Pay-to-Delay Settlements in the Wake of ActavisCurrent, Former FTC Officials Offer Answers

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Held Oct. 15, 2013

On June 17,2013  the Supreme Court ruled that pay-to-delay settlements in Hatch-Waxman cases are subject to antitrust scrutiny.

It’s a green light for Federal Trade Commission enforcement. As many as 40 deals done in 2012 can be considered pay-to-delay, up from 28 the year before. Because there is no statute of limitations, the FTC has said it can make you investigate retroactively.

The FTC’s top enforcement officer and two stars of the Washington healthcare antitrust bar engage over the present — and future — of drug patent settlements.

Without ever leaving your office, you’ll have a ringside seat as the FTC’s Markus Meier discloses — and debates — FTC enforcement policy with: Seth Sibler, Partner, Wilson Sonsini Goodrich & Rosati PC (Conference Chair); and Jeff Brennan, Partner, McDermott Will & Emery LLP.

For years, the federal courts have wrestled with pay-to-delay deals. The FTC has argued they almost surely harm competition and therefore violate antitrust laws. Now the Supreme Court has ruled 5-3 in the FTC’s favor, creating a new playing field.

This virtual conference CD and transcript set brings you up-to-the-minute information, alerting you to FTC strategy and tactics and helping unravel legal tangles. You’ll discover answers to such key questions as:

  • How the Actavis ruling affects options for settling Hatch-Waxman lawsuits
  • How size of payment and size of market affects risk of antitrust litigation
  • Which “side deals” will face greatest scrutiny by the FTC
  • How likely are challenges to no-authorized-generic settlements in the wake of Actavis
  • How Actavis may affect settlements filed with the FTC prior to the ruling
  • How the FTC is investigating and enforcing pending pay-to-delay cases
  • What sort of relief the agency will seek for consumers
  • How the FTC monitors private litigation alleging pay-to-delay agreements
  • In which situations the FTC can be expected to file amicus briefs
  • What the FTC looks for in new settlements under the Medicare Modernization Act of 2003 (“MMA”) — anticompetitive concerns
  • And much more

You discover what the Actavis decision really says … What to do if you’re in the middle of structuring a patent deal right now … whether no-authorized-generic deals are on the table or out the window.
 
Most importantly, you discover what the FTC is thinking. Who will the agency target first? How much time will it spend on retroactive prosecutions? This virtual conference CD and transcript set gives you a rare chance to hear directly from the FTC’s lead authority on patent settlements. You can’t get better regulatory and business intel than this.

The FTC says many pay-to-delay cases have no statute of limitations — meaning the agency can investigate and prosecute cases long considered closed. If drug patents are your life’s blood, you owe it to yourself — and your team — to order now.

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Meet Your Faculty

  • Markus Meier is Assistant Director, Health Care Division, FTC Bureau of Competition, managing a staff of more than 30 lawyers and support staff. Mr. Meier leads investigations and litigation involving alleged violations of the antitrust law by pharma companies, hospitals, health plans, physicians and other healthcare professionals. Mr. Meier joined the FTC in 1990 following more than 20 years’ service as an officer in the U.S. Army.
  • Seth Silber (Chair) is a partner in the Washington office of Wilson Sonsini Goodrich & Rosati PC. His antitrust practice focuses on the pharma and healthcare markets, including pharmaceutical patent settlements, mergers and acquisitions, and anticompetitive conduct. He regularly represents clients before both the FTC and Justice Dept. Mr. Silber was an FTC lawyer from 2000-2006, working at all levels of antitrust and enforcement. During 2004-2006, he served as an advisor to Commissioner (now FTC Chair) Jon Leibowitz, advising on enforcement of anticompetitive conduct and merger cases affecting industries, including healthcare and medical devices.
  • Jeff Brennan is a partner in the Washington office of McDermott Will & Emery LLP, focusing on mergers, litigation, government investigations and counseling in healthcare. As Associate Director of the Bureau of Competition, Mr. Brennan directed FTC merger and non-merger investigations and enforcement across healthcare and other industries, with a focus on health care competition. Previously, he headed the FTC's Health Care Services and Products Division, responsible for managing antitrust investigations, litigation, and policy affecting drug and device manufacturers, hospitals, healthcare professionals and group purchasing organizations. He holds the FTC's Award for Distinguished Service, with special recognition for achievements in the healthcare sector and merger analysis.

