City, CA)

Senior Vice President, Intellectual Property Astellas Pharma US, Inc. (Northbrook, IL)

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

Counsel, IP Litigation Merck & Company (Rahway, NJ)

Vice President & Assistant General Counsel Pfizer Inc (New York, NY)

Senior Vice President and Head Intellectual Property Design Therapeutics (Woodcliff Lake, NJ)

Associate General Counsel Global Legal-Regulatory Viatris (Washington, DC)

Head, US Patent Litigation Novartis Pharmaceuticals Corporation (East Hanover, NJ)

Vice President, General Counsel Apotex Inc. (Toronto, CA)

Partner, Chair of Pharmaceutical & Life Sciences Litigation Taft Stettinius & Hollister LLP (Chicago, IL) (Former Vice President, IP, Sandoz, Inc.) Counsel Gibbons P.C. (Newark, NJ) (Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Partner Axinn, Veltrop & Harkrider LLP (New York, NY) (Former Senior Director, Intellectual Property, Par Pharmaceutical, Inc)

Shareholder Margaret M. Snowden, P.C. (San Francisco, CA) (Former Vice President, Intellectual Property, Impax Laboratories) Partner Upadhye Tang LLP (Chicago, IL) (Former Vice President – Global Intellectual Property, Apotex, Inc.)

Staci Julie

SVP and Chief IP Counsel Teva Pharmaceuticals (Horsham, PA)

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D I S T I N G U I S H E D FA C U LT Y “If you want to meet and hear from leaders in the pharmaceutical industry, you need to attend ACI’s Paragraph IV. You cannot find another event that brings together such a knowledgeable group of in-house representatives, outside counsel, members of the judiciary, and members of the USPTO. These are the folks that have and continue to shape Hatch-Waxman law.”

“The ACI PIV conference is the “must attend” conference for any Hatch-Waxman practitioner. No other conference provides the opportunity to hear from and network with the top in-house representatives and leading law firms representing companies on both sides of the “v.” This conference annually delivers lively discussion and debate with thought leaders on up-to-the-minute trends and hot-button issues in this specialized practice area.”

2022 Co-Chairs

Lars Taavola VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals

Stephanie Donahue Senior Director, Patent Litigation Sanofi-Aventis

Members of the Judiciary

Honorable Honorable Kathleen M. O’Malley (Ret.) Julien Xavier Neals United States Circuit Judge District Judge United States Court of Appeals United States District Court for the Federal Circuit District of New Jersey

Honorable Honorable Joshua Wolson Mary Pat Thynge District Judge Chief Magistrate Judge United States District Court United States District Court Eastern District of Pennsylvania District of Delaware (Visiting Judge, District of Delaware)

Honorable Tonianne J. Bongiovanni Magistrate Judge United States District Court District of New Jersey

Honorable Christopher J. Burke Magistrate Judge United States District Court District of Delaware

Government Representatives from Key Agencies

Hon. Jacqueline Bonilla Deputy Chief Administrative Patent Judge Patent Trial & Appeal Board U.S. Patent and Trademark Office

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Honorable Michelle N. Ankenbrand Senior Lead Administrative Patent Judge Patent Trial & Appeal Board USPTO

Beckey Egeland Attorney, Health Care Division Federal Trade Commission

Maryll Toufanian Director, Office of Generic Drug Policy U.S. FDA

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Christopher Pruitt Director, Division of Legal and Regulatory Support Office of Generic Drug Policy U.S. FDA

Saami Zain Assistant Attorney General Antitrust Bureau Office of the New York State Attorney General

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In-House Counsel Ryan Daniel Chief Patent Counsel Fresenius Kabi USA

Donna M. Meuth Associate General Counsel, IP Eisai Inc.

Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals

Huong Nguyen General Counsel & Compliance Officer Fosun Pharma USA Inc.

Henry Gu Vice President, Head of IP Morphic Therapeutic

Donna Meuth Associate General Counsel, IP Eisai Inc.

