14th Summit on Biosimilars & Innovator Biologics - WEB

June 27–28, 2023

Metcalf Trustee Center, Boston University | Boston, MA

14th Summit on Biosimilars & Innovator Biologics

Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilar Market Place

2023 Chairs:

James T. Evans, Ph.D Senior Director | Assistant General Counsel, Dispute Resolution Regeneron Pharmaceuticals

Henry Gu SVP, Head of IP Zentalis Pharmaceutcials

Cory Wohlbach Global Vice President Biosimilar Regulatory Affairs Teva Pharmaceuticals

Agency Insights from:

Dr. Mustafa Ünlü Policy Staff Director, CDER U.S. Food and Drug Administration

Anu Sawkar Special Counsel for Intellectual Property Federal Trade Commission

APJ Insights from:

Hon. Jacqueline Wright Bonilla Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Hon. Susan Mitchell Lead Judge Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Hon. Grace Obermann

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

Meet and Network with Key Stakeholders at the Forefront of Innovation from:

2023 will be a critical year for the success of biosimilar uptake and patient access.

Biosimilar launches are growing at a steady pace — but they are still not readily prescribed.

Despite the number of product launches, biosimilar adoption in the U.S. has been deficient, especially compared to Europe. Since 2007, 30 biosimilars for 12 large molecules have launched in the U.S. 10 more biosimilars have been approved and are set to launch by the end of 2023, and more significant launches are expected in the next five years.

What do the Humira biosimilars launches say for the future of the industry?

Since the beginning of the year, all eyes have been on the Humira biosimilar launches. Questions arise as to how these launches will predict future biosimilar spending and savings scenarios. Factors impacting biosimilar uptake, including reimbursement and provider type, are huge considerations for stakeholders, especially in light of the budget pressures which continue to drive healthcare decision-making in the U.S. and abroad.

The IRA, lack of prescriber knowledge, and questions of interchangeability are affecting biosimilar market access.

The Inflation Reduction Act calls into question the competitive advantage of being the first to launch and the potential return on investment. Even the value of the interchangeable designation is being questioned by industry as prescribers lack the necessary education for understanding what a biosimilar is. As such, the ability to gain market share for these biosimilar products hangs in the balance as few prescribers will even recommend interchangeable product to their patients.

The innovator biologics market is also facing challenges.

Despite hindrances to biosimilar access, innovators are still rightfully concerned about looming biosimilar competition as innovation takes time and considerable money, since innovation and pricing remain inextricably tied together. The traditional barriers and financial risks like market expansion and contraction remain persistent.

The immunology market has seen significant growth in spending and volume but overall, the market continues to grow, including antidiabetics and oncology. Leaving everyone wondering — will biosimilar competition hinder innovators? What innovator defense strategies exist?

Attendance for this conference is not optional.

These questions and more will be analyzed by the “who’s who” of the biosimilar and innovator biologic industries at this conference. With the current and future uncertainties, a wide range of market outcomes are possible. Join our faculty of global thought-leaders at this groundbreaking event to discuss legal, regulatory, and commercial strategies for the innovator and biosimilars marketplace that are essential to the proliferation of these products.

ACI’S BIOSIMILARS AND INNOVATOR BIOLOGICS ADVISORY BOARD

Ali I. Ahmed

Senior Vice President, Biosimilars

Fresenius Kabi USA

Larry Coury

VP, Associate General Counsel Regeneron Pharmaceuticals

Mira A. Mulvaney

Associate VP — Assistant General Patent Counsel, IP Litigation Eli Lilly and Company

Neal Dahiya Head of Litigation Genentech

Henry Gu SVP, Head of IP Zentalis Pharmaceuticals

Brian McCormick Vice President –Chief Regulatory Counsel Head of Global Regulatory Policy Teva Pharmaceuticals

Sonia Tadjalli Oskouei Vice President, Biosimilars and Specialty Sandoz, Inc.

Chuck Sholtz Vice President, IP Legal Department Nutcracker Therapeutics, Inc.

