16th Annual Paragraph IV Disputes - WEB

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LIVE and IN-PERSON November 9–10 | Sheraton New York Times Square | New York City

16th Annual

PARAGRAPH IV DISPUTES Expert Strategies for Brand Names and Generics

Pearl Siew Senior Vice President and Head, Intellectual Property Design Therapeutics

EARN CLE/ETHICS/DIVERSITY CREDITS

Supporting Sponsors

2021 Conference Co-Chairs

Associate Sponsors

Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals

Conference Sponsor

Premium Exhibitors

AmericanConference.com/PIVDisputes

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It’s time to come back to New York City. Meet in-person and

network with the key influencers shaping the law, policy and proceedings of Paragraph IV litigation at the “original and best’’ event of its kind.

Dear Colleagues:

I

t is an evolving and transformative time in the world of Paragraph IV Disputes, and the risks for brand name and generic pharmaceutical companies have never been greater. As drugmakers respond to the global pandemic by developing vaccines and therapeutics, many are losing patent control over lucrative products. The United States Supreme Court tackled blockbuster cases in United States v. Arthrex and Minvera v. Hologic, while the Federal Circuit aimed to provide clarity on dilemmas related to venue and skinny labeling. There is also a renewed focus on healthcare and competition in the White House as exemplified by an Executive Order encouraging the FTC to ban “pay for delay” and similar agreements.

Through this ongoing metamorphosis, one thing is certain: the “who’s who” of HatchWaxman litigators, industry decision makers and stakeholders, as well as Judges and government representatives will gather in-person in New York City to attend ACI’s Paragraph IV Disputes event—for the first time since the pandemic started.

Watch the Co-Chairs’ Welcome Video

As we enter this new, post-pandemic era together, ACI’s 16th Anniversary Paragraph IV Disputes Conference will continue to do what it has done since 2006. Namely, we will bring you up-to-the minute information on the latest developments impacting every facet of this complex type of litigation, from pre-suit considerations, case filings, final adjudication and every step in between.

Play

Our esteemed faculty of industry thought leaders will confer with one another, discuss, evaluate, and assess new and evolving jurisprudence and related legal and economic consequences by examining victories and vanquishments before the courts.

In short, this year’s conference will help you rewrite your Hatch-Waxman patent playbook for the next decade by helping you develop strategies for the defensive moves and offensive plays of this very complicated and high stakes endgame.

Do not miss this opportunity to be part of the only conference that continues to provide top level guidance for Hatch-Waxman litigation. We look forward to seeing you once again this fall in New York City.

Register Now

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Guy Donatiello

Senior Vice President, Intellectual Property Endo Pharmaceuticals

Pearl Siew

Senior Vice President and Head, Intellectual Property Design Therapeutics

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DISTINGUISHED FACULTY Co-Chairs Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals Pearl Siew Senior Vice President and Head, Intellectual Property Design Therapeutics

Members of the Judiciary U.S. District Court Honorable Mitchell Goldberg District Judge United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Government Representatives from Key Agencies Valencia Martin Wallace Deputy Commissioner for Patents U.S. Patent and Trademark Office Maryll W. Toufanian Director, Office of Generic Drug Policy U.S. Food and Drug Administration

In-House Counsel Andrew J. Allen Senior Director, Legal Counsel Dr. Reddy’s Laboratories Ryan M. Daniel Chief Patent Counsel, Region North America Fresenius Kabi USA, LLC

Hon. Maryellen Noreika District Judge United States District Court, District of Delaware

Stephanie Donahue Senior Director, Patent Litigation Sanofi-Aventis

Hon. Mary Pat Thynge Chief Magistrate Judge District of Delaware

Henry H. Gu VP, Head of Intellectual Property Morphic Therapeutic

Hon. Christopher J. Burke Magistrate Judge District of Delaware

James Kellerman Senior Vice President, IP Astellas Pharma US, Inc.

