18th Annual Paragraph IV Disputes - DS

EARN CLE/ETHICS

CREDITS

ACI’s

April 19-20, 2023 • The Intercontinental Times Square, NYC

HatchWaxman SERIES

18th Annual

PARAGRAPH IV DISPUTES Expert Strategies for Brand Names and Generics

Judicial Insights: Honorable Leonard P. Stark United States Judge U.S. Court of Appeals for the Federal Circuit (Former Chief Judge, United States District Court, District of Delaware Honorable Maryellen Noreika District Judge United States District Court, District of Delaware Honorable Joshua Wolson District Judge United States District Court Eastern District of Pennsylvania

2023 CHAIRS

Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP

Neema Kumar Vice President, IP, North America Sandoz

Patent Trial & Appeal Board, USPTO: Honorable Christopher J. Burke Magistrate Judge District of Delaware Honorable Stanley R. Chesler District Judge United States District Court, District of New Jersey Honorable Mitchell Goldberg District Judge United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Honorable Jacqueline Bonilla Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Honorable Susan Mitchell Senior Lead Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office

Serena Farquharson Torres Executive Director, Assistant General Counsel Bristol Myers Squibb

Government Insights: Christopher Pruitt Deputy Director, Office of Generic Policy U.S. FDA Rebecca Egeland Attorney Federal Trade Commission

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

(Visiting Judge, District of Delaware)

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

2023 not only marks the next wave of the pharmaceutical patent cliff, but also the beginning of legislative and regulatory measures that will put new limits on exclusivities.¹ Industry experts estimate that between 2023 and 2030, that 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 win-fall for the generic industry, they too are facing challenges with an increasingly crowded marketplace, rising costs and supply chain constraints, while brands struggle to develop new product. As a result of these tensions, the industry has entered an era of Paragraph IV litigation where the monetary ante has never been higher.

Meet and Network with Key Influencers Shaping the Law, Policy and Proceedings of Paragraph IV litigation from: Greater-than Amneal Pharmaceuticals Greater-than Bristol Myers Squibb

Grants of Cert. and Surprising Denials at the Supreme Court and Congressional Activity May Create Even More Paragraph IV Conundrums.

Greater-than Fresenius Kabi USA, LLC

This year the Supreme Court will hear Amgen v. Sanofi and decide the future of §112 jurisprudence. There are indications that Congress has §101 reform on their to-do list – and guidance may come from the Federal Circuit if they refuse to act. All this and more signify that the challenges are becoming more complex and the practice is transforming at an alarming rate.

Greater-than Johnson & Johnson

Attend the only forum which shapes the law, policy, and proceedings of Paragraph IV litigation. To help you respond to the challenges of this new era, ACI’s 18th Annual Paragraph IV Disputes conference will guarantee your access to the leading legal minds in this area. 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.

Greater-than Merck Sharp & Dohme LLC

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.

Greater-than Sandoz

Greater-than Genentech

Greater-than Mallinckrodt Pharmaceuticals

Greater-than Novartis Pharmaceuticals Corporation

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

Greater-than Sanofi-Aventis

¹https://scrip.pharmaintelligence.informa.com/SC146175/The-Next-Big-Patent-Cliff-Is-Coming-And-Time-Is-Running-Out-To-Pad-The-Fall

Greater-than Viatris

REGISTER NOW

2 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

THANK YOU TO OUR SPONSORS AND PARTNERS Supporting Sponsors

Cocktail Sponsor

Associate Sponsors

Lanyard Sponsor & Day 1 Luncheon Sponsor LOGO

Conference Sponsor

Premium Exhibitors

Media Partners

hands-helping BECOME A SPONSOR 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.

