9th Annual Paragraph IV Disputes Master Symposium - DS

EARN CLE/ETHICS CREDITS

ACI’s

October 24–25, 2023 Hyatt Regency McCormick Place, Chicago, IL

HatchWaxman SERIES

9th Annual

Paragraph IV Disputes MASTER SYMPOSIUM Master the Skills to Meet the Challenges of the Ever Evolving Pharmaceutical Patent Endgame

2023 Chairs

Members of the Judiciary

Hon. Teresa Rea Partner, Crowell & Moring LLP (Former Acting Director of the USPTO)

Hon. Joshua Wolson District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Laura DeMoor Associate General Counsel, IP Baxter Healthcare Corporation

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

Andrea D. Tiglio Executive Director / Assistant General Counsel, Intellectual Property Jazz Pharmaceuticals

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

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Supporting Sponsors

Associate Sponsors

Luncheon Sponsor

AmericanConference.com/PIVDisputesChicago • 888 224 2480

Premium Exhibitor CERTIFIED PARTNER

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Hatch-Waxman at the Precipice: 2023 Marked the Next Edge of the Pharmaceutical Patent Cliff, and the Beginning of Legislative and Regulatory Measures that Will Put New Limits on Exclusivities.

Industry experts estimate that between 2023 and 2030, pharmaceutical patent expirations on the next band of blockbuster drugs will exceed losses of $200B.† The Inflation Reduction Act, with its new exclusivity limits, will only hasten this fall.

While this may look like a windfall for the generic drug industry, it too is facing challenges with an increasingly crowded marketplace, rising costs, and supply chain constraints, all while brands struggle to develop new products. As a result of these tensions, the industry has entered an era of Paragraph IV litigation where the monetary ante has never been higher.

Grants of Cert., Surprising Denials, and Remarkable Decisions at the Supreme Court – regarding §101, §112, and skinny labeling are causing more conundrums.

This year the Supreme Court heard Amgen v. Sanofi and decided the future of §112 jurisprudence. However, the Court denied cert. on two §101 cases – Interactive Wearables LLC v. Polar Electro Oy, and Tropp v. Travel Sentry Inc, despite the Solicitor General’s recommendation, thus leaving the question of patent eligibility out in the cold again. There are indications that Congress has §101 reform on their to-do list – and guidance may come from the Federal Circuit if Congress does not act.

IP Developments in Europe with the Unitary Patent and the Unified Patent Court Will Influence Pharmaceutical Patent Strategies in the U.S. Across the pond, it is a new dawn for European patents. The creation of a new Unified Patent Court and a new patent with unitary effect will fundamentally change the international pharmaceutical patent litigation landscape for years to come.

To Be Competitive in an Already Competitive Market, You Must Understand the Implications of These New Developments for the Patent Endgame and Revise Your Playbook.

Over the course of two days, our faculty of esteemed thought-leaders will outline the contours of the current Hatch-Waxman litigation landscape, analyze the existing statutory framework that is designed to balance the competing interests of brands and generics, consider the implications of new legislation and regulation, and most importantly, evaluate their potential impact.

We look forward to seeing you and your contemporaries in Chicago for another successful conference! https://advisory.kpmg.us/articles/2020/generics-2030-curb-downward-spiral.html

†

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Media Partners

2 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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.

Ryan M. Daniel

AGC, Corporate and Business Transactions Fresenius Kabi USA, LLC (Lake Zurich, IL)

Stephanie Donahue Senior Director, Patent Litigation Sanofi (Bridgewater, NJ)

Serena FarquharsonTorres

Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb (Princeton, NJ)

Linda Friedlieb Division Counsel AbbVie (North Chicago, IL)

James Kellerman

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

Neema Kumar

Assistant General Patent Counsel, Vice President, IP, North America Sandoz (Princeton, NJ)

James P. Leeds

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

Pearl T. L. Siew

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

Brian Stone

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

Lars Taavola

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

Mary Morry

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

Maryll Toufanian

Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals

Jeffrey N. Myers, Ph.D.

Peter Waibel

Staci Julie

Aaron Pereira

Kevin Zive

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

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Stephen R. Auten

Partner, Chair of Pharmaceutical & Life Sciences Litigation Taft Stettinius & Hollister LLP (Chicago, IL) (Former Vice President, IP, Sandoz, Inc.)