Gillian Woollett VP, Head of Regulatory Strategy and Policy Samsung Bioepis

DISTINGUISHED FACULTY

2023 Chairs

James T. Evans, Ph.D

Senior Director

Assistant General Counsel, Dispute Resolution

Regeneron Pharmaceuticals

Henry Gu

SVP, Head of IP Zentalis Pharmaceutcials

Cory Wohlbach

Global Vice President

Biosimilar Regulatory Affairs

Teva Pharmaceuticals

Government

Dr. Mustafa Ünlü

Policy Staff Director, CDER

U.S. Food and Drug Administration

Anu Sawkar

Special Counsel for Intellectual Property Federal Trade Commission

The PTAB

Hon. Jacqueline Bonilla

Deputy Chief Administrative Patent Judge

Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Hon. Susan Mitchell Lead Judge

Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Hon. Grace Obermann

Administrative Patent Judge Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Associations

Kelly Goldberg

Vice President, Law and Senior Counsel for Biopharmaceutical Regulation

PhRMA

Hans Sauer

Deputy General Counsel, VP for IP BIO

In-House Counsel

Ali I. Ahmed

Senior Vice President, Biosimilars Fresenius Kabi USA, LLC

Maureen A. Bresnahan

Assistant General Counsel

Eisai Inc.

Lawrence M. Brown Ph.D., J.D.

Associate General Counsel, Head of Legal (FUSION BioVenture)

Fosun Pharma USA Inc.

Mike Cottler Global Head of Litigation Alvotech

James T. Evans, Ph.D Senior Director | Assistant General Counsel, Dispute Resolution Regeneron Pharmaceuticals

Henry Gu SVP, Head of IP Zentalis Pharmaceutcials

Pavi Kullar Pharmacy Purchasing Manager Boston Medical Center

Sergio Napolitano LL.M. General Counsel and External Relations Director Medicines for Europe

Cory Wohlbach Global Vice President Biosimilar Regulatory Affairs Teva Pharmaceuticals

Outside Counsel

Benjamin Anger Partner Knobbe Martens

Aziz Burgy Partner

Axinn, Veltrop & Harkrider LLP

Jonathan Caplan Partner

Kramer Levin Naftalis & Frankel LLP

Lisa J. Cameron Principal The Brattle Group, Inc.

Robert Cerwinski Founding Partner Gemini Law

Andrea Cheek Partner

Knobbe Martens

Alice Chen Associate Professor of Public Policy Vice Dean for Research USC Sol Price School of Public Policy Cornerstone

Natasha E. Daughtrey Partner Goodwin Procter LLP

Rachel J. Elsby Partner

Akin Gump Strauss Hauer & Feld LLP

Eamonn Garnder Partner Cooley LLP

Vishal C. Gupta Partner

Steptoe & Johnson LLP

Otto Licks

Founding Partner

Licks Attorneys

Christopher Loh Partner Venable LLP

Daniel Margolis Partner Allen & Overy LLP

John J. Molenda Partner

Steptoe & Johnson LLP

Jason Murata Partner Axinn, Veltrop & Harkrider LLP

Brian Nolan Partner Mayer Brown LLP

Kevin E. Noonan, Ph.D. Partner

McDonnell Boehnen Hulbert & Berghoff LLP

Tina Papagiannopoulos Counsel Foley Hoag LLP

Ivan Poullaos Partner

Winston & Strawn LLP

Honorable Teresa Rea Partner

Crowell & Moring LLP

(Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

Irena Royzman Partner

Kramer Levin Naftalis & Frankel LLP

J.C. Rozendaal Director

Sterne Kessler Goldstein & Fox

Alicia A. Russo Partner Venable LLP

Hassen A. Sayeed Partner

O’Melveny & Myers LLP

Elizabeth S. Weiswasser Partner

Weil, Gotshal & Manges LLP

Josie Young Partner

Groombridge, Wu, Baughman & Stone LLP

7:00am Registration and Breakfast

8:00am

Opening Remarks from the Chairs

microphone-alt James T. Evans, Ph.D, Senior Director, Assistant General Counsel, Dispute Resolution, Regeneron Pharmaceuticals

Henry Gu, SVP, Head of IP, Zentalis Pharmaceutcials

Cory Wohlbach, Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals

8:15am

The Inflation Reduction Act: Understanding the Impact on Biologic Innovation and the Biosimilar Marketplace

microphone-alt Ali I. Ahmed, Senior Vice President, Biosimilars, Fresenius Kabi USA, LLC

Pavi Kullar, Pharmacy Purchasing Manager, Boston Medical Center

Alice Chen, Associate Professor of Public Policy, Vice Dean for Research, USC Sol Price School of Public Policy, Cornerstone

Kelly Goldberg, Vice President, Law and Senior Counsel for Biopharmaceutical Regulation, PhRMA

