11th Summit on Biosimilars & Innovator Biologics by C5Group

No Need to Travel. We are Coming to You, Virtually!

September 23–24, 2020

Virtual Conference

11th Summit on

Biosimilars & Innovator Biologics EARN CLE/ETHICS

Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace

CREDITS

Exclusive Insights from: Markus H. Meier Assistant Director, Health Care Division Bureau of Competition U.S. Federal Trade Commission

Association Insights from:

2020 Features:

Association for Accessible Medicines (AAM)

» PTAB Roundtable: The APJs Speak on Practice, Policy and Procedure

Biotechnology Innovation Organization (BIO) Pharmaceutical Research and Manufacturers of America (PhRMA)

Industry Acumen from:

» In-House Counsel Town Hall: An Insider’s Guide to What In-House Counsel Expect from Law Firm Counterparts » Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus

Apotex Inc.

Eisai Inc.

Baxter Healthcare Corporation

Fosun Pharma USA

Biocon Biologics

Fresenius Kabi

Supporting Sponsors

Eva Temkin Acting Director, Policy Staff Office of Therapeutic Biologics and Biosimilars Office of New Drugs Center for Drug Evaluation and Research U.S. Food & Drug Administration

» Preparing for the Future: Calling Attention to Biliogical Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies

Associate Sponsors

Custom Sponsors

Exhibitor

a C5 Group Company

Business Information in a Global Context

This year, the BPCIA turns 10! ACI’S 11th Annual Summit on Biosimilars & Innovator Biologics

is coming to you this September, VIRTUALLY!

Charles K. Sholtz, Director and Associate General Counsel, Biosimilars, Manufacturing & Litigation Readiness Lead, Genentech

CONTINUING LEGAL EDUCATION CREDITS

Nonetheless, the traditional barriers that affect the use of biosimilars, such as lack of familiarity and education remain. If this were not enough, with new threats to the Affordable Care Act, the BPCIA’s origin legislation — there is a question as to whether a pathway for biosimilars will still exist.

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.

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

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.

2020 will see more litigations under the BPCIA — more than ever before. Further, and to an increasing extent, IPR proceedings challenging patents protecting biologic medicines, including IPRs filed before any action was under the BPCIA. Finally, 2020 will usher in considerable changes growing the scope of products that are regulated and litigated under the BPCIA.

For more information on ACI’s CLE process for virtual events visit: www.americanconference. com/accreditation-instructions-for-virtualattendance/

GLOBAL SPONSORSHIP OPPORTUNITIES

This September, join the “who’s who” of the biosimilars and innovator biologics industries as they gather virtually for ACI’s 2020 Summit on Biosimilars & Innovator Biologics, and contemplate the impact of these critical developments.

Join the Conversation

Immac “Casey” Thampoe, Executive Director/Assistant General Counsel, IP Portfolio Development, Regeneron Pharmaceuticals, Inc.

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

he Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed and signed into law in March of 2010 creating a pathway for biosimilars. The incorporation of these products into the U.S. market was designed to improve patient access and decrease healthcare costs. While the abbreviated licensure pathway has been slower to materialize in the U.S. as compared to the European marketplace, on its tenth birthday, the BPCIA will celebrate with 26 approved biosimilars.

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

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. Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: American Conference Institute SponsorInfo@AmericanConference.com

@ACI_Pharma #Biosimilars

ACI: Pharmaceutical/Biotech/Life Sciences

More Speakers to be announced soon. Please visit us online for updates.

CONFERENCE CO-CHAIRS Maureen A. Bresnahan Assistant General Counsel Legal Department Eisai Inc.

