Day One, Tuesday May 10, 2011

8:15 Registration and Continental Breakfast

9:00 Co-Chairs’ Opening Remarks

Stephen C. Cipolla
Counsel
Merck & Co., Inc. (North Wales, PA)

Jonathan Wasserman
Vice President & Associate General
Bristol-Myers Squibb (Plainsboro, NJ)

9:15 Keynote Address: FTC Priorities in Pharmaceutical Antitrust Enforcement

Richard A. Feinstein
Director, Bureau of Competition
Federal Trade Commission (Washington, D.C.)

10:00 Morning Refreshment Break

10:15 Demystifying the Processes and Authority of the FTC

Tara Isa Koslov
Deputy Director, Office of Policy Planning
Federal Trade Commission (Washington, D.C.)

Seth Silber
Partner
Wilson Sonsini Goodrich & Rosati (Washington, DC)

Recently, the authority and processes of the FTC have come under question. In this unique session, current and former FTC officials will share their inside knowledge and illuminate the way that the Commission operates, with special focus on the weapons that are at the agency’s disposal and how this power is exercised.

  • Understanding the current use of discovery devices by the FTC
    • potential scope of discovery requests
    • how the FTC can make use of its subpoena power
  • Analyzing recent debate over the extent of the FTC’s authority
    • judicial examination of the agency’s powers
  • Incorporating knowledge of FTC processes to work more effectively with the Commission
    • maintaining a working relationship while negotiating or discussing a case
    • setting an internal strategy that reflects current government policy direction and case selection criteria
    • recognizing the priorities and resources of the FTC investigative staff
    • weighing how to respond to requests
    • tactics for seeking closure of the matter without further FTC action

MERGERS AND ACQUISITIONS

11:15 The Changing Landscape of M&A Post Pfizer- Wyeth: What Can We Gleam From the Revised Merger Guidelines?


Michael Moiseyev
Assistant Director, Mergers 1, Bureau of Competition
Federal Trade Commission (Washington, DC)

Aryeh Friedman
Vice President and Assistant General Counsel
Pfizer Inc (Collegeville, PA)

Kenneth L. Glazer
Partner
K&L Gates (Washington, DC)
Former Deputy Director, Bureau of Competition, FTC

Michael S. McFalls
Partner
Ropes & Gray LLP (Washington, DC)

  • Analyzing the changing landscape featuring fewer and larger pharmaceutical companies
    • impact of the current financial picture on deal activity and structuring
    • how antitrust considerations may change in response
  • Dissecting how the revised DOJ and FTC Horizontal Merger Guidelines change the prior approach to analyzing mergers between competitors
    • putting the guidelines in the proper context of recent
  • agency practices
    • movement away from a precise, step-by-step framework for analyzing horizontal mergers measuring market concentration
    • understanding the new analytical approach as set out in the Guidelines
  • Discerning the implications for analyzing potential M&A transactions
    • anticipating whether there will be greater scrutiny of transactions in the pharmaceutical industry
  • Weighing whether an uptick in merger activity will impact on enforcement activities
    • potential rise in use of disgorgement proceedings
  • Examining enforcement focus on recent vertical merger activity
  • Evaluating required divestitures

 

12:15 Networking Luncheon for Speakers and Delegates

Luncheon Address:

Lars Kjølbye
Partner
Covington & Burling LLP (Brussels, Belgium)
Former head of unit for antitrust in the energy and environment sectors in DG Competition

Hosted By:

1:30 Product Acquisitions: Analyzing Market Definition, Power and Pricing

Melissa S. Barnes
Assistant General Counsel
Eli Lilly and Company (Indianapolis, IN)

Robert F. Leibenluft
Partner
HoganLovells LLP (Washington, DC)

  • FTC v. Lundbeck (Ovation): analyzing the considerations that were applied by the court to determine market definition in product acquisitions:
    • cross-elasticity and substitutability of drugs
    • industry or public recognition of the submarket as a separate economic entity
    • product characteristics and uses
    • manufacturing and production
    • defining the consumer
    • distinct prices
    • consumer sensitivity to price changes
    • specialized vendors
  • Understanding why the Court held what it did
    • dissecting the conclusions relating to market power and pricing
    • why some observers found the decision surprising
  • Assessing how courts hearing future challenges will consider market definition

Reverse Settlement Payment Agreements

2:15 Structuring Reverse Settlement Payment Agreements that Align with Current FTC Concerns

Michael B. Kades
Attorney Advisor to Chairman Jon Leibowitz
Federal Trade Commission (Washington, D.C.)