John Haberman Senior Director, IP Sarepta Therapeutics

Mary J. Morry Counsel, IP Litigation Office of the General Counsel Merck Sharp & Dohme Corp

Colin Heitzmann Vice President, Head of Intellectual Property Sumitovant Biopharma, Inc

Serge Illin-Schneider Sr. Vice President, Corporate Development & General Counsel Cosette Pharmaceuticals Abigail Struthers Partner Arnold & Porter Kaye Scholer LLP Peter Waibel Head, Patent Litigation Novartis Pharmaceuticals Corporation Martin Wilson General Counsel and Chief Compliance Officer Rocket Pharmaceuticals Kevin Zive Vice President, General Counsel Apotex, Inc.

Law Firms David B. Abramowitz Partner Locke Lord LLP

David G. Conlin Partner McCarter & English, LLP

Vishal Gupta Partner Steptoe & Johnson LLP

David L. Anstaett Partner Perkins Coie LLP

Steven M. Coyle Partner Cantor Colburn LLP

John Bennett Partner Allen & Overy LLP

Jay R. Deshmukh Partner Kasowitz Benson Torres

Andrei Iancu Partner Irell & Manella LLP (Former Director, U.S. Patent and Trademark Office)

Richard J. Berman Partner ArentFox Schiff LLP

Eric W. Dittmann Partner and Global Vice-Chair, Intellectual Property Paul Hastings LLP

Aziz Burgy Partner Axinn, Veltron & Harkrider LLP

Gerald J. Flattmann, Jr. Partner King & Spalding LLP

Kathleen B. Carr Partner McCarter English, LLP

Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP

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April Abele Isaacson Partner Kilpatrick Townsend & Stockton LLP Kurt R. Karst Director Hyman, Phelps & McNamara, P.C. Chad Landmon Partner Axinn, Veltrop & Harkrider LLP Christopher Loh Partner Venable LLP

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Aaron S. Lukas Co-Chair, Hatch-Waxman & Biologics Practice Cozen O’Connor

Matthew Pearson Partner Akin Gump Strauss Hauer & Feld LLP

Jeanna Wacker Partner Kirkland & Ellis P.C.

Jeffrey Martin Senior Director, Legal Counsel IP Dr. Reddy’s Laboratories Inc.

Adam L. Perlman Partner Latham & Watkins LLP

Mark Waddell Partner Loeb & Loeb LLP

Steven Maslowski Partner Akin Gump Strauss Hauer & Feld LLP

Kevin S. Prussia Partner Wilmer Cutler Pickering Hale and Dorr LLP

Rachel L. Pernic Waldron Partner Rakoczy Molino Mazzochi Siwik LLP

Robert McSorley Managing Director Ocean Tomo, LLC

Joseph Reisman, Ph.D. Partner Knobbe Martens

Elizabeth S. Weiswasser Partner Weil, Gotshal & Manges LLP

Dan Minion Partner Venable

Mark Rubinshtein, Ph.D. Attorney Knobbe Martens

Bruce M. Wexler Partner and Global Co-Chair, Intellectual Property Paul Hastings LLP

John J. Molenda Partner Steptoe & Johnson LLP

Luke T. Shannon Shareholder Polsinelli

Jovial Wong Partner Winston & Strawn LLP

Gregory A. Morris Partner Honigman LLP

Sanya Sukduang Partner Cooley LLP

Alyson Wooten Director Berkeley Research Group LLC

Deepro R. Mukerjee Partner Katten Muchin Rosenman LLP

Shashank Upadhye Partner Upadhye Tang LLP

Vanessa Yen Partner King & Spalding LLP

Sailesh Patel Partner ArentFox Schiff LLP

Robert M. Vrana Partner Young Conaway Stargatt & Taylor LLP

CONTINUING LEGAL EDUCATION CREDITS EARN CLE/ETHICS Accreditation will be sought in those jurisdictions requested by the registrants which have CREDITS

continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

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DAY ONE | Tuesday, April 26 7:00

