Emerging Antitrust Issues: Exploring Reverse Payment Settlements in 2016
Under the Supreme Court’s landmark FTC v. Actavis decision, patent litigation settlements involving a “large and unexplained” reverse payment from a brand pharmaceutical company to a potential generic challenger “may sometimes violate the antitrust laws.” Recently, both the Third Circuit and the California Supreme Court have ruled that patent settlements involving non-cash payments -- including, the case of the Third Circuit decision, so-called “no-AG commitments” -- may be subject to antitrust review under the Actavis framework. This issue is also pending before the First Circuit Court of Appeals. Meanwhile, reverse payment litigation continues throughout the country, and litigants are grappling with numerous other aspects of the Actavis framework.
Our panel of key thought leaders and practitioners will offer views on the issues surrounding Actavis and the law governing reverse payment settlements, as well as updates on the many ongoing reverse payment litigations.
Key topics include:
- Significant Litigations
- King Drug
- In re: Cipro Cases I & II
- In re Nexium
- In re Loestrin
- Theories of Competitive Harm from Reverse Payment Settlements
- No-AG clauses
- The role of patent validity
Joseph R. Saveri, Founding Partner
Joseph Saveri Law Firm, Inc
- Introductory comments
- A brief idea of what was happening in the decade before Actavis
- Cipro Case going to trial in California
Anna M. Fabish, Counsel
O'Melveny & Myers LLP
- What is the anticompetitive harm in a reverse payment settlement case, and when does it occur? Is it the actual alleged delay, resulting alleged overcharges during the period of delay? Or is it something more like the elimination of potential competition, payments designed to induce delay - a harm complete whether or not, in the but-for world, a generic could have and would have come to market sooner (alaAggrenox)? Another rubric this topic could be placed under is causation. See discussion in Wellbutrin MSJ decision, discussing private plaintiff’s burden of proving causation in these cases.
- Class certification issues in reverse payment cases (many issues here, some recent decisions to fuel discussion)
- Determining large and unexplained payment - exchange of value and inducement type approaches versus excess value or threshold approaches. This is a bit of a repeat from the last webinar, but remains a core issue, and there are new decisions and pending appeals that deal with it (e.g., Loestrin appeal issues; Actos).
- FTC enforcement issues - disgorgement, recent settlements and what their terms say about the future of enforcement
Kevin D. McDonald, Partner
- Pay Without Delay: Does the Nexium defense verdict disprove the FTC's theory of competitive harm in Actavis?
- Reverse Payments as a Thought Crime: What is the difference between Actavis and California's Cipro decision, and does it matter?
- Protecting Unlawful Competition: Can a private plaintiff really prove antitrust injury without resolving the question of infringement?
- ANDA Settlements and Dangerous Drugs: How does a REMS program provision affect the Actavis rule of reason? (REMS means Risk Evaluation and Mitigation Strategies)
Matthew B. Wright, Corporate Vice President and Principal
- What does it mean to “eliminate the risk of competition?” What is an appropriate standard for determining the competitive effect of patent settlements?
- What is a “large and unjustified” reverse payment? Are avoided litigation costs alone a proper standard?
- Economic variables affecting the potential magnitude of “reasonable” reverse payments (Brand’s risk aversion, asymmetric expectations of litigation outcomes, etc.)
- Evaluating patent settlements in their entirety—how to credit potential “out-of-market” benefits of settlements, avoided litigation costs including elimination of litigation risk, etc.
Who Should Attend:
- Bio/Pharma and Related Attorneys & In-House Counsel
- IP Attorneys and Related Consultants
- Antitrust Lawyers
- General Counsel
- Senior Management
- Senior Executives
- Professionals from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries
- Other Related/Interested Professionals and Organizations
Kevin D. McDonald is a partner in Jones Day's Washington D.C. office who specializes in antitrust litigation. Mr. McDonald has tried cases and argued appeals at all levels of federal and state courts. His cases for clients in the healthcare and pharmaceutical industry have established precedents in the application of antitrust law to intellectual property. In 2005, he was chosen by the ABA to author two amicus briefs in the Supreme Court, successfully urging the rejection of a presumption that the seller of a patented product has market power. He currently is defending several clients in nationwide antitrust class actions involving claims based on settlements of ANDA patent litigation (containing "reverse payments"), on allegedly anticompetitive product innovation ("product hopping"), on refusals to sell products to rivals due to safety restrictions (so-called "REMS abuse"), on allegedly "sham" Citizen Petitions before the FDA, and on much else.
Mr. McDonald frequently writes and lectures on antitrust law. He is a member of the ABA Antitrust Section’s senior leadership, and currently serves as Editor-in-Chief of the Antitrust Law Journal. His article “Antitrust and Baseball: Stealing Holmes” was runner-up for the Hughes Gosset Award of 1998, and his article commenting on the Supreme Court's Actavis decision ("Because I Said So: On the Competitive Rationale of FTC v. Actavis") appeared in the Fall 2013 Issue of Antitrust Magazine.