Jeffrey W. Brennan
Partner
Dechert LLP (Washington, DC)

Christopher Stomberg, PhD
Partner
Bates White (Washington, DC)

  • Current guidance on how to structure agreements that will pass antitrust scrutiny
    • identifying what factors you need to consider
    • considering whether a limited term or delayed license will be granted
    • amount of the payment/consideration to the generic company
    • complying with filing requirements
    • anticipating how “side deals” may be reviewed
    • incorporating understanding of recent standards applied in the judicial circuits

3:15 Afternoon Refreshment Break

3:30 Staying Abreast of the Evolving Judicial, Regulatory and Legislative Landscape for Reverse Settlement Payment Agreements

Christine White
Staff Attorney
Federal Trade Commission (New York, NY)

William F. Cavanaugh, Jr.
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)
Former Deputy Assistant Attorney General for Civil
Enforcement, Antitrust Division, Department of Justice

Mark S. Popofsky
Partner
Ropes & Gray LLP (Washington, DC)

In September 2010, the 2nd U.S. Circuit Court of Appeals denied a petition for a rehearing en banc of the case Arkansas Carpenters Health and Welfare Fund v. Bayer AG (Cipro). In a dissent, Judge Pooler stated her “vigorous criticism” of the precedent established by In re Tamoxifen Citrate Antitrust Litigation, calling the decision “incorrect” and said a rehearing was supported by “a majority of the States Attorneys General, the Federal Trade Commission, the American Medical Association, and an impressive array of consumer groups and academic commentators.” In February, the Northern District of Georgia in Androgel dismissed the FTC’s claims against Solvay, Watson and Parr Pharmaceuticals. This session will provide a platform to continue the debate as well as delving into important potential legislative developments on the horizon.

  • Translating and measuring the potential impact on the industry of specific components of the Preserve Access to Affordable Generics Act
    • enforcement authority given to the FTC under the proposed legislation
    • new settlement notification requirements
    • which settlements will be viewed as presumptively anticompetitive
    • burdens placed on settling parties to justify settlement
    • penalties under the Act and potential impact on marketing exclusivity periods
  • Anticipating how the industry will respond if the Act becomes law
    • impact on patent strategies and ANDA challenges
    • vague provisions in the Act that could be tested in litigation
  • Assessing whether by engaging in new internal rule-making the FTC may be able to strengthen its position on settlements
  • Analyzing the significance of recent decisions in the circuit courts
    • U.S. Court of Appeals for the Second Circuit’s denial of rehearing in Arkansas Carpenters Health and Welfare Fund v. Bayer AG (Cipro)
    • Androgel ruling in the 11th Circuit
  • Considering whether the antitrust analysis would be different were the settlement to follow after a product launch
  • Examining requests for stays of litigation by generics
    • brand company responses to this tactic
    • practical considerations to delay of litigation and anticipating when the court will agree to the stay
  • Anticipating potential Supreme Court review of:
    • Cipro
    • In re Tamoxifen Citrate Antitrust Litigation

 

4:30 Updating Life Cycle Strategies to Reflect Current Concerns Relating to Follow-On Biologics, REMS, and other Emerging Areas of Antitrust Focus

Bruce A. Pokras
Senior Corporate Counsel
Pfizer Inc. (Madison, NJ)

Suzanne Munck
Counsel for Intellectual Property
Federal Trade Commission (Washington, DC)

Moderator:
Deborah A. Garza
Partner
Covington & Burling LLP (Washington, DC)
Former Acting Assistant Attorney General in Charge of the Antitrust Division, U.S. Department of Justice, Former Deputy Assistant Attorney General for Regulatory Affairs

  • Looking at developing areas of FTC enforcement of “unreasonable restraints of trade” beyond the scope of traditional antitrust laws
  • Analyzing the impact of the 12 year market exclusivity period for follow-on biologics products on antitrust enforcement
    • predicting what the future litigation will look like and its impact on antitrust law
    • assessing how markets will be defined
    • anticipating how follow-on biologic cases will be treated in the courts by examining recent Hatch-Waxman holdings that may be a guide
    • comparison to treatment of Hatch-Waxman antitrust concerns
  • Addressing the impact of antitrust concerns on biologic pricing
  • Understanding the debate over patent protection for REMS and the potential for new antitrust issues
  • Evaluating whether complex and costly REMS strategies create a barrier to entry and minimize potential cost savings to consumers
  • Evaluating recent examples of product migration and understanding the litigation risks and impact on the patenting process
    • knowing what may trigger charges of patent hopping and applying takeaways from the Tricor investigation
  • Analyzing antitrust strategies and controversies concerning
  • Orange Book listing and de-listings
  • Discerning what tactics companies have pursued to avoid the forfeiture risks under the MMA
  • Anticipating where we are heading on authorized generic drugs
    • setting strategies while awaiting the FTC Final Report, and estimating what the implications of the final version will be on competition between brand and generic manufacturers

 

5:30 Conference Adjourns to Day 2