Law Seminars International Presents: An Intensive Two-Day Conference on

Pharmaceutical Antitrust
Practical insights on navigating government investigations and private litigation

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April 24 & 25, 2008
The Westin Washington DC City Center in Washington, DC

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 government enforcers and policy makers from the Federal Trade Commission and Congress to provide an on-the-ground assessment of the new Washington challenges for pharmaceutical companies. Prominent in-house and outside counsel as well as industry executives will join us to offer guidance on current competition issues facing the pharmaceutical industry and practical ways to handle key business decisions with potential antitrust hazards.

You will learn how to determine antitrust exposure in the current legal and regulatory environment, how to identify and form pro-competitive mergers and joint ventures and how to approach a variety of transactions in order to maximize your products' values without triggering expensive and time-consuming government actions or litigation. Additionally, this conference will provide practical insight on navigating government investigations and private litigation. We hope you'll join us for what promises to be a very valuable and informative program.

~ David A. Balto, Esq., Shashank S. Upadhye, Esq. and Jonathan A. Wasserman, Esq., Program Co-Chairs

You Will Learn About

Agenda

Thursday, April 24, 2008

8:00 am

Registration and Continental Breakfast

 
8:30 am

Introduction and Overview

David A. Balto, Esq., Program Co-Chair
Attorney at Law / Washington, DC

Shashank S. Upadhye, Esq., Program Co-Chair, Vice President, Global Intellectual Property
Apotex, Inc. / Weston, ON

Jonathan A. Wasserman, Esq., Program Co-Chair, Senior Legal Director for Antitrust & Litigation
Schering-Plough Corporation / Kenilworth, NJ

 
8:45 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

Michael G. Cowie, Esq.
Howrey LLP / Washington, DC

Eric J. Stock, Esq.
Hogan & Hartson LLP / New York, NY

 
10:00 am

Break

 
10:15 am

Pricing and Distribution Agreements: Maximizing Flexibility While Controlling Risk

Practical advice on managing pricing discrimination, bundled discounts, market share 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

Mergers, Strategic Alliances and Joint Ventures

Economic, regulatory, legal and industry perspectives on the key elements in identifying competition; market power questions from the litigation and counseling perspectives

Jonathan A. Wasserman, Esq., Program Co-Chair, Senior Legal Director for Antitrust & Litigation
Schering-Plough Corporation / Kenilworth, NJ

Economic perspective

Sumanth Addanki, Ph.D., Senior Vice President
NERA Economic Consulting / White Plains, NY

Regulatory perspective

Elizabeth A. Jex, Esq., Staff Attorney, Bureau of Competition
Federal Trade Commission / Washington, DC

Seth C. Silber, Esq.
Wilson Sonsini Goodrich & Rosati / Washington, DC

 
3:00 pm

Break

 
3:15 pm

Should We Allow Brand Companies to Pay Generics to End Patent Challenges: James J. Kirkpatrick Meet Shana Alexander

Merril J. Hirsh, Esq.
Ross, Dixon & Bell, LLP / Washington, DC

 
3:45 pm

Nuts and Bolts of Government Investigations

How to survive a government investigation in a cost-efficient, practical fashion

Claudia R. Higgins, Esq.
Kaye Scholer LLP / Washington, DC

Eric L. Yaffe, Esq.
Gray Plant Mooty / Washington, DC

 
5:30 pm

Reception Sponsored by David Balto, Attorney at Law and Howrey LLP

 

Friday, April 25, 2008

8:00 am

Registration and Continental Breakfast

 
8:30 am

Introduction to Day Two

David A. Balto, Esq., Program Co-Chair
Attorney at Law / Washington, DC

Shashank Upadhye, Esq., Program Co-Chair, Vice President, Global Intellectual Property
Apotex, Inc. / Toronto, ON

Jonathan A. Wasserman, Esq., Program Co-Chair, Senior Legal Director for Antitrust & Litigation
Schering-Plough Corporation / Kenilworth, NJ

 
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

 
10:00 am

Break

 
10:15 am

Maximizing the Life-Cycle of Products

Lessons from recent cases: identifying 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

Shashank Upadhye, Esq., Program Co-Chair, Vice President - Global Intellectual Property
Apotex, Inc. / Weston, ON

Joel M. Cohen, Esq.
Davis Polk & Wardwell / New York, NY

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

 
12:00 pm

Lunch (on your own)

 
1:15 pm

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

Michael B. Kades, Esq., Attorney-Advisor to Commissioner Jon Leibowitz
Federal Trade Commission / Washington, DC

Kevin D. McDonald, Esq.
Jones Day / Washington, DC

Andrew J. Miller, Esq.
Budd Larner / Short Hills, NJ

 
2:45 pm

Break

 
3:00 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

 
4:00 pm

Evaluations and 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 18, 2008. 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 incl. 1 ethics. Upon request, we will apply for CLE credits in other states and other types of credits.

