Biosimilars & Innovator Biologics

June 27 – 28, 2023

Agenda

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Day 1 - Tuesday, June 27, 2023

7:00	Registration and Breakfast
8:00	Opening Remarks from the Chairs
8:15	The Inflation Reduction Act: Understanding the Impact on Biologic Innovation and the Biosimilar Marketplace
9:15	Hedging Your Bets Ahead of Amgen v Sanofi: Anticipating How the Supreme Court’s Enablement Ruling Will Affect Biologic Patent Portfolio Strategies
10:15	Networking Break
10:25	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
10:30	Part I: A Matter of Exclusivity and Offset Losses
11:30	Part II: Market Entry and Commercialization
12:30	Networking Lunch Sponsored by:
1:45	Policy, Procedure and Practice Points with the PTAB
2:45	Key Litigations and Decisions at the Federal Circuit, the District Courts and the PTAB That Are Transforming the BPCIA Landscape
4:00	Networking Break
4:15	Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?
5:15	Conference Adjourns to Day Two

Day 2 - Wednesday, June 28, 2023

7:00	Registration and Breakfast
8:00	Opening Remarks from Chairs
8:15	Revisiting Interchangeability: Does the Designation Benefit Biosimilars?
9:30	FDA Keynote on Interchangeability
10:15	Networking Break
10:30	Competitive Implications of the Global Biosimilars and Biologics Markets: Spotlight on the EU, Brazil, and China
11:30	Breaking into the Biologics and Biosimilars Market: Devising Forward-Thinking Portfolio Strategies
12:30	Networking Lunch
1:45	FTC Keynote
2:15	Dissecting Damages and BPCIA Settlements: Strategic Choices, Evolving Standards, and Practical Solutions
3:15	Networking Break
3:30	Biologics Ethics Module: Understanding the Duties of Disclosure and Reasonable Inquiry
4:30	Conference Concludes

Day 1 - Tuesday, June 27, 2023

7:00	Registration and Breakfast
8:00	Opening Remarks from the Chairs James T. Evans, Ph.D. Senior Director \| Assistant General Counsel, Dispute Resolution Regeneron Pharmaceuticals Henry Gu SVP, Head of IP Zentalis Pharmaceuticals Cory Wohlbach Global Vice President, Biosimilar Regulatory Affairs Teva Pharmaceuticals
8:15	The Inflation Reduction Act: Understanding the Impact on Biologic Innovation and the Biosimilar Marketplace Jocelyn Ulrich Director – Policy and Research PhRMA Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA, LLC Alice Chen Associate Professor of Public Policy, Vice Dean for Research USC Sol Price School of Public Policy Pavi Kullar Pharmacy Purchasing Manager Boston Medical Center 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 biologic-biosimilar 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
9:15	Hedging Your Bets Ahead of Amgen v Sanofi: Anticipating How the Supreme Court’s Enablement Ruling Will Affect Biologic Patent Portfolio Strategies Maureen A. Bresnahan Assistant General Counsel Eisai Inc. Ivan M. Poullaos Partner Winston & Strawn LLP Nicholas Mitrokostas Partner Allen & Overy LLP John J. 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
10:15	Networking Break
10:25	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
10:30	Part I: A Matter of Exclusivity and Offset Losses Natasha E. Daughtrey Partner Goodwin Procter LLP 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
11:30	Part II: Market Entry and Commercialization Jonathan S. Caplan Partner Kramer Levin Naftalis & Frankel LLP Honorable Teresa Rea Partner Crowell & Moring LLP (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
12:30	Networking Lunch Sponsored by:
1:45	Policy, Procedure and Practice Points with the PTAB Hon. Jacqueline Wright 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, Ph.D. Partner \| Head of Life Sciences Kramer Levin Neftalis & Frankel LLP
2:45	Key Litigations and Decisions at the Federal Circuit, the District Courts and the PTAB That Are Transforming the BPCIA Landscape Lisa Cameron Principal The Brattle Group Rachel 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
4:00	Networking Break
4:15	Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars? Aziz Burgy Partner Axinn, Veltron & Harkrider LLP Mike Cottler Global Head of Litigation Alvotech 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?
5:15	Conference Adjourns to Day Two

Day 2 - Wednesday, June 28, 2023

7:00	Registration and Breakfast
8:00	Opening Remarks from Chairs James T. Evans, Ph.D. Senior Director \| Assistant General Counsel, Dispute Resolution Regeneron Pharmaceuticals Henry Gu SVP, Head of IP Zentalis Pharmaceuticals Cory Wohlbach Global Vice President, Biosimilar Regulatory Affairs Teva Pharmaceuticals
8:15	Revisiting Interchangeability: Does the Designation Benefit Biosimilars? Huong Nguyen VP, General Counsel & Compliance Officer 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
9:30	FDA Keynote on Interchangeability Dr. Mustafa Ünlü Policy Staff Director, CDER U.S. Food and Drug Administration Moderator: Cory Wohlbach Global Vice President, Biosimilar Regulatory Affairs Teva Pharmaceuticals
10:15	Networking Break
10:30	Competitive Implications of the Global Biosimilars and Biologics Markets: Spotlight on the EU, Brazil, and China Otto Licks Founding Partner Licks Attorneys Robert Cerwinski Founding Partner Gemini Law LLP 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
11:30	Breaking into the Biologics and Biosimilars Market: Devising Forward-Thinking Portfolio Strategies Alicia A. Russo Partner Venable LLP Hans Sauer, Ph.D., J.D. Deputy General Counsel, VP of IP Biotechnology Innovation Organization Eamonn Garnder Partner Cooley 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
12:30	Networking Lunch
1:45	FTC Keynote Anu Sawkar Special Counsel for Intellectual Property Federal Trade Commission
2:15	Dissecting Damages and BPCIA Settlements: Strategic Choices, Evolving Standards, and Practical Solutions Brian Nolan Partner Mayer Brown LLP William Zimmerman 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: 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 Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages Applying that judicial cadence to your litigation or settlement strategy
3:15	Networking Break
3:30	Biologics Ethics Module: Understanding the Duties of Disclosure and Reasonable Inquiry Josie Young Partner Groombridge, Wu, Baughman & Stone LLP Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff 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?
4:30	Conference Concludes

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