Reverse Payment Settlements: Hot Topics in 2017
“Pay-for-delay” settlements, also referred to as “reverse payments,” are settlements in which a generic manufacturer threatens to enter the market for a particular drug. In order to settle the dispute, the generic manufacturer agrees not to challenge the patent and to enter at a later date; in return, the patent holder agrees to pay (in cash or other compensation) the generic manufacturer. Such settlements have been subjects of debate and litigation because they can be seen as the brand manufacturer paying the a generic drug maker to stay off the market (and, thus, refrain from competing with the brand product) for a certain period of time.
In 2013, the U.S. Supreme Court ruled in Federal Trade Commission v. Actavis that such settlements may be challenged under antitrust laws on the ground that they may have an adverse effect on competition. Prior to the Supreme Court’s decision in FTC v. Actavis, there was a split in the circuits regarding the applicable standard, with the Second, Eleventh and D.C. Circuits applying a “scope of the patent” test and the Third Circuit applying a “quick look test.” In Actavis, the court rejected both of these approaches and found that a rule-of-reason test should be applied to determine if harm to consumers outweighs the benefits of the settlement.
According to an FTC study, pay-to-delay deals cost consumers and taxpayers $3.5 billion in higher drug prices every year. Thus, the FTC has been committed to blocking such settlements through enforcement actions and support of legislation to ban them. However, there is uncertainty whether that posture will continue in the Trump Administration, especially when the composition of the Supreme Court is also in play.
In this two-hour LIVE Webcast, a panel of key thought leaders and practitioners will discuss the viability of reverse-payment settlements under Actavis and its interpretations in the courts and in the FTC. They will also analyze how the legal landscape may change under the current administration.
Key topics include:
- Hatch-Waxman Act
- Evolution of Reverse-Payment Cases
- Anticompetitive Effect
- The Actavis Ruling
- Actavis Decision
- Rule of Reason
- Recent Litigation
- Viability of Pay-for-Delay
- Legal and Economic Predictions
Lisa J. Cameron, Principal
The Brattle Group, Inc.
- Market power—is the market the molecule or does it encompass branded and generic versions of other drugs?
- What does the size of the settlement payment tell us about the strength of the patent?
- The economics of non-cash payments including no AG clauses
Thane D. Scott, Partner
Morgan Lewis & Bockius LLP
- Simple deconstruction of the elements
- Where the law’s going and what’s expected over the next several years
Joseph R. Saveri, Founding Partner
Joseph Saveri Law Firm, Inc
- Measures of anti-competitive harm, proving it
Stephanie Demperio, Senior Consultant
NERA Economic Consulting
- Economic introduction
- Market definition piece
- Different scenarios anti competititive vs. pro-competitive
Who Should Attend:
- Antitrust Lawyers
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Litigators
- IP Attorneys & Related Consultants
- Pharmaceutical Industry Lawyers
- Biotech/Pharma/Healthcare Attorneys & Advisors
- Drug Manufacturing Company Executives
Thane D. Scott concentrates his practice on matters involving antitrust and trade regulation. Throughout the past 30 years, he has counseled industry leaders and litigated prominent cases that define modern antitrust law. He actively litigates in both state and federal courts and has served as lead or liaison counsel in numerous multidistrict, complex, and class action cases. In the United States, he is consistently ranked in the top tier of antitrust lawyers by Chambers USA, is listed in Best Lawyers, and is highlighted in Legal 500 and the Benchmark Litigation.
Thane D. Scott concentrates his practice on matters involving antitrust and trade regulation. Throughout the past 30 years, he has …
Dr. Lisa Cameron is an economist with two decades of experience consulting for attorneys and companies involved in commercial litigation, regulatory proceedings, and other complex matters. She has deep experience in intellectual property issues in the pharmaceutical industry, including analyses of commercial success, irreparable harm, and damages. She also has an extensive background in antitrust issues related to the pharmaceutical industry, including product hopping and reverse payment cases. On the product hopping front, Dr. Cameron led economic analyses in support of multiple experts in the Doryx matter, which the client won on summary judgment. In the area of reverse payment settlements, Dr. Cameron has conducted analyses of the economic implications of provisions commonly found in reverse payment settlements, including “no AG clauses” and “acceleration clauses.” Her paper, “An Empirical Approach to Reverse Payment Settlements,” provides a method for evaluating the competitive implications of these settlements on a case-by-case basis.