Breakfast and Registration

9:15

Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense

8:00

Co-Chairs’ Opening Remarks microphone Lars Taavola, VP, Chief IP Counsel & General Counsel, Specialty Generics, Mallinckrodt Pharmaceuticals Stephanie Donahue, Senior Director, Patent Litigation, Sanofi-Aventis

microphone John Haberman, Senior Director, IP, Sarepta Therapeutics Steven M. Coyle, Partner, Cantor Colburn LLP Matthew Pearson, Partner, Akin Gump Strauss Hauer & Feld LLP Kevin S. Prussia, Partner, Wilmer Cutler Pickering Hale and Dorr LLP

8:15

60 Minutes on Patents, Politics, Policies, and Pricing: Examining Legislation, Executive Orders, and New Policy Trends Which Are Transforming Paragraph IV Disputes microphone Jay R. Deshmukh, Partner, Kasowtiz Benson Torres LLP Nicholas Groombridge, Partner, Paul, Weiss, Rifkind, Wharton & Garrison LLP Andrei Iancu, Partner, Irell & Manella LLP (Former Director, U.S. Patent and Trademark Office) Joseph Reisman, Ph.D., Partner, Knobbe Martens

Moderator: Vanessa Yen, Partner, King & Spalding LLP • Reviewing Biogen International GMBH v. Mylan Pharmaceuticals Inc. Appeal No. 20-1933, where the Federal Circuit affirmed invalidity of a method of treatment patent for lack of written description • Appreciating the importance of inventor testimony and the impact of post-filing clinical data » When can witness admissions strengthen a written description invalidity defense?

• Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation • Considering the dissent and determining whether the district court erred in applying judicial estoppel 10:15

Networking Break

• Analyzing recent federal and state executive actions and legislation » Anticipating the impact on the pharmaceutical industry Patent listing statutes

State legislative initiatives

“Buy America” policies and Executive Orders

Recent Hatch-Waxman and BPCIA amendments

• Navigating state laws governing transparency in drug pricing » Reviewing which states proposed or enacted drug pricing laws » Detailing the scope and applicability • Appreciating the impact of pharmaceutical patent enforcement trends in the U.S. and around the world » Forecasting the impact of the WTO TRIPS waiver for COVID-19 technologies

10:45

FTC Keynote microphone Beckey Egeland, Attorney, Federal Trade Commission 11:15

The Future of Inducement Claims: Reconciling the Demarcation Between Describing an Infringing Use and Encouraging That Use in a Label microphone Huong Nguyen, General Counsel & Compliance Officer, Fosun Pharma USA Inc. Abigail Struthers, Partner, Arnold & Porter Kaye Scholer LLP April Abele Isaacson, Partner, Kilpatrick Townsend & Stockton LLP Sanya Sukduang, Partner, Cooley LLP Moderator: Aaron S. Lukas, Co-Chair, Hatch-Waxman & Biologics Practice, Cozen O’Connor

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• Analyzing whether a skinny label alone is enough to preclude induced infringement allegations • Reviewing the implications of recent decisions for induced infringement » Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs • Devising strategic considerations of label language for inducement infringement » What considerations should patent owners keep in mind when labeling drugs?

• Reviewing the approval of generic drug labeling » On what basis will FDA determine the scope of an appropriate carve-out?

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Meet and Network with Key Influencers Shaping the Law, Policy and Proceedings of Paragraph IV litigation from: y Apotex, Inc.

» Must FDA review the patent to ensure the only information carved out is covered by the patent?

y Cosette Pharmaceuticals

» Is the interpretation of the patent claims subject only to a jury’s interpretation?

y Eisai

• Assessing the flurry of follow-on cases in the courts

y Endo Pharmaceutical

12:15

y Fosun Pharma USA Inc.

