Biosimilars & Innovator Biologics

Registration and Breakfast

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

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, Cornerstone

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

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.

Jason Murata
Partner
Axinn, Veltrop & Harkrider LLP

Ivan M. Poullaos
Partner
Winston & Strawn LLP

Nicholas Mitrokostas
Partner
Allen & Overy 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

Networking Break

Humira Biosimilars Case Study Part I: A Matter of Exclusivity and Offset Losses

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

• 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

Humira Biosimilars Case Study Part II: Market Entry and Commercialization

Jonathan S. Caplan
Partner
Kramer Levin Naftalis & Frankel LLP

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

Networking Lunch

Policy, Procedure and Practice Points with the PTAB

Honorable Susan Mitchell
Lead Judge Patent Trial & Appeal Board
U.S. Patent and Trademark Office

Moderator:

Irena Royzman, Ph.D.
Partner | Head of Life Sciences
Kramer Levin Neftalis & Frankel LLP

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

Omar Jabri
Assistant General Counsel, IP
Apotex Inc.

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

Networking Break

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?

Conference Adjourns to Day Two

Registration and Breakfast

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

Revisiting Interchangeability: Does the Designation Benefit Biosimilars?

Huong Nguyen
VP, General Counsel & Compliance Officer
Fosun Pharma USA Inc.

• 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

FDA Keynote on Interchangeability

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

Networking Break

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

Otto Licks
Founding Partner
Licks Attorneys

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

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

Networking Lunch

FTC Keynote

Anu Sawkar
Special Counsel for Intellectual Property
Federal Trade Commission

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

• 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

Networking Break

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

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?

Conference Concludes