12th Summit on Biosimilars & Innovator Biologics - WEB

2021 Co-Chairs Calendar-alt June 22 – 23, 2021 (EDT)

Virtual Conference

HUONG T. NGUYEN

12 Summit on th

Biosimilars & Innovator Biologics

General Counsel Fosun Pharma USA Inc.

KATIE NOLAN-STEVAUX

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

Specialist, Assistant General Counsel Genentech

EARN CLE/ETHICS/DIVERSITY CREDITS

Exclusive Insights from:

Hon. Jacqueline Wright Bonilla Deputy Chief Judge, PTAB USPTO

Jessica Greenbaum Regulatory Counsel, Therapeutic Biologics and Biosimilars Staff U.S. FDA

Valencia Martin-Wallace Deputy Commissioner for Patents USPTO

Markus Meier Assistant Director, Health Care Division, Bureau of Competition U.S. FTC

Lead Sponsor: Supporting Sponsors:

Associate Sponsors:

Custom Sponsor:

Sponsored by:

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AmericanConference.com/Biosimilars • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

As we prepare to enter the next decade of this revolutionary pathway, we cordially invite you to join us for ACI’s 12th Annual Biosimilars & Innovator Biologics Summit.

MEET OUR 2021 CO-CHAIRS!

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man.

The incorporation of biosimilar products into the U.S. marketplace was designed to improve patient access and decrease healthcare costs. While much has evolved since the enactment of the BPCIA, the traditional barriers remain.

Now, more than ever, strategies to overcome these barriers are essential to improve the understanding of biosimilar products in the United States. The need for a solid guiding framework becomes more critical than ever before.

The next decade will see more litigation in this sphere. Further, and to an increasing extent, IPR proceedings challenging patents protecting biologic medicines, including IPRs filed before any action was taken under the BPCIA. Finally the future will usher in considerable changes growing the scope of products that are regulated and litigated under the BPCIA.

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather virtually for ACI’s 2021 Summit on Biosimilars & Biologics, and contemplate the impact of these critical developments.

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Interactive Virtual Conference Experience This event is premised on true engagement and interaction in our virtual conference room.

Join smaller-group interactions where attendees will be able to turn on audio and video to chat Participate in 1:1 networking that emulates the impromptu meetups that would ordinarily occur in-person

Click Here to Watch Demo

2 | #ACIBiosimilars

Additionally, attendees will be able to private message, start a video chat and exchange contact details

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

HUONG T. NGUYEN

General Counsel Fosun Pharma USA Inc.

KATIE NOLAN-STEVAUX Specialist, Assistant General Counsel Genentech

WATCH HERE

Media Sponsors

ACI’s Biosimilars and Innovator Biologics Advisory Board Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA

USER

Henry Gu Vice President, Head of IP Morphic Therapeutic Scott Kamholz Vice President of Intellectual Property Tessera Therapeutics

Neal Dahiya SVP, Head of Litigation Moderna

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

Juliana “Julie” Reed Vice President, Global Corporate Affairs Lead, Immunology, Inflammation (I&I) and Biosimilars Pfizer

Julia Pike Global Head of IP Sandoz

Chuck Sholtz Director and Associate General Counsel, Biosimilars, Manufacturing & Litigation Readiness Lead

Genentech Marina Volin VP, General Counsel and Corporate Secretary Amring Pharmaceuticals Inc.

Distinguished Faculty CO-CHAIRS

ASSOCIATIONS Karin Hessler Assistant General Counselor AAM

Huong T. Nguyen General Counsel Fosun Pharma USA Inc.

David Korn Vice President, IP and Law PhRMA

Katie Nolan-Stevaux Specialist, Assistant General Counsel Genentech

Hans Sauer Deputy General Counsel, VP of IP BIO

IN-HOUSE COUNSEL Maureen Bresnahan Assistant General Counsel Eisai US Brian McCormick Vice President – Chief Regulatory Counsel, Head of Global Regulatory Policy Teva Pharmaceuticals Tara Rahemba Executive Director, Intellectual Property Alexion Pharmaceuticals, Inc. Laura Sim Sr. Counsel, Development, Regulatory, Operations, & Contracting Law Amgen