Networking Luncheon

y Fresenius Kabi USA, LLC

1:45

The Costs and the Consequences of Determining Venue PostValeant v. Mylan: Coordinating Multiple ANDA Suits Through MDLs microphone David L. Anstaett, Partner, Perkins Coie LLP

y Jounce Therapeutics y Mallinckrodt Pharmaceuticals

Steven Maslowski, Partner, Akin Gump Strauss Hauer & Feld LLP

y Merck Sharp & Dohme Corp

Mark Rubinshtein, Ph.D., Attorney, Knobbe Martens

y Morphic Therapeutic

Moderator: Jeanna Wacker, Partner, Kirkland & Ellis P.C.

y Novartis Pharmaceuticals Corporation

• Reviewing the Federal Circuit’s holding in Celgene v. Mylan from November 2021 where Celgene’s argument that a branded drug company should be able to file suit where it receives notice was rejected • Anticipating circumstances when brands can file suit where generics reside toward using multidistrict litigation for the consolidation of discovery » Coordinating MDLs “to promote the just and efficient conduct of the patent infringement actions” • Identifying when parties may agree to proceed in one jurisdiction to streamline litigation • Reconciling when Maryland (where U.S. FDA is located) may be a proper venue for Hatch-Waxman litigation 2:45

y Gilead Sciences

Networking Break

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y Sandoz y Sanofi-Aventis y Sarepta Therapeutics y Sumitovant Biopharma, Inc y Viatris

Why Attend

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

track 1 The Business of Paragraph IV Disputes

Venue

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track 2 The Practice of Paragraph IV Disputes

3:00 | Breakout Sessions (Choose Track 1 or 2)

Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation Microphone Henry Gu, Vice President, Head of IP, Morphic Therapeutic

Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely Microphone Hon. Christopher J. Burke, Magistrate Judge, District of Delaware Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider, LLP

Deepro R. Mukerjee, Partner, Katten Muchin Rosenman LLP

Aziz Burgy, Partner, Axinn, Veltrop & Harkrider LLP

Kevin Zive, Vice President, General Counsel, Apotex, Inc.

Carolyn Blessing, Partner, Locke Lord LLP

• Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss

Complaint

Answer and Counterclaims

• Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers

• Ensuring that all counts of the complaint are plead with specificity

• Choosing your defenses with prudence

• Building a winning global litigation team

• Avoiding Rule 11 sanctions

• Selecting the right foreign counsel

• Devising strategies for situations with multiple

• Coordinating multi-jurisdictional proceedings • Assessing the impact and dangers of applicable international treaties on the PIV landscape

ANDA filers

• Understanding the advantages of not pleading every defense • Knowing which patents to ask to delist; assessing allegations of improper Orange book listing

• Assessing damages prayer and request for jury trial • Considerations relative to willfulness

3:45 | Breakout Sessions (Choose Track 1 or 2)

The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Microphone Donna Meuth, Associate General Counsel, Intellectual Property, Eisai Inc. Bruce Wexler, Partner, Paul Hastings LLP • Conducting IP and economic due diligence assessments for brand name and generic manufacturers relative to such matters as NCE exclusivity, patent positions, screenings and alleged product hopping

Mastering the Use of Experts in Parallel Proceedings Microphone Jovial Wong, Partner, Winston & Strawn LLP Alyson Wooten, Director, Berkeley Research Group LLC • Developing strategies to use expert testimony to your advantage at both the District Court and the PTAB in a dual proceedings scenario • Understanding the scope and limitations of expert testimony at the PTAB, and how this may impact the District Court proceeding

• Factoring-in R&D considerations and market trends

• Appreciating the nuances of expert depositions for PTAB and District Court proceedings

• Analyzing available exclusivities, both regulatory and patent

• Ensuring that your expert communicates properly for the requisite forum

• Assessing key litigation considerations and related costs for pharmaceutical patent challenges • Considering the likelihood of victory at the District Court level and the PTAB on patent type and review of recent decisions • Mastering the art of budgeting, forecasting, and aligning litigation costs to business goals • Exploring cost saving options in litigation, including alternate billing, contingency clauses and outside funding • Examining value of licensing deals and structures

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DAY TWO | Wednesday, April 27 4:30

