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University of Florida
Levin College of Law

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Tuesday, December 1, 2009

5th Annual In-House Counsel Forum on Pharmaceutical Antitrust: Understanding Antitrust Priorities Under a New Enforcement Regime

Posted by D. Daniel Sokol

5th Annual In-House Counsel Forum on Pharmaceutical Antitrust
Understanding Antitrust Priorities Under a New Enforcement Regime

Wednesday, February 17 to Thursday, February 18, 2010

For registration and other information click here.

DAY ONE | Wednesday, February 17, 2010

8:00 Registration and Continental Breakfast

8:45 Co-Chairs’ Opening Remarks – Identifying the Players

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

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

9:15 Keynote Address: Focus on Pharmaceutical Antitrust Enforcement Priorities

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

10:00 Morning Refreshment Break

10:15 Perspectives from the Inside and Out: An Overview of FTC Enforcement Activity Affecting the Pharmaceutical Industry

Markus H. Meier
Assistant Director, Health Care Division, Bureau of Competition
Federal Trade Commission (Washington, DC)

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

With new leadership at the helm at both the FTC and DOJ Antitrust Division, it is clear that a closer alignment is being forged between the two agencies. The DOJ has assumed a new position on enforcement under Section 2 of the Sherman Act, while continued activity by the FTC leaves many in the industry trying to determine how actions taken by the two agencies will impact the pharmaceutical industry as a whole.

During this session, hear directly from both the current and former Assistant Director of the FTC’s Health Care Division as they provide you with an overview of what the Division’s pharmaceutical antitrust enforcement priorities are. Providing you with specific insights into what you can expect in the near future by way of FTC enforcement in this area, topics of discussion will include:

  • How has the Commission has adjusted its enforcement prerogatives or modified its competitive analysis of pharmaceutical sector conduct due to changes in the economy or political leadership over the past year?
  • Patent settlement agreements have been an FTC priority for about a decade. What has staff learned over that time? Has experience affected how staff investigates settlement agreements? Has private antitrust counseling had to change over this period?
  • You filed your settlement agreement with the Agencies; what happens next?
    • Insights into FTC processes: When is the settlement reviewed? How long does the review take? What is staff looking to find? Will staff want more information? If so, what do they want to know?
    • Perspectives on effective counseling strategies before and after you file your settlement. Should counsel initiate discussion with staff or “lay low” unless/until staff calls?

11:15 Assessing the Impact of the EC Pharmaceutical Sector Inquiry on Global Antitrust Enforcement in the EU and Emerging Markets

“It is important to note that a sector inquiry ‘bears fruit’ over a number of years … So please look out for further news in the coming months.”
– Neelie Kroes
Commissioner for Competition
European Commission, September 2009

Spotlight Address: (11:15-11:45)

Harald Mische
European Commission, DG Competition, Directorate F
Pharmaceuticals Task Force (Brussels, Belgium)

Panel: (11:45-12:30)

Marleen Van Kerckhove
Head, European Competition Practice & Brussels Office
Arnold & Porter LLP (Brussels, Belgium)

Brian Healy
Senior Advisor
European Federation of Pharmaceutical Industries and Associations (Brussels, Belgium)
Former Vice President, Economic and Industrial Policy
Global Human Health, Merck & Co.

Frances Murphy
Partner
Jones Day (London, UK)

Never before has the interface between IP and antitrust laws across the globe become more pronounced. On July 8, 2009, Directorate General of Competition for the European Commission issued its final report on the Pharmaceutical Sector Inquiry, confirming its preliminary findings that “market entry of generic drugs is [being] delayed.” Already taking action on its promise to pursue investigations into industry practices that are curtailing innovation and generic product entry, many within the pharmaceutical industry are wondering how the EC’s findings and current investigation will impact global pharmaceutical operations.

During this session, hear directly from the European Commission’s Harald Mische and experienced foreign counsel, knowledgeable in current pharmaceutical enforcement initiatives in the E.U., as they provide insights into how to minimize your antitrust exposure both in the U.S. and abroad.

