Patent Settlement Agreements: Impacts on Antitrust Enforcement – A 2016 Outlook
Patent and antitrust issues are expected to affect the pharmaceutical industry this year. In particular, reverse payments in drug patent litigation settlements remain to be a hot issue. Reverse payment or pay-for-delay patent litigation settlements usually involve agreement between a branded drug company and a generic drug company to keep the generic off the market. In FTC v. Actavis Inc., the Supreme Court dealt with the antitrust implications of "reverse payment" settlements under the Hatch-Waxman Act. The Court held that large and unjustified payments made by the patent holder to the generic company accused of infringement to settle litigation will be subjected to antitrust scrutiny under the rule of reason. However, the Actavis decision has left many unanswered questions.
This CLE course offers a 2016 outlook on the current issues relating to patent settlement agreements and their impact on antitrust enforcement. Speakers will also share helpful approaches when entering into settlements involving competitors to avoid antitrust issues.
In a two-hour LIVE Webcast, the speakers will discuss:
- Patent Settlement Concerns
- Overview of Antitrust Laws
- Anticompetitive Issues
- Actavis Opinion: Guidance and Ambiguity
- Economists’ Approaches to Evaluating “Reverse Payments”
- Application and Interpretation of Actavis Decision in Lower Courts
- Recent FTC Actions
- Insights on Recent Cases
Lauren K. Peay, Attorney
Federal Trade Commission, Health Care Division
FTC v. Actavis – Basic framework and the FTC’s approach
- Brief overview of the Supreme Court’s decision in FTC v. Actavis
- Current state of play in the courts
- Recent developments and what’s next for the FTC
Brian Ellman, Vice President
Analysis Group, Inc.
- Static versus dynamic perspectives of consumer surplus
- Differential costs (and opportunities) of patent litigation for brands and generics, and the motivation for settlement
- Valuing contemporaneous business agreements
Zoya Marriott, Principal
- Risk aversion as a potential explanation for a reverse payment settlement
- Impact of litigation uncertainty on business decisions of biopharmaceutical companies
- Can we rely on stock price reaction to judge the anti-competitiveness of a reverse payment settlement?
Professor Daryl Lim, Associate Professor and Director, Center for Intellectual Property, Information Technology & Privacy Law
John Marshall Law School
- The implications of Actavis for patent misuse
- Product hopping and Schneiderman
- No AG agreements and King Drug
David Blackburn, Vice President
NERA Economic Consulting
Red flags in Patent Settlement Agreements:
- Patent Strength and No Authorized Generic Agreements
- Differences in US and EU views of PSAs
Who Should Attend:
- Antitrust Lawyers
- IP Attorneys & Related Consultants
- Patent Owners
- Compliance Program Directors
- Compliance and Risk Professionals
- Senior Counsel
- In-house Counsel
- Senior Executives
- Board of Directors
- Pharmaceutical Companies
- Other Related/Interested Professionals or Organizations
Lauren Peay is a staff attorney in the Federal Trade Commission’s Health Care Division in Washington, D.C. She investigates and litigates anticompetitive conduct cases in the pharmaceutical industry. Prior to joining the FTC in 2014, Lauren was in private practice at Arnold & Porter LLP, where her practice included civil antitrust litigation and government investigations. Lauren is a graduate of Vanderbilt University Law School, where she served as a managing editor of the Vanderbilt Law Review. She earned her bachelor’s degree from Washington & Lee University.