Networking Break

7:15

Breakfast and Registration

8:00

4:45

View from the Bench: The Federal Judges Speak on Paragraph IV Litigation Microphone Honorable Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Honorable Julien Zavier Neals, District Judge, United States District Court, District of New Jersey Moderated by: Rachel L. Pernic Waldron, Partner, Rakoczy Molino Mazzochi Siwik LLP

Co-Chairs’ Opening Remarks microphone Lars Taavola, VP, Chief IP Counsel & General Counsel, Specialty Generics, Mallinckrodt Pharmaceuticals Stephanie Donahue, Senior Director, Patent Litigation, Sanofi-Aventis 8:15

Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents microphone Maryll Toufanian, Director, Office of Generic Drug Policy, U.S. FDA

Gregory A. Morris, Partner, Honigman LLP

Christopher Pruitt, Director, Division of Legal and Regulatory Support, Office of Generic Drug Policy, U.S. FDA

Distinguished jurists with some of the liveliest Paragraph IV litigation dockets in the country will examine decision-making practices employed by the judicial system and provide sage advice for both patent holders and patent challengers. These federal judges will identify the impediments to resolving such multifaceted contests and provide you with solutions to your most unyielding Paragraph IV predicaments.

6:00

Cocktail Reception

David B. Abramowitz, Partner, Locke Lord LLP John Bennett, Partner, Allen & Overy LLP Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C. • Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence Hatch-Waxman litigation strategies » Teva’s Copaxone citizen’s petition • Exploring branded and generic interests in GDUFA and PDUFA renewals • Examining new attacks on 180-day exclusivity per the propose Blocking Act • Assessing status of FDA activity concerning Hatch-Waxman reform 9:30

Networking Break

10:00

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Federal Circuit Fireside Chat AN INTERVIEW WITH: Microphone Honorable Kathleen M. O’Malley (Ret.), United States Circuit Judge, United States Court of Appeals for the Federal Circuit BY: Honorable Mary Pat Thynge, Chief Magistrate Judge, United States District Court, District of Delaware Join us for a conversation with Federal Circuit Judges as they provide exceptional insights into working at the Appellate Court tasked with reviewing the country’s patent cases.

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Why Attend

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

track 1 The Business of Paragraph IV Disputes

Venue

All Secure Shield-check

Pricing

track 2 The Practice of Paragraph IV Disputes

10:30 | Breakout Sessions (Choose Track 1 or 2)

Monitoring Legal Spend and Balancing the Budget Microphone Serge Illin-Schneider, Sr. Vice President, Corporate Development & General Counsel, Cosette Pharmaceuticals David Silverstein, Partner, Axinn, Veltrop & Harkrider LLP Martin Wilson, General Counsel and Chief Compliance Officer, Rocket Pharmaceuticals • Implementing practices to minimize surprises and increase predictability • Forecasting the budget by phase and quarter » Knowing when to reevaluate use of task codes • Deciding what components go into the budget » Vendors

Seeking Damages and Assessing Value Calculations Microphone Shashank Upadhye, Partner, Upadhye Tang LLP Robert McSorley, Managing Director, Ocean Tomo, LLC • Revisiting damages in an at- risk-launch scenario • Exploring questions of royalties, lost profits and exceptional findings • Examining grounds for mitigation • Considering the practical consequences of the Supreme Court’s WesternGeco decision on Hatch-Waxman damages awards • Exploring when U.S. patent owners may recover foreign lost profits tied to domestic acts of infringement under § 271(f)(2) • Examining cases where the relevant infringing conduct occurred in the United States

» Experts • Understanding the source of error when surprises and overages occur • Evaluating the appropriateness of alternative fee arrangements

11:15 | Breakout Sessions (Choose Track 1 or 2)

Communicating Value and Collaboration Between Corporate Legal and Outside Counsel Microphone Stephanie Donahue, Senior Director, Patent Litigation, Sanofi Colin Heitzmann, Vice President, Head of Intellectual Property, Sumitovant Biopharma, Inc

Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Microphone Honorable Tonianne J. Bongiovanni, Magistrate Judge, United States District Court, District of New Jersey Ryan Daniel, Chief Patent Counsel, Fresenius Kabi USA

Sam Deka, Partner, DLA Piper

Robert M. Vrana, Partner, Young Conaway Stargatt & Taylor, LLP

Jeffrey Martin, Senior Director, Legal Counsel IP, Dr. Reddy’s Laboratories Inc.