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

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

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

ACI’s

Sponsors

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

ACI’s Hatch-Waxman Series Advisory Board

HatchWaxman 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

Neema Kumar

Brian Stone

Stephanie Donahue

James P. Leeds

Lars Taavola

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

Senior Director, Patent Litigation Sanofi (Bridgewater, NJ)

Linda Friedlieb Division Counsel AbbVie (North Chicago, IL)

Andrea Hutchison

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

Staci Julie

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

James Kellerman

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

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

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

Mary Morry

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

Jeffrey N. Myers, Ph.D. Vice President & Assistant General Counsel Pfizer Inc (New York, NY)

Aaron Pereira

Senior Director of Patents Ferring Pharmaceuticals (Parsippany, NJ)

Pearl T. L. Siew

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

4 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

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

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

Maryll Toufanian

Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals

Serena Farquharson Torres

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

Peter Waibel

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

Kevin Zive

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

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 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.)

Why Attend

Speaker Faculty DISTINGUISHED CHAIRS Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP (Former United States Circuit Judge, U.S. Court of Appeals for the Federal Circuit) Neema Kumar Vice President, IP, North America Sandoz Serena Farquharson Torres Executive Director, Assistant General Counsel Bristol Myers Squibb MEMBERS OF THE JUDICIARY: Honorable Leonard P. Stark United States Judge U.S. Court of Appeals for the Federal Circuit (Former Chief Judge, United States District Court, District of Delaware) Honorable Maryellen Noreika District Judge United States District Court, District of Delaware Honorable Joshua Wolson District Judge United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Honorable Christopher J. Burke Magistrate Judge District of Delaware Honorable Stanley R. Chesler District Judge United States District Court, District of New Jersey Honorable Mitchell Goldberg District Judge United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Sponsors

PATENT TRIAL & APPEAL BOARD, USPTO: Honorable Jacqueline Bonilla Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Honorable Susan Mitchell Senior Lead Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Honorable Grace Obermann Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office GOVERNMENT REPRESENTATIVES FROM KEY AGENCIES: Christopher Pruitt Deputy Director, Office of Generic Drug Policy U.S. FDA Rebecca Egeland Attorney Federal Trade Commission IN-HOUSE COUNSEL: Ryan Daniel AGC, Corporate and Business Transactions Fresenius Kabi Stephanie Donahue Principal Counsel, Patent Litigation Sanofi John Kirkland Executive Director, IP and Litigation Counsel Alkermes David Korn Vice President, IP and Law PhRMA James P. Leeds Vice President and Chief Patent Counsel – Hatch Waxman Litigation Eli Lilly and Company

Advisory Board

Faculty

Agenda Day 1

Mira A. Mulvaney Associate VP – Assistant General Patent Counsel, IP Litigation Eli Lilly and Company Aaron Pereira Senior Director of Patents Ferring Pharmaceuticals Brian Stone Associate General Counsel, Global Legal-Regulatory Viatris Maryll Toufanian Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals Peter Waibel Head, Patent Litigation (US) Novartis Pharmaceuticals Corporation Angie Verrecchio Senior Counsel, Patent Litigation Johnson & Johnson Kevin Zive Vice President – General Counsel, and Head of Global Intellectual Property Apotex Inc. OUTSIDE COUNSEL: David B. Abramowitz Partner Locke Lord LLP Isaac S Ashkenazi Partner Paul Hastings LLP Daniel G. Brown Partner Latham & Watkins LLP Douglas H. Carsten Partner McDermott Will & Emery Andrew Cochran Attorney Cahill Gordon & Reindel LLP Andrew D. Cohen Partner Patterson Belknap Webb & Tyler LLP

