Antitrust Enforcement for Pay-For-Delay Settlements: U.S. and E.U. Perspective
Reverse payment settlements, also referred to as pay-for-delay agreements, describe a settlement of patent infringement litigation between a branded pharmaceutical company and generic in which payment is received by the generic from the branded pharmaceutical company. In typical patent infringement litigation settlement, the alleged infringer pays the patent holder. In a reverse payment settlement, the reverse occurs.
In recent years, these agreements have caused considerable argument within the pharma industry of both the United States and the European Union. Antitrust agencies and courts have come to conflicting conclusions regarding the agreements’ conformity with competition rules.
The question agencies and courts seek to answer is whether a reverse payment settlement includes payment by the incumbent firm to keep a competitor out of the market (pay for delay) or compensation that is competitively benign. Since the Supreme Court’s decision in Actavis, district courts have been attempting to follow a rule-of-reason approach described by the decision. However, considerable disagreement persists about what aspects of these settlements may demonstrate that a deal is anticompetitive or not.
In this LIVE Webcast, a notable panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the fundamentals as well as recent developments in this dynamics area of antitrust enforcement.
Key topics include:
- Reverse Payment Settlements – A Legal Primer
- “By Object” Vs. “By Effect” Infringements
- Recent Challenges of Patent Settlements
- Identifying and Mitigating Risks
- Antitrust Enforcement Priorities
- Reverse Payment Agreements: Costs and Damages
- Role of No Authorized Generic Clauses and Ancillary Agreements
- Recent Legal Issues and Insights
Megan Browdie, Attorney
- What is a reverse payment?
- Counseling ideas
- Payments for litigation costs
Stephanie Demperio, Ph.D., Senior Consultant
NERA Economic Consulting
- From the economic standpoint, it is a mistake to categorize all reverse payments as illegal per se; Actavis’ primary finding that cases must be based on rule of reason is correct.
- Some settlements would not be possible without a payment for many different reasons; such settlements may be procompetitive and prohibiting procompetitive settlements leads to welfare loss
- The first step in a rule of reason analysis is to determine whether the defendant has/had market power
- When assessing whether an agreement is anticompetitive, one must consider which benchmark is reasonable (i.e., anticompetitive compared to what?)
- A large reverse payment not necessarily indicative of anticompetitive conduct
Ted Davis, Vice President
Analysis Group, Inc.
- Hatch-Waxman and the balance of incentives
- How large is large - measuring the size of the payment in practice
- Patent strength – the elephant in the room
- Relationship between “payment” and the negotiated entry date
Cleve B. Tyler, PhD, Director
Berkeley Research Group, LLC
- No-AG settlements - Address the Economics of Settlements including the promise of no-Authorized Generic (no-AG settlements)
- Exclusive licensing perspective of no-AG deals
- Would the Branded Manufacturer have not introduced an AG but for the settlement?
- No-AG provisions part of a broader analysis
- Broader implications for patent settlements
David Blackburn, Vice President
NERA Economic Consulting
- Talk about things in these deals that are red flags.
- Parallels in product hopping issues and cases.
David Hull, Partner
Van Bael & Bellis
- EU Perspective
Who Should Attend:
- Patent and Pharma Attorneys
- Patent Licensing Attorneys
- Patent Holders and Infringers
- Executives from Pharmaceutical Companies
- Patent Litigators
- Drug Manufacturing Executives
- Drug and Pharmaceutical Companies
- Other Related/Interested Professionals and Organizations
Dr. Blackburn’s areas of expertise include intellectual property, antitrust and competition policy, and econometric analysis. In his IP practice, he has conducted research and prepared expert reports for patent, trademark, and copyright infringement disputes and as well as conducted analyses related to the issues of commercial success in Hatch-Waxman proceedings. In his antitrust and commercial damages practices, he has assessed liability and damages in disputes related to, for example, tying, price discrimination, monopolization, and breaches of contract. He has also assessed the competitive effects of mergers and acquisitions. Dr. Blackburn has written and spoken publically on a number of these issues.
In both his antitrust and IP practices, Dr. Blackburn’s experience covers a variety of industries, including the pharmaceutical industry, media (music, television and film) computer software, medical devices, industrial goods and chemicals, and consumer products, among others.
Dr. Blackburn’s areas of expertise include intellectual property, antitrust and competition policy, and econometric analysis. In his IP practice, he …
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 predatory pricing practices. 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 …
Andreas Reindl is of counsel at Van Bael & Bellis. Andreas previously served as Director of the Fordham Competition Law Institute at Fordham Law School, New York, and as a Principal Administrator at the OECD's Competition Division. Prior to joining the OECD, Andreas worked for several years for a major international law firm in Brussels and Washington, DC.
Andreas has held many teaching posts. He has taught U.S. antitrust law, European competition law, intellectual property law and EU law at the University of Michigan Law School, and at Fordham Law School, New York, as well as in Europe. Andreas has published widely on antitrust law and intellectual property law.
