Law Seminars International Presents

A Comprehensive Two-Day Conference on Licensing, Life-Cycle Management, and M&A Issues in the field of

Pharmaceutical Antitrust

Featuring a special address by FTC Commissioner J. Thomas Rosch and presentations by six other federal and state enforcers

April 26 & 27, 2007
Capital Hilton in Washington, DC
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Who Should Attend

Lawyers and business executives involved with product management, licensing and distribution, and corporate transactions in the pharmaceutical industry; patent attorneys working with pharmaceutical products

Why Attend

Antitrust issues are a significant concern at every stage of a pharmaceutical product's life-cycle from initial development through launch, marketing and distribution. We have assembled leading in-house and outside counsel, industry executives, and government policy-makers, law enforcers, and regulators to offer insights into current competition issues facing the pharmaceutical industry and to provide guidance on practical ways to handle key business decisions and transactions that may raise antitrust problems. You will learn how to identify antitrust exposure in the current legal and regulatory environment, assess competitive conditions by accurately identifying the relevant market, and become better informed on how to approach various kinds of transactions in a way that maximizes the value of your products without triggering expensive and time-consuming enforcement actions or litigation. In the event litigation occurs, you'll learn the limits on what you can do to settle the case without triggering charges that the settlement is anticompetitive. We hope you'll join us for what promises to be a very valuable and informative program. ~ Program Co-Chairs: David A. Balto, Esq., Jeffrey W. Brennan, Esq., and George Frank, Ph.D., Esq.

What You Will Learn

~ Regulatory perspectives on the intersection of intellectual property protection and antitrust laws ~ Tips for developing pricing and distribution agreements ~ Lessons from recent regulatory enforcement actions ~ Tips for business decision-making when there is antitrust exposure ~ Nuts and bolts of government investigations ~ Tips for maximizing the life-cycle of products ~ Current parameters for settling patent disputes ~ Tips for structuring joint ventures and M&A transactions ~ Prospects for new legislation ~ Ethical standards for industry lawyers dealing with antitrust issues

What Attendees Have Said About Similar Programs

FEATURING SPEAKERS FROM: *Bell, Boyd & Lloyd LLP *Budd Larner *David A. Balto, Esq., Attorney at Law *Dechert LLP *Drinker Biddle & Reath LLP *Edwards Angell Palmer & Dodge LLP *Endo Pharmaceuticals *Federal Trade Commission *Gray Plant Mooty *Haynes and Boone, LLP *Impax Laboratories, Inc. *Jones Day *Merck & Co., Inc. *NERA Economic Consulting *Office of the Attorney General of Pennsylvania *Sandoz *Schering-Plough Corporation *U.S. Senate Antitrust Subcommittee *WilmerHale

Agenda

Thursday, April 26, 2007

8:00 am Registration & Continental Breakfast
8:30 am Introduction to Day One
  David A. Balto, Esq., Program Co-Chair
Attorney at Law / Washington, DC
  Jeffrey W. Brennan, Esq., Program Co-Chair
Dechert LLP / Washington, DC
8:45 am Special Address: Intellectual Property Rules of the Road in the Pharmaceutical Industry--Is There Room for the Antitrust Laws?
  J. Thomas Rosch, Esq., Commissioner
Federal Trade Commission / Washington, DC
9:30 am Recent Pharmaceutical Antitrust Cases and Enforcement Initiatives
  Review of recent case law and enforcement initiatives in settlements, brand extension strategies, patent challenges, pricing strategies, mergers and joint ventures
  David A. Balto, Esq., Program Co-Chair
Attorney at Law / Washington, DC
  Paul H. Saint-Antoine, Esq.
Drinker Biddle & Reath LLP / Philadelphia, PA
10:15 am Break
10:30 am Pricing and Distribution Agreements: Maximizing Flexibility While Controlling Risk
  Practical advice on managing pricing discrimination, bundled discounts, marketshare rebates, distribution system structures, and special considerations for the so-called dominant firm
  Kenneth L. Glazer, Esq., Deputy Director, Bureau of Competition
Federal Trade Commission / Washington, DC
  Stephen J. Cipolla, Esq.
Merck & Co., Inc. / North Wales, PA
  Veronica G. Kayne, Esq.
Haynes and Boone, LLP / Washington, DC
12:00 pm Lunch (on your own)
1:15 pm Understanding and Assessing Market Power in Pharmaceuticals: Screens for Potential Antitrust Exposure
  Economic, regulatory, legal and industry perspectives on the key elements in identifying competition; market power questions from the litigation and counseling perspectives
  Economic perspective
  Sumanth Addanki, Ph.D., Senior Vice President
NERA Economic Consulting / White Plains, NY
  Regulatory perspective
  Elizabeth Jex, Esq., Attorney, Bureau of Competition
Federal Trade Commission / Washington, DC
  Industry perspective
  Douglas D. Macpherson, Esq., Vice President & Associate General Counsel
Endo Pharmaceuticals / Chadds Ford, PA
2:15 pm Joint Ventures and M&A Transactions
  Competitive analysis of market and innovation issues; how IP rights affect the analysis; combined patent portfolios; HSR vs. non-HSR investigation; anticipating investigation questions
  Matthew J. Reilly, Esq., Deputy Assistant Director, Mergers I, Bureau of Competition
Federal Trade Commission / Washington, DC
  Stephen A. Stack, Jr., Esq.
Dechert LLP / Philadelphia, PA
3:30 pm Break
3:45 pm Nuts and Bolts of Government Investigations
  How to survive a government investigation in a cost efficient, practical fashion
  Bradley S. Albert, Esq., Deputy Assistant Director, Health Care Division, Bureau of Competition
Federal Trade Commission / Washington, DC
  Pamela L. Taylor, Esq.
Bell, Boyd & Lloyd LLP / Chicago, IL
  Eric L. Yaffe, Esq.
Gray Plant Mooty / Washington, DC
5:00 pm Reception Sponsored by David Balto, Attorney at Law, WilmerHale and Drinker Biddle & Reath LLP