Dr. Lisa Cameron is an economist with two decades of experience consulting for attorneys and companies involved in commercial litigation, …
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 hundreds of millions of dollars and other successful resolutions for its clients. The firm serves or has served as Lead Counsel in the In re Capacitors 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 …
Dr. Demperio conducts economic research and analysis in the areas of antitrust, intellectual property economics, commercial damages, public health and policy, and business valuation. In antitrust matters, she has evaluated the competitive effects of mergers and acquisitions, and analyzed antitrust claims and damages in cases involving alleged monopolization and misuses of market power. In addition, Dr. Demperio has analyzed antitrust impact related to class certification. Her project experience in antitrust matters spans a wide variety of industries including agricultural commodities, auto parts, paper, telecommunications, food products, and pharmaceuticals. She has supported clients in matters brought before courts and government authorities in the US, Canada, Australia, and the UK.
Dr. Demperio conducts economic research and analysis in the areas of antitrust, intellectual property economics, commercial damages, public health and …
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About Morgan Lewis & Bockius LLP
Morgan Lewis offers more than 2,000 lawyers, patent agents, benefits advisers, regulatory scientists, and other specialists—in 29 offices across North America, Europe, Asia, and the Middle East. The firm provides comprehensive litigation, corporate, transactional, regulatory, intellectual property, and labor and employment legal services to clients of all sizes—from globally established industry leaders to just-conceived start-ups. For more information about Morgan Lewis or its practices, please visit us online at www.morganlewis.com.
Morgan Lewis’s antitrust and competition practice offers cross-jurisdictional depth that includes many former high-level government officials with insights into enforcement agendas and practices around the world. The firm’s clients benefit from the broad experience of lawyers who regularly practice before antitrust enforcement agencies and courts globally.
About The Brattle Group, Inc.
The Brattle Group provides consulting and expert testimony in economics, finance, and regulation to corporations, law firms, and governments around the world. We are distinguished by our credibility and the clarity of our insights, which arise from the stature of our experts, affiliations with leading international academics and industry specialists, and thoughtful, timely, and transparent work. Our clients value our commitment to providing clear, independent results.
Brattle’s intellectual property group has a proven track record of successful case execution, and has submitted expert reports in over 100 IP matters. Our Principals have expertise in patent infringement damages, theft of trade secrets, contract disputes, and trademark and false advertising. Our collective experience spans a wide range of industries, including medical devices, pharmaceuticals, biologic drugs, computer hardware and software, telecommunications, navigation and location technologies, and consumer products.
About Joseph Saveri Law Firm, Inc
The Joseph Saveri Law Firm, Inc. officially opened for business in June, 2012. Since that time, Joseph Saveri and his growing 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 involving high-tech anti-poaching, price-fixing of titanium dioxide and capacitors, illegal reverse-payment agreements involving the drugs Cipro, Lidoderm and Opana ER, and antitrust cases involving sports and sports leagues. The Joseph Saveri Law Firm represents entrepreneurs, individuals, consumers, small business owners, public officials, and corporations in complex commercial disputes. Since its opening, the Joseph Saveri Law Firm has generated over $600 million in settlements and successful resolutions for its clients.
About NERA Economic Consulting
NERA Economic Consulting (www.nera.com) is a global firm of experts dedicated to applying economic, finance, and quantitative principles to complex business and legal challenges. For over half a century, NERA's economists have been creating strategies, studies, reports, expert testimony, and policy recommendations for government authorities and the world's leading law firms and corporations. We bring academic rigor, objectivity, and real world industry experience to bear on issues arising from competition, regulation, public policy, strategy, finance, and litigation.
NERA's clients value our ability to apply and communicate state-of-the-art approaches clearly and convincingly, our commitment to deliver unbiased findings, and our reputation for quality and independence. Our clients rely on the integrity and skills of our unparalleled team of economists and other experts backed by the resources and reliability of one of the world's largest economic consultancies. With its main office in New York City, NERA serves clients from more than 25 offices across North America, Europe, and Asia Pacific.