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Agenda

10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference by Chairperson
Seth Sibler, Partner, Wilson Sonsini Goodrich & Rosati; Former advisor to FTC commissioner (now chairman) Jon Leibowitz

10:15 a.m. – 10:45 a.m.

What FTC v. Actavis Really Means for the Pharma Landscape
On June 17, the Supreme Court, in a 5-3 decision, ruled for the FTC in its long-running battle with industry over pay-to-delay patent settlements. But the FTC didn't get all it asked for. In this presentation, noted attorney Jeff Brennan will detail what the FTC v. Actavis majority decision said — and what it didn't say — and whether the dissenting opinion can provide valuable legal strategies going forward.

Attendees will learn:

  • What the five-judge majority focused on and what the determining factors were to their decision
  • In light of the decision, cases must now be decided in the lower courts; how will the lower courts rule on pending cases and what the first case decided might be
  • What you can glean from the dissenting opinion and the Court’s refusal to allow presumptive illegality

Jeff Brennan, Partner, McDermott Will & Emery LLP; Former Head of FTC’s Health Care Services and Products Division

10:45 a.m. – 11:15 a.m.

How to Structure Settlements to Minimize Risk of FTC Investigation and/or Private Plaintiff Suits
In Actavis the Supreme Court stopped short of declaring reverse-payment arrangements presumptively illegal, but subjected them to further scrutiny subject to a “rule of reason” analysis. The FTC has said it will challenge more cases going forward. If you’re currently involved in settlement talks or expect to be in the near future, what’s your strategy? This presentation will teach attendees how to assess the risk of deals ending up in litigation and what factors the FTC is focusing on regarding future prosecutions.

Attendees will learn:

  • What the Actavis decision means regarding options for settling Hatch-Waxman suits
  • The importance of size of payment and size of market to evaluating risk of antitrust litigation
  • Which “side deals” will face greatest scrutiny by the FTC
  • The likelihood of challenge to “no-authorized generic” settlements in the wake of Actavis

Seth Sibler, Partner, Wilson Sonsini Goodrich & Rosati; Former Advisor to FTC Commissioner (Now Chairman) Jon Leibowitz

11:15 a.m. – 11:30 a.m.

Break

11:30 a.m. – 12:00 p.m.

The Past is the Present – FTC Actions on Pay-to-Delay in the Post-Actavis World
The Federal Trade Commission has said that ending anticompetitive “pay- to-delay” agreements in the pharmaceutical industry is one of the agency’s top priorities. With the recent Actavis decision, the FTC can now investigate and prosecute deals that don’t measure up to the Supreme Court’s five-factor framework. In this presentation, the FTC’s point person for pharmaceutical and medical device antitrust issues, Markus Meier, will explain the FTC’s position regarding past, present and future deals.

Attendees will learn:

  • How the FTC is re-examining agreements previously filed with the commission to determine whether they merit further investigation in light of Actavis
  • How the FTC is pursuing pay-to-delay matters currently in litigation and seeking appropriate relief for consumers
  • How the FTC is monitoring private pay-to-delay litigations and leveraging its experience and expertise by filing amicus briefs where appropriate
  • How the FTC is examining new agreements that companies file with the commission pursuant to the Medicare Modernization Act of 2003 (“MMA”) to determine whether they merit investigation

Markus Meier, Assistant Director, Health Care Division, Bureau of Competition, FTC

12:00 p.m. – 12:30 p.m.

Questions and Answers and Closing Comments

  • CEOs/COOs
  • General Counsel
  • Outside Counsel
  • VP/ Directors of Regulatory Affairs
  • VP/Directors of IP
  • VP/Directors of Portfolio Management

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600