Friday, April 27, 2007

8:00 am Registration & Continental Breakfast
8:30 am Introduction to Day Two
  Intellectual Property Strategies; Government Perspective on Enforcement Actions and Strategies for Responding to Investigations
  George A. Frank, Ph.D., Esq., Program Co-Chair
Drinker Biddle & Reath LLP / Philadelphia, PA
8:45 am The Regulators Speak: Discussion of Important Enforcement Developments and Initiatives
  Federal-level Enforcement
  David P. Wales, Esq., Deputy Director, Bureau of Competition
Federal Trade Commission / Washington, DC
  State-level Enforcement
  James A. Donahue, III, Esq., Chief Deputy Attorney General
Office of the Attorney General of Pennsylvania--Antitrust Section / Harrisburg, PA
9:45 am Maximizing the Life-Cycle of Products
  Lessons from recent cases: Identifying the antitrust risks; strategies for patent acquisition, Orange Book de-listing, and end-of-life management; citizen petitions; authorized generics; aggressive patent strategies while minimizing antitrust risks
  James C. Burling, Esq.
WilmerHale / Boston, MA
  Markus H. Meier, Esq., Assistant Director, Health Care Division, Bureau of Competition
Federal Trade Commission / Washington, DC
  Margaret M. Snowden, Esq., Vice President, Intellectual Property
Impax Laboratories, Inc. / Hayward, CA
  Shashank Upadhye, Esq., VP, Head of Intellectual Property & Regulatory
Sandoz / Princeton, NJ
10:45 am Break
11:00 am Settling Pharmaceutical Patent Disputes
  The shifting case law on patent settlements; new FTC initiatives; the FTC settlement report; trends in recent FTC and private challenges to settlements; Noerr-Pennington; recognizing notification triggers; standards for demonstrating competitive harm
  Suzanne T. Michel, Ph.D., Esq., Deputy Assistant Director for Policy and Coordination
Federal Trade Commission / Washington, DC
  Kevin D. McDonald, Esq.
Jones Day / Washington, DC
  Andrew J. Miller, Esq.
Budd Larner / Short Hills, NJ
12:30 pm Lunch (on your own)
1:45 pm Legislative Perspectives
  Potential reform of the Hatch Waxman Act: approach to settlements, citizen petition, and product extension strategies
  Jeffrey W. Brennan, Esq., Program Co-Chair
Dechert LLP / Washington, DC
  Seth Bloom, Esq., Senior Counsel
U.S. Senate Antitrust Subcommittee / Washington, DC
  Gary Heimberg, Esq., Vice President of Federal Affairs
Generic Pharmaceutical Association / Arlington, VA
  Ivy Johnson, Esq., Chief Antitrust Counsel to the Minority Staff
U.S. Senate Judiciary Committee / Washington, DC
  Eric J. Stock, Esq.
Hogan & Hartson LLP / New York, NY
3:15 pm Break
3:30 pm Ethics
  Special ethics issues relating to antitrust cases including identifying your client, privilege, and conflicts
  Cathy Fleming, Esq.
Nixon Peabody LLP / New York, NY
4:30 pm Evaluations & Adjourn

Tuition

Regular tuition for this program is $995 with a group rate of $895 each for two or more registrants from the same firm. For government employees, we offer a special rate of $795. For students and people in their job for less than a year, our rate is $497.50. All rates include admission to all seminar sessions, food and beverages at breaks, and all course materials. Make checks payable to Law Seminars International.