USPTO’s Patent Trial and Appeal Board (PTAB) Hon. Jacqueline Bonilla Deputy Chief Administrative Patent Judge Patent Trial & Appeal Board U.S. Patent and Trademark Office

Forrester Liddle Senior Director, Head of IP Jounce Therapeutics Josephine Liu Global Head of IP Litigation Sandoz Donna Meuth Associate General Counsel, IP Eisai

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Huong T. Nguyen General Counsel Fosun Pharma USA Inc. Brian Stone Associate General Counsel, Global Legal-Regulatory Viatris Lars Taavola VP, Chief IP Counsel Mallinckrodt Pharmaceuticals Peter Waibel Head, US Patent Litigation Novartis Pharmaceuticals Corporation

Esteemed Faculty Brian Anderson Counsel Polsinelli PC David L. Anstaett Partner Perkins Coie David Blackburn Director NERA Economic Consulting Michael A. Carrier Distinguished Professor of Law Rutgers Law Dominic A. Conde Partner Venable LLP Steven M. Coyle Partner Cantor Colburn LLP Neal Dahiya SVP, Head of Litigation Moderna

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Jonathan Davies Partner Cooley LLP

Gregory A. Morris Partner Honigman LLP

Dmitry V. Shelhoff Partner, Chair of Litigation Pergament & Cepeda LLP

Jay R. Deshmukh Partner Kasowitz Benson Torres

Mary Morry Counsel Merck Sharp & Dohme Corp.

Michael Sitzman US Chair, Life Sciences Patent Litigation DLA Piper

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

Jeffrey N. Myers Vice President & Assistant General Counsel Pfizer Inc.

Jeanna M. Wacker Partner Kirkland & Ellis

Vishal C. Gupta Partner Steptoe & Johnson LLP

Michael K. Nutter Partner Winston & Strawn LLP

Sharon M. Walker Director, Legal Translate Bio, A Sanofi Company

Elizabeth Holland Partner Goodwin Procter LLP

Adam L. Perlman Partner Latham & Watkins LLP

Elizabeth S. Weiswasser Partner Weil, Gotshal & Manges LLP

Kurt Karst Director Hyman, Phelps & McNamara P.C.

James Peterka Partner Locke Lord LLP

Alyson Wooten Director Berkeley Research Group LLC

Noah M. Leibowitz Partner Dechert LLP

Adam Poff Partner Young Conaway Stargatt & Taylor, LLP

Vanessa Yen Partner King & Spalding LLP

Alejandro Menchaca Shareholder McAndrews, Held & Malloy, Ltd.

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

Dr. Christine Siegwarth Meyer Managing Director Chair of IP NERA Economic Consulting

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)

Robert C. Millonig Director Sterne, Kessler, Goldstein & Fox P.L.L.C. John J. Molenda Partner Steptoe & Johnson LLP Paul J. Molino Managing Partner Rakoczy Molino Mazzochi Siwik LLP

4 | #ACIPIV

Simon Roberts Partner Hogan Lovells Melanie R. Rupert Partner, Global Co-Chair of Talent Development Paul Hastings LLP Emily Savas Partner Locke Lord LLP

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

Meet and Network with Key Influencers Shaping the Law, Policy and Proceedings of Paragraph IV litigation from: y Astellas Pharma US, Inc. y Dr. Reddy’s Laboratories y Eagle Pharmaceuticals y Eisai y Endo Pharmaceutical y Fosun Pharma USA Inc. y Fresenius Kabi USA, LLC y Jounce Therapeutics

y Mallinckrodt Pharmaceuticals y Morphic Therapeutic y Novartis Pharmaceuticals Corporation y Sandoz y Sanofi-Aventis y Viatris

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ACI’s

HatchWaxman SERIES

Faculty

Advisory Board

Agenda Day 1

Agenda Day 2

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C5’s All Secure Safety Plan

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ACI’s Hatch-Waxman Series Advisory Board 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 Intellectual Property Counsel 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)

Senior Associate General Counsel, IP 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 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 – Global Intellectual Property and Legal Affairs 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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DAY ONE | Tuesday, November 9 8:00

9:30

Co-Chair’s Opening Remarks

GSK v. Teva: Awaiting the Fate of Section VIII Carve-Outs

Microphone Guy Donatiello, Senior Vice President, Intellectual Property, Endo Pharmaceuticals