Donna Meuth Associate General Counsel IP Eisai

Jonathan Davies Partner Cooley LLP

Mary Morry Counsel, IP Litigation Merck & Company

Gerald J. Flattmann Jr. Partner Cahill Gordon & Reindel LLP

Agenda Day 2

Workshops

Venue

Pricing

Kathleen Gersh Partner Loeb & Loeb LLP

Daniel J. Minion Partner Venable LLP

Emily J. Greb Partner Perkins Coie LLP

John J. Molenda Partner Steptoe & Johnson, LLP

Benjamin M. Greenblum Partner Williams & Connolly LLP Vishal C. Gupta Partner Steptoe & Johnson LLP Ryan Hagglund Partner Loeb & Loeb LLP Whitney Meier Howard Partner Venable LLP William James Partner Allen & Overy LLP Michael P. Kahn Partner Akin Gump Strauss Hauer & Feld LLP David J. Kappos Partner Cravath, Swaine & Moore LLP Kurt Karst Director Hyman, Phelps & McNamara PC Pilar G. Kraman Partner Young Conaway Stargatt & Taylor, LLP Noah M. Leibowitz Partner Dechert LLP Jason Leonard Partner McDermott Will & Emery Kurt Mathas Partner Winston & Strawn LLP Ted Mathias Partner Axinn, Veltrop & Harkrider LLP Vikram Mathrani Partner Honigman LLP Robert Milne Partner White & Case LLP

Gregory A. Morris Partner O’Melveny & Myers LLP Rashad Morgan Partner Crowell & Moring LLP Deepro R. Mukerjee Partner and Chair, IP Katten Muchin Rosenman LLP Kevin M. Nelson Partner ArentFox Schiff LLP Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP Richard C. Pettus Shareholder Greenberg Traurig LLP Kevin S. Prussia Partner Wilmer Cutler Pickering Hale and Dorr LLP Preston K. Ratliff II Partner Paul Hastings LLP Michael Sitzman Partner DLA Piper LLP Eric Stone Partner Groombridge, Wu, Baughman & Stone LLP Jonathan B. Turpin Attorney Locke Lord LLP Shashank Upadhye Partner Upadhye Tang LLP Jeanna M. Wacker Partner Kirkland & Ellis LLP Alyson Wooten Managing Director Berkeley Research Group, LLC

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

DAY ONE • April 19 7:00

Breakfast and Registration for Main Conference Attendees

8:00

Chairs’ Opening Remarks microphone-alt Honorable Kathleen M. O’Malley (Ret.), Of Counsel, Irell & Manella LLP

(Former United States Circuit Judge, U.S. Court of Appeals for the Federal Circuit) Neema Kumar, Vice President, IP, North America, Sandoz

Serena Farquharson Torres, Executive Director, Assistant General Counsel, Bristol Myers Squibb 8:15

A VIEW FROM CAPITOL HILL

Patents, Politics and Policies: Understanding Impact of The Inflation Reduction Act on Hatch-Waxman Litigation microphone-alt Michael P. Kahn, Partner, Akin Gump Strauss Hauer & Feld LLP

Workshops

Venue

Pricing

• Analyzing why SCOTUS granted cert only in Amgen v. Sanofi despite the presentation of the same single issue of the proper interpretation of §112 in Juno v. Kite • Assessing the current state of 112 jurisprudence and predicting how the law may evolve in the future • Preparing for the impact to existing patents with functional claims • Evaluating the impact on patent prosecution practice in the future • Best practices for strengthening or invalidating patent claims » What is the true test for enablement? » What is the relevant inquiry for written description post-Biogen v. Mylan?

10:30

FEDERAL CIRCUIT FIRESIDE CHAT

A Conversation with the Federal Circuit microphone-alt Honorable Leonard P. Stark, United States Judge, U.S. Court of Appeals for the

Federal Circuit (Former Chief Judge, United States District Court, District of Delaware INTERVIEWED BY:

Honorable Kathleen M. O’Malley (Ret.), Of Counsel, Irell & Manella LLP (Former United States Circuit Judge, U.S. Court of Appeals for the Federal Circuit)

David J. Kappos, Partner, Cravath, Swaine & Moore LLP

11:00

David Korn, Vice President, IP and Law, PhRMA

11:15

MODERATOR: William James, Partner, Allen & Overy LLP

Skinny Labeling and the Infringement of Repurposed Patents: Winning Strategies, New Approaches to Carve Outs, and Induced Infringement of Method Claims

• Analyzing the impact of the Inflation Reduction Act (IRA) on Hatch-Waxman patent protections, exclusitivies, and market entry » Examining the key provisions designed to lower prescription drug prices - Evaluating which drugs will be negotiated and strategies to get your product outside of the four corners of the statute » How will the IRA impact the ability to secure investments, partnerships, and acquisitions?

• How will the Biden EO support industry, R&D, and workforce development?

• Understanding the efforts to support the development of critical medicines » The PASTEUR Act • Taking stock of the Biden Executive Orders promoting competition in the American Economy 9:15

SUPREME COURT UPDATE

Amgen v. Sanofi: Understanding How the Supreme Court May Re-Shape §112 microphone-alt Matthew A. Pearson , Partner, Akin Gump Strauss Hauer & Feld LLP Emily J. Greb, Partner, Perkins Coie LLP Richard C. Pettus, Shareholder, Greenberg Traurig LLP Eric Stone, Partner, Groombridge, Wu, Baughman & Stone LLP MODERATOR: Vishal C. Gupta, Partner, Steptoe & Johnson LLP In November of 2022, The U.S. Supreme Court granted cert. in Amgen v. Sanofi, but strangely denied cert. in Juno v. Kite, a case with remarkably similar questions presented. At the time of press, Juno petitioned the Court for rehearing, arguing that the grant of cert. in Amgen warrants reconsideration.

The fate of §112 hangs in the balance leaving Hatch-Waxman practitioners wondering how this will impact litigation strategies. Topics of discussion will include:

Morning Networking Break

microphone-alt Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP Jason Leonard, Partner, McDermott Will & Emery Kevin S. Prussia, Partner, Wilmer Cutler Pickering Hale and Dorr LLP Jeanna M. Wacker, Partner, Kirkland & Ellis LLP MODERATOR: Michael Sitzman, Partner, DLA Piper The battle over the common generic carve-out has made its way to the White House. The Supreme Court has asked the Solicitor General to weigh in on the matter of carve outs. The industry ponders the implications of the pending opinion on pharmaceutical patents as well as the practice of patent law. In this session, points of discussion will include: • Evaluating the impact of GSK v. Teva, Amarin v. Hikma and their progeny on proving induced infringement » Analyzing recent court treatment » Types of evidence to demonstrate inducement » Pre-launch v. post-launch • Distinguishing between skinny labels and partial labels • Explaining the patentability of further medical use inventions • Strategies for claim drafting in view of these decisions » Reevaluating claim and label language • Detailing what every patent owner needs to consider when labeling FDA-approved products » Best practices for aligning patent claims with the label » Considerations for multiple approved indications

6 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

Why Attend

Sponsors

Advisory Board

12:15

Networking Luncheon SPONSORED BY 1:45

§101 in the Balance: Comparing Current Requirements with Proposed Reforms for Patent Subject Matter Eligibility microphone-alt Ryan Hagglund, Partner, Loeb & Loeb LLP John Kirkland, Executive Director, IP and Litigation Counsel, Alkermes Noah M. Leibowitz, Partner, Dechert LLP Whitney Meier Howard, Partner, Venable LLP Rashad Morgan, Partner, Crowell & Moring LLP

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

The Supreme Court’s denial of cert. in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020) contributes to the history of uncertainty surrounding patent eligible subject matter determinations. The case has also spurred debate over whether the current state of play advances or harms innovation.

The Federal Courts, the USPTO, and Congress have responded to this the uncertainty in several ways, including proposed legislation. In this session, points of discussion will include: • Evaluating the Supreme Court’s denial to grant cert. in American Axle & Manufacturing v. Neapco Holdings after the Solicitor General’s support for a partial grant • Examining the Second Tillis-Coons proposal to reform §101 » Understanding the rationale behind the Patent Eligibility Restoration Act of 2022 (PERA) • Analyzing the impact of the Deferred Subject Matter Eligibility Project on U.S. patent drafting • Devising strategies for overcoming ineligibility rejections from the USPTO • Discussing the future statutory and jurisprudential landscape of §101 • Predicting the impact on investment and innovation 2:45

Networking Break

What did [I] like about the event?