GOVERNMENT Jessica Greenbaum Regulatory Counsel, Therapeutic Biologics and Biosimilars Staff U.S. FDA Gwendolyn J. Lindsay Cooley Assistant Attorney General Wisconsin Department of Justice Valencia Martin-Wallace Deputy Commissioner for Patents USPTO Markus Meier Assistant Director, Health Care Division, Bureau of Competition U.S. FTC Hon. Jacqueline Wright Bonilla Deputy Chief Judge, PTAB USPTO PTAB Hon. Michelle Ankenbrand Lead Administrative Patent Judge, PTAB USPTO Hon. Kristi Sawert Administrative Patent Judge, PTAB USPTO

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LAW FIRMS Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA Klaas Bisschop Partner Hogan Lovells (Amsterdam) Jonathan S. Caplan Partner Kramer Levin Naftalis & Frankel LLP Linnea P. Cipriano Partner Goodwin Procter LLP W. Blake Coblentz Chair, Hatch-Waxman & Biologics Litigation Cozen O’Connor Evan Diamond Partner King & Spalding LLP Rachel J. Elsby Partner Akin Gump Strauss Hauer & Feld LLP Amy Feng Partner Wu, Feng & Zhang Joseph P. Fuhr, PhD Professor Emeritus of Economics, Pharmaceutical and Healthcare Business Widener University

AmericanConference.com/Biosimilars • 888 224 2480

Gerald Flattmann Partner King & Spalding LLP Wanda D. French-Brown Partner Loeb & Loeb LLP Nicholas P. Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Siegmund Y. Gutman Partner Proskauer Rose LLP Ryan Hagglund Partner Loeb & Loeb LLP Samantha Hong Attorney Kleinfeld, Kaplan & Becker, LLP (Former Associate Chief Counsel, Office of the Chief Counsel, U.S. FDA) Eric R. Hunt Partner Rakoczy Molino Mazzochi Siwik LLP Steven D. Maslowski Partner Akin Gump Strauss Hauer & Feld LLP Ashley N. Mays-Williams Attorney, Litigation Department Paul Hastings LLP

John J. Molenda Partner Steptoe & Johnson LLP Gregory A. Morris Partner Honigman LLP Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP Ricardo Nunes Partner Daniel Law

Terry Rea Partner Crowell & Moring LLP Stacie L. Ropka Partner Axinn, Veltrop & Harkrider LLP Irena Royzman Partner Kramer Levin Neftalis & Frankel LLP Alicia A. Russo Partner Venable LLP

Christopher E. Ondeck Partner Proskauer Rose LLP

David H. Silverstein Partner Axinn, Veltrop & Harkrider LLP

Sonia T. Oskouei VP, Biosimilars Cardinal Health

Celeste C. Saravia Vice President Cornerstone Research

Young J. Park Partner, Litigation Department Paul Hastings LLP

Steven R. Trybus Partner Locke Lord LLP

Jeanna Wacker Partner Kirkland & Ellis LLP

Chad J. Peterman Partner, Litigation Department Paul Hastings LLP Ivan M. Poullaos Partner Winston & Strawn LLP Emily Rapalino Partner Goodwin Procter LLP

Elizabeth Weiswasser Partner Weil, Gotshal & Manges LLP Vanessa Yen Partner King & Spalding LLP

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

11:55

DAY ONE

Tuesday, June 22, 2021 (EDT) 9:50

Opening Remarks from the Conference Co-Chairs microphone-alt Huong T. Nguyen, General Counsel, Fosun Pharma USA Inc.

Katie Nolan-Stevaux, Specialist, Assistant General Counsel, Genentech 10:00

Year in Review: Regulatory and Legislative Developments Impacting the Biopharmaceutical Industry microphone-alt Hans Sauer, Deputy General Counsel, VP of IP, BIO Karin Hessler, Assistant General Counsel, AAM David Korn, Vice President, IP and Law, PhRMA