Guy Donatiello

Legal Executive / Intellectual Property Attorney (Former Senior Vice President, Intellectual Property, Endo Pharmaceuticals) (Malvern, PA)

George W. Johnston

Andrea Hutchison

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

EMERITUS MEMBERS

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

Senior Director of Patents Ferring Pharmaceuticals (Parsippany, NJ)

AmericanConference.com/PIVDisputesChicago • 888 224 2480

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

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

Counsel Gibbons P.C. (Newark, NJ) (Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Meg Snowden

Shareholder Margaret M. Snowden, P.C. (San Francisco, CA) (Former Vice President, Intellectual Property, Impax Laboratories)

Shashank Upadhye

Partner Upadhye Tang LLP (Chicago, IL) (Former Vice President – Global Intellectual Property, Apotex, Inc.)

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

As the legal landscape shifts, with precedential opinions from the Supreme Court, new legislation in the way of the Inflation Reduction Act, and the opening of the UPC, it’s an exciting time to be involved in the intellectual property field, and particularly in the Hatch-Waxman area. Join us for a robust discussion on these emerging topics; for a view to round tables with chief IP counsel, judges and regulators; and for updates on some of the fundamentals! – Laura DeMoor, Baxter Healthcare Corporation, 2023 Chair

Speaker Faculty DISTINGUISHED CHAIRS Hon. Teresa Rea Partner Crowell & Moring LLP (Former Acting Director of the USPTO) Laura DeMoor Associate General Counsel, IP Baxter Healthcare Corporation Andrea D. Tiglio Executive Director / Assistant General Counsel, Intellectual Property Jazz Pharmaceuticals MEMBERS OF THE JUDICIARY Hon. Joshua Wolson District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Hon. Tonianne J. Bongiovanni Magistrate Judge United States District Court, District of New Jersey Hon. Christopher J. Burke Magistrate Judge United States District Court, District of Delaware USPTO PATENT TRIAL AND APPEAL BOARD Honorable Grace Obermann Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Honorable Linda Horner Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office

GOVERNMENT REPRESENTATIVES FROM KEY AGENCIES Beckey Egeland Attorney, Health Care Division Federal Trade Commission Mary C. Till Senior Legal Advisor Office of Patent Legal Administration U.S. Patent and Trademark Office IN-HOUSE COUNSEL Ryan Daniel AGC, Corporate and Business Transactions Fresenius Kabi USA Sarah Fendrick, Ph.D., J.D. Director, Patent Counsel Alnylam Pharmaceuticals Ryan Kaat Assistant General Counsel PhRMA Neema Kumar Vice President, Intellectual Property, North America Sandoz Lars Taavola VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals Maryll W. Toufanian Senior Vice President, Regulatory Strategy and Government Affairs Amneal Pharmaceuticals LAW FIRM COUNSEL John T. Bennett Partner Allen & Overy LLP Arlene Chow Partner Latham & Watkins LLP

Liz Cohen Partner Bristows LLP Jay R. Deshmukh Partner Kasowitz Benson Torres LLP Tasha Francis Gerasmiow Partner Kirkland & Ellis LLP Eric Grannon Partner White & Case LLP Steven J. Horowitz Partner Sidley Austin LLP

Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP Adam W. Poff Partner Young Conaway Stargatt & Taylor, LLP James T. Peterka Partner Locke Lord LLP Joseph Reisman Partner Knobbe Martens

Tom Irving Partner The Marbury Law Group

Irena Royzman Partner Kramer Levin Naftalis & Frankel LLP

Sara W. Koblitz Director Hyman, Phelps & McNamara PC

Emily Larrimer Savas Partner Locke Lord LLP

Richard Kurz Partner Haug Partners LLP

Emer Simic Partner Neal, Gerber & Eisenberg LLP

Justin A. Maleson Director Longford Capital Management LP

Anita Spieth Co-Chair, IP Litigation Choate, Hall & Stewart LLP

Ted Mathias Partner Axinn, Veltrop & Harkrider LLP Alejandro Menchaca Shareholder McAndrews, Hel & Malloy, Ltd. Gregory A. Morris Partner Choate, Hall & Stewart LLP Jason Murata Partner Axinn, Veltrop & Harkrider, LLP Kevin Nelson Partner ArentFox Schiff LLP

Shashank Upadhye Partner Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.) Ruud van der Velden Partner Hogan Lovells Ha Kung Wong Partner Venable LLP William Zimmerman Partner Knobbe Martens

DAY ONE | Tuesday, October 24 8:00

Pharmaceutical Chief IP Counsel sit at the helm of the Hatch-Waxman litigation nerve center where they navigate the ever-evolving landscape of pharmaceutical patent litigation. With the intent of IP protection and preservation or defeat at the forefront of their agendas, these panelists will discuss best practices and strategies they employ to control or covet patents and profits.

