Antitrust & Competition Policy Blog

Editor: D. Daniel Sokol
University of Florida
Levin College of Law

A Member of the Law Professor Blogs Network

Wednesday, November 19, 2008

FTC Announces Agenda for Roundtable on Follow-on Biologic Drugs

Posted by D. Daniel Sokol

FTC ROUNDTABLE ON
FOLLOW-ON BIOLOGIC DRUGS:
FRAMEWORK FOR COMPETITION AND CONTINUED INNOVATION

Tentative Agenda
November 21, 2008
Federal Trade Commission
600 Pennsylvania Avenue, N.W., Room HQ 432
Washington, D.C. 20580

8:30 - 8:45 Welcoming Remarks: FTC Commissioner Pamela Jones Harbour,

8:45 - 9:00 Opening Remarks: Rachel Behrman, FDA,
“How Do Biologic Drugs Differ from Small Molecule Drugs?”

9:00 - 10:30 Likely Market Effects of Follow-On Biologic (FOB) Drug
Competition
Moderators: Michael Wroblewski and Elizabeth Jex, Attorneys, FTC, Bureau of
Competition, Office of Policy and Coordination and Mergers I

9:05 - 9:20 Background Presentation: Paul Heldman, Senior Health Policy
Analyst, Potomac Research, “Overview of Biologic Drug Markets”

9:20 - 10:30 Participant Discussion
Discussion Topics: Participants will discuss the price and market share effects of entry
by both biosimilar and biogeneric (i.e., substitutable and interchangeable with the
referenced product) drug products. They also will discuss the likely competitive effects
Follow-on Biologic (FOB) drug products will have on reimbursement by private and
public (e.g., Medicare Part B) payers.
Roundtable Participants:
• Alexis Ahlstrom, MPH, Director, Avalere Health LLC
• Rachel E. Behrman, MD, MPH, Director, Office of Critical Path Programs,
Office of the Commissioner, Food and Drug Administration
• Steven B. Brugger, MBA, Chief Operating Officer, Momenta Pharmaceuticals,
Inc.
• Ted Buckley, PhD, Director, Economic Policy, Biotechnology Industry
Organization
• David Golding, Executive Vice President for Specialty Pharmacy Services, CVS
Caremark
• Henry C. Grabowski, PhD, Professor, Duke University
• Paul Heldman, Senior Health Policy Analyst, Potomac Research
• John Lane, Vice President, Biologics, Hospira, Inc.
• Mateja Urlep, R. Ph, MS, Head Global Marketing & Medical,
Biopharmaceuticals, Sandoz International
-2-

10:30 - 10:45 Morning Break

10:45 - 12:00 Likely Competitive Effects of Reference Product Regulatory
Exclusivity
Moderators: Michael Wroblewski, Attorney, FTC, Bureau of Competition, Office
of Policy and Coordination, and Christopher Garmon, FTC, Bureau of Economics

10:45 - 10:55 Background Presentation: Linda Horton, Hogan & Hartson, “The
European Experience with Follow-On Biologic Legislation”

10:55 - 12:00 Participant Discussion
Discussion Topics: The participants will discuss the economic model to assess the pros
and cons of any regulatory exclusivity period provided to referenced products from both
the innovator firms’ and FOB applicants’ perspectives. In particular, panelists will
discuss issues of recoupment and innovation in relation to the time periods preventing
FOB competitors from seeking regulatory approval. Panelists also will explore the pros
and cons of varying the length of any regulatory exclusivity period based on whether an
FOB entrant is a biogeneric or biosimilar product and other ways to encourage
innovation.
Roundtable Participants:
• Alexis Ahlstrom, MPH, Director, Avalere Health LLC
• Geoffrey Allan, PhD, President and CEO, Insmed Inc
• Alex M. Brill, Research Fellow, American Enterprise Institute
• Linda Horton, Partner, Hogan & Hartson
• David Golding, Executive Vice President for Specialty Pharmacy Services, CVS
Caremark
• Henry C. Grabowski, PhD, Professor, Duke University
• Paul Heldman, Senior Health Policy Analyst, Potomac Research
• Audrey Phillips, PhD, Executive Director of Biopharmaceutical Public Policy and
Advocacy, Johnson & Johnson
• Mateja Urlep, R. Ph, MS, Head Global Marketing & Medical,
Biopharmaceuticals, Sandoz International

12:00-1:00 Lunch Break

1:00-2:00 Biotechnology Patent Issues
Moderators: Suzanne Michel, Assistant Director, FTC Bureau of Competition,
Office of Policy and Coordination, and Suzanne Drennon, Attorney, FTC Bureau of
Competition, Office of Policy and Coordination