Morning Break

12:15

Amgen v. Sanofi: Analyzing the Impact of the Antibody Enablement Ruling on In-House Strategies microphone-alt Maureen Bresnahan, Assistant General Counsel, Eisai US Gerald Flattmann, Partner, King & Spalding LLP Jeanna Wacker, Partner, Kirkland & Ellis LLP Alicia A. Russo, Partner, Venable LLP Siegmund Y. Gutman, Partner, Proskauer Rose LLP The Federal Circuit’s decision in Amgen Inc. v. Sanofi, No. 201074 (Fed. Cir. 2021) is one of the most important patent stories of the year. In this case which concerns the validity of antibody epitome claims, the Federal Circuit held that “a genus of antibodies claimed only by specific functional properties are invalid for lack of enablement.” The court went on to invalidate all claims for lack of enablement, holding that “the binding limitation itself was sufficient for the claims to require undue experimentation.” In view of this precedential decision, this panel will offer practical patenting strategies for the critical stages of the lifecycle, including:

As we await a final decision, this panel will provide strategies and tactics in view of the decision, including: • Reevaluating claim and label language for optimal drafting • Analyzing what types of evidence should be used to prove infringement • Understanding second medical use patents and carve-out strategies » Clarifying the patentability of further medical use inventions • Outlining the implications of the Federal Circuit decision striking down labeling carve-outs • Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use • Balancing competing interests in promoting innovation v. permitting generic drugs 2:15

Lunch Break

3:00

GLOBAL STRATEGIES

Spotlight on Europe and China: From Patent Protection to Cost and Market Access microphone-alt Tara Rahemba, Executive Director, Intellectual Property, Alexion Pharmaceuticals, Inc.

• Patent preparation and prosecution • Licensing • Transactional IP due diligence

Amy Feng, Partner, Wu, Feng & Zhang

• Enforcement

Ricardo Nunes, Partner, Daniel Law

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation

1:00

microphone-alt Jessica Greenbaum, Regulatory Counsel, Therapeutic

microphone-alt W. Blake Coblentz, Chair, Hatch-Waxman & Biologics

Biosimilar and innovator biologic markets and their governing regulations have steadily evolved in Europe and the United States.

The European biosimilar marketplace – nearly a decade ahead of the U.S. has experienced the most commercial success. As pharmaceutical drug pricing continues to attract global scrutiny and political pressure, a growing number of potentially cost-saving drugs are in the pipeline.

Interviewed by: Samantha Hong, Attorney, Kleinfeld, Kaplan & Becker, LLP (Former Associate Chief Counsel, Office of the Chief Counsel, U.S. FDA)

Steven D. Maslowski, Partner, Akin Gump Strauss Hauer & Feld LLP

Moderator: Irena Royzman, Partner, Kramer Levin Neftalis & Frankel LLP 11:00

FDA KEYNOTE

Biologics and Biosimilars Staff, U.S. FDA

11:45

1:1 Networking

Take advantage of this networking break and see how many people you meet. Your next legal team, business partner or client could be right in our virtual networking room – it is up to you to find them! To maximize your connections, benefit from virtual business card exchange opportunities.

4 | #ACIBiosimilars

Skinny Labeling Post-GSK v. Teva: How the Decision Will Inform Biosimilar Carve-Outs Litigation, Cozen O’Connor

Brian McCormick, Vice President – Chief Regulatory Counsel, Head of Global Regulatory Policy, Teva Pharmaceuticals Vanessa Yen, Partner, King & Spalding LLP Moderator: David H. Silverstein, Partner, Axinn, Veltrop & Harkrider LLP In GSK v. Teva (Fed. Cir. Feb. 9, 2021), the Federal Circuit vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product.

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

Klaas Bisschop, Partner, Hogan Lovells (Amsterdam)

Not far behind, and thanks to a favorable regulatory environment, the Chinese biosimilar marketplace is booming. Although the regulatory approaches are similar in general scientific content, certain key differences have amplified acceptance and market growth in China relative to the United States and Europe. This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like 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

4:00

Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum microphone-alt John J. Molenda, Partner, Steptoe & Johnson LLP Gregory A. Morris, Partner, Honigman LLP Rachel J. Elsby, Partner, Akin Gump Strauss Hauer & Feld LLP Linnea P. Cipriano, Partner, Goodwin Procter LLP Eric R. Hunt, Partner, Rakoczy Molino Mazzochi Siwik LLP IPRs offer biosimilar and generic drug manufactures the benefit of challenging innovator patents with comparative haste and efficiency. While IPRs continue to provide an alternative forum for biosimilar manufactures who seek a faster alternative to BPCIA litigation, successful IPRs of biologics patents remain a challenge.