Opening Remarks from the Co-Chairs

BRAND PERSPECTIVES

microphone-alt Hon. Teresa Rea, Partner, Crowell & Moring LLP (Former Acting Director of the USPTO)

• Appreciating the importance of patents for innovation

Laura DeMoor, Associate General Counsel, IP, Baxter Healthcare Corporation Andrea D. Tiglio, Executive Director, Assistant General Counsel, Intellectual Property, Jazz Pharmaceuticals

• Understanding the keys to growing a strong portfolio » Orange Book listing strategies • Gauging when to expect a Paragraph IV lawsuit

GENERIC PERSPECTIVES

8:15

• Determining which patents are ripe to challenge in today’s environment

Patents, Drug Pricing, and Price Controls: Understanding How the Inflation Reduction Act (IRA) Will Impact The Value of Pharmaceutical IP

• What makes one patent more attractive than another?

microphone-alt John T. Bennett, Partner, Allen & Overy LLP Anita Spieth, Co-Chair, IP Litigation, Choate, Hall & Stewart LLP • Analyzing how the IRA’s provisions on drug pricing is impacting pharmaceutical patents » Understanding how price negotiation may circumvent pharmaceutical patent values SQUARE

SQUARE

How is the value of IP impacted when drugs are not approved for Medicare/Medicaid formularies?

• Evaluating invalidity and non-infringement for the patent target • Formulating your ANDA strategy

CONSIDERATIONS FOR BOTH SIDES • Deciding when to refer to outside counsel and detailing which matters typically remain in-house • Taking stock of significantly challenging situations and predicting the challenges in-house lawyers will face in the future 10:15

Networking Coffee Break

How does renegotiation affect the value of the drug’s patent?

• Appreciating the significance of Merck v. Becerra with respect to pro-competitive intent of Hatch-Waxman • Evaluating the potential impact of the IRA on pharmaceutical patent litigation » What happens when a patent holder’s product is selected for negotiation before or during litigation? » What is the impact on recoverable damages in an at-risk launch scenario?

• Understanding the impact on coordination and discovery • Exploring how the IRA can encourage settlement of infringement litigation • Practical strategies for safeguarding IP value when your drug is selected for negotiation 9:15

Chief IP Counsel Roundtable: Day-to-Day Concerns and Forward-Looking Strategic Planning microphone-alt Neema Kumar, Vice President, Intellectual Property, North America, Sandoz Lars Taavola, VP, Chief IP Counsel & General Counsel, Specialty Generics, Mallinckrodt Pharmaceuticals

ACI’s PIV events is a fabulous way to keep up with all the changes involving Hatch-Waxman and pharma. They corral the best speakers from government, corporations, associations and private practice to address the most current topics and the schedule is modified when new developments arise. With that platform, they are able to attract a talented audience that actively participates in the discussion and contribute their unique perspectives. We hope that you can join us!

– Hon. Teresa Rea, Crowell & Moring LLP, 2023 Chair

MODERATOR:

William A. Rakoczy, Founding Partner, Rakoczy Molino Mazzochi Siwki LLP

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AmericanConference.com/PIVDisputesChicago • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

SPOTLIGHT ON THE SUPREME COURT

1:00

Sponsored by

10:30

Insights on the Future of §112: Satisfying the Requirements of Enablement and Written Description under Amgen v. Sanofi microphone-alt Mary C. Till , Senior Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office Jason Murata, Partner, Axinn, Veltrop & Harkrider, LLP Emily Larrimer Savas, Partner, Locke Lord LLP Emer Simic, Partner, Neal, Gerber & Eisenberg LLP • Analyzing the Supreme Court’s decision in Amgen v. Sanofi relative to the enablement requirement » Taking stock of what the decision means when a patent claims a class of novel compounds or antibodies • Understanding the impact of the decision on the ability to protect broader foundational innovations • Reviewing the impact of other influential §112 cases, such as Juno, Biogen and Idenix • Reconciling whether patentees must disclose enough information to “enable” people of ordinary skill in the relevant art to “reach the full scope” of a claimed invention • Assessing how the decision could make changes to the Federal Circuit’s approach • Implementing best practices for patent prosecution in view of the Court’s decision 11:45