Microphone Josephine Liu, Global Head of IP Litigation, Sandoz

James Peterka, Partner, Locke Lord LLP

Michael Sitzman, US Chair, Life Sciences Patent Litigation, DLA Piper

Vanessa Yen, Partner, King & Spalding LLP

Moderator: Paul J. Molino, Managing Partner, Rakoczy Molino Mazzochi Siwik LLP

Pearl Siew, Senior Vice President and Head, Intellectual Property, Design Therapeutics

8:15 WELCOME BACK TOWN HALL

Forecasting the Future of Pharmaceutical Patents: Trends, Legal Analyses, and Business Prognoses Post-COVID Microphone Jay R. Deshmukh, Partner, Kasowitz Benson Torres

Simon Roberts, Partner, Hogan Lovells

The global pandemic completely disrupted the pharmaceutical IP world with an exceptional challenge.

Innovative companies reacted by collaborating and sharing intellectual property to introduce revolutionary vaccines and therapeutics. These efforts demonstrated the value of IP protections in encouraging innovation as well as highlighted the dilemmas of affordable market access.

This opening annual report will outline the key factors brands and generics need to consider to protect patents, products, and market share in the future.

• Analyzing recent federal and state executive actions and legislative initiatives and their potential impact on the pharmaceutical industry » Orange Book Transparency Act » “Buy America” policies and executive orders » California’s A824 patent settlement law and related federal and state legislative initiatives » Potential amendments to the Hatch-Waxman Act, and more

On February 23, 2021, the Federal Circuit, on Teva’s petition, reheard a second oral argument in GSK v. Teva. The court had previously vacated its prior ruling finding in GSK’s favor that Teva induced infringement based on so-called skinny labeling. As we await the Federal Circuit’s new opinion, this panel will provide insights into strategies and tactics regarding section viii carve outs in view of the decision.

• Reevaluating claim and label language for optimal drafting • Analyzing what types of evidence should be used to prove infringement • Understanding second medical use patents and carve-out strategies » Clarifying the patentability of further medical use inventions • Outlining the implications of the Federal Circuit decision striking down labeling carve-outs • Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use • Balancing competing interests in promoting innovation v. permitting generic drugs 10:40 | Networking Break

• Navigating state laws governing transparency in drug pricing • Evaluating the factors impacting the pharmaceutical global supply chain • Understanding the impact on pharma of patent enforcement trends in ex-U.S. jurisdictions, as well as ongoing international developments at the WTO

6 | #ACIPIV

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11:00

12:15 | Networking Luncheon

The Current State of Patent Eligibility Jurisprudence: Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco

1:30

Microphone Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC

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The Future of Obviousness: Objective Indicia of Nonobviousness and Obviousness-Type Double Patenting

Steven M. Coyle, Partner, Cantor Colburn LLP

Microphone Forrester Liddle, Senior Director, Head of IP, Jounce Therapeutics

Alejandro Menchaca, Shareholder, McAndrews, Held & Malloy, Ltd.

David Blackburn, Director, NERA Economic Consulting

Jonathan Davies, Partner, Cooley LLP

Elizabeth Holland, Partner, Goodwin Procter LLP

Robert C. Millonig, Director, Sterne, Kessler, Goldstein & Fox P.L.L.C.

The saga continues. Competing interests have kept the reformation of patentable subject matter eligibility under 35 U.S.C. 101 from getting before has Congress. At the time of press, a petition for writ of cert has been filed and the Supreme Court invited the Acting Solicitor General to file a brief in the American Axle. At issue is what standard determines whether a patent claim is directed to a patent-ineligible concept and whether patent eligibility is a question of law.

This session will review the most impactful cases from the last 12 months in 101 jurisprudence and review the Court’s attempt to resolve the “bitter divide” in the application of §101:

• Analyzing the impact of Immunex v. Sandoz (Fed. Cir. 2020) on the standard for determining common ownership in applying obviousness-type double patenting (OTDP) • Outlining recent federal circuit and district court trends related to OTDP » Evaluating activity on OTDP as it applies to PTA • Reviewing the status of proposed OTDP legislation

• Examining the Biden administration’s views on patent law and eligibility

• Developing strategies for overcoming OTDP rejections

• Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages

• Evaluating circumstances in which a terminal disclaimer must be made

• Taking stock of recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit » Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020) » Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020) • Deciding whether a new application of an abstract idea is abstract • Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter » Whether there was direction to a natural phenomenon

Paragraph IV Disputes is the indispensable conference on Hatch-Waxman litigation for those practicing in this area. With everyone’s time in short supply, this conference gives a welcomed comprehensive and focused overview on the current thinking from both experienced in-house and law firm practitioners about the most crucial developments in the law, challenges that occur in litigation, related regulatory and antitrust issues, and the creative strategic approaches that are necessary to succeed.