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

DISTINGUISHED FACULTY Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA, LLC

Arshad Jamil Global Head â&#x20AC;&#x201C; IPR/Chief IP Counsel Biocon Biologics

Hon. Jacqueline Wright Bonilla Vice Chief, Administrative Patent Judge Patent Trial and Appeal Board U.S. Patent & Trademark Office

Derek Johnson Associate General Counsel, IP Baxter Healthcare Corporation

Melissa Brand Assistant General Counsel and Director Intellectual Property Biotechnology Innovation Organization Aziz Burgy Partner Axinn, Veltron & Harkrider LLP Alan B. Clement Partner Locke Lord LLP Joseph P. Fuhr Jr. Ph.D. Professor Emeritus of Economics Widener University Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Vishal C. Gupta Partner Steptoe & Johnson LLP Siegmund Y. Gutman Partner Proskauer Rose LLP Karin A. Hessler Assistant General Counsel Association for Accessible Medicines (AAM) Amanda Hollis Partner Kirkland & Ellis LLP Omar Jabri Senior Director | Global Intellectual Property Apotex Inc. William G. James Partner Goodwin Procter LLP

David E. Korn Vice President, Intellectual Property and Law Pharmaceutical Research and Manufacturers of America Dr. Sheng Li Associate Director NERA Economic Consulting Steven D. Maslowski Partner Akin Gump Strauss Hauer & Feld LLP Ashley N. Mays-Williams, Ph.D. Associate Paul Hastings, LLP Markus H. Meier Assistant Director, Health Care Division Bureau of Competition U.S. Federal Trade Commission

Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP Lisa B. Pensabene Partner Oâ&#x20AC;&#x2122;Melveny & Myers LLP Chad J. Peterman Partner Paul Hastings, LLP Julia Pike Global Head of IP Sandoz Kevin S. Prussia Partner WilmerHale Dr. Omar Robles Senior Consultant NERA Economic Consulting Stacie L. Ropka Partner Axinn, Veltron & Harkrider LLP Alicia A. Russo Partner Venable LLP

John J. Molenda Partner Steptoe & Johnson LLP

Honorable Kristi Rupert Sawert Administrative Patent Judge U.S. Patent & Trademark Office

Gregory A. Morris Partner Honigman LLP

Bhavesh Shah Senior Director of Specialty Pharmacy Strategy and Market Access Hematology and Oncology Pharmacy Boston Medical Center

Amir A. Naini Senior Counsel Proskauer Rose LLP Sergio Napolitano General Counsel Medicines for Europe Kevin E. Noonan Partner McConnell Boehnen Hulbert & Berghoff LLP Huong Nguyen General Counsel Fosun Pharma USA

Eva Temkin Acting Director, Policy Staff Office of Therapeutic Biologics and Biosimilars Office of New Drugs Center for Drug Evaluation and Research U.S. Food & Drug Administration Kevin Warner Partner Winston & Strawn Vanessa Yen Partner King & Spalding LLP

a C5 Group Company

Business Information in a Global Context

Main Conference Day One

Wednesday, September 23, 2020 7:45

9:45 Break

Opening Remarks from the Conference Co-Chairs Maureen Bresnahan Assistant General Counsel Legal Department Eisai Inc.

10:15

Key Litigations and Decisions at the Federal Circuit, the District Courts and the PTAB Affecting the Biologics Landscape

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

Arshad Jamil Global Head – IPR/Chief IP Counsel Biocon Biologics

8:00

Siegmund Gutman Partner Proskauer Rose

Biosimilars State of the Union: Regulatory and Legislative Developments Impacting the Biopharmaceutical Industry Melissa Brand Assistant General Counsel Director of IP BIO Karin Hessler Assistant General Counselor AAM

Moderator: Matthew Pearson Partner Akin Gump

• Analyzing the implications of the STRONGER Act » Understanding the attempt to mitigate perceived inequities created by the Leahy-Smith America Invents Act What is the likelihood that this will pass? If it passes, would this limit or eliminate IPRs as a viable option for generics/biosimilars? • Assessing the impact and repercussions of price controls and restrictions • Evaluating recent efforts to strengthen government negotiating power • Considering how patent system reforms are being designed to increase competition • Tracking patent settlement bills • Comparing bills being introduced concerning the ability to enforce patents • Reviewing patent thicket/product hopping bills • Predicting how prepared the United States market is for the transition of insulins to regulation as biologics 9:00