The Pain of Rejection: A Deep Dive into the Business and Legal Implications of the Supreme Court’s Denial of Cert. in Recent Patent Eligibility and Carve-Out Cases microphone-alt Jay R. Deshmukh, Partner, Kasowitz Benson Torres LLP Steven J. Horowitz, Partner, Sidley Austin LLP Alejandro Menchaca, Shareholder, McAndrews, Hel & Malloy, Ltd. James T. Peterka, Partner, Locke Lord LLP Irena Royzman, Partner and Head of Life Sciences, Kramer Levin Naftalis & Frankel LLP Last Spring, despite the push from the U.S. Solicitor General, the Supreme Court declined to hear three key patent cases, two cases involving §101, Tropp v. Travel Sentry et al. and Interactive Wearables v. Polar Electro Oy, et al., and the infamous GSK v. Teva.

During this session, our panelists will analyze the significance of the Supreme Court's refusal to hear these cases and explore the potential impact on Hatch-Waxman litigation strategies.

They will also comment on market dynamics, and the overall impact of these rejections on the pharmaceutical IP landscape. Points of discussion will include:

• Uncovering the business consequences stemming from the Court's refusal to hear these cases • Exploring how these decisions may collectively affect the balance of power between brandname drug manufacturers and generic challengers, market entry opportunities, and the overall competitive landscape.

• Assessing how lower courts may interpret and apply the existing § 101 and carve-out legal frameworks • Evaluating the potential impact of the absence of the Supreme Court’s pronouncement on the evolving landscape of pharmaceutical patent disputes in the areas of patent eligibility and skinny labeling

6 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

Networking Luncheon

2:00

What Every U.S. Pharmaceutical Patent Litigator Needs to Know About the Unitary Patent (UP) and the Unified Patent Court (UPC) microphone-alt Liz Cohen, Partner, Bristows LLP Sarah Fendrick, Ph.D., J.D., Director, Patent Counsel, Alnylam Pharmaceuticals Ha Kung Wong, Partner, Venable LLP Ruud van der Velden, Partner, Hogan Lovells The introduction of the UP and the establishment of the UPC have far-reaching implications for pharmaceutical patents issued in the U.S. that cannot be ignored. Without an understanding of the UP and the UPC, pharmaceutical patent holders in the U.S. may not be able to protect innovations globally. This undoubtedly would hinder cost savings, as well as compromise streamlined portfolio management and limit alternative enforcement options.

During this session, our global thought-leaders will delve into the intricacies of the UP and the UPC, and explore their significant impact on the global patent ecosystem. Topics of discussion will include: • Understanding why U.S. pharmaceutical patent practitioners need to know about the UP and the UPC • Exploring the UP and the UPC, including their legal frameworks and operational procedures • Evaluating the associated advantages and disadvantages of the UP and the UPC and how they may impact your global patent portfolio • Navigating the UPC’s jurisdiction and the potential risks and opportunities associated with litigating in this new court system.

• Developing offensive litigation strategies for the UPC, as well as defensive strategies if you believe you will be sued in the UPC • Understanding the interplay between opposition proceedings at the EPO and validity challenges in the UPC 3:00

Patent Reissue and Reexamination in the Hatch-Waxman Realm: Strategies for When to Pursue and Correct Patent Errors microphone-alt Vikram A. Mathrani, Partner, Honigman LLP Joseph Reisman, Partner , Knobbe Martens

Gregory A. Morris, Partner, O’Melveny & Myers LLP In this session, our panelists will navigate the legal nuances and practical implications of patent reissue and reexamination in Hatch-Waxman litigation. Topics of discussion will include: • Assessing how these processes can influence the strength, scope, and enforceability of pharmaceutical patents • Understanding the impact on market exclusivity, generic drug entry, and patient access to affordable medications • Analyzing the key considerations when deciding to pursue reissue/reexaminaiton in a Hatch-Waxman scenario » Grounds for filing » Process before USPTO » Timing • Identifying the risks and limitations of utilizing reissue proceedings to resolve patent errors • Employing a cost-benefit analysis while your patent application is pending • Reconciling when supplemental examination is beneficial relative to reissue

4:00

Afternoon Refreshment Break

MAGISTRATE TOWN HALL 4:15

Upcoming Related Events

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings microphone-alt Honorable Tonianne J. Bongiovanni, Magistrate Judge, United States District Court, District of New Jersey Honorable Christopher Burke, Magistrate Judge, United States District Court, District of Delaware MODERATOR:

Adam W. Poff, Partner, Young Conaway Stargatt & Taylor, LLP In the complex landscape of pharmaceutical patent disputes, these esteemed magistrate judges play a pivotal role in ensuring fair and efficient resolution of cases. With their unique perspective, Magistrate Judges bring a wealth of knowledge to the bench, navigating the intricate interplay between pharmaceutical innovation and intellectual property rights.

