Day 1 - Monday, June 24, 2019

7:45
Registration and Continental Breakfast
8:00
Co-Chair’s Opening Remarks
8:15
The Politics and Policies of BLAs and aBLAs: Analyzing the Present State of Affairs of the Innovator and Biosimilars Environment
9:15

FDA KEYNOTE

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation and the Future of Policy Development
10:15
Morning Refreshment Break
10:30
A Question of Standing: Establishing the Right to Appeal a PTAB Decision
11:30
Biosimilars Trial Tracker: New Developments at the District Courts and the PTAB
12:30
Networking Luncheon Hosted by:
1:30
The ITC: Examining the Role of this Alternate Forum in Biosimilars Disputes
2:15
Networking Refreshment Break
Sponsored by:
2:30
To Dance or Not to Dance: Addressing Contentions and Controversies in the aBLA Information Exchange
3:30
Challenging Patents on Reference Drugs at the PTAB in the Age of Reform
4:30
The In-House Perspective: Current Topics in Biosimilars Development
5:30
Day One Adjourns to Cocktail Reception

Day 2 - Tuesday, June 25, 2019

8:00
Continental Breakfast
8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
The Economics of Biosimilar Drugs: New Considerations for Market Access, Sustainable Pricing and Reimbursement Policies
9:45
View from the Bench
10:30
Morning Refreshment Break
10:45
Naming, Labeling and Marketing Biosimilars: Overcoming Inherent Barriers to Break into the U.S. Marketplace
12:00
Networking Luncheon Hosted by:
1:00

INTERNATIONAL

Global Focus on Biosimilars Abroad: From Patent Protection to Cost and Market Access
2:00
Networking Refreshment Break
Sponsored by:
2:15
The Growing Antitrust Scrutiny of Biosimilars and Biologics Manufacturers and Linked Settlement Considerations
3:15

ETHICS

Navigating Ethical Dilemmas in the Biologics Industries
4:15
Conference Concludes

Day 1 - Monday, June 24, 2019

7:45
Registration and Continental Breakfast
8:00
Co-Chair’s Opening Remarks

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

Genentech (South San Francisco, CA)

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

8:15
The Politics and Policies of BLAs and aBLAs: Analyzing the Present State of Affairs of the Innovator and Biosimilars Environment

Jeffrey K. Francer
Senior Vice President & General Counsel
Association for Accessible Medicines (AAM) (Washington, DC)

David Korn
Vice President, Intellectual Property and Law
PhRMA (Washington, DC)

Kristan Lansbery
Sr Director, Asst GC, IP
Regeneron Pharmaceuticals, Inc.

Hans Sauer
Deputy General Counsel, VP for Intellectual Property
Biotechnology Innovation Organization (Washington, DC)

Recently, political talking points like rising drug costs and patient access to medicine have become cornerstones of several 2020 campaigns. Now more than ever, the anticipated cost savings that biosimilar drugs could offer is
attracting the minds of policymakers, along with industry stakeholders. This session will consider Congressional proposals on biosimilars, review HHS’s and FDA’s plans to embolden the biosimilar market, and other potentially impactful measures.

 

  • Reviewing Congressional proposals on biosimilars, including the Preserve Access to Affordable Generics and Biosimilars Act
  • Assessing the potential impact of the proposed HHS rule to end safe harbor and the HHS Blueprint on drug pricing
  • Assessing FDA’s implementation of the Biosimilar Action Plan
  • Analyzing key components of the house-passed Biosimilars Competition Act of 2018
  • Questioning why the path to market is still congested and considering what Congress could do to ease congestion

9:15

FDA KEYNOTE

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation and the Future of Policy Development

Joseph Franklin
Associate Director for Policy, Therapeutic Biologics and Biosimilars Staff Office of New Drugs, CDER
U.S. Food & Drug Administration (Washington, DC)

10:15
Morning Refreshment Break
10:30
A Question of Standing: Establishing the Right to Appeal a PTAB Decision

Steven D. Maslowski
Partner
Akin Gump Strauss Hauer & Feld LLP (Philadelphia, PA)

Jason Murata
Partner
Axinn, Veltrop & Harkrider LLP (San Francisco, CA)

Tara A. Nealey
Shareholder
Polsinelli PC

Jeanna M. Wacker
Partner
Kirkland & Ellis LLP(New York, NY)

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (2017-1694), the Federal Circuit dismissed Momenta’s appeal of the PTAB’s final written decision sustaining BMS’s patentability of claims for lack of standing/jurisdiction and for mootness. This session will review the applicable standards for standing to appeal an adverse PTAB decision. Points of discussion will include:

  • 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

11:30
Biosimilars Trial Tracker: New Developments at the District Courts and the PTAB

Maureen Bresnahan
Assistant General Counsel
Eisai (Andover, MA)

Alan B. Clement
Partner
Locke Lord LLP

David W. Clough
Senior Partner
Polsinelli PC (Chicago, IL)