During this interactive session, points of discussion will include: • Reducing risk by challenging patents in advance of launching biosimilars at risk • Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs • Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars • Anticipating an answer to the unresolved question as to how much investment is required in the biosimilar context under Article III in order to establish standing • Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation » Assessing concerns surrounding multiple filer petitions and relevant timing considerations • Analyzing biosimilars IPR filings and recent PTAB decisions

5:00

EQUITY, DIVERSITY, & INCLUSION

Advocating for Diversity in IP: Practical Ideas for Implementing Change microphone-alt Huong T. Nguyen, General Counsel, Fosun Pharma USA Inc.

• Understanding what specific evidence of diversity pharmaceutical companies, and IP departments, are seeking from their law firm counterparts • Implementing organizational changes that promote diversity

Katie Nolan-Stevaux, Specialist, Assistant General Counsel, Genentech

» How clients can seek out partnerships with firms that promote: • Utilizing NAMWOLF lists

Wanda D. French-Brown, Partner, Loeb & Loeb LLP

• Abiding by the Mansfield Declaration

Stacie L. Ropka, Partner, Axinn, Veltrop & Harkrider LLP Young J. Park, Partner, Litigation Department, Paul Hastings LLP

• Using a DuPont Legal Model • Identifying best practices for evaluating your outside firm’s efforts in promoting diversity » Reviewing firm statistics on women, minorities, sexual orientation, etc.

Valencia Martin-Wallace, Deputy Commissioner for Patents, USPTO The Director of the National Institute of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science”. The growing call to action seems clear: the pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. In this interactive session, points of discussion will include: • Growing the awareness of the pharmaceutical IP practitioners among underrepresented racial and ethnic groups » Championing their representation in the pharmaceutical IP work force » Advocating for diverse and young attorneys appearing in the court room

• Sharing data-driven strategies to address current diversity challenges in STEM 5:15

Day One Adjourns

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• Reviewing data showing the benefits of a diverse workforce

Quote-left Year after year, the ACI Biosimilar Conference has featured a top-notch faculty from the pharma/biotech industry, private practice and government to address hot-button issues in this rapidly evolving area—I am looking forward to another outstanding event. Quote-right Immac “Casey” Thampoe, Executive Director/Assistant General Counsel, IP Portfolio Development, Regeneron Pharmaceuticals, Inc.

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• Accelerating the advancement of a more diverse pharmaceutical IP community via mentoring and networking

AmericanConference.com/Biosimilars • 888 224 2480

Quote-left If I had to pick only one event to get the latest on issues impacting biosimilars, it would be the ACI Biosimilar Conference—highly informative presentations and ample opportunities to network and catch-up with players in this space. Quote-right Charles K. Sholtz, Director and Associate General Counsel, Biosimilars, Manufacturing & Litigation Readiness Lead, Genentech

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

12:00

DAY TWO

Wednesday, June 23, 2021 (EDT) 9:55

Co-Chairs’ Recap of Day One and Opening Remarks microphone-alt Huong T. Nguyen, General Counsel, Fosun Pharma USA Inc.

Katie Nolan-Stevaux, Specialist, Assistant General Counsel, Genentech 10:00

The APJs Speak on Practice, Policy and Procedure microphone-alt Hon. Jacqueline Wright Bonilla, Deputy Chief Judge, PTAB, USPTO

Hon. Michelle Ankenbrand, Lead Administrative Patent Judge, PTAB, USPTO Hon. Kristi Sawert, Administrative Patent Judge, PTAB, USPTO

Think Tank on State and Federal Antitrust Initiatives: Commercial Considerations for Patent Settlements, Reverse Payments, and Emerging Legislation microphone-alt Evan Diamond, Partner, King & Spalding LLP Celeste C. Saravia, Vice President, Cornerstone Research Gwendolyn J. Lindsay Cooley, Assistant Attorney General, Wisconsin Department of Justice Jonathan S. Caplan, Partner, Kramer Levin Naftalis & Frankel LLP Antitrust enforcement is routinely triggered via the approval of a biosimilar. This session will consider the economic implications of biosimilar reverse payment litigation, the competitive effects, and economic damages. Topics of discussion will include: • Understanding settlement strategies between innovator biologic companies and biosimilar applicants • Highlighting the state legislation directly addressing “reverse payment” patent settlements » When biologic manufacturers should expect antitrust scrutiny • Reviewing the proper standards of antitrust review and the rising call for a legislative response