Oct. 10 – 26, 2023 Virtual Event

During this session, Magistrate Judges from the most active jurisdictions will share their invaluable insights and experiences, shedding light on the critical decisions they make and the profound impact they have on shaping the future of pharmaceutical patent litigation.

VIEW FROM THE BENCH 5:15

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Settlements and Timings microphone-alt Honorable Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Nov. 28 – 29, 2023 Boston, MA

INTERVIEWED BY:

Arlene Chow, Partner, Latham & Watkins LLP District Court Judges are at the forefront of shaping the landscape of pharmaceutical IP law.

During this can’t-miss roundtable, distinguished District Court Judges will share their unique perspectives, illuminating the delicate balance between patent holders, generic drug manufacturers, and public interest.

6:15

Conference Adjourns to Day Two

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AmericanConference.com/PIVDisputesChicago • 888 224 2480

Apr. 17 – 18, 2024 New York, NY

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY TWO | Wednesday, October 25 8:00

Opening Remarks microphone-alt Hon. Teresa Rea, Partner, Crowell & Moring LLP (Former Acting Director of the USPTO) Laura DeMoor, Associate General Counsel, IP, Baxter Healthcare Corporation Andrea D. Tiglio, Executive Director, Assistant General Counsel, Intellectual Property, Jazz Pharmaceuticals 8:15

Brand and Generic Insights on FDA Programs Impacting Pharmaceutical Patents: Regulatory Initiatives and Recent FDA Litigation Every PIV Practitioner Needs to Know About microphone-alt Maryll W. Toufanian, Senior Vice President, Regulatory Strategy and Government Affairs, Amneal Pharmaceuticals

In this session, panelists will demystify the 505(q) Citizens Petition process, equipping HatchWaxman litigators with the knowledge and tools to effectively utilize this valuable regulatory tool.

Topics of discussion will include: • Leveraging 505(q) Citizens Petitions as a strategic tool in Hatch-Waxman litigation » Examining how 505(q) petitions have impacted FDA drug approvals » Understanding of the petition process, including the nuances of drafting, submission, and navigating potential challenges • Understanding the criteria FDA considers when evaluating a petition » How does FDA determine the petition’s primary purpose was to delay?

• Analyzing market exclusivities to be addressed in the petition • Detailing what should be included and what the process entails • Taking stock of recent decisions involving Citizens Petitions • Best practices for the reconsideration process and litigation 10:15

Networking Coffee Break

ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES 10:30

FTC KEYNOTE

Antitrust Developments Concerning Brands and Generics

Maarika L. Kimbrell, Partner, Morgan, Lewis & Bockius LLP For Hatch-Waxman litigators, staying up to date with new FDA regulations is crucial. By monitoring these developments, Hatch-Waxman litigators can adapt their strategies, assess the potential impact on patent validity and infringement disputes, and navigate the evolving landscape of pharmaceutical patent litigation effectively. During this session, our panelists will help you understand the nuances of new regulations and initiatives, empowering you to provide valuable insights, and advocate for your clients’ interests. Topics of discussion will include:

microphone-alt Rebecca Egeland, Attorney, Federal Trade Commission 11:15

• Exploring the progress of the FDA/USPTO collaboration

A 360 Degree Examination of Reverse-Payment Settlements: Non-Monetary Provisions, State Legislation, Expert Testimony, and Recent Litigation

• Dissecting FDORA and 2024 priorities

microphone-alt Eric Grannon, Partner, White & Case LLP

» Proposed GDUFA riders included in FDORA and adapting your litigation strategies accordingly » GDUFA II user fees, guidances and MAPPs

Richard Kurz, Partner, Haug Partners LLP

• Exploring how FDORA is influencing pharmaceutical patent litigation • Detailing the impact of recent FDA and related litigation on brands and generics » Melinta v. FDA

