Antitrust & Competition Policy Blog

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

Tuesday, March 8, 2011

6th American Conference Institute’s Pharmaceutical Antitrust Conference

Posted by D. Daniel Sokol

Day One, Tuesday May 10, 2011

8:15 Registration and Continental Breakfast

9:00 Co-Chairs’ Opening Remarks

Stephen C. Cipolla
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
Attorney Advisor to Commissioner Ramirez
Federal Trade Commission (Washington, D.C.)

Seth Silber
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



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)

Michael S. McFalls
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:

Deborah A. Garza
Covington & Burling LLP (Washington, DC)

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
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
Dechert LLP (Washington, DC)

Christopher Stomberg, PhD
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.
Patterson Belknap Webb & Tyler LLP (New York, NY)
Former Deputy Assistant Attorney General for Civil
Enforcement, Antitrust Division, Department of Justice

Mark S. Popofsky
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)

Pamela Jones Harbour
Fulbright & Jaworski L.L.P. (Washington, DC)
Former Commissioner, FTC

  • 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

Day Two, Wednesday May 11, 2011

8:15 Continental Breakfast

9:00 Co-Chairs’ Remarks

9:15 Day 2 Keynote Address:

The Honorable J. Thomas Rosch
Federal Trade Commission (Washington, D.C.)

10:00 Morning Refreshment Break

10:15 Adjusting Pharmaceutical Strategies to Reflect Increased Industry Focus by Global Regulatory Authorities

Satish Sule
European Commission, DG Competition
Pharmaceuticals Task Force (Brussels, Belgium)

José Antonio B. M. Ziebarth
Professor of Antitrust, Getulio Vargas Foundation
Advisor to Brazilian Competition Tribunal (CADE)

Lars Kjølbye
Covington & Burling LLP (Brussels, Belgium)

Kristina Nordlander
Sidley Austin LLP (Brussels, Belgium)


C. Scott Hemphill
Professor of Law
Columbia Law School (New York, NY)

  • Looking at interaction between agencies around the world
  • Assessing whether EU enforcers are influencing the US authorities
  • Examining the underlying regulatory background or enforcement in the EU
    • how generic entry works in Europe
    • issues relating to life cycle management
  • Understanding the European enforcers’ authority and enforcement focus
    • manner in which recent raids in the EU were conducted
  • Impact of recent antimonopoly laws in India and China
  • Analyzing which other regions/countries may present unique enforcement challenges
    • Korea
    • Brazil
  • Anticipating where we are heading globally as foreign antitrust agencies gain experience
  • Minimizing your potential international antitrust exposure


11:30 Why Sham Claims Need to be Taken Seriously: Meeting the Increased Risk of Private Antitrust Litigation

Christopher L. Gaenzle
Assistant General Counsel - Litigation
Pfizer Inc. (New York, NY)

Sean Gates
Morrison & Foerster LLP (Los Angeles, CA)
Former Deputy Assistant Director, Anticompetitive Practices
Division, Bureau of Competition, FTC

John Roberti
Mayer Brown LLP (Washington, DC)


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

  • Comparing and contrasting theories put forth during patent infringement litigation or a government investigation that may open the door to follow-on private litigation
  • Pinpointing what factors from recent cases opened the door to sham litigation claims
    • assessing the probability of litigation resulting from Noerr-Pennington and Walker Process claims
  • Proactively anticipating when you will be drawn into a private suit and incorporating projections for damages and costs into an upfront project plan
    • weighing your level of risk and understanding when courts are awarding treble damages
  • Implementing patent prosecution protocols to help undermine future plaintiff ’s claims
  • Setting strategies for seeking dismissal of the claim in a sham litigation suit
    • understanding the applicable standards of proof
  • Defending claims by utilizing information related to government investigations and infringement litigation
  • Anticipating how plaintiffs will use evidence and information from prior litigation to seek to prevail on their claims
  • Staying ahead of the curve with regard to class actions on the horizon
  • Analyzing recent case law developments and the evolution of pleading standards for class actions in the antitrust context
    • current plaintiff tactics for class certification
    • defense tactics for creative attacks on the class
    • limiting the class so it is not nationwide
  • Implementing class action settlement strategies that control the risk of future litigation
  • Impact of the recent U.S. Supreme Court ruling denying arbitration of class antitrust claims
  • Concerns when participating as a named plaintiff in class actions
  • Anticipating the impact of public relations and reputation on litigation