Daryl L. Wiesen
Partner
Goodwin Procter LLP

In 2018, seven biosimilar drugs were approved by the FDA, 12 district court patent litigations were filed, and 144 petitions for post-grant review were submitted. As the FDA continues to accept additional aBLAs, the potential to spur further BPCIA litigation activity is growing. This session will review the present state of biosimilars litigation, including:

  • Evaluating the concept of “biosimilar vs. biosimilar litigation”
  • Reviewing recent blind biosimilar infringement lawsuits post-Amgen v. Adello
  • Assessing the scope of the safe harbor under 35 U.S.C. § 271(e)(1) in view of Amgen v. Hospira
  • Understanding Article III standing requirements in view of Momenta v. Bristol-Myers Squibb

12:30
Networking Luncheon Hosted by:
1:30
The ITC: Examining the Role of this Alternate Forum in Biosimilars Disputes

Paul A. Ainsworth
Director
Sterne Kessler Goldstein Fox

Jonathan Bachand
Partner
Knobbe Martens

Kevin S. Prussia
Partner
Wilmer Cutler Pickering Hale and Dorr LLP (Boston, MA)

  • Exploring the ITC as a venue for reaching a relatively swifter and earlier resolution of a biosimilars challenge
    • Weighing the pros and cons of avoiding the patent dance and assessing the benefits of asserting any number of claims in lieu of the aBLA process
  • Capitalizing on the benefit of receiving remedies beyond the restrictions imposed by the district courts

2:15
Networking Refreshment Break
Sponsored by:
2:30
To Dance or Not to Dance: Addressing Contentions and Controversies in the aBLA Information Exchange

Charles B. Klein
Partner
Winston & Strawn LLP (Washington, DC)

Matthew A. Pearson
Partner
Akin Gump Strauss Hauer & Feld LLP (Philadelphia, PA)

Irena Royzman
Partner
Kramer Levin (New York, NY)

Petra Scamborova
Director, Dispute Resolution
Regeneron Pharmaceuticals, Inc.

Recent decisions by the Supreme Court and the Court of Appeals f or the Federal Circuit have significantly transformed the practice of biosimilar litigation. After Amgen Inc. v. Sandoz Inc. was decided, the path to litigation was abridged, opening the door for fast-tracked market entry. The number of biosimilar suits filed in the wake of the decision has increased year on year. This session will consider what the recent decisions in the post-Amgen world have attempted to clarify, including how biosimilar applicants can command the stride of litigation as arranged under the BPCIA.

3:30
Challenging Patents on Reference Drugs at the PTAB in the Age of Reform

Carol Pitzel Cruz
Partner
Knobbe Martens (Seattle, WA)

Jonathan A. Harris
Partner
Axinn Veltrop & Harkrider LLP (Hartford, CT)

Elizabeth S. Weiswasser
Partner
Weil, Gotshal & Manges LLP (New York, NY)

MODERATOR:

Eric W. Dittmann
Partner
Paul Hastings LLP (New York, NY)

In October of 2018, the USPTO announced their final rule which introduced the Phillips standard, replacing the broadest reasonable interpretation standard in IPR, PGR and CMB proceedings. Biosimilar manufacturers have traditionally turned to inter partes review (IPR) proceedings as a means to challenge patents covering biologic drugs. However, in December of 2018, lawmakers introduced a bill intended to limit the usage of IPRs by these same biosimilar developers. This session will review the legislation and discuss recent developments such as:

  • Understanding how the Hatch-Waxman Integrity Act would restrict biosimilar developers from challenging patents on reference through filing an IPR
  • Understanding how the PTAB’s adoption of the Phillips standard will impact biosimilar litigation practice
  • Evaluating biosimilars IPR filings and recent PTAB decisions
  • Assessing concerns surrounding multiple filer petitions and relevant timing considerations

4:30
The In-House Perspective: Current Topics in Biosimilars Development

Omar Jabri
Senior Director of Global Intellectual Property
Apotex Inc. (Toronto, CA)

Rachel Moodie
VP, IP
Fresenius Kabi

Julia Pike
Vice President of Intellectual Property, North America
Sandoz (Princeton, NJ)

Colman Ragan
VP & General Counsel
North America IP

Teva Pharmaceuticals

Laura Sim

Laura Sim
Sr. Counsel
Development, Regulatory, Operations & Contracting Law

Amgen

Moderator:

John J. Molenda
Partner
Steptoe & Johnson LLP (New York, NY)

  • Role of the PTAB in accelerating market access
  • Evolving perspectives on the patent dance in biosimilars litigation
  • Impact of the new interchangeability guidance
  • Proposed legislation and its impact on biopharmaceutical development programs

5:30
Day One Adjourns to Cocktail Reception

Day 2 - Tuesday, June 25, 2019

8:00
Continental Breakfast
8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
The Economics of Biosimilar Drugs: New Considerations for Market Access, Sustainable Pricing and Reimbursement Policies