1:00 - 2:00 Participant Discussion
Discussion Topics: The participants will discuss the interaction between patents
claiming biotechnology products and regulatory exclusivity periods. The panelists will
discuss whether there are differences between biotechnology patents and small molecule
patents relating to (1) claim drafting and PTO approval processes; and (2) trends
regarding judicial review. They also will discuss whether regulatory exclusivity and
patent rights affect innovator firm and FOB applicant needs for business planning
certainty.
Roundtable Participants
• Alisa Harbin, Head Corporate Intellectual Property, Novartis International AG
• Esther Kepplinger, Director, Patent Operations, Wilson Sonsini Goodrich &
Rosati
• Jeffrey P. Kushan, Partner, Sidley Austin LLP
• Bruce A. Leicher, Senior Vice President and General Counsel, Momenta
Pharmaceuticals, Inc.
• David Manspeizer, VP Intellectual Property & Associate General Counsel, Wyeth
• Doug Norman, General Patent Counsel, Eli Lilly and Company
• Naomi Pearce, IP Director and Counsel, Hospira, Inc.
• Rochelle Seide, Senior Counsel, Schwegman, Lundberg & Woessner

2:00 - 2:45: Likely Competitive Effects of Follow-on Biologic Regulatory Incentives
Moderators: Michael Wroblewski and Elizabeth Jex, Attorneys, FTC, Bureau of
Competition, Office of Policy and Coordination and Mergers I

2:00 - 2:45: Participant Discussion
Discussion Topics: Participants will discuss whether there is a need to provide
regulatory incentives for the filing of FOB applications. The participants will examine
the effects of using a marketing exclusivity period for FOB products similar to the one
provided generic applicants under the Hatch-Waxman Act. They also will discuss
whether such incentives are necessary to encourage the development of biogeneric FOB
products.
Roundtable Participants
• Geoffrey Allan, PhD, President and CEO, Insmed, Inc.
• Aaron Barkoff, PhD, Partner, McDonnell Boehnen Hulbert & Berghoff LLP
• Marc A. Goshko, Executive Director Legal Affairs, TEVA Pharmaceuticals,
North America
• Doug Norman, General Patent Counsel, Eli Lilly and Company
• William B. Schultz, Partner, Zuckerman Spaeder LLP
• Bryan Zielinski, Assistant General Counsel, Intellectual Property, Pfizer

2:45 - 3:00 Afternoon Break

3:00 - 5:00: Patent Dispute Resolution Processes
Moderators: Michael Wroblewski and Suzanne Drennon, Attorneys, FTC, Bureau
of Competition, Office of Policy and Coordination

3:00 - 3:15 Presentation of Biotechnology Patent Portfolio Case Study: Rochelle
Seide, Senior Counsel, Schwegman, Lundberg & Woessner

3:15 - 5:00 Participant Discussion
Discussion Topics: The participants will discuss the need for, and the likely competitive
effects of, different ways to structure a process to resolve patent disputes between
innovator firms and FOB applicants prior to FDA approval of FOB products. The
participants will use the Case Study to focus on: (1) when to start such a process; (2) how
and to whom such notifications will be provided; and (3) what patents to be included in
such a process (including patents obtained after such a process has begun).
Roundtable Participants
• Ken Dow, Assistant Patent Counsel, Johnson & Johnson
• Elaine Blais, Partner, Goodwin Proctor LLP, outside patent counsel to TEVA
Pharmaceuticals, North America
• Alisa Harbin, Head Corporate Intellectual Property, Novartis International AG
• Bruce A. Leicher, Senior Vice President and General Counsel, Momenta
Pharmaceuticals, Inc.
• Esther Kepplinger, Director, Patent Operations, Wilson Sonsini Goodrich &
Rosati
• Daniel A. Kracov, Partner, Arnold & Porter LLP
• Jeffrey P. Kushan, Partner, Sidley Austin LLP
• David Manspeizer, VP Intellectual Property & Associate General Counsel, Wyeth
• Hans Sauer, Associate General Counsel, Intellecutal Property, BIO
• Rochelle Seide, Senior Counsel, Schwegman, Lundberg & Woessner
• William B. Shultz, Partner, Zuckerman Spaeder LLP
• Christine J. Siwik, Partner, Rakoczy Molino Mazzochi Siwik LLP

http://lawprofessors.typepad.com/antitrustprof_blog/2008/11/ftc-announces-a.html

| Permalink

TrackBack URL for this entry:

http://www.typepad.com/services/trackback/6a00d8341bfae553ef010536036fbd970c

Listed below are links to weblogs that reference FTC Announces Agenda for Roundtable on Follow-on Biologic Drugs:

Comments

Post a comment