12:30 Networking Luncheon for Speakers and Delegates

1:45 Factoring Health Care Reform into Compliant and Pro-Competitive Pricing and Distribution Strategies

Michael Wroblewski
Deputy Director, Office of Policy Planning
Bureau of Competition
Federal Trade Commission (Washington, DC)

James Dean
Covington & Burling LLP (Washington, DC)

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

The passage of the Patient Protection and Affordable Care Act created heightened pricing and distribution risks for the
pharmaceutical industry. Coupled with existing challenges for overcoming risks of enforcement actions alleging predatory pricing and price manipulation, the industry is faced with new enforcement initiatives at the intersection of health care reform and antitrust law. This session will explore the strategies for traditional pricing and distribution challenges, as well as provide insight into solutions for withstanding intense scrutiny for PPACA compliance.

  • Avoiding antitrust scrutiny tied to exclusive dealings and product bundling with group purchasers
  • Understanding the changing dynamics of pricing structures for manufacturers and drug distributors stemming from the Patient Protection and Affordable Care Act (PPACA)
  • Proactively evaluating and implementing key strategies for pricing risks related to market power and potential market foreclosure including increased physician market concentration
  • Preparing for pending changes in PPACA related to Medicare and Medicaid reimbursement and the implications for increased fraud enforcement
  • Tackling resale maintenance, minimum advertised and average wholesale price
  • Counseling your client on the antitrust factors involved in discount and rebate programs for drug product bundles
  • Addressing antitrust risks of Accountable Care Organizations for hospital group purchasing and distribution
    • lessons learned from traditionally clinically integrated physician networks
    • structural variations impacting formularies
    • impact of physician-led integration on pricing


2:45 Afternoon Refreshment Break

3:00 Case Study: Structuring Collaborative Agreements to Proactively Minimize Potential Exposure to Antitrust Enforcement & Litigation

Mark J. Botti
Akin Gump Strauss Hauer & Feld LLP (Washington, DC)

David L. Meyer
Co-Chair of the Global Antitrust and Competition Law
Practice Group
Morrison & Foerster LLP (Washington, DC)
Former Principal Deputy Assistant Attorney General,
Antitrust Division, USDOJ

Complex collaborative agreements continue to attract the government’s antitrust scrutiny, and the industry’s increasing
use of co-promotions places companies at greater risk of enforcement. This session will examine a sample co-promotion agreement and delve into the use of advanced strategies for structuring agreements to minimize future antitrust exposure.

  • Considering different structuring options when negotiating an international co-promotion to preserve competition
  • Dissecting the deal sheet and understanding why the deal is structured in a certain way
  • Understanding how the deal will be scrutinized by antitrust authorities
  • Identifying the red flags: determining which aspects of a multi-faceted collaborative agreement are most likely to trigger an antitrust probe
    • ensuring the international aspects of the deal are factored into your strategies
  • Drafting terms that will overcome challenges of price fixing or market division
    • crafting exclusivity and non-compete provisions that will withstand scrutiny
    • making use of restrictions that can be imposed on a licensee without triggering antitrust scrutiny
  • Incorporating lessons from recent industry litigation into your collaboration strategy
    • recognizing what may serve as evidence in future antitrust litigation
  • Preparing for differing antitrust enforcement issues for majority and minority stakeholders in a joint venture


4:00 Examining the Potential Acquisition of a Generic Manufacturer

William H. Rooney
Willkie Farr & Gallagher LLP (New York, New York)

Michelle H. Seagull
Axinn Veltrop Harkrider LLP (Hartford, CT)

This session will provide practical direction for navigating the antitrust issues that may be raised when a company seeks to acquire a generic drug maker. We will examine how to anticipate what anticompetitive issues the FTC may raise relating to the deal, and apply relevant takeaways from the Teva/Barr merger. Points of discussion will include:

  • Examining how the FTC will analyze whether the combined companies could exercise unilateral market power
  • Making arguments for and against whether there is a likelihood that consumers will pay higher prices for certain drugs
  • Assessing whether there may be entry into the relevant markets that would counteract any anticompetitive impact of the acquisition
  • Likelihood of the use of FTC enforcement authority to require divestiture of rights to certain drugs
  • Negotiating a consent order with the FTC
  • Finding acceptable acquirers of assets that must be divested
  • Meeting requirements for assisting buyers with assets transfers and obtaining necessary FDA approvals


5:00 Conference Concludes

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