Pretty much everything. [From the] topics (compliments to ACI for selection), speakers/presentations, venue.

ACI’s Paragraph IV Conference is the premier conference for Hatch-Waxman litigation and all IP related to life sciences. I really liked the quality of the speakers and presentations.

– Patent Attorney, George W. Johnston, Esq.

– VP, Head of IP, Morphic Therapeutic

I particularly loved the inducement to infringe and the written description and enablement sessions.

I was very happy that the event was in-person again. Also, like usual, the content and people participating were great.

– Partner, Finnegan Henderson

– Partner, Haug Partners LLP

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

Pricing

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Track 1: The Business of PIV Disputes

Agenda Day 2

Workshops

Venue

Track 2: The Practice of PIV Disputes

3:00

3:00

International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy

Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner

microphone-alt Kevin Zive, Vice President – General Counsel, and

microphone-alt Honorable Christopher J. Burke, Magistrate Judge,

Head of Global Intellectual Property, Apotex Inc. Deepro R. Mukerjee, Partner and Chair, IP, Katten Muchin Rosenman LLP

United States District Court, District of Delaware

Pilar G. Kraman, Partner, Young Conaway Stargatt & Taylor, LLP

• Assessing common international business scenarios encountered by both brand name and generic manufacturers which lead to patent disputes • Identifying potential safe-harbor concerns related to foreign manufacturers and finishers • Building and managing a winning global litigation team • Understanding the importance of aligning legal and business functions for global patent litigation planning • Exploring matters of international trade and impacting the value of pharmaceutical patents

• Evaluating the benefits and detriments of joint defense groups in PIV disputes • Maximizing efficiency and minimizing risk by protecting joint legal interests resourcefully • Devising brand name strategies for addressing litigation with joint defense groups • Establishing clear leadership at the outset to simplify future occurrences • Understanding when and how many consulting firms to utilize toward avoiding too many cooks in the kitchen

3:45

3:45

The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge microphone-alt Isaac S Ashkenazi, Partner, Paul Hastings LLP Jonathan Davies, Partner, Cooley LLP • IP and economic assessments on product selection and defense • Factoring-in R&D considerations and market trends • Analyzing available exclusivities, both regulatory and patent • Assessing key litigation considerations and related costs • Considering the likelihood of victory depending on patent type • Budgeting, forecasting, and aligning litigation costs to business goals • Exploring cost saving options in litigation • Examining value of licensing deals and structures

505(q) Citizens Petitions: Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Access and Petitions for Reconsideration microphone-alt Kathleen Gersh, Partner, Loeb & Loeb LLP Kurt R. Karst, Director, Hyman, Phelps & McNamara PC • Reviewing FDA’s citizen petition processes and protocols • 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

8 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

Pricing

Closed Door Executive Meeting with ACI’S Hatch-Waxman Series Advisory Board 3:00 – 3:45

microphone-alt Ryan Daniel, AGC, Corporate and Business Transactions, Fresenius Kabi

Stephanie Donahue, Principal Counsel, Patent Litigation, Sanofi James P. Leeds, Vice President and Chief Patent Counsel – Hatch Waxman Litigation, Eli Lilly and Company Aaron Pereira, Senor Director of Patents, Ferring Pharmaceuticals Limited to 24 participants (12 brand; 12 generic) by invitationonly, this unique, interactive discussion will provide an exclusive and intimate networking and benchmarking opportunity that will shed light on the expectations of in-house counsel from their law firm partners.

It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with those of the Board.

• “Cost”, will offer insights on the monitoring of legal spend and balancing a budget.

• “Competency”, will provide best practices for overcoming talent limitations with demonstrable advice.

• “Communication”, will engage attendees in the art of communicating value and fostering collaboration between corporate legal counsel and outside counsel.

Why Attend 4:30

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

Networking Break

4:45

View from the Bench: Spotlight on PIV Litigation in DE and NJ Honorable Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

microphone-alt Honorable Stanley R. Chesler, District Judge, United States District Court, District of New Jersey

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

MODERATOR:

Jonathan B. Turpin, Partner, Locke Lord LLP

Honorable Maryellen Noreika, District Judge, United States District Court, District of Delaware

Glass-Martini

6:00

Cocktail Reception Sponsored by

SUPPORTING SPONSOR Dechert LLP has a dedicated Hatch-Waxman team with extensive experience in litigating Abbreviated New Drug Applications (ANDAs). Having taken on and won cases involving as many as a dozen ANDA filers, we regularly take these disputes to trial. When necessary, our team is adept at handling follow-on antitrust litigation.

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

DAY TWO • April 20 7:15

Breakfast and Registration

• Analyzing user fee reauthorization riders • Taking stock of recent litigations with FDA

8:00

» Avadel v. FDA

Chairs’ Opening Remarks

» Melinta v. FDA

microphone-alt Honorable Kathleen M. O’Malley (Ret.), Of Counsel,

Irell & Manella LLP (Former United States Circuit Judge, U.S. Court of Appeals for the Federal Circuit) Neema Kumar, Vice President, IP, North America, Sandoz

Serena Farquharson Torres, Executive Director, Assistant General Counsel, Bristol Myers Squibb

FOCUS ON FDA 8:15

Part I: GDUFA III User Fees, Guidances, and MAPPs – User Fee Reauthorization Riders and New Litigation with FDA microphone-alt Christopher Pruitt, Deputy Director (Acting), Office of Generic Policy, U.S. FDA Brian Stone, Associate General Counsel, Global Legal–Regulatory, Viatris Maryll Toufanian, Senior Vice President, Regulatory Strategy and Policy, Amneal Pharmaceuticals MODERATOR:

David B. Abramowitz, Partner, Locke Lord LLP

9:00

Part II: What Every PIV Litigator Needs to Know about the USPTO-FDA Collaboration and the Efforts to Promote Competition microphone-alt Christopher Pruitt, Deputy Director (Acting), Office of Generic Policy, U.S. FDA Brian Stone, Associate General Counsel, Global Legal–Regulatory, Viatris Maryll Toufanian, Senior Vice President, Regulatory Strategy and Policy, Amneal Pharmaceuticals MODERATOR:

Daniel G. Brown, Partner, Latham &Watkins LLP President Biden and Congress have applied pressure on USPTO and FDA to change patent policies to keep drug prices down and promote competition. The two agencies are exploring initiatives, as the Order required USPTO and FDA to identify inter-agency goals for collaboration.

Areas of collaboration to be discussed will include: • Reconciling how the two agencies can collaborate on PTE determinations • Policy considerations for method of use patents, use codes and skinny labeling • Considerations regarding risk evaluation and mitigation strategies (REMS) » Avadel CNS Pharmaceuticals v. Jazz Pharmaceuticals • Efforts to thwart the misuse of patents to delay completion

• Examining the areas of focus in GDUFA III 9:30

» Complex drugs

Morning Networking Break

» Facility inspections and re-inspections » Understanding the GDUFA III commitment letter

Join Our Email List to Stay Connected SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES AmericanConference.com/join-our-email-list/

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 30 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.

10 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

Why Attend

Sponsors

Advisory Board

Faculty

Track 1: The Business of PIV Disputes 10:00

Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget microphone-alt Peter Waibel, V.P. US Patent Litigation, Novartis Pharmaceuticals Corporation Douglas H. Carsten, Partner, McDermott Will & Emery

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

Track 2: The Practice of PIV Disputes 10:00

Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation microphone-alt Andrew J. Cochran, Partner, Cahill Gordon & Reindel LLP Ted Mathias, Partner, Axinn, Veltrop & Harkrider LLP Vikram A. Mathrani, Partner, Honigman LLP

• Accounting for inflation and implementing practices to minimize surprises and increase predictability • Forecasting the budget by phase and quarter » Strategies for reevaluating the use of task codes • Deciding what components should be incorporated into the budget » Vendors » Experts • Understanding the source of error when unforeseen events or overages occur • Evaluating the appropriateness of alternative fee arrangements

• Exploring questions of royalties, lost profits, and exceptional findings » Market reconstruction considerations » Alternatives for noninfringement » Examining the value of the use of the patented technology • Examining grounds for mitigation • Considering the practical consequences of the Supreme Court’s WesternGeco decision on HatchWaxman 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

10:45

10:45

The Essential Skills In-House Counsel Require: Communicating Value and Collaboration microphone-alt Donna Meuth, Associate General Counsel IP, Eisai Kevin M. Nelson, Partner, ArentFox Schiff LLP

• 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 verse academic guidance

ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES 11:30

FTC KEYNOTE

microphone-alt Mira A. Mulvaney, Associate VP – Assistant General Patent Counsel, IP Litigation, Eli Lilly and Company Preston K. Ratliff II, Partner, Paul Hastings LLP Mary Morry, Counsel, IP Litigation, Merck & Company

• Analyzing what to consider when evaluating the possibility of reissue/reexamination • Identifying the risks and limitations of using 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

1:45

Reverse-Payment Settlements: Demystifying the Current State of Pharmaceutical Litigation Settlements in the Hatch-Waxman Context microphone-alt Julia Chapman, Partner, Dechert LLP

microphone-alt Beckey Egeland, Attorney, Health Care Division, Federal Trade Commission 12:00

Patent Reissue and Reexamination: Determining When and How to Correct Patent Errors

Networking Luncheon

Benjamin M. Greenblum, Partner, Williams & Connolly LLP Kurt Mathas, Partner, Winston & Strawn LLP Alyson Wooten, Managing Director, Berkeley Research Group, LLC Robert Milne, Partner, White & Case LLP

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

• Understanding settlement strategies between 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 • 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 » Abuse of dominance » Life cycle management and contracting » Pricing strategies • Avoiding costly litigation and associated penalties by effectively complying with the law • At-Risk Launch considerations

THE PATENT TRIAL AND APPEAL BOARD THINK TANK 2:45

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes microphone-alt Honorable Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Susan Mitchell, Lead Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office Honorable Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office MODERATORS:

Workshops

» Detailing the key provisions and critical takeaways from pending legislation • Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials in view of parallel litigation • Analyzing recent IPR estoppel decisions • Reviewing trends before the PTAB involving §112 • Interpreting the duty of reasonable inquiry » Confidentiality concerns • Reviewing the latest stats at PTAB, highlighting bio/pharma cases • 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

Pricing

• Interpreting PTAB precedent and other information » Newly designated precedent at PTAB 3:45

Networking Break

4:00

Preparing for Parallel Proceedings: Maneuvering through the District Court and Inter Partes Review microphone-alt Angie Verrecchio, Senior Counsel, Patent Litigation, Johnson & Johnson Andrew D. Cohen, Partner, Patterson Belknap Webb & Tyler LLP Gerald J. Flattmann Jr., Partner, Cahill Gordon & Reindel LLP MODERATOR: Daniel J. Minion, Partner, Venable 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

CYBERSECURITY, PRIVACY and ETHICAL DATA PROTECTION

Gregory A. Morris, Partner, O’Melveny & Myers LLP John J. Molenda, Partner, Steptoe & Johnson, LLP • Reviewing the provisions and consequences of the Patent Trial and Appeal Board Reform Act (2022)

Venue

5:00

ETHICS TRAINING MODULE

Cybersecurity and Information Security Concerns for Hatch-Waxman Litigators: Practical and Ethical Considerations microphone-alt Shashank Upadhye, Founder, Upadhye Tang LLP 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.

6:00

Conference Concludes

12 | #ACIPIV #HatchWaxman twitter: @ACILegal linkedin: ACI’s Hatch-Waxman Series

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

CONTINUING LEGAL EDUCATION CREDITS EARN CLE/ ETHICS CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have 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/

UPCOMING RELATED EVENTS

March 21 – 22, 2023 • Boston, MA

March 22 – 23, 2023 • Virtual Event

May 18 – 19, 2023 • New York, NY

May 23 – 24, 2023 • Amsterdam

June 27 – 28, 2023 • Boston, MA

September 20 – 21, 2023 Chicago, IL

REGISTER NOW

AmericanConference.com/PIVDisputes • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Why Attend

Sponsors

Advisory Board

Faculty

Agenda Day 1

Agenda Day 2

Workshops

Venue

Pricing

Venue Information 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 “ACI’s Paragraph IV”.

Hotel: Address: Reservations:

Intercontinental New York Times Square 300 West 44th Street and 8th Avenue, New York, NY 10036 212-803-4500 or 1-888-465-4329

Please note that the guest room block cut-off date is March 24, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book with confidence!

WORRY FREE Registration

GUARANTEE

Interested in attending virtually?

Register and pay to lock in your early rate and be eligible for a full refund until April 5, 2023.

Emma McAdam VP, Government Affairs

Janet Smith VP, General Counsel

Olivia Thomson Chief Compliance Officer

If you are unable to attend for any reason, you will have the following options: y A full credit note for you, or a colleague to attend another event. y A full refund.

Luis Santos Director

Ramesh Kumar Partner

Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing

All cancellations and changes must be submitted to CustomerService@CanadianInstitute.com by April 5, 2023.

Looking to Register?

Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP

Mark Parrish, American Conference Institute

Contact our Customer Service Representatives:

Jean Roux VP, Business Development

2023 CO-CHAIRS



M.Parrish@AmericanConference.com



1 212 352 3220 x7207

Use Registration Code: B00-999-MPH23

Neema Kumar Vice President, IP, North America Sandoz

Serena Farquharson Torres Executive Director, Assistant General Counsel Bristol Myers Squibb

Dan Manganiello, American Conference Institute 

D.Manganiello@AmericanConference.com



1 212 352 3220 x5464

Use Registration Code: B00-999-DMO23

SAVE $200

SAVE $100

Register & Pay by February 17, 2023

Register & Pay by March 17, 2023

Register & Pay after March 17, 2023

IN-PERSON: Conference Only – In-House Rate*

$1695

$1795

$1895

IN-PERSON: Conference Only

$2195

$2295

$2395

PRICING

If you choose to attend via livestream you can expect true interaction virtually — from start to finish. Contact our customer service team at 1-888-224-2480 or customerservice@americanconference.com to learn more about this option.

* In-House Counsel rates above are only available for pharmaceutical, biotech or manufacturing organizations. The regular rate will be applied to law firms, private equity, venture capital, consultancies, etc.

CONFERENCE CODE:

896L23.NYC

Bringing a Team?* 3–4

10% Conference Discount

5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

All program participants will receive an online link to access the conference materials as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

Special Discount 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.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

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

PLEASE NOTE THE FOLLOWING PANDEMIC-RELATED PROTOCOLS: ACI conferences and events will be organized in accordance with the latest health and safety regulations, guidelines, and recommendations, directed by the CDC and local government authorities. Attendees are advised to consider their personal health needs. © American Conference Institute, 2023

Attendees are asked to self-screen in the days leading up to, before and after attending an ACI event and/or conference.

We will continue to monitor the health situation and relevant authorities. Changes to health and safety measures may be made by ACI at any time as required.