12:30 Luncheon and Keynote Address

David P. Wales
Partner
Jones Day (Washington, DC)
Former Acting Director & Deputy Director of the Bureau of Competition, FTC

Hosted By:

Jones Day

1:45 Update on FTC Policies and Congressional Action Impacting on Pharmaceutical Antitrust Enforcement: Reverse Settlement Payments, Follow-On Biologics, Authorized Generics and Healthcare Reform

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

Seth Bloom
General Counsel
Senate Antitrust Subcommittee (Washington, DC)

Moderator:

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

At press time, the status of several key bills affecting the pharmaceutical industry is still unknown. The outcome of these and other pending legislative matters could cause shockwaves throughout the pharmaceutical industry. The speakers will provide strategic guidance on how to prepare for potential changes in the status of the law concerning:

  • Reverse settlement payments – Protecting Consumer Access to Generic Drugs Act of 2009 (H.R. 1706), Preserve Access to Affordable Generics Act (S. 369) which would restrict brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market
  • Follow-on biologics – Promoting Innovation and Access to Life-Savings Medicine Act of 2009 (H.R. 1427; S. 729) which would create a regulatory pathway for the approval of biologic products as well as outline what the applicable period of market exclusivity will be for biologic products
    • considering the impact of various market exclusivity periods on competition within the market (5/7/14 years exclusivity)
    • will biologic products qualify for use under state substitution laws?
    • potential impacts on pricing?
  • Authorized Generics – A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs (H.R. 573; S. 501)

2:45 Avoiding the Appearance of “Predatory Pricing” by Carefully Crafting Pricing and Distribution Strategies That Are In Line with Robinson-Patman

Robert P. Reznick
Co-Chair, Pharmaceuticals and Healthcare Industry Practice Group
Chair, Antitrust Practice Group, Washington, DC Office
(Washington, DC)

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

Moderator:

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

  • Addressing key pricing issues such as presence of market power and potential market foreclosure when evaluating the risks of implementing such strategies
  • Dealing with wholesalers and other customers in order to determine what your company’s “channels of trade” are
  • Tackling resale maintenance, minimum advertised and average wholesale price, particularly when a company has several classes of trade
  • Structuring pricing for combination products
  • Verifying competitive pricing in association and payment systems
  • Counseling your client on the antitrust factors involved in discount and rebate programs for drug product bundles
  • Exploring antitrust concerns associated with exclusive dealing, tying and bundling
  • Assessing the impact of the Alabama Supreme Court’s recent AWP decision addressing state fraud claims relating to pricing

3:45 Afternoon Coffee Break

4:00 View from the Bench: Judicial Perspectives on Pharmaceutical Antitrust Litigation

The Honorable Gerald Bard Tjoflat
Circuit Court Judge
U.S. Court of Appeals for the Eleventh Circuit (Atlanta, GA)

Paul D. Clement
Head, National Appellate Practice Group
King & Spalding (Washington, DC)
Former Solicitor General of the United States

During this session, Judge Tjoflat and Paul Clement will provide their thoughts and commentary on the key pharmaceutical cases involving reverse settlement payment agreements. This session will be concluded with a brief Q & A session during which time Mr. Clement and Judge Tjoflat will accept questions from the audience.

5:00 Conference Adjourns to Day Two

DAY TWO | Thursday, February 18, 2010

8:00 Continental Breakfast

8:30 Co-Chairs’ Remarks

8:45 Keynote Address: Focus on Reverse Settlements Payment Agreements, Authorized Generics and Pharmaceutical Mergers

The Honorable J. Thomas Rosch
Commissioner
Federal Trade Commission (Washington, DC)

9:30 Morning Refreshment Break

9:45 Life Cycle Management: Perspectives from State Attorneys General on Current Enforcement and Strategies for Expanding Product Life While Also Minimizing Exposure to Antitrust Scrutiny

Recent high-profile mergers within the pharmaceutical industry have cast a new light on how the industry is tackling the inherent challenges presented by the expiration of key blockbuster patents in coming years. In this increasingly competitive market, companies both large and small are beginning to take strategic steps towards maintaining (and even expanding) their current position within a given treatment area.

During this session, gain firsthand insights into how state Attorneys General have been prosecuting cases arising out of life cycle management issues, as well as insights into the use of product migration tactics, authorized generics, and citizens petitions.