» Sandoz v. Becerra

» Avadel v. FDA

» Vanda v. FDA

Tasha Francis Gerasmiow, Partner, Kirkland & Ellis LLP

» Avadel v. Jazz

9:15

Best Practices for Utilizing FDA’s Citizen Petition Process: Brand and Generic Recommendations for Achieving Market Access and Petitions for Reconsideration microphone-alt Ryan Kaat, Assistant General Counsel, PhRMA Sara W. Koblitz, Director, Hyman, Phelps & McNamara PC

Ted Mathias, Partner, Axinn, Veltrop & Harkrider LLP • Analyzing recent trends in how agencies and courts approach reverse payments » In re Zetia » In re Glumetza • Understanding settlement strategies from the perspectives of brands and generics • Structuring agreements and identifying antitrust concerns » Understanding investigation and liability risks • Highlighting the state legislation directly addressing “reverse payment” patent settlements » Presumption of unlawfulness – California AB 824 » Which states have modeled their legislation after California?

• Reviewing the proper standards of antitrust review and the rising call for a legislative response • Avoiding costly litigation and associated penalties by effectively complying with the law • At-risk Launch considerations

8 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

12:15

Networking Luncheon

3:45

Afternoon Break

1:30

THE PTAB LIVE!

4:00

ETHICS CASE STUDIES

The APJs Speak on Practices, Policy and Procedure

Cybersecurity, Information Security, and the Ethical Protection of Data

microphone-alt Honorable Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

microphone-alt Tom Irving, Partner, The Marbury Law Group

Honorable Linda Horner, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office MODERATOR:

William Zimmerman, Partner, Knobbe Martens • Surveying notable pharmaceutical patent wins and losses • Reviewing IPR, PGR and CBM filings involving pharmaceutical patents • Examining the latest statistics for types of challenges brought and types of patents challenged • Examining when the PTAB will issue a “good cause” extension of trial • Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review

Kevin Noonan, Partner, McDonnell, Boehnen, Hulbert & Berghoff LLP Shashank Upadhye, Partner, Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.) Attorneys oversee myriad of sensitive information daily, and confidentiality is a core tenet of the legal profession. Now, more than ever before, cybersecurity must be an ever-present priority for Hatch-Waxman practitioners. This session will offer best practices for protecting your clients’ information, identify the main risks specific to the life sciences and intellectual property, and provide proven strategies on optimizing your firm’s cybersecurity approach that you can immediately implement.

5:00

Conference Concludes

• Evaluating when petitioners may rely on prior art previously considered by the PTAB 2:30

A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding and Alternative Fee Arrangements microphone-alt Ryan Daniel, AGC, Corporate and Business Transactions, Fresenius Kabi USA Justin A. Maleson, Director, Longford Capital Management, LP Kevin Nelson, Partner, ArentFox Schiff LLP Litigation funding can help businesses pay for legal fees and expenses, including increasingly costly expert fees. Alternative fee arrangements can provide risk averse litigants with the confidence to see cases through to their conclusion, even against the best-capitalized defendants.

In this interactive practical session, topics of discussion will include:

I am excited to co-chair ACI’s 9th Annual Paragraph IV Master Symposium in Chicago! I look forward to the top-notch content and breadth of insight from key in-house and outside counsel and judges. It’s an excellent opportunity to connect and engage with colleagues and the judiciary to share ideas and strategies in the constantly changing landscape of Hatch-Waxman law and the pharmaceutical industry.

– Andrea D. Tiglio, Jazz Pharmaceuticals, 2023 Chair

• Reviewing the sweeping reform being considered by the PTAB to address discretionary denials and petitions filed by certain for-profit entities • Reviewing litigation funding and other alternative fee arrangements and the advantages for litigants • Assessing risk-sharing solutions to provide better predictability and value • Appreciating the call for mandatory funding disclosures for U.S. patents to increase transparency

LUNCHEON SPONSOR:

» Reviewing Chief Judge Connolly’s order regarding third-party litigation funding • Recognizing the essential criteria of a feasible funding opportunity based on meritorious claims • Analyzing the mechanics of the financer’s underwriting process • Exploring the key modules of a pharmaceutical patent litigation funding agreement

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Knobbe Martens is a highly respected intellectual property law firm, offering legal services in all aspects of intellectual property and technology law. Founded in 1962, the firm serves a diverse international client base, from multinational corporations to emerging businesses of all stages.

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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10 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

© American Conference Institute, 2023

CONFERENCE CODE:

815L24-CHI

Special Discount

Bringing a Team?* 3–4

10% Conference Discount

5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. *Team/group registrations must be from the same organization/firm and register together in one transaction.

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES