18th Annual Paragraph IV Disputes - DS

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

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 (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)

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 Insights:

Christopher Pruitt Deputy Director, Office of Generic Policy U.S. FDA

Rebecca Egeland Attorney Federal Trade Commission

Honorable Kathleen M. O’Malley (Ret.) Of Counsel

Irell & Manella LLP

Neema Kumar Vice President, IP, North America Sandoz

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

2023 CHAIRS

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.

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

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.

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.

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

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

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

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

Greater-than Fresenius Kabi USA, LLC

Greater-than Genentech

Greater-than Johnson & Johnson

Greater-than Mallinckrodt Pharmaceuticals

Greater-than Merck Sharp & Dohme LLC

Greater-than Novartis Pharmaceuticals Corporation

Greater-than Sandoz

Greater-than Sanofi-Aventis

Greater-than Viatris

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

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HatchWaxman

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.

Ryan M. Daniel

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

Stephanie Donahue Senior Director, Patent Litigation

Sanofi (Bridgewater, NJ)

Linda Friedlieb

Division Counsel AbbVie (North Chicago, 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)

Brian Stone

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

EMERITUS MEMBERS

Stephen R. Auten

Partner, Chair of Pharmaceutical & Life Sciences Litigation

Taft Stettinius & Hollister LLP (Chicago, IL) (Former Vice President, IP, Sandoz, Inc.)

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

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

Maryll Toufanian

Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals

Guy Donatiello

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

George W. Johnston Counsel

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)

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)

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)

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.)

Speaker Faculty

DISTING U IS HE D 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)

PAT ENT TRIA L & 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

Donna Meuth Associate General Counsel IP

Eisai

Mary Morry Counsel, IP Litigation

Merck & Company

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

Jonathan Davies Partner Cooley LLP

Gerald J. Flattmann Jr. Partner

Cahill Gordon & Reindel LLP

Kathleen Gersh Partner Loeb & Loeb LLP

Emily J. Greb Partner Perkins Coie 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

Daniel J. Minion Partner Venable LLP

John J. Molenda Partner Steptoe & Johnson, 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

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

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

David Korn, Vice President, IP and Law, PhRMA

MODERATOR: William James, Partner, Allen & Overy LLP

• 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:

• 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 FEDE RAL 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)

11:00 Morning Networking Break

11:15

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

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

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

What did [I] like about the event?

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

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

– Patent Attorney, George W. Johnston, Esq.

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

– Partner, Finnegan Henderson

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.

– VP, Head of IP, Morphic Therapeutic

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

– Partner, Haug Partners LLP

Track 1: The Business of PIV

3:00

Disputes

Track 2: The Practice of PIV Disputes

3:00

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

microphone-alt Kevin Zive, Vice President – General Counsel, and Head of Global Intellectual Property, Apotex Inc.

Deepro R. Mukerjee, Partner and Chair, IP, Katten Muchin Rosenman 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

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

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

microphone-alt Honorable Christopher J. Burke, Magistrate Judge, United States District Court, District of Delaware

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

• 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

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

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.

4:45

View from the Bench: Spotlight on PIV Litigation in DE and NJ

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)

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)

MODERATOR: Jonathan B. Turpin, Partner, Locke Lord LLP

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.

7:15 Breakfast and Registration

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

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

• Examining the areas of focus in GDUFA III

» Complex drugs

» Facility inspections and re-inspections

» Understanding the GDUFA III commitment letter

• Analyzing user fee reauthorization riders

• Taking stock of recent litigations with FDA

» Avadel v. FDA

» Melinta v. FDA

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

9:30 Morning Networking Break

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Track 1: The Business of PIV Disputes

Track 2: The Practice 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

• 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

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

• 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

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 Beckey Egeland, Attorney, Health Care Division, Federal Trade Commission

12:00 Networking Luncheon

10:45

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

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

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

• 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:

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)

» 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

• 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

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

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Emma McAdam Janet Smith Olivia Thomson Partner VP, Business Development Head Sanctions VP, Manufacturing

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