Kevin D. McDonald is a partner in Jones Day's Washington D.C. office who specializes in antitrust litigation. Mr. McDonald has …
Anna M. Fabish is a counsel in O’Melveny’s Los Angeles office and a member of the Antitrust and Competition Practice within the Litigation Department. Her practice focuses on complex antitrust litigation in both the civil and criminal areas. She has worked on numerous internal investigations and represented international clients in Europe and Asia. Anna has represented clients in the airline, aeronautics, computer, and pharmaceutical industries. Anna frequently works closely with economic experts to craft arguments and strategies that best represent her client’s interests.
Anna M. Fabish is a counsel in O’Melveny’s Los Angeles office and a member of the Antitrust and Competition Practice …
Matt Wright is a Corporate Vice President and Principal in the Washington, DC office of Economists Incorporated. Dr. Wright’s work as a consultant has included analysis of mergers, Hatch-Waxman matters, vertical restraints, price-fixing claims, monopolization, damages, price discrimination, and intellectual property matters. Dr. Wright has also provided economic testimony on antitrust liability, damages, Robinson-Patman, and intellectual property matters. Dr. Wright is a co-author of “Activating Actavis: A More Complete Story,” which addressed certain economic issues related to the Supreme Court’s Actavis decision.
As a consultant, Dr. Wright has represented clients before the U.S. Department of Justice, the Federal Trade Commission, and the European Commission. Prior to joining Economists Incorporated, Dr. Wright served for seven years as an economist with the U.S. Department of Justice’s Antitrust Division.
Matt Wright is a Corporate Vice President and Principal in the Washington, DC office of Economists Incorporated. Dr. Wright’s work …
Joe founded the Joseph Saveri Law Firm in 2012. He possesses over 25 years of experience in antitrust and other complex civil and class action litigation as well as knowledge of a broad range of industries including banking and financial services, hardware, software, consumer electronics, labor, manufacturing inputs, agricultural products, and pharmaceuticals. Joe assists entrepreneurs, corporate executives, public officials, business owners, and their counsel who were harmed by anti-competitive conduct to determine whether and how to pursue litigation to achieve their goals.
Since its founding, the Joseph Saveri Law Firm has established a track record of success. To date, the firm has obtained successful resolutions for its clients in excess of $700 million. The firm has served as Lead Counsel in the In re Capacitor Antitrust Litigation, In re Titanium Dioxide Antitrust Litigation, California Cipro Cases and In re High Tech Employee Antitrust Litigation.
Joe founded the Joseph Saveri Law Firm in 2012. He possesses over 25 years of experience in antitrust and other complex …
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About Jones Day
Jones Day is one of the largest, most decorated, and most geographically diverse private law firms in the world. Operating as a single firm worldwide, with over 2500 lawyers in more than 40 of the world's commercial and financial centers, Jones Day serves its clients across all industries and legal disciplines. Jones Day's clients include approximately half of the Fortune Global 500, the Fortune 500 and the FT Global 500.
About O'Melveny & Myers LLP
With approximately 700 lawyers in 15 offices worldwide, O’Melveny & Myers LLP helps industry leaders across a broad array of sectors manage the complex challenges of succeeding in the global economy. We are a values-driven law firm, guided by the principles of excellence, leadership, and citizenship. Our commitment to these values is reflected in our dedication to improving access to justice through pro bono work and championing initiatives that increase the diversity of the legal profession. For more information, please visit www.omm.com.
About Economists Inc.
Founded in 1981, Economists Incorporated (www.ei.com) is a premier economic consulting firm in the fields of law and economics, public policy, and business strategy. EI offers expert consulting and testifying services in the context of litigation, proposed mergers and acquisitions, industry regulation, labor and employment, auction design, and business planning. Throughout its existence, EI has established a reputation for delivering consistently high-quality economic analysis while participating in high-profile antitrust, commercial litigation, and regulatory matters. EI has offices in Washington, D.C., San Francisco, and Tallahassee, FL.
About Joseph Saveri Law Firm, Inc
The Joseph Saveri Law Firm, Inc. specializes in antitrust law and complex civil and class action litigation in federal and state courts throughout the United States and in cases across the globe. Since its founding in 2012, the firm has quickly developed a track record of success in prosecuting cases on behalf of its clients and performing the highest quality legal work. Since that time, the Joseph Saveri Law Firm and its staff of experienced attorneys have been busy fighting anticompetitive business practices throughout the country, serving as lead and co-counsel in a variety of cases. The firm has generated over $700 million in settlements and successful resolutions for its clients.