Moderator: Anna K. Abram, Senior Advisor, Akin Gump Strauss Hauer & Feld LLP

• Understanding how the IRA is affecting innovation, R&D, and economics in the biologic and biosimilars marketplaces

• Assessing how the IRA’s changes to reimbursement for these products under Medicare Parts B and D may lead to legal challenges and economic uncertainties

• Reviewing the CMS proposed timeline for inflation rebates on biologicbiosimilar products

• Analyzing the competition between new biologics and biosimilar drugs in the commercial marketplace outside of government payor programs

• Devising best practices to assess the commercial viability of your biopharmaceutical portfolio in this new political and economic atmosphere

9:15am

Hedging Your Bets Ahead of Amgen v Sanofi: Anticipating How the Supreme Court’s Enablement Ruling Will Affect Biologic Patent Portfolio Strategies

microphone-alt Maureen A. Bresnahan, Assistant General Counsel, Eisai Inc.

Ivan Poullaos, Partner, Winston & Strawn LLP

Daniel Margolis, Partner, Allen & Overy LLP

John Molenda, Partner, Steptoe & Johnson LLP

Moderator: Jason Murata, Partner, Axinn, Veltrop & Harkrider LLP

• Devising alternate strategies for drafting enforceable claims

» Outlining the scope of appropriate claims for antibodies

• Implementing new strategies for drafting enforceable claims in view of the Supreme Court’s decision

• Understanding the nuances between written description and enablement

» Why did the Supreme Court decline to hear Kite v Juno?

• Reconciling whether written description is met when the specification discloses formulas

10:30am Networking Break

HUMIRA BIOSIMILAR CASE STUDY

Amgen’s Amjevita is the first in a string of nine Humira biosimilars that are coming to market in 2023. All eyes are on these products as industry watchers ponder matters of exclusivity and market access to determine if biosimilars will be a successful venture in the US. In this two-part case study, our leaders will draw on lessons learned from the Humira biosimilars and engage in a predicative analysis of what this all means for other biosimilar launches

10:45am

Part I: A Matter of Exclusivity and Offset Losses

microphone-alt Natasha E. Daughtrey, Partner, Goodwin Procter LLP

James T. Evans, Ph.D, Senior Director, Assistant General Counsel, Dispute Resolution, Regeneron Pharmaceuticals

• What lessons were learned from the Humira biosimilars about the exclusivities afforded under the BPCIA - and now the IRA?

• Assessing the possibility — or impossibility — of circumventing a patent thicket in view of the Humira District Court and Federal Circuit rulings

» Extending exclusivity beyond the initial patent

» Devising strategies for obtaining the longest exclusivity period for your biosimilar

• Negotiating the best settlement agreement for sharing exclusivity period

» Determining entry dates in the U.S. and abroad

11:45pm

Part II: Market Entry and Commercialization

microphone-alt Jonathan Caplan, Partner, Kramer Levin Naftalis & Frankel LLP

Hon. Teresa Rea, Partner, Crowell & Moring LLP

(Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

An approved biosimilar may not be profitable without the right market entry and commercialization plan. In part II, topics of discussion will include:

• Timing market entry with data and market exclusivity expirations

• Meeting manufacturing requirements once exclusivity is decided

• Devising strategies for achieving preferred access with managed care plans

• Managing stakeholder education

• Reconciling post market and pharmacovigilance requirements

• Mastering distribution and delivery across borders

12:45pm Networking Lunch

1:45pm

Policy, Procedure and Practice Points with the PTAB

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:

Andrea Cheek, Partner, Knobbe Martens

Irena Royzman, Partner, Kramer Levin Naftalis & Frankel LLP

2:45pm

Key Litigations and Decisions at the Federal Circuit, the District Courts and the PTAB That Are Transforming the BPCIA Landscape

microphone-alt Lisa J. Cameron, Principal, The Brattle Group, Inc.