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

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

11:00

FTC KEYNOTE

» Abuse of dominance

Antitrust Developments Impacting Biosimilars and Innovators microphone-alt Markus Meier, Assistant Director, Health Care Division, Bureau of Competition, U.S. FTC

11:30

» Pricing strategies • Avoiding costly litigation and associated penalties by effectively complying with the law 1:00

1:1 Networking

Take advantage of this networking break and see how many people you meet. Your next legal team, business partner or client could be right in our virtual networking room – it is up to you to find them! To maximize your connections, benefit from virtual business card exchange opportunities.

11:40

» Life cycle management and contracting

Morning Break

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Lunch Break

1:45

The Future of Patent Thickets: Balancing Innovation and Competition in the Biologic Ecosystem microphone-alt Ivan M. Poullaos, Partner, Winston & Strawn LLP Nicholas P. Groombridge, Partner, Paul, Weiss, Rifkind, Wharton & Garrison LLP Steven R. Trybus, Partner, Locke Lord LLP

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

Christopher E. Ondeck, Partner, Proskauer Rose LLP In recent years, there have been bipartisan efforts to curb illegal product hopping and patent thickets. In March 2019, a group of indirect payers for Humira filed suit against AbbVie, alleging antitrust activity in violation of Sections 1 and 2 of the Sherman Antitrust Act. The antitrust challenge is centered on AbbVie’s alleged patent thicket involving Humira and the settlements reached with six biosimilar companies to keep them off market until 2023.

This session will consider the impact of the decision on the IP landscape for biologic drugs. Topics of discussion will include: • Whether developing a patent thicket is an antitrust violation » UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020) • Reviewing what are deemed “anti-competitive activities” • Whether you need to prove that all the patents in the ‘thicket’ around a drug are invalid 2:45

Naming, Labeling, Interchangeability, and Promotion: Regulatory Considerations for the growing U.S. Marketplace for Biosimilars microphone-alt Laura Sim, Sr. Counsel, Development, Regulatory, Operations, & Contracting Law, Amgen

Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Use of biosimilars in the United States is gaining ground and promoting competition. FDA’s naming convention for biologics, guidance on biosimilar labeling, approach toward interchangeability, and guidance on advertising and promotion are helping shape the landscape for marketing and use of biosimilars.

This session will outline the central components of naming, labeling, interchangeability, and marketing considerations for biosimilars. Points of discussion will include: • Analyzing the Latest developments concerning interchangeability designations and exclusivity and state substitution laws • Assessing FDA’s published Guidance for Industry on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products • Evaluating the benefits and challenges of a naming system that allows biosimilars to be differentiated and traced to promote pharmacovigilance • Understanding how best manufacturers can communicate the clinical and economic benefits of a drug

3:45

The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies

RELATED CONFERENCES

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

Joseph P. Fuhr, PhD, Professor Emeritus of Economics, Pharmaceutical and Healthcare Business, Widener University Terry Rea, Partner, Crowell & Moring LLP Sonia T. Oskouei, VP, Biosimilars, Cardinal Health

PARAGRAPH IV DISPUTES 2021

ACI’s

HatchWaxman SERIES

• Evaluating the clinical pipeline by company, indication and phase • Considering the implications of insurers placing biosimilars on “primary tiers” and what that means for the future

CALENDAR-ALT November 9 – 10, 2021 MAP-MARKER New York, NY

• Reviewing the implications of the House passed Lower Drug Costs Now Act » Understanding the implications of empowering the government to negotiate directly with manufacturers 4:45

INTERACTIVE ETHICS DRILLS

New Developments Impacting Professional Responsibility in the Biologics Arena microphone-alt Vishal Gupta, Partner, Steptoe & Johnson LLP Ryan Hagglund, Partner, Loeb & Loeb LLP

Women Leaders LIFE SCIENCES LAW 8TH ANNUAL CONFERENCE ON

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Chad J. Peterman, Partner, Litigation Department, Paul Hastings LLP

CALENDAR-ALT July 29, 2021 MAP-MARKER Virtual Conference

• Establishing standards for determining when attorneys and/or firms should be disqualified • Determining who is a client based on actual representation 5:45

Conference Concludes

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