Location

The conference will be held at the The Westin Washington, D.C. City Center Hotel at 1400 M Street, NW in Washington, DC 20005. Call the hotel directly at (888) 627-9035 for reservations at the special negotiated rate of $245.00 and mention that you are attending a Law Seminars International conference. Rooms are on a first come, first served basis.
More about the Location
Map & Directions

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 and attorney at law in Washington, DC, focuses on antitrust and trade regulation and intellectual property litigation and represents pharmaceutical companies on pricing, distribution, mergers and joint ventures. Previously, he was Policy Director of the Bureau of Competition of the Federal Trade Commission.

Shashank S. Upadhye, Program Co-Chair and Vice President, Global Intellectual Property for Apotex, Inc., advises on intellectual property, regulatory affairs and related antitrust implications of pharmaceutical law. Previously, he was Vice President, Head of Intellectual Property at Sandoz.

Jonathan A. Wasserman, Program Co-Chair and Senior Legal Director for Antitrust and Litigation at Schering-Plough Corporation, is responsible for antitrust counseling, as well as managing antitrust litigation and commercial litigation. Previously, he was an attorney with the U.S. Justice Department

Dr. Sumanth Addanki, Ph.D., Senior Vice President at NERA Economic Consulting, specializes in antitrust, intellectual property and the evaluation of commercial damages.

Stephen J. Cipolla, counsel with Merck & Co., Inc., advises on unfair trade practices and domestic antitrust law including the Sherman and Clayton Acts and their state law analogues, and is responsible for the management of civil commercial litigation rising out of the company's marketing and sales activities.

Joel M. Cohen, partner at Davis Polk & Wardwel and Practice Group Coordinator of the Litigation Department, focuses on representation in antitrust and general civil litigation and arbitration matters.

Michael G. Cowie, partner in Howrey LLP's Antitrust Practice Group, was previously Assistant Director of the Federal Trade Commission's Bureau of Competition. He was also the Commission's Senior Litigation Counsel, directing antitrust litigation.

James A. Donahue III, chief deputy Attorney General of Pennsylvania, Antitrust Section, is responsible for supervising Pennsylvania's antitrust enforcement efforts.

Cathy Fleming, partner at Nixon Peabody LLP, focuses on corporate integrity, government enforcement and civil and white-collar criminal litigation. She is past President of the National Association of Women Lawyers and recognized by Law & Politics as a "New York SuperLawyer."

Kenneth L Glazer, Deputy Director of the Federal Trade Commission's Bureau of Competition, was previously Senior Competition Counsel for the Coca-Cola Company.

Claudia R. Higgins, partner in Kaye Scholar LLP's Antitrust Practice Group, concentrates in merger & acquisitions antitrust issues and counseling. Previously, with the Federal Trade Commission's Bureau of Competition, she led pharmaceutical merger investigations and was later Assistant Director of the Bureau.

Merril J. Hirsh, partner at Ross, Dixon & Bell, LLP, litigates on both the plaintiff and defense sides in antitrust, IP, insurance, securities, corporate, discrimination, class action and false claims actions. Previously he was a trial attorney in the Civil Division of the U.S. Department of Justice.

Elizabeth A. Jex, staff attorney at the Federal Trade Commission's Bureau of Competition, reviews pharmaceutical and biotechnology mergers and acquisitions.

Michael B. Kades is an Attorney Advisor to Commissioner Jon Leibowitz of the Federal Trade Commission. Previously, he focused on antitrust enforcement in the pharmaceutical industry at the Commission's Health Care Division.

Veronica G. Kayne, partner at Haynes Boone, LLP, specializes in manufacturing and retail pricing and distribution issues. Former Assistant Director of the Federal Trade Commission's Bureau of Competition, she now represents clients at the FTC, the Department of Justice and in civil antitrust litigation.

Kevin D. McDonald, partner in the Trial Practice Group at Jones Day, specializes in antitrust litigation. He wrote the Supreme Court amicus briefs filed by the American Bar Association in Illinois Tool Works and is contributing editor to the ABA Antitrust Law Journal.

Markus H. Meier, Assistant Director of the Health Care Division of Federal Trade Commission's Bureau of Competition, leads investigations and litigation involving alleged violations of antitrust laws by health-care professionals, pharmaceutical companies, hospitals and health plans.

Andrew J. Miller, partner and head of Intellectual Property Group at Budd Larner, concentrates on litigation and corporate business arrangements in the pharmaceutical and chemical fields.

Seth C. Silber, of counsel with Wilson Sonsini Goodrich & Rosati, counsels pharmaceutical firms on antitrust issues. Previously he was at the Federal Trade Commission, most recently as Antitrust Advisor to Commissioner Jon Leibowitz, and currently chairs the ABA Antitrust Section's Health Care and Pharmaceuticals Committee.

Margaret M. Snowden, Vice President, Intellectual Property at IMPAX Laboratories, Inc., is responsible for intellectual property matters, including patent prosecution, design-around advice and patent litigation, as well as Hatch-Waxman Act advice and counseling.

Eric J. Stock, partner at Hogan & Hartson LLP, focuses on antitrust litigation, merger investigations, RICO litigation and commercial disputes. He represents clients before the U.S. Department of Justice and the Federal Trade Commission in connection with merger and non-merger investigations.

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

Eric L. Yaffe, a managing officer with Gray Plant Mooty, co-chairs their Business and General Litigation Practice Group and practices white-collar, franchise and distribution law.

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