Spotlight Address: (9:45-10:15)

TriCor – A Case Study

Elizabeth G. Arthur (Invited)
Assistant Attorney General, Antitrust Division
Office of the Attorney General of the State of Florida (Tallahassee, FL)

Panel: (10:15-11:00)

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

Michael S. McFalls
Partner
Jones Day (Washington, DC)

Moderator:

Elinor R. Hoffman (Invited)
Assistant Attorney General, Antitrust Bureau,
Office of the Attorney General of the State of New York
(New York, NY)

Product Migration

  • Conducting an antitrust analysis of various product migration strategies to extend product life
    • line extensions
    • special issues surrounding “me-too” products
    • revisiting dosage form
  • Understanding what litigation risks are presented by various product migration strategies – and what you can do to minimize your exposure to them

Authorized Generics

  • FTC Interim Report on “Authorized Generic” Drugs – understanding the implications of the report’s findings on drug competition between brand name and generic manufacturers
    • balancing competing interests – weighing the benefit of allowing authorized generics prior to the expiration of the brand name patent vs. the incentives of first ANDA filers to pursue generic entry prior to patent expiration
    • addressing the FTC’s current position on brand-generic agreements which delay the introduction of both authorized generics and independent generics

Citizens Petitions & Other Forms of Regulatory Practice

  • Antitrust analysis regarding citizen petitions
  • Determining when petitioning conduct is/is not immune from attack under Noerr-Pennington
  • Lessons from recent private actions challenging citizen petitions as sham

11:00 Minimizing Exposure to Liability by Preemptively Analyzing the Antitrust Implications of Engaging in Collaborative Activities

Thomas O. Barnett
Co-Chair, Antitrust & Consumer Law Practice Group
Covington & Burling LLP (Washington, DC)
Former Assistant Attorney General, Antitrust Division, USDOJ

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

In-licensing and co-development

  • Understanding what types of restrictions/limitations can be imposed on a licensee without triggering antitrust scrutiny
  • Anticipating issues that may arise with potential competition and innovation during the diligence review process
    • considering how Quanta and developing case law on patent exhaustion will impact antitrust analyses conducted during pharmaceutical transactions
  • Handling exclusive in-licenses
  • Screening and distributing antitrust-sensitive royalty payments
  • Drafting non-compete provisions that will withstand government scrutiny
  • Strategies for fulfilling government notification requirements (Hart-Scott-Rodino)
  • Handling unique issues that arise in the context of joint ventures – calculating product assessments that both parties will agree with

Co-promotion and co-marketing

  • Ensuring the arrangement avoids credible charges of market division or price fixing
  • Drafting exclusivity and non-compete provisions that will withstand government scrutiny

12:00 Networking Lunch

1:15 Forward Thinking: Preparing for New and Emerging Trends in Government and Private Litigation Arising Out of Pharmaceutical Antitrust and Patent Infringement Litigation

Plaintiff’s Perspective:

Linda P. Nussbaum
Partner, Kaplan Fox & Kilsheimer LLP
(New York, NY)

Defense Perspective:

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

Jonathan Wasserman
Vice President & Senior Counsel
Litigation & Government Investigations
Bristol-Meyers Squibb (Plainsboro, NJ)

  • Identifying and evaluating the similarities and differences in theories put forth during patent infringement litigation that may open the door to an antitrust counterclaim
  • Harnessing information related to government investigations and infringement litigation in a manner that can be used if later private litigation ensues
  • Defending against allegations of “sham” litigation based on Noerr-Pennington challenges and Walker Process claims
  • Overview of state attorneys general offices that have been active in bringing parens patriae actions to pursue violations of the Sherman Act
  • The latest developments in antitrust class actions
    • handling them in court and in the court of public opinion
    • staying ahead of the curve with regard to class actions on the horizon
    • what you must know about participating as a named plaintiff
    • handling the claims process as a class member
    • recent caselaw developments in pharmaceutical antitrust litigation
      • the evolution of pleading standards for class actions in the antitrust context – In re Hydrogen Peroxide Antitrust Litigation, Iqbal, Twombly

2:15 Afternoon Coffee Break

2:30 Pharmaceutical Mergers and Acquisitions: Lessons Learned from Recent High-Profile Activity and Best Practices Going Forward

“Even in “down markets,” the Commission must hold the line against industry consolidation that may threaten competitive markets far into the future.”
– John Leibowitz
Chairman, Federal Trade Commission, March 2009

Despite a turbulent financial climate, this year has seen the return of high-profile mergers within the pharmaceutical industry, providing insight into whether the FTC’s approach to evaluating mergers has changed under the new administration, and if so, what the new approach may be. Additionally, with the FTC’s recent challenge to an already consummated merger that fell below the Hart-Scott-Rodino threshold, new issues are being exposed that may cause companies to re-examine their merger to assess the risk of later challenges by the FTC or DOJ.