Luke T. Shannon, Shareholder, Polsinelli

• Establishing early-on in the relationship the desired level of commitment, availability and responsiveness • Succinctly focusing on shared, pragmatic business goals • Determining preferences for formality of correspondence and practical versus academic guidance

• Evaluating the benefits and detriments of joint defense groups in ANDA cases • Maximizing efficiency and minimizing risk by protecting join legal interests resourcefully • Devising brand name strategies for addressing litigation with joint defense groups • Establishing clear leadership at the out-set to simplify future occurrences • Understanding when and how many consulting firms to employ in order to avoid the “too many cooks” phenomenon

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12:00

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• Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials • Reviewing the latest stats at PTAB, highlighting bio/pharma cases

1:15

Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits

• Outlining the latest developments on pilot programs at PTAB » Legal Experience and Advancement Program (LEAP) » Fast-Track Appeals

Microphone Sailesh Patel, Partner, ArentFox Schiff LLP

» Motions to Amend (MTAs) in AIA proceedings

Adam L. Perlman, Partner, Latham & Watkins LLP

• Detailing recent rules at PTAB » New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies)

Saami Zain, Assistant Attorney General, Antitrust Bureau, Office of the New York State Attorney General In April 2021, lawmakers from the House and Senate introduced legislation “targeting conduct that prevents competition.” Complicating matters further, several states have enacted laws meant to curb reverse-payment patent settlements – with no comparable statute at the federal level. This session will consider the economic implications of the resurgence of antitrust conundrums during drug development and launch, the competitive effects, and economic damages. Topics of discussion will include: • Understanding settlement strategies between innovator companies and generic applicants • Highlighting the state legislation directly addressing “reverse payment” patent settlements • Reviewing the proper standards of antitrust review and the rising call for a legislative response » Analyzing the current legislative and regulatory framework » Mergers, acquisitions and exclusive licenses » Anticompetitive agreements

• Interpreting PTAB precedent and other information » Newly designated precedent at PTAB » New memorandum regarding indefiniteness approach in AIA proceedings 3:15

Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Parte Review (IPR) Microphone Peter Waibel, Head, Patent Litigation, Novartis Pharmaceutical Corporation

» Life cycle management and contracting

Dan Minion, Partner, Venable LLP

» Pricing strategies

Eric W. Dittmann, Partner, Paul Hastings LLP

» Avoiding costly litigation and associated penalties by effectively complying with the law

» Abuse of dominance 2:15

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes Microphone Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, USPTO Honorable Michelle N. Ankenbrand, Senior Lead Administrative Patent Judge, Patent Trial & Appeal Board, USPTO Co-Moderators: John J. Molenda, Partner, Co-Chair, Healthcare & Life Sciences Practice, Steptoe & Johnson LLP Elizabeth S. Weiswasser, Partner, Weil, Gotshal & Manges LLP

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» New rule relating to burdens of persuasion in MTAs

Kathleen B. Carr, Partner, McCarter English, LLP Moderator: Gerald J. Flattmann, Jr., Partner, King & Spalding LLP • Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard » Weighing the future of parallel proceedings in view of a single standard adoption • Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective • Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation • Formulating strategies based on type of pharmaceutical patent • Establishing jurisdiction at the PTAB » Special considerations for ex-U.S. parties • Developing sound discovery strategies relative to dual proceedings • Evaluating chances of getting a stay granted in the District Court • Managing experts and use of experts in both forums • Appealing decisions in both forums

#HatchWaxman twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

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Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

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Afternoon Break

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4:30

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena Microphone Mary J. Morry, Counsel, IP Litigation, Office of the General Counsel, Merck Sharp & Dohme Corp