Global Head, Chemistry Patents for R&D IP, Novartis Institutes for BioMedical Research

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AmericanConference.com/PIVDisputes • 888 224 2480

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A

Faculty

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Agenda Day 1

The Business of Hatch-Waxman Litigation: A Global Approach

Agenda Day 2

B

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The Practice of Hatch-Waxman Litigation: Town Hall with the Magistrate Judges

2:30 | Breakout Sessions (Choose A or B)

Managing Global Pharmaceutical Patent Litigation: International and Domestic Considerations

When to Reduce Claims and Defenses to a Manageable Level in Paragraph IV Litigation

Microphone Donna Meuth, Associate General Counsel, IP, Eiasai

Microphone Hon. Christopher J. Burke, Magistrate Judge, District of Delaware

Henry H Gu, VP, Head of Intellectual Property, Morphic Therapeutic

Michael K. Nutter, Partner, Winston & Strawn LLP

Melanie R. Rupert, Partner, Litigation Department, Paul Hastings LLP

Adam Poff, Partner, Young Conaway Stargatt & Taylor, LLP

• Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss • Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers • Building a winning global litigation team » Selecting the right foreign counsel

• Utilizing claim reduction during scheduling negotiations to avoid excessive patent claims • Deciding when to oppose consolidation of new actions in litigation based on patents issuing from new applications • Determining when to demand that claims to be tried are representative of all asserted claims and give ride to estoppel

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

3:30 | Breakout Sessions (Choose A or B)

Understanding the Importance of Aligning Legal and Business Functions for Patent Litigation Planning

Practical Strategies and Tactics for Effective Settlement Negotiation Microphone Hon. Mary Pat Thynge, Chief Magistrate Judge, District of Delaware

Microphone Stephanie Donahue, Senior Director, Patent Litigation, Sanofi-Aventis

Vishal C. Gupta, Partner, Steptoe & Johnson LLP

Lars Taavola, VP, Chief IP Counsel, Mallinckrodt Pharmaceuticals

Adam L. Perlman, Partner, Latham & Watkins LLP

Noah M. Leibowitz, Partner, Dechert LLP

Alyson Wooten, Director, Berkeley Research Group LLC

• Utilizing business functions such as operations, business development and life cycle management to advance product portfolio acquisitions and IP protections • Understanding the importance of global portfolio planning from the get-go

• Developing timelines for business and legal milestones relative to the terms of the settlement • Understanding the application of antitrust law’s “rule of reason” on pharmaceutical patent settlement practice • Examining recent decisions concerning pharmaceutical patent settlements in the PIV context • Analyzing practical strategies and tactics for effective settlement negotiation

• Responding in kind to continued growth on a global scale by building a team structure that is sustainable on a long-term basis to address IP litigation around the world • Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss • Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers • Considering FDA warning letters relative to foreign manufacturing sites and reviewing related manufacturer liability » 180-day exclusivity forfeiture

8 | #ACIPIV

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4:30 | Networking Break

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6:00

Welcome Back Cocktail Reception

4:45

Spotlight on Delaware: District Court Judges Address Brand and Generic Concerns Microphone Honorable Mitchell Goldberg, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Hon. Maryellen Noreika, District Judge, United States District Court, District of Delaware

Moderator: Elizabeth S. Weiswasser, Partner, Weil, Gotshal & Manges LLP

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 discuss best practices for both patent holders and patent challengers. These federal judges will identify the impediments to resolving such multifaceted contests and provide you with a rare opportunity to find solutions to your most unyielding Paragraph IV predicaments.