During this session, learn how the FTC evaluates pharmaceutical mergers and gain specific insights into what the evolving issues are in the area of M&A enforcement activity.

Spotlight Address: (2:30-3:00)

Michael R. Moiseyev
Assistant Directors, Mergers I, Bureau of Competition
Federal Trade Commission (Washington, DC)

Panel: (3:00-4:00)

Aryeh Friedman
Chief Counsel, Antitrust
Wyeth (Collegeville, PA)

Marc Brotman
Assistant General Counsel
Pfizer Inc (New York, NY)

  • Understanding how the Hart-Scott-Rodino process is applied to pharmaceutical mergers
  • Incorporating a comprehensive due diligence analysis into your assessment of the deal to uncover potential antitrust issues
  • Recognizing how changes within the pharmaceutical development pipeline have impacted companies’ motivations for pursuing mergers
    • expansion within a particular treatment vs. expansion based on general innovation
  • Determining what substantive analysis is being applied to evaluate pharmaceutical mergers (both horizontal and vertical), as well as analysis of potential competition between and among industries
    • brand-brand
    • brand-generic
    • generic-generic
    • with biotechnology companies
    • divestiture of product lines
    • being aware of various red flags that may trigger downstream FTC/DOJ interest in your deal although premerger notification was not required under Hart-Scott-Rodino
  • Knowing the FTC’s approach to remedies –
    • relationship to substantive violation
    • procedural pitfalls

4:00 Pharmaceutical Patent Settlements: Staying Abreast of the Evolving Status of the Law on Reverse Settlement Payment Agreements

“No matter what you call them, eliminating these deals is one of the Federal Trade Commission’s highest priorities.”
– Jon Leibowitz
Chairman, Federal Trade Commission, June 23, 2009

Government Panel: (4:00 – 4:40)

Analysis of the USDOJ’s Position in In re Cipro

Philip Weiser
Deputy Assistant Attorney General, Antitrust Division
U.S. Department of Justice (Washington, DC)

Current FTC View on Pay-for-Delay Settlements

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

Industry Panel: (4:40 – 5:30)

Structuring Settlement Agreements that Won’t Raise Antitrust Concerns

Lauren Freeman-Bosworth
Legal Director, Schering-Plough Corporation
(Kenilworth, NJ)

Donald L. Flexner
Managing Partner, Boies, Schiller & Flexner LLP
(New York, NY)

Over the past few years,” reverse settlement” or “pay-for-delay” agreements have become an increasingly contentious point of debate within the pharmaceutical industry. The FTC, and now the DOJ, both hold the position that these agreements are anti-competitive, while the Courts have taken varying approaches to this issue. Additionally, although the FTC has been steadfastly pursuing litigation that would bring a final resolution to this issue, the U.S. Supreme Court, for the third time, in In re Ciprofloxacin Hydrochloride Antitrust Litigation, declined to grant certiorari on yet another case where the legality of reverse settlement payments was at issue. Adding another layer of complexity to this issue, is legislation pending in Congress which would prohibit reverse settlement payments all together. With the law on this issue in such a state of flux, companies must tread carefully when considering the options for structuring settlements as part of Hatch-Waxman litigation.

During this session, learn how to structure settlement agreements that will pass antitrust scrutiny, as well as what steps you can take now to prepare for changes in the law that may take place over the next year.

Topics of discussion will include:

  • Identifying what factors to consider when crafting a Hatch-Waxman settlement
    • will a limited term or delayed license be granted?
    • understanding the impact of the following on settlement –
      • 180-day exclusivity for later infringers
      • forfeiture provisions under the MMA
    • considering the amount of the payment/consideration being given to the generic company
  • Complying with the MMA filing requirements
    • understanding how “side deals” with patent settlements are being reviewed by the FTC
    • how to apply the varying standards among the circuits to your proposed settlement agreement
    • considering the impact a change in position by the 2nd Circuit could have on the Supreme Court’s willingness to accept a case

5:30 Conference Concludes

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