Cancellation & Substitution

You may substitute another person at any time. We will refund tuition, less a $50 cancellation fee, if we receive your cancellation by 5:00 p.m. on Friday, April 20, 2007. After that time, we will credit your tuition toward attendance at another program or the purchase of a homestudy. There is a $25 cancellation fee for Course Materials orders and $50 for Homestudy orders.

Continuing Education Credits

This program qualifies for 12.5 VA CLE credits including 1 ethics credit. Upon request, we will apply for CLE credits in other states and other types of credits.

Location

The conference will be held at the Capital Hilton Hotel at 1001 16th Street NW in Washington, DC 20036, (202) 393-1000. As of March 1, the Capital Hilton is sold out, although rooms may become available closer to the conference dates. Sleeping rooms are available three blocks away at the Courtyard by Marriott--Embassy Row, 1600 Rhode Island Ave. NW, Washington, DC 20036. Call the reservations line at (800) 321-2211 and ask for the Law Seminars International discounted rate of $209/nt. This rate may not be available after Mar. 23, 2007.
More about the Location
Map & Directions
Sleeping Accommodations
Map for Sleeping Accommodations

If You Cannot Attend

Our complete Homestudy Course, consisting of a VHS or DVD recording and the written course materials, is available for $1005. The written course materials alone are available for $100. We will ship your homestudy order via UPS ground within two weeks after the seminar or the date we receive payment (whichever is later).
Order Homestudy

Faculty Bios

David A. Balto, Program Co-Chair, is attorney at law in Washington, DC, and focuses on antitrust and trade regulation and intellectual property litigation. Previously he was Policy Director of the Bureau of Competition of the Federal Trade Commission and attorney advisor to Chairman Robert Pitofsky.

Jeffrey W. Brennan, Program Co-Chair, partner in the Antitrust Practice Group of Dechert LLP, specializes in antitrust law and litigation. Most recently, he was with the FTC Bureau of Competition as Associate Director and earlier as Assistant Director in charge of the Health Care Services and Products Division.

George A. Frank, Program Co-Chair, joined Drinker Biddle & Reath LLP after serving as Corporate Counsel and IP Group Leader for E. I. du Pont de Nemours and Company. He is Chair of the firm's Licensing and Technology Transfer Practice Team and focuses his transactional and litigation practice on corporate partnering, licensing, and joint ventures involving patent law, chemical technologies, and biotechnology.

J. Thomas Rosch, Special Address, is a Commissioner for the FTC. Previously, he was managing partner of Latham & Watkins' San Francisco office, working in the firm's Antitrust and Litigation Practice Areas and chair of the American Bar Association's Antitrust Section.

Sumanth Addanki is Senior Vice President of NERA Economic Consulting.

Bradley S. Albert is Deputy Assistant Director for Healthcare Services and Products at the FTC's Bureau of Competition.

Seth Bloom, Senior Counsel on the U.S. Senate Antitrust Subcommittee on the staff of Senator Herb Kohl, the Chairman of the Subcommittee, is responsible for antitrust, competition, and other business regulation issues. He has worked to bring more competition to the pharmaceutical industry and reduce barriers to the entry of generic competition.

James C. Burling is a co-chair of the Antitrust and Competition Department and a member of the Litigation Department of WilmerHale. He concentrates in antitrust litigation and merger clearance for high technology clients, particularly in the computer, Internet, biotech and pharmaceutical industries.

Stephen J. Cipolla is counsel with Merck & Co., Inc., where he advises clients in the areas of Robinson Patman, unfair trade practices, and domestic antitrust law including the Sherman and Clayton Acts and their state law analogues. In addition, he is responsible for the management of civil commercial litigation arising out of the company's marketing and sales activities.

James A. Donahue, III is Chief Deputy Attorney General of Pennsylvania--Antitrust Section, where he is responsible for supervising Pennsylvania's antitrust enforcement efforts. Pennsylvania has been especially active in investigations and litigation involving generic drugs, Pharmacy Benefit Managers and Average Wholesale Pricing.

Cathy Fleming, partner with Nixon Peabody LLP, focuses on corporate integrity, government enforcement, and complex civil and white-collar criminal litigation. She is President of the National Association of Women Lawyers.