Gregory Morris Partner Honigman LLP

David Korn Vice President, IP and Law PhRMA

FDA KEYNOTE

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation Eva Temkin Acting Director, Policy Staff Office of Therapeutic Biologics and Biosimilars Office of New Drugs Center for Drug Evaluation and Research U.S. Food & Drug Administration Interviewed By: Amanda Hollis Partner Kirkland & Ellis

Join the Conversation

Julia Pike Global Head of IP Sandoz Ashley N. MaysWilliams, Ph.D. Associate Paul Hastings, LLP Moderator: Kevin Prussia Partner WilmerHale

• Analyzing why the biosimilar pipeline has been congested by patent litigation blockages in courts across the globe • Dissecting the most significant, surprising and impactful cases in the last 12 months from the: » Federal Circuit » District Courts » PTAB • Evaluating recent key settlements and understanding the legal and business implications impacting the future of settlements • Investigating the concept of “biosimilar v. biosimilar litigation” • Considering new litigations on the radar that will inform strategic decisions concerning: » Safe harbor » Damages » Claim construction » Article III standing 11:15

The Evolving Saga Surrounding §101: Patent Eligibility and Biosimilar Patents Maureen Bresnahan Assistant General Counsel Legal Department Eisai Inc. Vanessa Yen Partner King & Spalding

Amir A. Naini Senior Counsel Proskauer Rose LLP

• Reviewing the requirements for an invention to be entitled under §101 • Understanding patent eligibility of biologic drug patents » Bristol-Myers Squibb Co. v. Merck & Co., Inc. • Evaluating the increase in patent eligibility threshold and the effect on biosimilar makers • Examining the recent USPTO guidance that reviews and expounds upon the Revised Patent Subject Matter Eligibility Guidance • Anticipating whether Congress will act considering the Supreme Court’s denial of cert. to resolve the manufactured irregularities that hinder predictable outcomes under §101

@ACI_Pharma #Biosimilars

ACI: Pharmaceutical/Biotech/Life Sciences

12:30

Lunch Break

3:00

Pre-Suit Exchanges and the BPCIA Tango: Production, Timing, and the Notice of Commercial Marketing

1:30

The Economics of Biosimilars: Considerations for Market Access, Sustainable Pricing and Reimbursement Policies Ali I. Ahmed Senior VP, Biosimilars Fresenius

Chad J. Peterman Partner Paul Hastings, LLP

Aziz Burgy Partner Axinn

Bhavesh Shah Senior Director of Specialty Pharmacy Strategy and Market Access Hematology and Oncology Pharmacy Boston Medical Center

Joseph P. Fuhr Jr. Ph.D. Professor Emeritus of Economics Widener University

• 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 • Analyzing the California legislation aimed at ending pay-for-delay in pharmaceutical patent infringement settlements » Reviewing the status of the challenge claiming that the legislation is unconstitutional » Understanding the goal and intention behind the legislation as pro-competitive and designed to keep drug prices down • Reviewing the implications of the House passed Lower Drug Costs Now Act » Understanding the implications of empowering the government to negotiate directly with manufacturers • Assessing the House passed United States-Mexico-Canada Agreement (USMCA) » Evaluating the provisions which guarantee market exclusivity for biologic manufacturers for 12 years in USA, 8 in Canada and 5 in Mexico, respectively

William G. James Partner Goodwin Procter LLP

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

Kevin Warner Partner Winston & Strawn

Dr. Omar Robles Senior Consultant NERA Economic Consulting

• Addressing contentions and controversies in the aBLA information exchange • Understanding how biosimilar applicants can command the stride of litigation under the BPCIA • Evaluating what is “manufacturing information” • Appreciating the limitations on declaratory judgment actions • Analyzing the biosimilar and innovator perspectives when deciding whether to dance 4:00

PTAB

Practice, Policy and Procedure Hon. Jacqueline Wright Bonilla Vice Chief, Administrative Patent Judge Patent Trial and Appeal Board U.S. Patent & Trademark Office Honorable Kristi Rupert Sawert Administrative Patent Judge U.S. Patent & Trademark Office Moderator: John Molenda Partner Steptoe

2:30 Break 5:00

Day One Adjourns

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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.