DAY TWO | Wednesday, November 10 7:50

9:00

Co-Chair’s Opening Remarks

The PTAB Live! Practice, Policy, and Procedure in the New World of Pharmaceutical Patent Validity Challenges

Microphone Guy Donatiello, Senior Vice President, Intellectual Property, Endo Pharmaceuticals

Pearl Siew, Senior Vice President and Head, Intellectual Property, Design Therapeutics

8:00 REGULATORY THINK TANK

Analyzing the Effect of the Latest FDA Initiatives on Generic Drug Access and Paragraph IV Disputes Microphone Maryll Toufanian, Director, Office of Generic Drug Policy, U.S. FDA

Brian Stone, Associate General Counsel, Global Legal-Regulatory, Viatris

Kurt 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

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AmericanConference.com/PIVDisputes • 888 224 2480

Microphone Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, USPTO

Honorable Michelle N. Ankenbrand, Lead Administrative Patent Judge

Honorable Kristi Rupert Sawert, Administrative Patent Judge

Moderated By:

John J. Molenda, Partner, Steptoe & Johnson LLP

Gregory A. Morris, Partner, Honigman LLP

• Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials • Examining the impact of the Supreme Court’s decision in Arthrex Inc. v. Smith & Nephew • Reviewing the latest stats at PTAB, highlighting bio/pharma cases • Analyzing the status of PTAB in a COVID environment » Oral hearings • Outlining the latest developments on pilot programs at PTAB » Legal Experience and Advancement Program (LEAP) Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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» Fast-Track Appeals

11:30 SPOTLIGHT ON DEI

» Motions to Amend (MTAs) in AIA proceedings

Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation

• Detailing recent rules at PTAB » New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies) » New rule relating to burdens of persuasion in MTAs • Interpreting PTAB precedent and other information » Newly designated precedent at PTAB » New memorandum regarding indefiniteness approach in AIA proceedings 10:00 | Networking Break 10:30

To Stay or Not to Stay: Winning Strategies for Addressing Parallel Proceedings at the District Court and IPR Microphone Dominick A. Conde, Partner, Venable LLP

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

Dmitry V. Shelhoff, Partner, Chair of Litigation, Pergament & Cepeda LLP

Brian Anderson, Counsel, Polsinelli PC

• 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

Microphone Valencia Martin Wallace, Deputy Commissioner for Patents, U.S. Patent and Trademark Office

Huong T. Nguyen, General Counsel, Fosun Pharma USA Inc.

Neal Dahiya, SVP, Head of Litigation, Moderna

Sharon M. Walker, Director, Legal, Translate Bio, A Sanofi Company

The Director of the National Institute of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science”. The growing call to action seems clear: the pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. This session will consider best practices for implementing change and expanding innovation by advocating for diversity, equity and inclusion in IP. 12:15 | Networking Luncheon 1:15

Think Tank on State and Federal Antitrust Initiatives: Commercial Considerations for Patent Settlements, Reverse Payments, and Emerging Legislation Microphone Dr. Christine Siegwarth Meyer, Managing Director, Chair of IP, NERA Economic Consulting

Michael A. Carrier, Distinguished Professor of Law, Rutgers Law

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 reverse payment litigation, the competitive effects, and economic consequences. Topics of discussion will include:

• Ensuring all RPIs are properly named

• Understanding settlement strategies between innovator biologic companies and biosimilar applicants

• Assessing split petition strategies

• Highlighting the state legislation directly addressing “reverse payment” patent settlements

• Understanding when requests for joinder can be made and when they should be made

• Reviewing the proper standards of antitrust review and the rising call for a legislative response

• Analyzing secondary considerations • 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 • Identifying best practices for simultaneous trials • Appealing decisions in both forums

10 | #ACIPIV

» Analyzing the current legislative and regulatory framework » Mergers, acquisitions and exclusive licenses

» Abuse of dominance » Life cycle management and contracting » Pricing strategies

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

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2:15

3:15

Written Description and Enablement: Defensive Strategies and Offensive Moves for §112 Rejections and Attacks

SCOTUS Weighs In: The Future and Scope of the Equitable Doctrine of Assignor Estoppel

Microphone David L. Anstaett, Partner, Perkins Coie

Andrew J. Allen, Senior Director, Legal Counsel, Dr. Reddy’s Laboratories

Kevin S. Prussia, Partner, WilmerHale

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

Moderator: Emily Savas, Partner, Locke Lord LLP

In one of the most important patent stories of the year, the Federal Circuit issued a groundbreaking decision concerning the validity of antibody epitome claims covering a reference product. In Amgen Inc. v. Sanofi, No. 20-1074 (Fed. Cir. 2021), the court held that “a genus of antibodies claimed only by specific functional properties are invalid for lack of enablement.” The Federal Circuit invalidated all claims for lack of enablement, holding that “the binding limitation itself was sufficient for the claims to require undue experimentation.” In view of this precedential decision, this panel will consider the new requirements for creating a valid patent and how best to leverage recent decisions.