Rachel J. Elsby, Partner, Akin Gump Strauss Hauer & Feld LLP

Christopher Loh, Partner, Venable LLP

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

Innovator

Biologic Patent Litigation Strategies

• Reviewing the timing for bringing lawsuits and seeking preliminary injunctions

• Filing for a preliminary injunction to block the accused infringers’ at risk launch

» Considering public interest issues when seeking preliminary or permanent injunction

» Delineating economic harm through factors other than price

• Considering the different standards of proof in BPCIA, the PTAB, and district courts

Biosimilar Patent Litigation Strategies

• Weighing the benefits of launching at risk

• Analyzing the decision to argue against a preliminary injunction versus not launching at the end of the market exclusivity period

» Considering whether, how, and under what circumstances courts will find a permanent injunction appropriate before FDA approval is obtained

» Dealing with the potential for FDA approval before trial of the patent claims in a BPCIA

• Coordinating BPCIA litigation with corresponding IPR/PGR petitions

» Understanding when it makes sense to challenge patents in IPR or PGR proceedings in advance of BPCIA litigation

4:00pm Networking Break

4:15pm

Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?

microphone-alt Mike Cottler, Global Head of Litigation, Alvotech

Aziz Burgy, Partner, Axinn, Veltrop & Harkrider LLP

Vishal C. Gupta, Partner, Steptoe & Johnson LLP

Hassen A. Sayeed, Partner, O’Melveny & Myers LLP

Moderator: J.C. Rozendaal, Director, Sterne Kessler

Goldstein & Fox

• Balancing the cost savings resulting from lowered litigation risk with the loss of market opportunities resulting from a carve-out

» How does this impact affordability to patients?

• Considering how the skinny label regime will work with biosimilar products that have interchangeable designation

• Considering whether the language of press releases, web pages and other marketing materials require more scrutiny

• Analyzing potential liability faced by insurers for placement of skinny label on formularies

• Whether carve-outs will add to the perception that the biosimilar product is different than and not as effective as the reference product

» When will stakeholder education cross the line into potential evidence of inducement of off-label, infringing uses?

5:15pm

Cocktail Reception

2023 CHAIR

"Biosimilars and biologics are at the forefront of transformation and innovation – and we need a regulatory framework that keeps pace. With significant changes on the horizon that may shape the future of biologics and biosimilars markets, gathering experts to discuss challenges and opportunities is both timely and essential. I am honored to chair ACI’s 14th Annual Summit on Biosimilars and Innovator Biologics this June, and look forward to robust discussions on how we can continue to advance therapies that are so important for patients worldwide."

Cory Wohlbach

Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals

7:00am Registration and Breakfast

8:00am

Opening Remarks from the Chairs

microphone-alt James T. Evans, Ph.D, Senior Director, Assistant General Counsel, Dispute Resolution, Regeneron Pharmaceuticals

Henry Gu, SVP, Head of IP, Zentalis Pharmaceutcials

Cory Wohlbach, Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals

8:15am

Revisiting Interchangeability: Does the Designation Benefit Biosimilars?

microphone-alt Lawrence M. Brown Ph.D., J.D., Associate General Counsel, Head of Legal (FUSION BioVenture), Fosun Pharma USA Inc.

Tina Papagiannopoulos, Counsel, Foley Hoag LLP

• Balancing the cost of procuring and providing additional information to obtain an interchangeable designation against the one-year exclusivity

» Will the interchangeable designation hold competitors at bay, or set off a new race for all contenders in the biosimilar space to obtain interchangeable status?

• Analyzing whether interchangeable designation will sufficiently offset the costs of developing the product and ongoing patent litigation?

• Understanding the nature and type of information needed to support a post-approval manufacturing change for a licensed biosimilar product

9:30am

FDA Keynote on Interchangeability

microphone-alt Dr. Mustafa Ünlü, Policy Staff Director, CDER, U.S. Food and Drug Administration

Moderator: Cory Wohlbach, Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals

10:15am Networking Break

10:30am

Competitive Implications of the Global Biosimilars and Biologics Markets: Spotlight on the EU, Brazil, and China

microphone-alt Otto Licks, Founding Partner, Licks Attorneys

Robert Cerwinski, Founding Partner, Gemini Law

Sergio Napolitano LL.M., General Counsel and External Relations Director, Medicines for Europe

The biosimilar and innovator biologic markets and regulation have steadily evolved in Europe and the United States, with the European marketplace experiencing the most commercial success. However, the cost of these products – whether innovator or biosimilar – continues to be of global concern, especially as new products will soon emerge from the pipeline.

This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like Brazil and China.

• Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region

• Understanding the economics and market influences

» Considerations for market access, sustainable pricing and reimbursement policies

» Market uptake of biosimilar products

» Biosimilar v. biosimilar litigation in a crowded market

• Understanding the economics and market size, share, growth and influences:

» Considerations for market access, sustainable pricing, and reimbursement policies

» Market uptake of biosimilar products

» Biosimilar v. biosimilar litigation in a crowded market

• Comparing differences in:

» What the regulatory application must show

» Whether decisions related to biosimilarity are made on a case-by-case basis

» Exclusivity period

» Post marketing requirements

» Exclusivity for first interchangeable drug

11:30am

Breaking into the Biologics and Biosimilars Market: Devising Forward-Thinking Portfolio Strategies

microphone-alt Hans Sauer, Ph.D., J.D., Deputy General Counsel, Vice President, Intellectual Property, Biotechnology Innovation Organization (BIO)

Eamonn Garnder, Partner, Cooley LLP

Alicia A. Russo, Partner, Venable LLP

• Reviewing the biggest deals and acquisitions in the market place

• Evaluating the clinical pipeline by company, indication and phase

» Analyzing the market share for biosimilars in the U.S. and abroad

» Target drugs with highest spending

» Current market dynamics and considerations for biosimilar adoption

» Utilizing historical biosimilar trends to provide potential future biosimilar spending and saving scenarios

• Considering partnership agreements to offset capital costs and risk of biosimilar development and production

2023 CHAIR

James T. Evans, Ph.D

Senior Director, Assistant General Counsel, Dispute Resolution, Regeneron Pharmaceuticals

"I’m honored to Chair ACI's 14th Summit on Biosimilars & Innovator Biologics this year. The conference provides a forum for professionals in biosimilar development, government agencies, and the judiciary to provide insights and discuss the challenges facing the biologic industry in navigating patent protection for innovative medicines and biosimilar entry into the market. I look forward to hearing from the field leaders scheduled to present and attend this conference."

12:30pm Networking Lunch

1:45pm

FTC Keynote

microphone-alt Anu Sawkar, Special Counsel for Intellectual Property, Federal Trade Commission

2:15pm

Dissecting Damages and BPCIA Settlements: Strategic Choices, Evolving Standards, and Practical Solutions

microphone-alt Brian Nolan, Partner, Mayer Brown LLP

Benjamin Anger, Partner, Knobbe Martens

• Analyzing the lessons learned from the settlement between Genentech and Tanvex in relation to their dispute over Tanvex’s BLA for a biosimilar

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

» Analyzing the current legislative and regulatory framework surrounding:

ƒ Mergers, acquisitions, and exclusive licenses

ƒ Anticompetitive agreements

ƒ Abuse of dominance

ƒ Life cycle management and contracting

ƒ Pricing strategies

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

• Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages

» Applying that judicial cadence to your litigation or settlement strategy

3:15pm Networking Break

3:30pm

Biologics Ethics Module: Understanding the Duties of Disclosure and Reasonable Inquiry

microphone-alt Kevin E. Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Josie Young, Partner, Groombridge, Wu, Baughman & Stone LLP

• Revisiting the duties of disclosure and reasonable inquiry

» Appreciating how inequitable conduct was found in Belcher Pharmaceuticals v. Hospira; Bruno Independent Living v. Acorn Mobility, and GS Cleantech Corp. v. Adkins Energy LLC

» Formulating new strategies for timing USPTO and FDA submissions

• Addressing Congress’s request for more transparency between the USPTO and the FDA

• When will false or misleading communications about biosimilars amount to anticompetitive practices?

• What constitutes acceptable access to samples of the reference product needed by the biosimilar?

4:30pm Conference Concludes

Henry Gu SVP, Head of IP, Zentalis Pharmaceutcials

"I’m excited to Chair ACI's 14th Summit on Biosimilars & Innovator Biologics in Boston this year. The conference provides a great opportunity for all stakeholders to learn from leading experts on how to devise a winning strategy to bring more innovative treatments to patients in a cost-effective manner. I look forward to hearing from industry leaders, government agencies, and the judiciary regarding various considerations impacting the biosimilars and innovator biologics industries."

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.

For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE

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VENUE INFORMATION

Metcalf Trustee Center, Boston University

Address: 1 Silber Way #9, Boston MA 02215

HOTEL ACCOMMODATIONS

Hotel Commonwealth

Address: 500 Commonwealth Ave Boston, MA 02215

Reservations: 617-532-5019

Email: allreservations@hotelcommonwealth.com

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 Biosimilars”.

Please note that the guest room block cut-off date is June 9, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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