Andreas Reindl is of counsel at Van Bael & Bellis. Andreas previously served as Director of the Fordham Competition Law …
Analysis Group Vice President Ted Davis specializes in the application of financial economics and data analysis to litigation and other complex business situations. His research has investigated issues related to intellectual property and patents, antitrust law, industrial organization, asset prices and financial market infrastructure. He is a CFA (Chartered Financial Analyst) charterholder.
Mr. Davis has managed case teams and supported testifying experts through all phases of complex business litigation, including fact and expert discovery, class certification, liability and damages, and trial. Mr. Davis has supported testifying experts in a variety of cases related to pharmaceutical markets, including antitrust cases involving allegations of delayed generic entry and settlements of patent litigation between brand and generic manufacturers.
Analysis Group Vice President Ted Davis specializes in the application of financial economics and data analysis to litigation and other …
Megan Browdie is an associate in Cooley's Antitrust & Competition practice group. She advises clients on antitrust issues, including with respect to mergers and acquisitions, antitrust issues related to intellectual property, patent pooling, and pricing and distribution. She has experience in matters before the Department of Justice, Federal Trade Commission, and state attorneys general, as well as in federal court. Megan has worked with clients in a number of industries, including pharmaceuticals, biotechnology, software, computer hardware, e-commerce, and telecommunications.
Megan is active in the antitrust bar, where she serves as the Young Lawyer Representative to the ABA Antitrust Section’s Mergers and Acquisitions Committee. Megan is recognized by Super Lawyers and LMG’s Expert Guides as a “Rising Star” in antitrust.
Megan Browdie is an associate in Cooley's Antitrust & Competition practice group. She advises clients on antitrust issues, including with …
Cleve B. Tyler is a Director in Berkeley Research Group’s Washington, DC office. He has analyzed competition, intellectual property, and damages issues in matters that are before federal and state courts, administrative law judges, and regulatory commissions, and in merger investigations. Dr. Tyler’s work includes evaluation of market definition and competitive effects using regression analysis and economic modeling. He has evaluated horizontal and vertical competition issues in many industries. Dr. Tyler has evaluated the antitrust implications of reverse payment settlements between branded and generic pharmaceutical companies under Hatch-Waxman regulations.
Dr. Tyler holds a PhD in economics specializing in industrial organization, finance, and public sector. He is an Adjunct Professor of Economics at Johns Hopkins University, taught economics at Clemson University, has published and made presentations on competition and damages issues, and is Editor of BRG Review.
Cleve B. Tyler is a Director in Berkeley Research Group’s Washington, DC office. He has analyzed competition, intellectual property, and …
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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.
About Van Bael & Bellis
Van Bael & Bellis is one of the largest leading independent law firms based in Brussels. Established in 1986, the firm houses a multinational team of lawyers who regularly advise a diverse group of clients ranging from multinational corporations and government bodies to international trade associations and global law firms.
With two of the largest teams in Brussels working in EU competition and international trade law, the firm is well known and highly regarded by all legal directories for its extensive expertise and deep partner-level experience. The firm also advises on EU regulatory matters and Belgian business law.
With nearly 70 lawyers coming from 20 different countries, Van Bael & Bellis offers clients the support of a highly effective team of professionals with multi-jurisdictional expertise and an international perspective.
About Analysis Group
Since 1981, Analysis Group has provided expertise in economics, finance, health care analytics, and strategy to top law firms, Fortune 500 companies, global health care corporations, and government agencies. Our work is grounded in a collaborative approach that allows us to effectively integrate the best ideas from leading academic and industry experts with our more than 600 professionals. As a result, our clients receive thoughtful, pragmatic solutions to their most challenging business and litigation problems. Through our work in thousands of cases across multiple industries, we have become one of the largest economics consulting firms in North America, with 11 offices in the United States, Canada, and China.
About Cooley LLP
Cooley’s attorneys solve legal issues for entrepreneurs, investors, financial institutions and established companies. Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law. Cooley has 900 lawyers across 12 offices in the United States, China and Europe. Cooley's antitrust & competition team is recognized as one of the top-tier practices in the area of antitrust by Legal 500, Chambers USA and Global Competition Review. We handle all aspects of antitrust and competition law matters – including counseling, litigation, agency representation and arbitration services – for Fortune 500 corporations, as well as growing companies.
About Berkeley Research Group, LLC
Berkeley Research Group is a leading global strategic advisory and expert consulting firm that provides independent advice, data analytics, authoritative studies, expert testimony, investigations, and regulatory and dispute consulting to Fortune 500 corporations, financial institutions, government agencies, major law firms, and regulatory bodies around the world. BRG experts and consultants combine intellectual rigor with practical, real-world experience and an in-depth understanding of industries and markets. Their expertise spans economics and finance, data analytics and statistics, and public policy in many of the major sectors of our economy, including healthcare, banking, information technology, energy, construction, and real estate. BRG is headquartered in Emeryville, California, with offices across the United States and in Asia, Australia, Canada, Latin America, the Middle East, and the United Kingdom.