Lauren Peay is a staff attorney in the Federal Trade Commission’s Health Care Division in Washington, D.C. She investigates and …
Mr. Ellman specializes in the application of microeconomics, statistics, and finance to complex commercial litigations and government investigations involving antitrust and competition, intellectual property, drug safety and product liability, and general damages issues. He has conducted market analyses and assessments of the competitive effects in major antitrust matters, including those pertaining to patent settlement agreements, generic product entry, and actual and proposed mergers. Mr. Ellman has also conducted statistical analysis, market research, and other economic analysis to evaluate the appropriateness of class certification in antitrust and commercial disputes, as well as to assess liability and damages. His case work has spanned a wide range of industries, including pharmaceuticals and managed health care, retail and consumer packaged goods, information technology, and financial services. He has authored articles on assessing the effects of most-favored-nation clauses, the evolving standards of class certification in antitrust cases, the appropriate analysis and interpretation of post-marketing surveillance data in product liability cases, and the use of average wholesale price in antitrust matters.
Mr. Ellman specializes in the application of microeconomics, statistics, and finance to complex commercial litigations and government investigations involving antitrust …
Zoya Marriott is a principal in the Boston office of Cornerstone Research. Dr. Marriott holds a Ph.D. in economics from Boston University. She has extensive experience in litigation matters in the life sciences industry, with an emphasis on antitrust, intellectual property, reimbursement, off-label marketing, and breach of contract issues. Dr. Marriott has testified at deposition and trial as an economic expert regarding commercial success issues in Hatch-Waxman litigation. She has published articles that examine the impact of generic entry for prescription drugs on consumer welfare and the link between stock price reactions to announcements of patent settlements and the alleged anticompetitive nature of those settlements. In addition to her life sciences industry experience, she has addressed intellectual property, antitrust, marketing, and valuation questions in other industries.
Zoya Marriott is a principal in the Boston office of Cornerstone Research. Dr. Marriott holds a Ph.D. in economics from …
Daryl Lim is the Director of the Center for Intellectual Property (IP), Information Technology & Privacy Law. He teaches courses in IP law as well as antitrust law. Professor Lim is a peer reviewer for the Max Planck Institute's International Review of IP and Competition Law (IIC), one of about thirty reviewers worldwide in recognition of his "knowledge and skill in the field." He is also a peer reviewer for The Yale Law Journal, the Hong Kong University Press, and Cambridge University Press. Professor Lim's book, Patent Misuse and Antitrust: Empirical, Doctrinal and Policy Perspectives was published by Edward Elgar Publishing in 2013. The book has been highly praised among patent and antitrust experts internationally.
Daryl Lim is the Director of the Center for Intellectual Property (IP), Information Technology & Privacy Law. He teaches courses …
David Blackburn is a Vice President with NERA Economic Consulting. Dr. Blackburn's areas of expertise include intellectual property, antitrust and competition policy, and econometric analysis. In his IP practice, he conducts research and prepares expert reports for patent, trademark, and copyright infringement disputes, and false and misleading advertising cases. Dr. Blackburn regularly conducts analyses related to the issues of commercial success and preliminary and permanent injunctions in both Inter Partes Review and Abbreviated New Drug Application proceedings pursuant to the Hatch-Waxman Act.
In his antitrust and commercial damages practices, he has assessed liability and damages in disputes related to tying, price discrimination, monopolization, and breaches of contract, among others. He has also assessed the competitive effects of mergers and acquisitions, as well as issues relating to impact and damages in class action litigation.
David Blackburn is a Vice President with NERA Economic Consulting. Dr. Blackburn's areas of expertise include intellectual property, antitrust and …
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Federal Trade Commission, Health Care Division
About Federal Trade Commission, Health Care Division
About Analysis Group, Inc.
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 Cornerstone Research
Cornerstone Research provides economic and financial consulting and expert testimony in all phases of complex litigation and regulatory proceedings. The firm works with an extensive network of prominent faculty and industry practitioners to identify the best-qualified expert for each assignment. Cornerstone Research has earned a reputation for consistent high quality and effectiveness by delivering rigorous, state-of-the-art analysis for over twenty-five years. The firm has six hundred staff and offices in Boston, Chicago, London, Los Angeles, Menlo Park, New York, San Francisco, and Washington.
About John Marshall Law School
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 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. With its main office in New York City, NERA serves clients from more than 25 offices across North America, Europe, and Asia Pacific.