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Business Information in a Global Context

Main Conference Day Two

1:30

Thursday, September 24, 2020

Biosimilars Patent Litigation in Europe and the U.S.: Strategies for Success Sergio Napolitano General Counsel Medicines for Europe

8:30

Recap of Day One from the Co-Chairs

Kevin E. Noonan Partner McConnell Boehnen Hulbert & Berghoff LLP

8:45

In-House Town Hall: An Insider’s Guide to What In-House IP Counsel Expect from Law Firm Counterparts Omar Jabri Senior Director, Global IP Apotex Inc. Huong Nguyen General Counsel Fosun Pharma USA

Stacie Ropka Partner Axinn

• Reviewing the impact of COVID-19 on global biosimilars market trends • Incentivizing the transition to biosimilars without political support • Combatting slow adoption and low stakeholder confidence with valuebased care • Analyzing whether manufacturers pursue interchangeability designations for products • Partnering with larger companies to advance therapies through Phase 3 9:45

Lisa B. Pensabene Partner O’Melveny & Myers LLP

Moderator:

• Reviewing research and Bolar exemptions that insulate activities from patent infringement • Analyzing the process and timeline for resolving patent disputes in Europe and the US • Understanding ley themes in European and US biosimilar litigation strategies • Cultivating label strategies » Carving out patented indications • Considering preliminary injunctions and evidentiary seizures • Evaluating the biosimilars markets in the United States and the EU • Comparing patent protections, costs and market access 2:30

Preparing for the Future: Calling Attention to Biliogical Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies

FTC KEYNOTE

Antitrust Developments Impacting Biosimilars and Innovators

Alan B. Clement Partner Locke Lord LLP

Markus H. Meier Assistant Director, Health Care Division Bureau of Competition U.S. Federal Trade Commission 10:30 Break 11:00

Tracking Changes in the BPCIA Antitrust Ecosystem: Regulatory Enforcement, Litigation, Settlements and New Economic Considerations Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Dr. Sheng Li Associate Director NERA Economic Consulting

Lunch Break

Join the Conversation

• Calling attention to the products coming off-patent » Analyzing approved and marketed biosimilars while looking ahead and considering clinical insights, pricing and dosages • Predicting what problems future competitors may run into with respect to their IP profiles • Forecasting which segments or regions will drive market growth • Reviewing key sustainability tactics adopted by leading market players • Evaluating the impact of off-patent drugs on competition and growth strategies • Developing techniques for an accurate assessment of the current value of your portfolio while devising forward-thinking product strategies 3:30 Break

• Understanding the FTC’s increased interest in biosimilar settlements • Evaluating instances where FTC sought additional information related to strategic decisions • Addressing pharmaceutical patent settlements after FTC v. Actavis • Understanding how to respond to subpoenas issued as part of official antitrust investigations • Reviewing new economic considerations for biosimilar reverse payments • Analyzing exclusivity and acceleration provisions • Considering the potential antitrust implications of at-risk launches • Assessing product-hop and pay-for-delay allegations 12:00

Derek Johnson Associate General Counsel, IP Baxter Healthcare Corporation

4:00

INTERACTIVE ETHICS DRILLS

New Developments Impacting Professional Responsibility in the Biologics Arena Vishal Gupta Partner Steptoe • Establishing standards for determining when attorneys and/or firms should be disqualified • Determining who is a client based on actual representation 5:00

Conference Concludes

@ACI_Pharma #Biosimilars

ACI: Pharmaceutical/Biotech/Life Sciences

C5 GROUP’S VIRTUAL EVENTS

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Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation.

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UPCOMING EVENTS:

FDA BOOT CAMP

PARAGRAPH IV DISPUTES

September 23–24, 2020

October 6–7, 2020

LIFE SCIENCES IP DUE DILIGENCE

November 9–10, 2020

To view the complete list of Life Sciences events, please visit: AmericanConference.com/LifeSciences

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