Hotel:

Intercontinental New York Times Square

Chris Borello, Partner, Venable LLP

Address: 300 West 44th Street and 8th Avenue, NY 10036, United States

Mark Waddell, Partner, Loeb & Loeb LLP

Reservations: +1 212-803-4500

David G. Conlin, Partner, McCarter & English, LLP Moderator: Vishal Gupta, Partner, Steptoe & Johnson LLP This interactive skills session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include: • Drafting conflicts of interest waivers, whether actual or potential • Identifying hidden dangers in joint defense arrangements » What happens if the clients do not agree or a dispute between them arises?

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ Paragraph IV Disputes”.

Please note that the guest room block cut-off date is April 4th, 2022.

After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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• Analyzing the requirements for pleadings, whether in the complaint, the answer, or the counterclaim Interpreting Rule 11 and other standards 5:30

Conference Concludes

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September 14–15, 2022 | Munich

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THANK YOU TO OUR SPONSORS SUPPORTING SPONSOR Locke Lord is among the most accomplished firms in HatchWaxman litigation, with vast experience at both the trial and appellate levels litigating patent infringement actions involving blockbuster prescription drugs. Locke Lord’s lawyers routinely assist on ANDAs and §505(b)(2) applications, paragraph IV certifications, paragraph IV notice letters, exclusivity and forfeiture issues, at-risk launches and patent settlements. We advocate your interests before the FDA and, if necessary, litigate approval and exclusivity issues against the agency.

LUNCHEON SPONSOR

Consistently ranked among top IP firms, worldwide, Knobbe Martens has long served clients in the generic pharmaceutical industry. Knobbe Martens has litigated over 150 cases under the Hatch-Waxman Act, and is “Highly Recommended for Hatch-Waxman Litigation, Patent Prosecution, and Patent Strategy & Management”

by Legal Media Group and ranked “Tier 1 Nationwide for Patent Litigation” by U.S. News – Best Lawyers® Best Law Firms.

ASSOCIATE SPONSORS Cantor Colburn LLP’s Pharmaceutical Practice Group handles litigation, patent prosecution, inter partes reviews and other Patent Office review proceedings, opinions, landscapes, licensing, portfolio management and more to pharmaceutical and life science clients worldwide. Our team is experienced in a wide variety of technologies, including chemistry, biochemistry, organic chemistry and pharmaceuticals, and has represents clients in Hatch-Waxman and pharmaceutical litigation matters. We secure intellectual property rights for drug discovery companies and also defend generic pharmaceutical companies against allegations of patent infringement, including those that arise out of ANDA filings. Cantor Colburn provides guidance to clients during the preparation of ANDAs, performing opinion work, and preparing Paragraph IV letters. Cantor Colburn is the #4 U.S. patent law firm and the #1 firm for overcoming Mayo/Myriad rejections.

Kilpatrick Townsend & Stockton LLP, established in 1860, has a long and rich history helping pharmaceutical, biologics, biotechnology, and medical device companies in complex patent disputes, transactions, and strategic counseling engagements concerning their most important inventions. Kilpatrick Townsend’s IP team combines leading patent professionals across the patent service areas with top-flight trial lawyers and an extensive life-sciences technical bench, meeting the needs of even the largest and most complex matters. Learn more at www.kilpatricktownsend.com.

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Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

14 | #ACIPIV

#HatchWaxman twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

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Planning Ahead for Live Conferences: C5’s All Secure Safety Plan

As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y Have not experienced any COVID-19 symptoms now or within the last 14 days. y Have not had close contact with any person with or suspected of having COVID-19 within the last 14 days. y Have not had a positive COVID-19 test within the last 14 days. y Have not been advised by any health authority, government agency or regulatory body, within the last 14 days, to self-isolate due to possible exposure to COVID-19.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

Increased Cleaning and Sanitation y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference.

Reduced Touchpoints

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Please check back frequently as we monitor and evolve our plan in the weeks ahead.

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