• Identifying best practices for meeting the written description and enablement requirements » How to survive invalidity and unpatentability challenges

Microphone Shashank Upadhye, Partner, Upadhye Tang LLP Jeffrey N. Myers, Ph.D., Vice President & Assistant General Counsel, Pfizer Inc

Rob Gorman, SVP & Asst. General Counsel, Bausch Health Companies

Last year, in Minerva Surgical, Inc. v. Hologic, Inc. the Federal Circuit held that the doctrine of assignor estoppel does not prevent an assignor from lodging a validity challenge of an assigned patent in an IPR proceeding. The doctrine precludes inventors from assigning a patent to someone and then challenging the validity of the patent. In reviewing the Federal Court’s decision, The Supreme Court vacated the Federal Circuit’s decision in a 5-4 decision, holding that the appeals court gave an overly broad interpretation of assignor estoppel. This session will consider the now limited doctrine and contemplate its future as an equitable matter. Points of discussion will include: • Reviewing recent approaches to assignors in patent invalidation » Taking stock of the impact to patent sale and assignment agreements • Assessing considerations for contract provisions • Examining how the decision could impact pharmaceutical patent law and related transactions

• Evaluating the enablement and written description of claims directed to a genus of antibodies

4:15 ETHICS LAB

• Examining the Federal Circuit’s recent approach and interpretation of written description under §112 as it applies to small molecules

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

• Assessing current patents for written description vulnerabilities under these Federal Circuit opinions • Examining patent challenges and defenses in ANDA proceedings under this new §112 jurisprudence

Media Partners:

Microphone Jonathan D.J. Loeb Ph.D., Partner, Dechert LLP

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)

Mary Morry, Counsel, Merck Sharp & Dohme Corp.

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?

Do all parties have to seek new counsel?

• Analyzing the requirements for pleadings, whether in the complaint, the answer, or the counterclaim Interpreting Rule 11 and other standards 5:15 | Conference Concludes

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Planning Ahead for Live Conferences: C5’s All Secure Safety Plan We look forward to the time when we are able to welcome you back to our live conferences.

When you are ready to attend one of our conferences, you will see that a lot has changed. Social distancing and cleaning procedures that have now become a way of life for all of us are now the standard for how we will run our conferences. Our events will continue to offer unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise and now with a greater focus on the safety, health and well-being of all our guests.

As American Conference Institute and our partners begin to look forward to live 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. Our live events will follow the commitments below.

In-person Conference Participation Requirements For the protection and wellbeing of all event attendees, we have implemented a vaccination requirement for entry into the conference. All attendees and staff are required to provide proof of being fully vaccinated with a COVID-19 vaccine. A negative COVID-19 test result will not qualify for entry into the conference. Vaccination proof must be accompanied with a government-issued ID.

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 They are not experiencing COVID-19 symptoms. y Have not traveled from an area under a travel health advisory. y Have not provided care for or had close contact with any person with or reasonably suspected of having COVID-19, or with any person who traveled outside of your home country or to an area under a travel health advisory. y Have not been advised by any health authority, government agency or regulation to selfisolate 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.

In addition, as per the guidance of the CDC, we encourage all attendees to wear a mask or face covering at all times while at the conference and its social functions, except in limited settings such as during meals.

We reserve the right to deny entry to anyone not following the requirements above. Please note our entry policy is subject to change at any time based on changing local regulations.

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

y A conference room layout with planned seating for appropriate physical distancing.

y Reduction of the physical distribution of onsite materials.

y We continue to work closely with our venue partners to ensure the safety of our attendees.

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

y Food and beverage options that ensure minimal handling and exposure.

Why Attend

Faculty

Advisory Board

Agenda Day 1

Agenda Day 2

Venue

C5’s All Secure Safety Plan

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About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

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With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

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