Gary Heimberg is Vice President of Federal Affairs for the Generic Pharmaceutical Association, where he is responsible for leading the association's federal lobbying efforts and coordinating the joint legislative activities of GPhA and its member companies.

Kenneth L. Glazer is Deputy Director of the FTC's Bureau of Competition. Previously, he was the Senior Competition Counsel for The Coca-Cola Company.

Elizabeth Jex is an attorney with the FTC's Bureau of Competition.

Ivy Johnson is Chief Antitrust Counsel to the Minority Staff of the U.S. Senate Judiciary Committee. As such, she has primary responsibility for issues related to antitrust as well as a broad range of other issues, including privacy and data security, bankruptcy and a variety of tort reform initiatives. Previously, she was with Skadden, Arps, Slate, Meagher & Flom.

Veronica G. Kayne, a partner with Haynes and Boone, LLP's Specialized Litigation Section, represents clients in a variety of industries, including energy, health care, telecommunications and consumer products. Her expertise is in the antitrust aspects of distribution and pricing, intellectual property licensing, joint ventures, and mergers and acquisitions.

Douglas D. Macpherson is Vice President and Associate General Counsel for Endo Pharmaceuticals, where his responsibilities include all the product licensing and company acquisition activities of Endo. His career responsibilities include securities, intellectual property and antitrust.

Kevin D. McDonald, a partner with Jones Day, specializes in antitrust litigation and has participated in a number of significant antitrust jury trials, FTC proceedings, and other civil litigation. In the health care industry, he has represented a wide variety of insurers, hospitals, and provider groups.

Markus H. Meier is the Assistant Director of the Health Care Division of the FTC's Bureau of Competition, where he leads investigations and litigation involving alleged violations of the antitrust law by physicians and other health-care professionals, pharmaceutical companies, hospitals, and health plans.

Suzanne T. Michel is Deputy Assistant Director for Policy and Coordination at the FTC where she participates in the IP and IP/antitrust issues that arise in the FTC's enforcement and policy initiatives. Before joining the FTC, she was at the Department of Justice.

Andrew J. Miller is a partner with Budd Larner and head of its Intellectual Property Group. He handles litigation and complex corporate business arrangements, concentrating in the pharmaceutical and chemical fields. Previously, Mr. Miller was General Counsel for Dr. Reddy's Laboratories.

Matthew J. Reilly is Deputy Assistant Director, Mergers I, at the FTC's Bureau of Competition. He supervises attorneys and support staff in investigating, preparing and presenting antitrust cases to the Commission and federal courts involving medical devices, pharmaceuticals, biotechnology, defense, aerospace, industrial goods, energy and food products.

Paul H. Saint-Antoine is a partner in Drinker Biddle & Reath LLP's Litigation Department and co-head of the Antitrust Practice Group. He has represented clients in FTC administrative proceedings, in preliminary injunction proceedings and in response to second requests.

Margaret M. Snowden is Vice President, Intellectual Property, for Impax Laboratories, Inc.

Stephen A. Stack, Jr. is a member of Dechert LLP's trial team and former co-chair of Dechert's Antitrust/Competition Group. He regularly counsels pharmaceutical and chemical clients on antitrust problems including intellectual property, mergers, joint ventures, price discrimination, vertical restrictions, and compliance programs.

Eric J. Stock, partner with Hogan & Hartson LLP, provides antitrust advice to clients in the pharmaceutical industry, including patent settlement and product extension issues. He is currently serving as a Vice-Chair of an ABA Antitrust Section Task Force reviewing proposed legislation on pharmaceutical patent settlements.

Pamela L. Taylor is a partner with Bell, Boyd & Lloyd LLP in the firm's Antitrust and Trade Regulation Department. She concentrates on the antitrust aspects of mergers and acquisitions, licensing and distribution issues facing clients in the pharmaceutical, chemical, medical product and heavy equipment industries.

Shashank Upadhye is Vice President, Head of Intellectual Property and Regulatory, for Sandoz, the generic unit of Novartis, Inc., where he counsels on the Hatch Waxman Act, notably in the areas of design around patents, FDA regulatory strategies, and patent litigation.

David P. Wales is Deputy Director of the FTC's Bureau of Competition, responsible for the oversight of the Bureau's divisions that review both mergers and conduct matters in the healthcare industry.

Eric L. Yaffe is the Managing Officer of the Washington, D.C. office of Gray Plant Mooty. He is Co-Chair of the firm's Business & General Litigation Practice Group and a member of the White Collar Crime and Franchise & Distribution Practice Groups. Previously, he was a federal prosecutor with the U.S. Department of Justice.

Firm Links

Bell, Boyd & Lloyd LLP