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
Commissioner
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
Former Advisor to Brazilian Competition Tribunal (CADE)

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

Kristina Nordlander
Partner
Sidley Austin LLP (Brussels, Belgium)

Moderator:

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

John Roberti
Partner
Mayer Brown LLP (Washington, DC)

Moderator:

Jonathan Wasserman
Vice President & Associate General Counsel
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

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

James Dean
Partner
Covington & Burling LLP (Washington, DC)

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
Partner
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
Partner
Willkie Farr & Gallagher LLP (New York, New York)

Michael Keeley
Partner
Axinn Veltrop Harkrider LLP (New York, NY)

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