Dr. David Blackburn
Managing Director and Head of NERA’s Life Sciences Industry Group
NERA Economic Consulting

Evan Diamond
Partner
King & Spalding LLP

Ha Kung Wong
Partner
Venable LLP (New York, NY)

New market entrants would increase competition, which, in theory at least, should lower drug prices. Decreased drug prices would improve patient access to pioneering biosimilar drugs. In fact, the subject of drug pricing transparency and reform is currently being addressed by the Trump administration. Presidential efforts notwithstanding, access could be restricted by numerous factors. This session will consider how effective biosimilar drugs have been in lowering drug prices and detail changes for how they are being reimbursed. Points of discussion will include:

  • Comparing the uptake of biosimilars in the U.S. to the EU
  • Understanding the elevated costs associated with developing and manufacturing biosimilar products and related regulatory hurdles that impact the ability to price biosimilars as low as generic drugs
  • Evaluating different reimbursement structures connected with medical benefits

9:45
View from the Bench

The Honorable Jacqueline Bonilla
Deputy Chief Judge
Patent Trial and Appeal Board

U.S. Patent & Trademark Office

INTERVIEWED BY:

Jonathan S. Caplan
Partner
Kramer Levin Naftalis & Frankel LLP

10:30
Morning Refreshment Break
10:45
Naming, Labeling and Marketing Biosimilars: Overcoming Inherent Barriers to Break into the U.S. Marketplace

Vishal C. Gupta
Partner
Steptoe & Johnson LLP (New York, NY)

Brian McCormick
Vice President & Chief Regulatory Counsel
Teva Pharmaceuitcals (Horsham, PA)

Kevin Noonan
Partner
McDonnell Boehnen Hulbert

  • Assessing the FDA’s draft guidance on the “Labeling for Biosimilar Products” licensed under section 351(k) of the Public Health Service Act
  • Evaluating the need for a naming system that allows biosimilar sot be differentiated and traced to promote market awareness surrounding product effectiveness
  • Appreciating the need for manufacturers to invest in sales and marketing schemes to communicate the clinical and economic benefits of biosimilars
  • Understanding the biosimilar value proposition

12:00
Networking Luncheon Hosted by:
1:00

INTERNATIONAL

Global Focus on Biosimilars Abroad: From Patent Protection to Cost and Market Access

Susanne L. Flanders
Partner
Venable LLP (New York, NY)

Otto Licks
Partner
Licks Attorneys

Tara Rahemba
Senior Director, Patent Counsel
Alexion Pharmaceuticals, Inc. (New Haven, CT)

Moderator:

Vanessa Yen
Partner
King & Spalding LLP

  • Reviewing policies for biosimilar approval in Europe, including barrier to entry and use of biosimilars
  • Examining market potential and incentivized companies and countries
  • Evaluating pricing structures of off-patent biologics and biosimilars
  • Understanding the reimbursement process of biosimilars in the EU

2:00
Networking Refreshment Break
Sponsored by:
2:15
The Growing Antitrust Scrutiny of Biosimilars and Biologics Manufacturers and Linked Settlement Considerations

Isaac S. Ashkenazi
Partner
Paul Hastings LLP

Nicholas Groombridge
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)

Dr. Christine Meyer
Managing Director and Chair of NERA’s Global Intellectual Property Practice
NERA Economic Consulting

Laura Storto
Assistant General Counsel, Associate Director
Genentech (South San Francisco, CA)

Vernon M. Winters
Partner
Sidley Austin LLP

In 2018, the industry saw intensified attention from regulators concerning competition amongst biologic and biosimilar products in the national marketplace. President Trump signed the “Patient Right to Know Drug Prices Act”, which requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. The courts have attempted to offer insight into what represents “fair competition” in the biosimilars market, and establish remedies for any unfair practices. Points of discussion will include:

  • Analyzing the Pfizer v. Johnson & Johnson case, which at the time of print, is still pending before the U.S. District Court for the Eastern District of Pennsylvania
  • Analyzing lessons learned from the FTC’s review of Paragraph IV settlement agreements
  • Reviewing key provisions of the new reporting requirements
  • Reviewing the FDA’s scrutinization of potential abuses of the citizen petition process
  • Understanding the FTC’s coordination with FDA to deter abuses of the citizen petition process that delay procompetitive biosimilar entry

3:15

ETHICS

Navigating Ethical Dilemmas in the Biologics Industries

Honorable Teresa Rea
Partner
Crowell & Moring LLP (Washington, DC) (Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

Mark E. Waddell
Co-Chair, Life Sciences
Loeb & Loeb LLP (New York, NY)

This session will identify common ethical dilemmas in biosimilar litigation and help you incorporate practices to avoid them. Points of discussion will include:

  • Instituting principles for deciding when attorneys must be disqualified based on conflict
  • Establishing who is a client based on actual representation

4:15
Conference Concludes