FTC ROUNDTABLE ON

FOLLOW-ON BIOLOGIC DRUGS:

FRAMEWORK FOR COMPETITION AND CONTINUED INNOVATION

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 likely price and market share effects of

entry by biosimilar and potential 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, R.Ph, 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, MBA, Vice President, Biologics, Hospira, Inc.

• Mateja Urlep, R.Ph, MS, Head Global Marketing & Medical,

Biopharmaceuticals, Sandoz International
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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, R.Ph, 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
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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

• Ken Dow, Assistant Patent Counsel, Johnson & Johnson

• Ken Goldman, MS, Vice President, Intellectual Property Strategy, 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

2:00-2:05: Break

2:05 - 2:50: 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

2:05 - 2:50: 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.
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Roundtable Participants

• Geoffrey Allan, PhD, President and CEO, Insmed, Inc.

• Aaron Barkoff, PhD, Partner, McDonnell Boehnen Hulbert & Berghoff LLP

• Marc A. Goshko, MS, Executive Director Legal Affairs, TEVA Pharmaceuticals,

North America

• Steven B. Miller, MD, MBA, Senior Vice President and Chief Medical Officer

Express Scripts, Inc.

• Doug Norman, General Patent Counsel, Eli Lilly and Company

• William B. Schultz, Partner, Zuckerman Spaeder LLP

• Bryan Zielinski, MS, Assistant General Counsel, Intellectual Property, Pfizer

2:50 - 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

• Elaine Blais, Partner, Goodwin Proctor LLP, outside patent counsel to TEVA

Pharmaceuticals, North America

• Ken Dow, Assistant Patent Counsel, Johnson & Johnson

• Ken Goldman, MS, Vice President Intellectual Property Strategy, Novartis

International AG

• Bruce A. Leicher, Senior Vice President and General Counsel, Momenta

Pharmaceuticals, Inc.

• Esther Kepplinger, Director, Patent Operations, Wilson Sonsini Goodrich &

Rosati

• Jeffrey P. Kushan, Partner, Sidley Austin LLP

• David Manspeizer, VP Intellectual Property & Associate General Counsel, Wyeth

• Hans Sauer, MS, PhD,Associate General Counsel, Intellectual Property, BIO

• Rochelle Seide, Senior Counsel, Schwegman, Lundberg & Woessner

• William B. Schultz, Partner, Zuckerman Spaeder LLP

• Christine J. Siwik, Partner, Rakoczy Molino Mazzochi Siwik LLP